Patient Global Impression Of Improvement Research Articles

Quality of Life after Treatment for Pelvic Organ Prolapse in Real-World Study: Recommendations, Vaginal Pessary, and Surgery.

Background and Objectives: Pelvic organ prolapse (POP) is a common condition in women, with its prevalence increasing with age, and can significantly impact the quality of life (QOL) of many individuals. The objective of this study was to assess the overall improvement, quality of life, and continuation of primary treatment for POP over a 24-month period in a real-world setting. Materials and Methods: This is a prospective, observational, follow-up study of women with symptomatic POP who, as a primary treatment, opted for recommendations (lifestyle changes and pelvic floor muscle training), pessary therapy, or surgery. The primary outcome measure was a subjective improvement at the 24-month follow-up, measured with the Patient Global Impression of Improvement (PGI-I) scale. Secondary outcome measures were the continuation rate of the primary treatment method, reason for discontinuation, and the quality of life evaluated with the P-QoL questionnaire. Results: We included 137 women, with 45 women (32.8%) in the recommendations group, 39 (28.5%) in the pessary group, and 53 women (38.7%) in the surgery group. After 24 months, surgery, in comparison with pessary treatment and recommendations, resulted in significantly more women reporting a subjective improvement: 89.6%, 66.7%, and 22.9% (p < 0.001), respectively. Overall, 52% of women from the recommendations group and 36.4% from the pessary group switched to another treatment or discontinued the primary treatment within 24 months. However, women who continued the primary treatment, pessary use, and surgery showed similar subjective improvements (90.5% and 89.6%, respectively) and quality-of-life improvement. Conclusions: The chance of significant improvement was higher following surgery. However, after 24 months, both vaginal pessaries and surgery showed an important quality-of life improvement and can be proposed as primary treatment methods for pelvic organ prolapse.

How Old Is Too Old? Outcomes of Prolapse Native-Tissue Repair through Uterosacral Suspension in Octogenarians.

Medical advancements are expected to lead to a substantial increase in the population of women aged 80 and older by 2050. Consequently, a significant number of individuals undergoing corrective prolapse surgery will fall into the elderly-patient category. The research indicates a notable rise in complications associated with prolapse surgery in patients older than 80, irrespective of frailty and other risk factors. Despite these challenges, the vaginal approach has been identified as the safest surgical method for pelvic organ prolapse (POP) repair in the elderly population. For this reason, we aimed to investigate the efficacy, complication rate, and functional outcomes associated with vaginal hysterectomy and an apical suspension/high uterosacral ligaments suspension as a primary technique for prolapse repair, both within a cohort of elderly patients. We retrospectively analyzed patients who underwent transvaginal hysterectomy plus an apical suspension procedure for stage ≥ II and symptomatic genital prolapse between January 2006 and December 2013. Anatomical and functional outcomes were evaluated. The Patient Global Impression of Improvement (PGI-I) score was used to evaluate subjective satisfaction after surgery. Sixty-five patients were included in the analysis. The median age was 81.3 years. All individuals exhibited an anterior compartment prolapse stage II or higher, and the majority also a central prolapse stage II or higher. Notably, all participants reported symptoms of vaginal bulging. Over half of the population (58.6%) complained of incomplete bladder emptying. The intervention for all participants involved a vaginal hysterectomy with an apical suspension. Sixty-three patients (96.9%) and forty-four patients (67.6%) underwent a simultaneous anterior or posterior repair, respectively. Long-term complications (>30 days from surgery) were observed during follow-up, with a median duration of 23 ± 20 months. Seven (10.7%) anatomical recurrences were recorded, five (7.69%) concerning the anterior compartment, one (1.5%) the central, and three (4.6%) the posterior. Nevertheless, none of them necessitated further surgical intervention due to symptoms. Significant anatomical improvements for the anterior, central, and posterior compartments were noticed, compared to preoperative assessment (p < 0.001 for Aa and Ba, p < 0.001 for Ap and Bp, and p < 0.001 for C). PGI-I values established that 100% of patients were satisfied (PGI-I ≥ 2), with a median score of 1.12. Consequently, objective and subjective cure rates were 89.5% and 100%, respectively. Vaginal hysterectomy combined with apical suspension, particularly high uterosacral ligaments suspension, is a safe and effective primary surgical approach, even in elderly patients.

Long-Term Outcomes of the Altis® Single-Incision Sling: Up to 10 Years' Follow-up.

Single-incision slings (SIS) have emerged as a less invasive alternative to conventional slings for stress urinary incontinence (SUI) treatment. However, long-term efficacy and safety results remain uncertain owing to a lack of studies. A retrospective review of 155 patients treated with Altis® for SUI between February 2012 and June 2017, held in 2022, as a continuation of a prospective study in which all patients (197) were reviewed for 2 years after surgery (1, 6, 12, and 24months). Preoperative demographic data, comorbidities, and pressure-flow studies were also recorded. Continence status and satisfaction rates were assessed using the International Consultation on Incontinence Questionnaire-short form (ICIQ-SF) and the Patient Global Impression of Improvement (PGI-I) respectively. The assessment in the 2022 retrospective review was performed via a telephone survey. Mean follow-up time after surgery was 85.3months (82.5-88.1). In 2022, complete continence was present in 75.4% of the patients. The presence of urinary urgency conditioned the ICIQ-SF score (10.9 vs 1.7 points, p < 0.01), with the ICIQ-SF = 0 in 84.5% of the patients with no associated urgency. Satisfaction assessed by the PGI-I was high, with 84.6% of the patients showing improvement. De novo urgency was present in 37,9% of the patients by 2022. Urinary tract infections were the most frequent complication (9.7%), with only 5 documented cases of mesh erosion. Altis® SIS is a safe and effective device for SUI treatment, with satisfaction rates comparable with those of the conventional slings. Persistence or development of urinary urgency influences the results.

Transcutaneous tibial nerve stimulation in patients with multiple sclerosis and overactive bladder: a real-life clinical and urodynamic assessment.

The aims of the present study were to assess the effectiveness of transcutaneous tibial nerve stimulation (TTNS) on overactive bladder (OAB) symptoms and on urodynamic parameters in patients with multiple sclerosis (PwMS) and to seek predictive factors of satisfaction. All PwMS who performed 12-24weeks of TTNS and who underwent urodynamic assessment before and after treatment between June 2020 and October 2022 were included retrospectively. Data collected were bladder diaries, symptoms assessed with Urinary Symptoms Profile (USP), and urodynamic parameters (bladder sensations, detrusor overactivity, and voiding phase). Patients with improvement rated as very good or good on Patient Global Impression of Improvement (PGI-I) score were considered as responders. Eighty-two patients were included (mean age: 47.1 ± 11.5years, 67 (82%) were women). The mean USP OAB sub-score decreased from 7.7 ± 3.5 to 6.0 ± 3.4 (p < 0.0001). On bladder diaries, voided volumes, void frequency, and the proportion of micturition done at urgent need to void significantly improved with TTNS (p < 0.05). No significant change was found in urodynamic parameters. According to the PGI-I, 34 (42.5%) patients were good responders. The only parameter associated with higher satisfaction was the percentage of micturition done at urgent need to void before the initiation of the treatment (39.8% ± 30.5 in the responder group vs 25.1% ± 25.6 in the low/no responder group; p = 0.04). TTNS improves OAB symptoms in PwMS, without significant changes on urodynamics. A high rate of strong or urgent need to void in daily life was associated with higher satisfaction.

Pilot Study of a Digital Behavioral Therapy for Overactive Bladder in Women.

The burden and high prevalence of overactive bladder (OAB) underline the urgent need for effective treatment. This study provides an initial look at an alternative approach to behavioral therapy for overactive bladder (OAB) that is delivered as an app on a smartphone. This study aimed to investigate feasibility, acceptability, and preliminary efficacy of a digital therapeutic for OAB. This was a multicentered prospective pilot study. We used a convenience sample (N = 30) from waiting lists of women referred for incontinence, excluding urinary tract infections, urinary retention, bladder pain syndrome, pelvic cancer, current pregnancy, kidney disease, dementia, stroke, and prior neuromodulation. The intervention, a smartphone app, provided an 8-week program with weekly modules combining evidence-based knowledge videos and skill-building exercises that incorporated behavioral therapy, cognitive behavioral therapy, pelvic muscle training, and general health information. Combined scores on the International Consultation on Incontinence Questionnaire was the primary outcome measure. Secondary outcomes included improvement in quality of life, based on International Consultation on Incontinence Questionnaire, a 72-hour urinary diary, and Patient Global Impression of Improvement. We evaluated usability with the Mobile Application Rating Scale. Statistical tests included Shapiro-Wilk tests and paired-sample t tests. Overall, 100% of participants reported a reduction in their OAB symptoms and 82% reported an improvement in quality of life. There was a significant improvement in diary parameters, including frequency (10.19-6.71 a day: SD, 1.25; P = 0.017) and incontinence (10-3.57: SD, 4.58). Participants rated the app highly on functionality, and 70% would recommend it. Patient Global Impression of Improvement improved for 72% of participants. This study supports the application of a digital platform to over-come the real-world barriers for first-line treatment for OAB and offers information to inform further evaluation of the safety and efficacy of the NUIG OAB App.

Mid- to long-term results of Polyacrylamide Hydrogel (Bulkamid®) as recourse for female stress urinary incontinence

Aim:We aimed to assess the mid- to long-term outcome of Polyacrylamide Hydrogel urethral injections as a treatment for women with stress urinary incontinence (SUI), who are not eligible for treatment with midurethral slings. Methods:We performed a single-arm, patient cohort study using the subjective improvement rate as primary outcome, defined as an answer “(very) much better” on the Patient Global Impression of Improvement. Secondary outcomes were the subjective cure rate (a negative answer to the Urogenital Distress Inventory stress subscale question 4), patient satisfaction (Visual Analogue Scale of ≥ 8.0), complication rate, the amount of Hydrogel injected, the number of reinjections and to what extent patients would recommend this treatment. Results:A total of 357 women with pure SUI, or mixed urinary incontinence with predominant SUI were included. Adverse events were retrieved from their patient records and all received a questionnaire, which was completed and returned by 153 (42.9%) women. After a median follow-up of two and a half years, the subjective improvement rate was 52.1%. The subjective cure rate was 30.9%. A satisfaction score of ≥ 8.0 was achieved in 48.6% of the patient group. Minor adverse events due to the procedure were reported in 21% of patients. No serious adverse events were noted. Conclusions:This study demonstrates that Polyacrylamide Hydrogel, even after a mid- to long-term follow-up, is a valuable treatment option for women with SUI, who are ineligible for midurethral sling surgery. No serious adverse events related to the procedure were reported during the follow-up period.

The Impact of Preoperative Pain on Outcomes After Vaginal Reconstructive Surgery and Perioperative Pelvic Floor Muscle Training

ABSTRACT In the United States, around 9 million women are affected by pelvic pain due to conditions such as interstitial cystitis/bladder syndrome, fibromyalgia, pelvic floor myalgias, chronic opioid use, or irritable bowel syndrome. Treatment options for concurrent pelvic floor disorders and pelvic pain can prove challenging due to the overall desire to avoid exacerbating overall pain while optimizing pelvic floor symptoms. The primary aim of this study was to compare both perioperative pelvic muscle training and vaginal reconstructive surgery among women who experienced or lacked preoperative pain and to inform better approaches to management of women with preoperative pain. The study was a secondary analysis of the Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) randomized clinical trial, as performed via the Pelvic Floor Disorders network. The main study's design was a 2 × 2 randomized factorial design with a surgical intervention and a perioperative behavioral intervention. The Eunice Kennedy Shriver National Institute of Child Health and Development data and specimen hub provided the data for this study. Included were 374 women undergoing surgery for both stress urinary incontinence and stage 2–4 pelvic organ prolapse from 2008 to 2013. All participants underwent vaginal prolapse repair and midurethral sling, and were randomized to either perioperative pelvic muscle therapy or usual care. The Pain scale, the Pelvic Floor Impact Questionnaire, the Pelvic Floor Distress Inventory, and the Patient Global Impression of Improvement were all completed by patients at baseline and repeated through month 24. The OPTIMAL trial had a primary outcome of surgical success as defined by anatomical success, but the primary outcome of this secondary analysis was a change in pain scale scores over 24 months after surgery. Three hundred seventy-four women participated in the original trial, with 368 in this secondary analysis. One hundred nine of the 368 women reported preoperative pain. Women with pelvic pain were more likely to be Hispanic, but there were no differences in surgical procedures performed, hospital stay, complications (ie, bladder injury, suture exposure, etc), or estimated blood loss in women with and without pelvic pain. Women with preoperative pain experienced greater pain at all time points, but also exhibited greater pain improvement at 24 months after surgery. Women with preoperative pain had worse baseline pelvic floor symptoms than those without pain. Although women with pain and women without pain had improvements in distress symptoms measured with the Pelvic Floor Distress Inventory, women with pain saw a greater improvement after surgery. All distress subscales improved significantly more in women with pain than women without pain. One additional interesting finding was that women randomized to sacrospinous suspension and pelvic muscle therapy had greater improvements in postoperative pain than those randomized to usual care. Notably, rates of surgical anatomic success and extent of Patient Global Impression of Improvement were not different between women with and without pain. Strengths of the study include its design as a secondary analysis of a large prospective multicenter randomized controlled trial. A substantial proportion of participants reported at least moderate pain at baseline but were not selected based on preoperative pain. Women in the trial were randomized to types of vaginal reconstructive surgery and pelvic muscle training, which allowed the authors to draw conclusions in categories of physical therapy treatments and surgeries for women with and without preoperative pain. Limitations of the study include a lack of preoperative pain data, pain diagnoses, and participant medications in the OPTIMAL trial. Furthermore, the study used no validated pain scale and was limited by OPTIMAL trial data collection intervals. Thankfully, data collected at numerous points over 24 months in some regard accounted for pain symptoms over time. The study found that, for patients with preoperative pain, significant improvement in pelvic floor symptoms and pain takes place after vaginal reconstructive surgery. Similar postoperative improvement rates were found. In addition, perioperative pelvic floor muscle training may be beneficial for patients with planned sacrospinous ligament fixation.

Effects of electroacupuncture on chronic urinary retention after pelvic or lumbosacral tumor resection surgeries: a retrospective cohort study.

Chronic urinary retention (CUR) resulting from lower motor neuron lesions (LMNL) is a medical condition secondary to pelvic or lumbosacral tumor resection surgeries. Electroacupuncture (EA) is proved to be effective and safe in treating certain lower urinary tract disorders. However, the clinical benefit and optimal duration of EA treatment for CUR following LMNL remain unknown. Using a retrospective cohort design, 20 eligible patients diagnosed with CUR resulting from LMNL secondary to pelvic or lumbosacral tumor resection surgeries were included from March 1, 2017, to June 30, 2020. The patients were treated by EA three times a week for 2 to 12 weeks and followed up for 24 weeks after treatment. The electric stimulators with a 5-Hz continuous wave (5-10 mA intensity) were separately connected to bilateral Ciliao (BL32), bilateral Zhongliao (BL33), and bilateral Huiyang (BL35), and stimulators with a 10-Hz continuous wave (1-2 mA intensity) were connected to bilateral Sanyinjiao (SP6). Current intensity was adjusted according to the patients' individual tolerance. The median follow-up was 32 weeks (range, 26-36 weeks). Responders were defined as patients whose post-void residuals (PVR) reduced by 50% or more from baseline. Adverse event was recorded. Totally 20 patients [mean (standard deviation) age, 48.1 (15.5) years; 9 men (45.0%); 11 women (55.0%)] were included. Of the 20 patients, 14 (70.0%) had responded to EA treatment and stopped catheterization for achieving satisfactory spontaneous urination (PVR <100 mL without complications), 7 (35.0%) had complete resolution (90-100% reduction in PVR from baseline), and 13 (65.0%) scored 1 (much better) or 2 (moderately better) in the Patient Global Impression of Improvement (PGI-I) assessment. Moreover, 6 (30.0%) patients had responded within 4 weeks of EA treatment. According to Kaplan-Meier survival curve, we found that more than 50% patients could respond to EA treatment within 8 weeks or longer. None of the responders had ever experienced relapse in 24 weeks after EA treatment ended. None of the patients manifested urinary tract infection (UTI), newly diagnosed hydroureter or hydronephrosis. One patient diagnosed with hydronephrosis at baseline recovered after 12-week EA treatment. Two patients with UTI at baseline were prescribed antibiotics and did not present UTI again during the follow-up. EA could be a promising treatment option for CUR caused by LMNL following pelvic or lumbosacral tumor resection surgeries, with long-term effects and a good safety profile. The optimal duration of EA should be of 8 weeks at least. But this was a retrospective cohort study of a small sample size, so future studies are needed to investigate EA in larger populations in randomized controlled trials.

Rehabilitation combined with dietary intervention improve urinary incontinence in women with obesity: A proof-of-principle study.

This study aimed to assess the impact of add-on pelvic floor exercises on a weight management rehabilitation program. This proof of principle study was conducted between July 2019 and December 2019. Ninety-three adult female inpatients with obesity and diagnosis of urinary incontinence (UI) were assessed for inclusion, and the suitable patients were randomly assigned to the experimental group and the control group. Both groups underwent a weight management rehabilitation program, while the experimental group also performed pelvic floor exercises. The primary outcome was UI severity, assessed by the 1-h pad test. Secondary outcomes were urinary symptoms, assessed by the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), Patient Global Impression of Improvement (PGI-I), and Incontinence Quality of Life Questionnaire (I-QOL). Sixty female inpatients were randomly assigned to the experimental group [n=30; median age: 64.50 (51.25 to 70.50) years] or the control group [n=30; median age: 67.50 (58.50 to 74.75) years]. The experimental group showed a statistically significant reduction in UI severity [pad test: 2.08 (1.21 to 8.85) g vs. 0.54 (0.24 to 1.13) g, p<0.01; ICIQ-SF: 14.00 (10.25 to 17.00) vs. 8.00 (6.25 to 11.75), p<0.01; I-QOL: 56.37 (42.28 to 73.64) vs. 78.64 (64.32 to 90.68), p<0.01]. Statistically significant differences were found in the between-groups analysis [pad test: 0.54 (0.24 to 1.13) g vs. 1.08 (0.83 to 3.86) g, p<0.01; ICIQ-SF: 8.00 (6.25 to 11.75) vs. 12.00 (10.00 to 16.00), p<0.01; I-QOL: 78.64 (64.32 to 90.68) vs. 68.18 (60.00 to 84.32), p<0.01]. Including pelvic floor exercises might provide additional benefits compared to standard rehabilitation in reducing UI symptoms in obese women.

Efficacy and safety of transvaginal mesh repair in a cohort with a minimum of 10-year follow-up.

Although transvaginal mesh (TVM) repair is no longer used in some countries, long-term outcomes after TVM surgery are of great importance globally. However, reports with follow-up >10 years are limited. Thus, this study aimed to report outcomes in a prospective cohort with at least 10 years of follow-up. Women with stage III-IV symptomatic prolapse were approached consecutively from 2008 to 2013 at one tertiary hospital. The main outcome measure was symptomatic failure. Secondary outcomes included anatomic failure, recurrence, patient satisfaction, complications, and reoperation. The Kaplan-Meier curve was used to estimate the cumulative failure rate. Of the 121 patients enrolled in the study, 103 (85.1%) completed a median follow-up of 11 years. The estimated probability rates of symptomatic and anatomic failure were 17.6% and 8.8% in 11 years, respectively. The estimated incidence of symptomatic failure increased by 8.2% between 5 and 11 years; however, the corresponding rate for anatomic failure was 3.7%. The most common complication was vaginal mesh exposure, and its estimated probability increased from 19.3% to 28.4% from 5 to 11 years, respectively. Office trimming resolved 80.0% of vaginal exposures. These patients did not report decreased overall satisfaction. Patients with vaginal mesh exposure requiring>3 office procedures or mesh removal in the operating room (5.8% by 11 years) had lower satisfaction rates (P<0.01) and were defined as having severe mesh exposure. The rates of postoperative pain, reoperation, and Patient Global Impression of Improvement ⩾2 were 2.5%, 3.3%, and 94.2%, respectively. The results of this study implied that TVM treatment gradually increased the symptomatic failure rate but provided durable anatomical support of the vaginal wall. Vaginal mesh exposure was common in women who were largely not sexually active; however, 80% of the cases could be managed in the outpatient clinic, which did not affect patient satisfaction.

Importance of vaginal packing after laparoscopic sacrocolpopexy - retrospective study.

To compare the subjective and objective results of laparoscopic sacrocolpopexy (LSC) with and without the introduction of a vaginal packing one year after surgery.Methodology:This is a retrospective cohort study of 125 women after laparoscopic sacrocolpopexy operated on in 2013-2016 with complete annual follow-up. Patients with a total hysterectomy were excluded from the study. Basic patient characteristics, preoperative POP-Q and surgery data were collected. The subjectiveoutcome of the surgery was assessed using the PGI-I (patient global impression of improvement). The anatomicoutcome of the surgery was evaluated using the composite definition of surgical failure based on POP-Q (Ba ≥ -1, C ≥ -3, Bp ≥ -1). Patients were divided into two groups according to whether or not they had vaginal packing after surgery. Statistical analysis was performed usingc2, Wilcoxon and Fischer test according to the distribution of normality.Results:A total of 125 women were enrolled in the study; 48 (38.4%) after LSC, 58 (46.4%) with concomitant supracervical hysterectomy and 19 (15.2%) after sacrohysterocolpopexy. Vaginal packing was introduced for 24-48 hours after surgery in 86 (68.8%) women. The groups did not differ in age, body mass index, smoking or preoperative pelvic organ prolapse quantification system. We did not observe statistically significant differences in PGI-I first year after surgery. The difference in anatomic surgical failure did not reach statistical significance, although more failures were observed in the group without packing (12.8 vs. 3.5%; P = 0.09). The mean C-point value one year after surgery was lower in the non-tamponade group (-7 vs. -7.5; P &lt; 0.009). No mesh extrusion or serious complications were recorded in the monitored group.Conclusion:Vaginal packing after LSC probably does not affect patient satisfaction after surgery, however, it may be associated with better anatomicaloutcome one year after the surgery. The results of the study must be confirmed by a more detailed prospective evaluation.

Minimum important difference of the ICIQ-UI SF score after self-management of urinary incontinence

BackgroundThis study aimed to evaluate clinically relevant improvement after conservative self-management of urinary incontinence via a mobile app. It further aimed to establish Minimum Important Differences (MIDs) based on the severity and type of urinary incontinence.MethodsData was collected in a prospective cohort study that evaluated the freely available app Tät®. The app provided pelvic floor muscle training (PFMT) and life-style advice. Non-pregnant, non-postpartum women (≥ 18 years) who downloaded the app to treat urinary incontinence were included, if they completed the Patient Global Impression of Improvement (PGI-I) question at the 3-month follow-up (n = 1,733). Participants answered the International Consultation on Incontinence Questionnaire (ICIQ-UI SF) at baseline and after 3 months. The score change was analysed for correlation (Spearman) with the PGI-I. We then analysed one-way ANOVAs to determine whether there were significant differences between the groups based on the answers to the PGI-I. The MID was set to the mean change of the group that selected the answer “a little better” to the PGI-I question.ResultsThe one-way ANOVA showed significant differences between PGI-I groups (p < 0.001). The MID for the general group was set to 1.46 (95% Confidence Interval [CI] 1.26–1.67). In the sub-group analyses, a MID for the group with slight incontinence could not be determined. For the group with moderate severity the MID was determined to be 1.33 (95% CI 1.10–1.57) and for the severe/very severe group it was 3.58 (95% CI 3.08–4.09). Analysis of different types of incontinence showed no difference in MIDs.ConclusionsThe MID for self-management via a mobile app was lower than previously established MIDs, but differed depending on baseline severity. This study shows that MIDs need adjustment for baseline severity and treatment intensity when interpreting clinical trial results. If using MIDs as exact numbers, the study population and the treatment must be comparable.

The effectiveness of adjustable trans-obturator male system (ATOMS) in radiated patients is reduced: A propensity score-matched analysis.

This study aimed to compare the effectiveness and safety of the adjustable trans-obturator male system (ATOMS®) to treat post-prostatectomy incontinence (PPI) in radiated patients compared with non-radiated patients, using propensity score-matching analysis to enhance the validity of the comparison. Consecutive men with PPI treated with silicone-covered scrotal port ATOMS (A.M.I., Feldkirch, Austria) in nine different institutions between 2016 and 2022 were included. Preoperative assessment evaluated 24-h pad usage, urethroscopy and urodynamics, if indicated. Propensity score-matching analysis was based on age, length of follow-up, previous PPI treatment, previous bladder neck stricture, androgen deprivation and pad usage. The primary endpoint was dry rate, defined as no pads post-operatively with a security pad allowed. The secondary endpoints were complications, device removal and self-perceived satisfaction with the Patient Global Impression of Improvement (PGI-I) scale. Of the 710 included patients, 342 were matched, and the study groups were balanced for the baseline matched variables. The mean baseline 24-h pad was 4.8 in both groups (p = 0.48). The mean follow-up was 27.5 ± 18.6 months, which was also equivalent between groups (p = 0.36). The primary outcome was achieved in 73 (42.7%) radiated patients and in 115 (67.3%) non-radiated patients (p < 0.0001). The mean pad count at the last follow-up was 1.5 and 0.8, respectively (p < 0.0001). There was no significant difference in complications (p = 0.94), but surgical revision and device explant rates were higher (p = 0.03 and p = 0.01, respectively), and the proportion of patients highly satisfied (PGI-I = 1) was lower in the radiated group (p = 0.01). At sensitivity analysis, the study was found to be reasonably robust to hidden bias. ATOMS implantation significantly outperformed in patients without adjuvant radiation over radiated patients.

(004) Correlations Between Immunohistochemical Staining and Pain-Related Assessments in Patients with Neuroproliferative Vestibulodynia

Abstract Introduction A clinically suspected diagnosis of neuroproliferative vestibulodynia (NPV) can be confirmed by examining immunohistochemical (IHC) staining of excised vestibular specimens. Compared to controls, specimens from NPV patients have been found to contain &amp;gt;8 mast cells per high-power field (HPF) and increased density of nerves. Objective To assess for correlations between patient reported pain-related measures and computer-assisted histometry of excised vestibulectomy specimen IHC staining with CD117 (marker for mast cells) and PGP9.5 (marker for nerves) in a cohort of histopathologically confirmed NPV patients. Methods Patients (n=65) with lifelong or acquired NPV undergoing vestibulectomy had IHC-staining of the vestibular tissue. Tissue sections from the 1:00-11:00 and/or 12:00 regions of the vestibule were examined and high-resolution images were captured using a microscope at 100x and 200x magnification. A minimum of 2 photomicrographs per magnification were taken for each tissue section that included epithelial basement membrane and adjacent subepithelium representative of the majority of immunostained tissue. Fractional area of positive immunostaining of all photomicrographs was determined using computer-assisted histometry by ImageJ. Mean fractional area was determined from 3 separate measurements of each photomicrograph. Correlations were made between density of IHC staining and the following assessments: pain domain of the Female Sexual Function Index (FSFI), the Short Form McGill Pain Questionnaire (SF-MPQ), and cotton-tipped swab testing. We also examined correlations with the Patient Global Impression of Improvement (PGI-I), a treatment response index and indirect assessment of pain. Data were analyzed using Spearman correlations and the Mann-Whitney test. Results While all patients reported high levels of pain, there were no correlations between CD117- or PGP9.5-immunopositive mean fractional area and FSFI pain domain or SF-MPQ scores. There was no difference in immunopositive mean fractional area between lifelong and acquired NPV. A positive correlation between fractional area of CD117 immunostaining in the 1:00-11:00 region of the vestibule and cotton-tipped swab test pain score approached but did not reach statistical significance (r = 0.24, p = 0.063). Fractional area of PGP9.5 immunostaining was negatively correlated with PGI-I scores (r = -0.50, p = 0.006) in the 1:00-11:00 region of the vestibule. Lower PGI-I scores are indicative of greater improvement after surgical intervention. No other correlations were observed between immunostaining and PGI-I or cotton-tipped swab testing scores. Likewise, SF-MPQ domain scores had no correlation to PGI-I or cotton-tipped swab testing. Median cotton-tipped swab testing pain scores were significantly higher (p &amp;lt; 0.001) in patients with lifelong NPV (7.6) compared to those with acquired NPV (5.7). Conclusions The lack of correlations between immunopositive staining and multiple pain-related assessment scores suggests a non-linear threshold for mast cell accumulation and nerve proliferation that produces pain symptoms for all NPV patients. Cotton-tipped swab pain scores were more closely associated with density of CD117 immunostaining, while clinical improvement in pain symptoms was significantly correlated with density of PGP9.5 immunostaining. The fact that patients with lifelong NPV had significantly more pain on cotton-tipped swab testing than the acquired NPV subgroup may be related to duration of the condition. Disclosure No.

(235) Use of Bremelanotide (Vyleesi) in Men with Sexual Dysfunctions

Abstract Introduction Bremelanotide (Vyleesi) is an FDA approved medication for the safe and efficacious treatment of hypoactive sexual desire disorder in premenopausal women, however phase 3 trials revealed it improved arousal and orgasm as well. As a centrally acting drug it was expected to be effective to treat sexual dysfunctions in men and has been prescribed off label routinely in our practice. Objective The primary aim of this study was to evaluate the use of bremelanotide in men with various sexual dysfunctions, the reasons why the medication was prescribed, improvements in sexual function and overall satisfaction, and side effects experienced. Methods This one-group study design involved men from a single clinic with various sexual dysfunctions prescribed bremelanotide beginning May 1, 2021. After signing consent participants answered the Quality of Life (QOL) Dimension of Sexual Quality of Life Questionnaire, the Patient Global Impression of Improvement (PGI-I) and the General Assessment Questions (GAQ) online. After confirming they had used the medication at least twice, participants completed a structured interview over the telephone with a single interviewer. Descriptive statistics were used to characterize the study cohort. Adverse events were collected. Results To date a total of 21 men signed consent and 19 completed the online questionnaires. 80% of these men were more satisfied with their lovemaking and duration of lovemaking; 93% reported vaginal insertion was easier and 71% said it was easier to orgasm. With regard to feelings about initiating lovemaking, 86% were more at ease and 79% anticipated it would be more pleasurable and more carefree. 69% believed orgasm was more pleasurable and 73% said that lovemaking was more pleasurable while 79% reported that the partner’s overall experience was more pleasurable. Using the PGI-I, 53% of participants felt that sexual function after using bremelanotide was a little better, much better, or very much better. Additional questions online revealed similar results. Twelve men completed the one-on-one interview: 69% of participants were prescribed bremelanotide for erectile dysfunction. 64% had at least other one sexual health issue, including anxiety about sex (54%), low sexual desire (45%), not enjoying sex (36%), orgasm difficulties (18%), and ejaculation difficulties and sensation loss (9% each). A total of 91% experienced improvements in sexual function, all with improved erectile function. 100% of those with complaints of low sexual desire and/or complaints of anxiety around sex reported improvement; 64% had decreased anxiety around sex; 55% had more enjoyment with sex; and orgasm improved for 36% of participants. Men reported longer erection and ability for additional erection for 18-24 hours after bremelanotide injection, better connection between genitals and brain, improved sensitivity, and increased confidence. Side effects included flushing (36%), nausea (36%), headache (27%), bothersome spontaneous erections without sexual stimulation for about 24 hours after injection (27%), and incontinence, cramping and abdominal burning (9% each). All adverse events were transient. Conclusions While bremelanotide is approved for hypoactive sexual desire disorder in premenopausal women, it has been prescribed and used successfully for men with erectile dysfunction and other concomitant sexual health issues. Disclosure Yes, this is sponsored by industry/sponsor: Palatin Technologies. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: Palatin Technologies.

(148) “Zebras” in Sexual Medicine from Cauda Equina Pathology

Abstract Introduction Unrelenting, bothersome sexual medicine problems in individuals with a vulva or penis sometimes do not respond to conventional therapies, frustrating both patient and provider. These distressing problems can be categorized as a genito-pelvic dysesthesia (GPD), including genito-pelvic (penile, scrotal, clitoral, vulvar, vestibular, vaginal, bladder, rectal) pain, persistent genital arousal disorder (PGAD), sleep related prolonged erections (SRPE) and hard-flaccid syndrome (HFS), currently considered as “zebras” in sexual medicine. We recently published a study on 20 patients with PGAD/GPD who underwent a multi-disciplinary management algorithm, were determined to have lumbosacral annular tear induced sacral radiculopathy, and with one year follow-up post-spine surgery, 80% revealed improvement in symptoms. Objective To apply our (spine-sexual medicine) multi-disciplinary management algorithm to sexual medicine “zebras”. Methods Patients who presented between July 1, 2021, and June 30, 2023, to our sexual medicine clinic were included in the study cohort. The management algorithm was as follows: biopsychosocial history, multiple validated instruments, physical examination, neurogenital testing, regional anesthesia testing, lumbosacral MRI, and when appropriate, a caudal epidural or transforaminal epidural spinal injection. Those with clinically significant symptom reduction from the spinal injection were offered appropriate spine surgery. Patient Global Impression of Improvement (PGI-I) was assessed post-operatively (1 = very much better, 2 = much better, 3 = better, 4 = no change, 5 = worse, 6 = much worse and 7 = very much worse. Results Our study cohort consisted of 24 patients, 14 with a vulva and 10 with a penis, mean age 42 years (range 25-69) who presented to our clinic over a period of two years. The patients' GPD complaints included genital pain (13), PGAD (6), SRPE (2), HFS (1), bladder pain (1) and rectal pain (1). All patients had results of neurogenital and regional anesthesia tests consistent with sacral radiculopathy, then underwent a diagnostic focal lidocaine spinal injection. Each had a positive response to either a transforaminal epidural spinal injection and underwent lumbar endoscopic spine surgery (n = 21) or a caudal epidural and underwent Tarlov cyst surgery (n = 3). PGI-I scores after surgery indicative of improvement (PGI-I = 1, 2, 3) at one week was 10/22 (45%), at 6 weeks was 9/17 (53%) at 3 months was 9/16 (56%) and at 6 months was 5/6 (83%). Conclusions Patients presenting with sexual medicine complaints not successfully managed by routine treatment strategies often experienced delay in diagnosis and excessive healthcare-seeking behavior resulting in significant distress. In our experience, GPD can result from triggers in the cauda equina, far from the location of the presenting genito-pelvic symptom(s). Our cohort of sexual medicine “zebras” who underwent our multi-disciplinary management algorithm were diagnosed with sacral radiculopathy. These patients opted for spine surgery and reported improvement of symptoms that continued to get better over time. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Eliquence.

(097) Psychosocial Factors in PGAD/GPD Patients Who Underwent Spine Surgery for Lumbosacral Annular Tear-Induced Sacral Radiculopathy

Abstract Introduction Persistent genital arousal disorder/genito-pelvic dysesthesia (PGAD/GPD) is characterized by persistent or recurrent, unwanted or intrusive, distressing sensations of genital arousal not associated with concomitant sexual interest, thoughts, or fantasies and/or other symptoms of GPD (e.g. itching, burning, throbbing, pain) that persist for ≥3 months. Multiple psychological and medical factors may contribute to the development and maintenance of PGAD/GPD. Concerning psychologic factors, women afflicted with PGAD experience more than double the rate of suicidal ideation (54%) compared to a control group, difficulty with mental health issues such as depression, high rates of negative emotions, and substantial difficulties with psychosocial adjustment. Objective This study focuses on psychosocial factors identified in a cohort of PGAD/GPD patients diagnosed with lumbosacral annular tear-induced sacral radiculopathy. Methods Using our multidisciplinary spine-sexual medicine management algorithm, 20 patients (15 cisgendered women, 5 cisgendered men, mean age 40.3 ± 16.8 years) diagnosed with PGAD/GPD fulfilled criteria for lumbosacral annular tear-induced sacral radiculopathy. A total of 22 lumbar endoscopic spine surgery (LESS) procedures were performed in these 20 patients. Validated instruments administered included the Sexual Distress Scale-Revised, Perceived Stress Scale, and Patient Health Questionnaire-9. The sex therapy evaluation performed on initial patient intake assessed psychosocial issues including effect of symptoms on quality of life, self-image, past trauma, and current relationship(s). Patients identified as having significant psychosocial issues were advised to undergo pre-op and/or post-op therapy. Results Ninety percent of patients were advised to undergo therapy. Our study cohort exhibited high levels of anxiety, depression, and/or obsessive-compulsive disorder as well as suicidal ideation. The Sexual Distress Scale–Revised revealed significant distress in 14 patients (82%). The Perceived Stress Scale showed 2 (12%) having high stress, 12 (70%) having moderate stress, and 3 patients (18%) having low stress. As assessed by item 1 of the Patient Health Questionnaire-9, 3 patients had a score consistent with warranting treatment for depression while an additional 10 had a score consistent with the possible need for treatment based on clinical judgment. As assessed by item 2 (“How difficult is it for you to do your work, take care of things at home, or get along with other people?”), 13 (65%) reported difficulties, with 3(15%) extremely difficult, 5 (25%) very, and 5 (25%) somewhat difficult. Overall, 7 (35%) showed improvement on the Patient Global Impression of Improvement after 3 months and by one year post-operatively, 80% (16/20) reported improvement. Conclusions There are many recognized triggers for PGAD/GPD. While this subgroup was diagnosed with lumbosacral annular tear-induced sacral radiculopathy and experienced long-term alleviation of symptoms by LESS, psychological factors likely contributed to the development, continuation, and consequences of PGAD/GPD. We believe that the significant mental health issues in this PGAD/GPD patient population made recovery from LESS more protracted than typically experienced after this surgery for sciatica alone. Psychological therapy would be beneficial in this population and should be continued postoperatively, as needed, to address psychological concerns and enhance quality of life. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Eliquence.

Daridorexant treatment for chronic insomnia: a real-world retrospective single-center study

IntroductionChronic insomnia disorder (CID) significantly impacts well-being and daily functioning. Daridorexant, a double orexin receptor blocker, has shown efficacy in randomized clinical trials and has been recently approved for the treatment of CID in adult patients. This retrospective observational study aimed to describe real-world data on daridorexant effectiveness and safety in adult patients with CID.MethodsConsecutive patients initiating on-label daridorexant at the Sleep Medicine Centre, University Hospital of Rome Tor Vergata were enrolled. Baseline and 30-day follow-up (FU) evaluations included patients’ and CID characteristics, comorbidities, and clinicians’ and patients’ subjective ratings of changes with the Clinical and Patient Global Impression-Improvement scores (CGI-Is and PGI-Is), as well as Insomnia Severity Index (ISI) scores in a subgroup of patients.ResultsSixty-nine patients initiated 50-mg daily dosage. At FU, 58% of both patients and clinicians rated CID as improved on CGI-Is and PGI-Is, with no differences based on comorbidities, sex, or number of previous medications. No significant predictors of CGI-Is and PGI-Is improvement were identified. At FU, ISI scores (n = 24) significantly decreased from 18.25 ± 3.21 to 12.08 ± 6.12 (Z = 8.000; p < 0.001). Of these, eight patients (33.3%) had absence of insomnia symptoms, and no patients reported a worsening in ISI score categories.ConclusionsThis study suggests daridorexant to be effective and safe in real-world CID treatment whether used as a first-ever treatment, switch, or add-on, as reflected by subjective and objective measures and the absence of serious treatment-related adverse events. Future research on larger cohorts should explore daridorexant potential across diverse patient characteristics.

A Motion-based Device Urinary Incontinence Treatment: A Longitudinal Analysis at 18 and 24 Months

Introduction and hypothesisThere are sparse data regarding the long-term efficacy of pelvic floor muscle training (PFMT) for the treatment of urinary incontinence (UI). The objective of this study was to evaluate the impact of an 8-week PFMT program guided by a motion-based intravaginal device versus a standard home program over 24 months.MethodsBetween October 2020 and March 2021, a total of 363 women with stress or stress-predominant mixed UI were randomized and completed an 8-week PFMT program using a motion-based intravaginal device (intervention group) or a home program following written/video instructions (control group). Participants were not asked to continue training after the 8-week program. At 18 and 24 months’ follow-up, the Urogenital Distress Inventory, short-form (UDI-6) and Patient Global Impression of Improvement (PGI-I) were collected. In the original trial, a total of 139 participants in each arm were needed to detect a 0.3 effect size (alpha = 0.05, power 0.8, one-tailed t test) in the difference in UDI-6 scores.ResultsA total of 231 participants returned 24-month data. Mean age at 24 months was 51.7 ± 14.5 years, and mean BMI was 31.8 ± 7.4 kg/m2. Mean change in UDI-6 scores from baseline to 24 months was greater in the intervention group than the control group (−21.1 ± 24.5 vs −14.8 ± 19.4, p = 0.04). Reported improvement using PGI-I was greater in the intervention group than in the control group at 24 months (35% vs 22%, p = 0.03, OR 1.95(95% CI 1.08, 3.57).ConclusionsPelvic floor muscle training guided by a motion-based prescription intravaginal device yielded durable and significantly greater UI symptom improvement than a standard home program, even in the absence of continued therapy.

Quality of Life and Sexual Function after Laparoscopic Posterior Vaginal Plication Plus Sacral Colpopexy for Severe Posterior Vaginal Prolapse.

Laparoscopic sacral colpopexy (LSC) is the gold standard treatment for women with apical/anterior pelvic organ prolapse (POP). For isolated posterior vaginal prolapse, instead, the literature suggests fascial native tissue repair. This is a retrospective 2-year quality-of-life follow-up study after laparoscopic posterior plication (LPP) combined with LSC in patients with anterior/apical prolapse combined with severe posterior colpocele. The primary endpoint was to evaluate the subjective outcomes quality of life (QoL), sexual function, and patient satisfaction rate. The secondary endpoint was to evaluate perioperative and anatomical outcomes at the 2-year follow-up. A total of 139 consecutive patients with anterior and/or apical prolapse (POP-Q stage ≥ II) and severe posterior vaginal prolapse (posterior POP-Q stage ≥ III) were retrospectively selected from our database among women who underwent, from November 2018 to February 2021, a "two-meshes" LSC. The patients were classified into Group A (81 patients; LSC plus LPP) and Group B (67 patients; LSC alone). The primary endpoint was evaluated using the Patient Global Impression of Improvement (PGI-I), the Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6), the Pelvic Floor Impact Questionnaire-7 (PFIQ-7), the Female Sexual Distress Scale (FSDS), the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), and the EuroQol (EQ-5D). The secondary endpoint was studied using the POP-Q study and an intra-, peri-, and post-operative complications assessment. Two-year follow-up data were analyzed for the study. At 2 years, all women showed a statistically significant amelioration of their symptoms on the QoL questionnaires. We found a statistical difference in favor of posterior plication in terms of the PGI-I successful outcome rate (Group A versus B: 85.3% versus 67.1%), FSDS (median 11 versus 21), and PISQ-12 (median 89 versus 62) (p < 0.05 for all comparisons). A significant improvement of all EQ-5D values was observed from baseline to 2-year follow-up, and only for the "pain/discomfort" domains did we observe a significant improvement in LSC plus LPP patients versus LSC alone (p < 0.05). LSC plus LPP women showed, at 2 years, a significant amelioration of their Ap and GH POP-Q points. We observed no statistical differences in terms of intra-post-operative complications or anatomic failure rate between groups. Our LPP approach to LSC appears to be a safe, feasible, and effective treatment for advanced pelvic organ prolapse with a significant impact on the patient's general health and sexual quality of life. Adding laparoscopic posterior vaginal plication to "two-meshes" sacral colpopexy is recommended in patients with apical/anterior prolapse and concomitant severe posterior colpocele. This surgical approach, in addition to improving the anatomical results of these patients, is associated with a significant improvement in sexual and quality of life indexes.