Global Impressions-Improvement Score Research Articles

Pilsner Modification of Mesh Sacrohysterocolpopexy(PiMMS): An Initial Report on Safety and Efficacy.

It is reported that up to 60% of women would prefer to spare their uterus during pelvic organ prolapse (POP) repair surgery. A reliable hysteropexy technique is therefore crucial. We aimed to describe the safety profile and initial core patient-reported and clinical outcomes of the Pilsner modification of laparoscopic mesh sacrohysterocolpopexy (PiMMS) in comparison with the laparoscopic sacrohysterocolpopexy technique (standard laparoscopic sacrohysterocolpopexy [sLSH]) previously used in our unit. This was a retrospective cohort study conducted in a single tertiary referral urogynecological center. All patients who underwent laparoscopic mesh sacrohysterocolpopexy between 1 January 2015, and 31 January 2022 were included in the study. Follow-up clinical, patient-reported, and imaging outcomes at the 12-month follow-up time point are presented. A total of 87 patients were included. Of these, 49 (56.3%) and 38 (43.7%) underwent sLSH and PiMMS respectively. Low numbers of perioperative complications were found in both groups with no mesh-related complications reported following PiMMS up to 12months postoperatively. There were no apical compartment failures in either group. There were 8 (17.0%) vs 1 (2.7%) anterior compartment failures (Ba ≤ -1) in the sLSH and PiMMS groups respectively (p = 0.07) at 12months. At the 1-year follow-up, 42 (89.4%) patients reported a Patient Global Impression of Improvement score of ≤ 2 in the sLSH groups compared with 35 (94.6%) patients following PiMMS. The PiMMS technique seems to have comparable safety profile and patient-reported outcomes with the sLSH technique. However, there is a trend toward reduced anterior compartment failures with this modification. The findings of this preliminary report need to be re-evaluated in a well-powered prospective study.

OUTCOME OF EARLY TRANSABDOMINAL SUPRAPUBIC REPAIR OF VESICOVAGINAL FISTULA SECONDARY TO BENIGN GYNECOLOGICAL AND OBSTETRIC SURGERIES

Objectives: To determine the effectiveness of early operative management of patients with Vesicovaginal fistula (VVF) secondary to benign gynecological surgeries. Material and methods: It is a descriptive case series of 70 patients selected from August 2018 to Oct 2022. All patients meeting inclusion criteria had routine lab investigations, imaging, cystoscopy, and vaginoscopy. The suprapubic approach described by O’Conor et al; was used. All surgeries were performed between the 4th and 6th weeks after the onset of the fistula to allow some time for tissue healing. All patients were followed after 2 weeks; a cystogram was performed to document fistula closure followed by removal of Foleys catheter. A second follow-up was at 3 months, patients were assessed with patient global impression of improvement score (PGI-I) for improvement in symptoms. Results: The mean age of the patients was 40.6 ± 10.2 years. 14(19.7%) patients were primipara while 56 (78.9%) patients were multipara. The mean fistula size was 11.5 ± 4.5mm. Supra-trigonal fistulas were more common than trigonal fistulas 43(60.6%) vs 27(38%). Hysterectomy (including cesarean hysterectomy and simple hysterectomy) was the commonest cause of VVF followed by cesarean section and difficult labor 33(46.5% vs 21(29.6) vs 12(16.9%). The overall mean operative time was 125.3 ± 10.7 minutes. The mean hospital stay was 3.8 ± 0.8 days. The fistula was successfully closed in 64 (90.1%) patients while 6 (9.9%) patients had failed surgery. The small-size fistulas (5-10mm) had a higher success rate of closure than larger fistulas (11-20mm) with statistical significance (p=0.02). Over 63 (90 %) patients responded PGI score below 3 with much improvement in symptoms. Conclusion: Our results show that early operative management of VVF secondary to benign gynecological and obstetric surgeries is feasible and effective. It also improves the symptoms of patients with PGI-I score. KEYWORDS: Vesicovaginal fistula (VVF), early repair, hysterectomy.

PD14-01 FRACTIONAL CARBON DIOXIDE VAGINAL LASER FOR THE TREATMENT OF URINARY SYMPTOMS: 24 MONTHS RESULTS

You have accessJournal of UrologyCME1 Apr 2023PD14-01 FRACTIONAL CARBON DIOXIDE VAGINAL LASER FOR THE TREATMENT OF URINARY SYMPTOMS: 24 MONTHS RESULTS Nataljia Kovacevic, Bernadette Zwaans, Royal Oak, Mi, Ly Hoang Roberts, Evelyn Shea, Lisa Vergos, Danielle Tenney, Larry Sirls, Priya Padmanabhan, and Kenneth Peters Nataljia KovacevicNataljia Kovacevic More articles by this author , Bernadette ZwaansBernadette Zwaans More articles by this author , Royal OakRoyal Oak More articles by this author , Mi Mi More articles by this author , Ly Hoang RobertsLy Hoang Roberts More articles by this author , Evelyn SheaEvelyn Shea More articles by this author , Lisa VergosLisa Vergos More articles by this author , Danielle TenneyDanielle Tenney More articles by this author , Larry SirlsLarry Sirls More articles by this author , Priya PadmanabhanPriya Padmanabhan More articles by this author , and Kenneth PetersKenneth Peters More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003261.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Fractional carbon dioxide laser (fCO2) has been proposed to treat frequency, urgency, urge urinary incontinence (UUI), and stress urinary incontinence (SUI) in genitourinary symptoms of menopause (GSM). The laser’s thermal effects help collagen remodeling, thereby improving vaginal tissue integrity and urethral support. Our aim was to prospectively measure the effect of vaginal fCO2 laser therapy on SUI and overactive bladder (OAB) symptoms at 24 months. METHODS: Women over 18 years with urogenital symptoms were enrolled in an open-label prospective trial. Participants underwent 3 laser treatments, each 6 weeks apart. Patients were required to be off vaginal estrogen for 3 months prior to receiving any treatments. Patients were offered additional annual treatment sessions. Follow up consisted of 6, 12-, 18-, and 24-month visits during which various questionnaires were administered including the Incontinence-Quality of Life (I-QOL), Overactive Bladder Questionnaire short form (OABq-SF), and Questionnaire for Urinary Incontinence Diagnosis (QUID). A voiding diary was collected at baseline, 6-, 12-, and 24- month visits. ANOVA analysis was used to compare means at each time point. RESULTS: 100 patients were enrolled at time of analysis. Baseline urinary symptoms consisted of 44.8% of patients with SUI, 57.1% with UUI, and 75.4% with frequency. Significant reduction in SUI episodes was observed at 6, and 24 months (p=0.0135; Figure 1), and participants noted improvement on QUID-SUI at 6, 12, and 24 months (p<0.0001). Number of urge leaks did not significantly improve on voiding diary (=0.0512), but significant subjective improvement was noted for OAB/UUI based on QUID-UUI and OABq-SF symptom scores at each time point (p<0.0001; Figure 1). Mean Patient Global Impression of Improvement scores improved at each treatment and follow up visit, with 46.4% reporting significant symptom improvement by 24 months. Participants had improvement between baseline and 24 months in vulvar dryness (50.9% vs 25%) and vulvar pain (48% vs 13%). CONCLUSIONS: This represents the longest prospective follow-up of laser effects on GSM associated urinary symptoms. Significant subjective improvement was noted for SUI and OAB/UUI up to 24 months after treatment. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e412 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Nataljia Kovacevic More articles by this author Bernadette Zwaans More articles by this author Royal Oak More articles by this author Mi More articles by this author Ly Hoang Roberts More articles by this author Evelyn Shea More articles by this author Lisa Vergos More articles by this author Danielle Tenney More articles by this author Larry Sirls More articles by this author Priya Padmanabhan More articles by this author Kenneth Peters More articles by this author Expand All Advertisement PDF downloadLoading ...

Prasterone in the treatment of mild to moderate urge incontinence: an observational study.

To assess the effects of prasterone compared with hyaluronic acid on symptoms of mild to moderate urinary urgency in women with genitourinary syndrome of menopause. This is an observational prospective cohort study. A total of 58 postmenopausal women were enrolled (from December 2019 to May 2021). Overactive Bladder Screener questionnaire, Patient Global Impression of Improvement questionnaire, International Consultation on Incontinence Questionnaire-Short Form, and International Quality of Life questionnaire were used. Fifty-eight women, 29 (50%) and 29 (50%), were treated with prasterone and hyaluronic acid for 12 weeks, respectively. At the end of the study, 26 (89.7%) versus 3 (10.3%) women reported an improvement (Patient Global Impression of Improvement score ≤3) of the symptoms in the prasterone versus hyaluronic acid group. According to the International Consultation on Incontinence Questionnaire-Short Form, no statistically significant difference was recorded before treatment between the prasterone and hyaluronic acid groups (median, 12 [6-12] vs 11 [8-12]; P = 0.8). Conversely, a statistically significant difference was recorded after treatment between the two groups (median, 8 [5-11] vs 10 [8-11]; P = 0.03). According to the International Quality of Life, a statistically significantly lower median score was recorded in the prasterone compared with the hyaluronic acid group, before (73 [interquartile range {IQR}, 55-81] vs 89 [IQR, 67-94]; P < 0.01) and after (78 [IQR, 65-86] vs 87 [IQR, 72-99]; P = 0.04) treatment. The current observational study supports the hypothesis that prasterone might improve the severity of urinary urge incontinence in this set of women. However, these results need to be confirmed in further studies with a controlled design and a larger population.

Neural networks outperform expert humans in predicting patient impressions of symptomatic improvement following overactive bladder treatment.

The objective was to accurately predict patient-centered subjective outcomes following the overactive bladder (OAB) treatments OnabotulinumtoxinA (OBTX-A) injection and sacral neuromodulation (SNM) using a neural network-based machine-learning approach. In the context of treatments designed to improve quality of life, a patient's perception of improvement should be the gold standard outcome measure. Cutting-edge neural network-based algorithms using reproducing kernel techniques were trained to predict patient-reported improvements in urinary leakage and bladder function as assessed by Patient Global Impression of Improvement score using the ROSETTA trial datasets. Blinded expert urologists provided with the same variables also predicted outcomes. Receiver operating characteristic curves and areas under the curve were generated for algorithm and human expert predictions in an out-of-sample holdout dataset. Algorithms demonstrated excellent accuracy in predicting patient subjective improvement in urinary leakage (OBTX-A: AUC 0.75; SNM: 0.80). Similarly, algorithms accurately predicted patient subjective improvement in bladder function (OBTX-A: AUC 0.86; SNM: 0.96). The top-performing algorithms outcompeted human experts across outcome measures. Novel neural network-based machine-learning algorithms accurately predicted OBTX-A and SNM patient subjective outcomes, and generally outcompeted expert humans. Subtle aspects of the physician-patient interaction remain uncomputable, and thus the machine-learning approach may serve as an aid, rather than as an alternative, to human interaction and clinical judgment.

Native-tissue prolapse repair: Efficacy and adverse effects of uterosacral ligaments suspension at 10-year follow up.

ObjectiveTo evaluate the 10‐year outcomes of high uterosacral ligaments suspension as a primary repair for apical prolapse and to evaluate the long‐term impact of prognostic factors.MethodsA retrospective study analyzed 10‐year follow up after repair of primary apical prolapse through high uterosacral ligament suspension. Bulging symptoms and postoperative prolapse stage II or above were considered subjective and objective recurrences, respectively. Patient Global Impression of Improvement score was used to evaluate subjective satisfaction after surgery.ResultsA total of 287 women were analyzed. Ten‐year recurrence rates were 19.1% for objective recurrence and 6.3% for subjective recurrence; surgical retreatment rate was 2.1%. Premenopausal status was related to 15‐fold increased risk of developing either objective or subjective recurrence. Conversely, anterior and posterior repair were protective factors against reoperation.ConclusionHigh uterosacral ligaments suspension is a safe and long‐lasting effective procedure for the treatment of uterovaginal prolapse even 10 years after index surgery. Premenopausal status and lack of anterior and posterior repair represented long‐term risk factors for surgical failure.

Two-year anatomical and functional outcomes of laparoscopic sacrocolpopexy using light-weight Y shaped mesh for post hysterectomy vaginal prolapse

ObjectiveThe aim of this study is to evaluate the efficacy, safety, anatomical and functional outcomes of patients undergoing laparoscopic sacrocolpopexy (LSC) using light-weight Y mesh for post hysterectomy vaginal prolapse. Study designA retrospective observational study of women who underwent LSC for post hysterectomy vaginal vault prolapse between January 2010 and January 2019. Y shaped mesh was used for the LSC after dissection of the rectum and the bladder. Pre-operative evaluation included symptoms’ assessment using the Prolpase Quality of Life Questionnaire (P-QOL) and objective assessment using the POP-Q scores. Post operatively, patient symptoms, anatomical outcomes, mesh complications and patient global impression of improvement scores were evaluated. Patients were followed up at 12 months and yearly thereafter. Results247 consecutive patients were included in this study. Patients’ age ranged from 35 to 86 years old with an average BMI of 28.8. The most common presenting symptoms were vaginal bulge (95%), vaginal heaviness (73%) and urinary urgency (46%). The time interval between hysterectomy and LSC was 10.5 years (5 months – 42 years). Complications reported were bladder injury (1.6%), small bowel injury (0.8%), major haemorrhage (0.4%), vaginal mesh extrusion (1.2 %). 85.8% of women reported cure of prolapse symptoms. 14.2% of patients developed further/unresolved prolapse symptoms and 6.5% went on to have further surgery for prolapse. 10% of women developed new onset dyspareunia. Anatomically, postoperative point C (apex) was at −7.6 cm (range −9 – +3 cm) ConclusionLSC using Y mesh for post hysterectomy vaginal prolapse is safe. LSC is effective in 85% of women who develop vaginal prolapse post hysterectomy. Further surgery for bothersome prolapse symptoms were needed in 6.5% with a 1.2% mesh extrusion rate and 10% new onset dyspareunia. This will help in counselling women undergoing this surgery.

Effect of Delayed Clozapine Initiation on Acute Treatment Response in Treatment-Resistant Schizophrenia

Objectives: Recent studies have reported that delayed initiation of clozapine can affect clinical response in patients with treatment-resistant schizophrenia (TRS). This study aimed to explore the relationship between delayed initiation of clozapine and acute treatment response.Methods: Sixty-five inpatients with TRS who started clozapine for the first time were included through a retrospective chart review. Acute treatment response was defined as a 30% reduction in the Positive and Negative Syndrome Scale score or a Clinical Global Impression of Improvement score of 1 (very much improved) or 2 (much improved) at 4 weeks after initiating clozapine.Results: After meeting the TRS criteria, the mean delay for initiating clozapine was approximately 13.8 months. The delay was shorter in patients who showed a better response to clozapine in logistic regression analysis (p=0.037).Conclusion: Our findings suggest that reducing the delay in initiating clozapine increases the effectiveness of clozapine in patients with TRS.

Autologous mid-urethral fascial sling for stress urinary incontinence: Long term outcomes

There has been an increasing interest in mesh-free surgical options for Stress Urinary Incontinence (SUI). Traditionally rectus fascia autologous slings were placed at the bladder neck but more recently they are positioned at the mid-urethra (aMUS). The long-term outcomes for these patients are described. A retrospective analysis of aMUS patients between 2009-2014 by a single surgeon for primary SUI was performed. All patients were evaluated preoperatively with urodynamics. Patient reported outcomes were collected via postal questionnaire using the ICIQ-UI short-form questionnaire, 7-point Global Impression of Improvement score, questions on pad usage, self-catheterisation, overactive bladder treatment and re-operation rates. Results included 31 patients (response rate 63.8%). The median age was 49 years and median BMI was 27. Twenty-seven per cent (27%) of patients had stress predominant mixed urinary incontinence pre-operatively. Median length of follow up was 8 years (5- 11); 60% of patients were dry and pad-free. Seventy-seven per cent (77%) found the surgery led to “much improvement” or “very much improvement” in quality of life. Thirteen per cent (13%) of patients reported a deterioration in quality of life. The median ICIQ-UI short form score was 5.5. 16.7% were taking medication and 1 patient received botulinum toxin therapy for overactive bladder symptoms. All these patients had mixed urinary incontinence on preoperative urodynamics. The re-operation rate was 13.3%. One patient was selfcatheterising. Three out of 31 (10%) had experienced pelvic pain, with 2 out of 31 (6%) experiencing dyspareunia. AMUS shows good long-term continence outcomes and is associated with low rates of de-novo overactive bladder symptoms and voiding dysfunction.

A randomized trial comparing continence pessary to continence device (Poise Impressa®) for stress incontinence.

To conduct a multi-centered randomized trial evaluating stress urinary incontinence (SUI) treatment based on the Patient Global Impression of Improvement score after 4weeks using a continence pessary (CP) or a disposable intravaginal continence device (DICD). The null hypothesis is no difference in treatment success between cohorts. This parallel group, active treatment comparative effectiveness trial randomized women with SUI to either CP or DICD for 4weeks in a 1:1 allocation ratio. Exclusion criteria included pregnancy, UTI, postmenopausal bleeding, neurogenic bladder, urinary retention, prolapse, contraindication to or prior treatment with CP/DICD, and prior SUI surgery. Assuming an80% power, an alpha of 5% and 20% dropout, we needed 138 participants to detect 50% success with CP versus 25% with DICD. Due to slow enrollment, the study was stopped after 16months with 50 participants enrolled. Of the 50 women enrolled, 25 (50%) were randomized to CP and 25 (50%) to DICD. Thirty-five of 50 (70%) completed a fitting, and 22/50 (44%) completed 4-week and 17/50 (34%) completed 6-month follow-up. Baseline characteristics were similar, and there was high treatment success in each cohort [80% (8/10) CP vs. 75% (9/12) DICD; p= 1.0]. DICD patients showed improvement on all questionnaires but had higher use of other therapies over 6months. CP patients showed improvements except for lower sexual function scores at 4weeks. No serious adverse events occurred. Most women fitted with a CP/DICD experienced treatment success after 4weeks without serious adverse events.

Comparison of the Efficacy and Safety of Ketoprofen Plaster and Diclofenac Plaster for Osteoarthritis-Related Knee Pain: A Multicenter, Randomized, Active-Controlled, Open-Label, Parallel-Group, Phase III Clinical Trial

PurposeTo compare the efficacy and safety of ketoprofen plasters and diclofenac plasters after 3 weeks of administration in patients with osteoarthritis-related knee pain. MethodsThis multicenter, randomized, active-controlled, open-label, parallel-group, noninferiority phase III study randomized 236 adults with osteoarthritis-related knee pain for 3 weeks with ketoprofen plaster 30 mg twice daily (n = 118) or diclofenac plaster 15 mg once daily (n = 118). The primary efficacy end point was the mean change from baseline to week 3 in the mean knee pain intensity score during walking, as measured by a 100-mm visual analog scale with a predefined noninferiority margin of 10.0 mm. Secondary end points included changes in knee pain intensity score during walking (weeks 1 and 2) and at rest (weeks 1, 2, and 3), Knee Injury and Osteoarthritis Outcome Score, Patient Global Impression of Improvement scale assessments, and frequency of rescue medication use after 2 and 3 weeks of treatment. FindingsA total of 223 patients (115 in the ketoprofen group and 108 in the diclofenac group) were included in the per-protocol analysis. After 3 weeks of treatment, the least squares mean change from baseline in knee pain intensity scores during walking was −35.9 (95% CI, −39.7 to −32.2) in the ketoprofen group and −31.7 (95% CI, −35.5 to −27.9) in the diclofenac group, with noninferiority found (least squares mean difference, −4.2; 95% CI, −9.6 to 1.1). Ketoprofen significantly (P < 0.05) reduced the pain intensity score at rest after 2 and 3 weeks of treatment compared with diclofenac. No statistically significant difference was found between the groups in terms of changes in pain intensity score during walking at weeks 1, 2, and 3. The mean Patient Global Impression of Improvement score was statistically significant (P < 0.001) in favor of ketoprofen after 2 and 3 weeks of treatment. In addition, the Knee Injury and Osteoarthritis Outcome Score improved in both groups, and no statistically significant difference was found between the groups in terms of frequency of rescue medication use. The overall adverse event profile of the groups was similar, and no difference was found in skin reaction rates between the 2 groups. ImplicationsKetoprofen plasters can be effectively and safely administered to patients with osteoarthritis-related knee pain.

Clinical Outcomes of a Multidisciplinary Female Chronic Pelvic Pain Program

The aim of this study was to describe patient-reported longitudinal outcomes in a multidisciplinary female chronic pelvic pain (CPP) program. We conducted a retrospective cohort study for women cared for in a tertiary, multidisciplinary, female (CPP) program between 2012 and 2017. Patient demographics were collected from electronic medical records. Patients completed the numerical rating scale for pain, Pain Disability Index (PDI), and Patient Global Impression of Improvement scale at each visit. Mixed-effects models were used to assess change in patient responses over time. Patients (N = 317) with a mean age of 44.3 years (SD, 14.6) and median duration of symptoms of 3 years (interquartile range, 1.0-7.0) were assessed in this analysis. The primary diagnosis was pelvic floor myofascial pain (67%). On multivariable analysis, numerical rating scale scores decreased by -0.11 point [95% confidence interval (CI), -0.20 to -0.01] every 3 months (P = 0.03). On multivariable analysis, total PDI score decreased by -0.88 point (95% CI, -1.43 to -0.33) (P = 0.003), and PDI sexual subscores decreased by -0.29 point (95% CI, -0.44 to -0.14) (P < 0.001) every 3 months. A higher (worse) Patient Global Impression of Improvement score was associated with a higher (worse) PDI score at follow-up (odds ratio, 1.04; 95% CI, 1.01-1.07; P = 0.01). Patients in a multidisciplinary CPP program demonstrated improvement over time in pain disability that was associated with an overall global impression of improvement.

The Influence of Patients' Goals on Surgical Satisfaction.

The objectives of this study were to describe patients' surgical goals and determine if goal attainment is associated with postoperative satisfaction and regret. Women undergoing surgery for pelvic floor disorders between June and December 2019 were recruited. At their initial visit, patients listed up to 4 surgical goals. Three months after surgery, patients completed the Pelvic Floor Distress Inventory, Patient Global Impression of Improvement, Satisfaction with Decision Scale, and Decision Regret Scale. They were also shown their initial goals and asked, "Did you achieve this goal by having surgery?" Women who achieved all goals were designated "goal achievers," and those who did not achieve even 1 goal were "goal nonachievers" (GNAs). Ninety-nine patients listed a median of 1 (range, 1-4) goals. Goals were categorized as follows: symptom improvement (52%), treatment achievement (23%), lifestyle improvement (17%), and information gathering (6%). Ninety-one percent of patients were goal achievers, and 9% were GNAs. Goal achievers had higher Satisfaction with Decision Scale scores (5.0 [4.7-5.0] vs 4.0 [3.8-4.8], P = 0.002), lower Decision Regret Scale scores (1.0 [1.0-1.4] vs 2.0 [1.1-2.7], P = 0.001), and better Patient Global Impression of Improvement scores (1.0 [1.0-2.0] vs 2.0 [1.0-4.0], P = 0.004). In prolapse surgery patients, postoperative Pelvic Floor Distress Inventory scores were similar; however, GNAs had higher postoperative Urinary Distress Inventory scores (17.0 ± 18.0 vs 45.8 ± 20.8, P = 0.01). Ninety-one percent of women achieved their presurgical goals, the most common being symptom relief. Goal achievers have higher satisfaction and less regret; however, those with worsening or de novo urinary symptoms are more likely to be GNAs and be unsatisfied.

Comparison of two different grafts for the surgical treatment of peyronie's disease.

The aim of this study was to compare two different graft techniques, namely saphenous vein (SV) and buccal mucosa (BM) used together with plaque incision for the treatment of Peyronie's disease (PD) in terms of success, safety and patient and partner satisfaction. The study included 41 patients diagnosed with PD and treated with plaque incision and grafting between December 2015 and November 2019. Eighteen patients underwent plaque incision and BM grafting while the remaining 23 patients underwent plaque incision and SV grafting. Pre-operative plaque size, curvature angle, curvature start time and penis length were statistically similar between the SV and BM graft groups. No statistical difference was detected between the BM and SV graft groups in terms of the sixth- and 12th-month mean International Index of Erectile Function scores, Patient Global Impression of Improvement scores, penis lengths and final partner satisfaction rates during the follow-up period. Residual curvature was observed in three (13.1%) patients in the SV graft group and two (11.2%) patients in the BM graft group. With their high success and low side effect rates, both grafting techniques with plaque incision can be safely performed for tunical lengthening, based on the surgeon's experience.

Sexually Inactive Status in Women With Pelvic Organ Prolapse Before Colpocleisis and Postoperative Satisfaction and Regret Rate.

The aim of the study was to investigate the sexually inactive status of patients with pelvic organ prolapse before colpocleisis and postoperative satisfaction and regret rate. A retrospective study of patients with pelvic organ prolapse who underwent colpocleisis was conducted in our hospital from January 2007 to April 2019. Records were reviewed before surgery for general clinical characteristics, duration, and reasons for being sexually inactive. Follow-up was conducted by telephone about patient satisfaction, Patient Global Impression of Improvement score, and regret rate after surgery. The mean age of the 247 patients was 73.8 ± 5.58 years. A total of 76.9% (190/247) described the duration of being sexually inactive, and the mean time was 12.6 ± 8.69 years. The 247 patients gave the following reasons for being sexually inactive: 52.2% (129/247) were widowed and 37.2% (92/247) reported the physical health factors of their spouses or sexual partners. The first male factor was nervous system disease (37.0%, 34/92). A total of 5.3% (13/247) were patient-related factors and 5.3% (13/247) were factors of both the male and female. A total of 195 patients underwent follow-up, the rate was 78.9% (195/247), and the follow-up time was 39.7 ± 37.5 (2-140) months. A total of 98.5% (192/195) of patients were very satisfied. A total of 98.9% (193/195) of patients were very much improved or improved in Patient Global Impression of Improvement score. A total of 1.02% (2/195) of patients regretted having colpocleisis nearly 2 years later. The main reason for being sexually inactive was having been widowed. Colpocleisis was associated with high satisfaction rates and low regret rate.

Surgical Decision Regret in Women Pursuing Surgery for Endometriosis or Chronic Pelvic Pain

To identify incidence of decision regret associated with surgery for endometriosis or chronic pelvic pain (CPP). Survey study. Academic medical center. All patients undergoing excisional surgery for endometriosis or CPP between January 2016 and June 2019. The women were contacted to complete 2 validated questionnaires: the Decision Regret and Patient Global Impression of Improvement scales. A total of 253 patients were contacted, and 154 patients responded (60.8% response rate) to the survey. A total of 137 women (90%) agreed or strongly agreed that having excisional surgery was the right decision; 134 women (87%) indicated that they would choose to have surgery again. The survey responders did not differ from nonresponders in age (years, 33.9 vs 35; p = .25), robotic route of surgery (83.1% vs 78.8%; p = .66), or performance of hysterectomy (27.3% vs 26.3%; p = .85). The responders were more likely to have stage III/IV endometriosis (50.6% vs 29.3%; p <.01), more previous surgeries for endometriosis (median surgeries, 1 vs 0; p = .01), higher complication rate (8.4% vs 2.0%; p = .03), and pathology test results more frequently positive for endometriosis (87.7% vs 77.8%; p = .03). Overall, 25 patients (16.3%) reported some level of regret after excisional surgery for endometriosis or CPP. Regret was not associated with a lower Patient Global Impression of Improvement score (odds ratio [OR] 4.37; 95% confidence interval [CI], 0.81-23.7), age (OR 0.98; 95% CI, 0.93-1.04), time since surgery (OR 1; 95% CI, 0.97-1.04), number of previous surgeries (OR 1.08; 95% CI, 0.9-1.31), negative pathology test results (OR 2.82; 95% CI, 0.95-8.32), hysterectomy (OR 1.23; 95% CI, 0.45-3.32), or complications (OR 1.07; 95% CI, 0.22-5.16). Most women who pursue excisional surgery for endometriosis or CPP are satisfied with their decision. Regret was not associated with patient-reported lack of improvement, negative pathology test results, hysterectomy, or complications. Gynecologic surgeons should engage in shared decision-making with patients and feel comfortable offering surgical evaluation and management to patients with endometriosis or CPP when clinically indicated.

Mesh-related complications of laparoscopic lateral suspension

Objective: Restorative procedures are essential for sexually active vaginal vault prolapse (VVP) cases. There are concerns about the long learning curve and major complications of sacrocolpopexy. Laparoscopic lateral suspension has a relatively short learning curve and no reported major complications. However, there are concerns about the use of mesh in prolapse surgeries and limited data is available about mesh complications with laparoscopic lateral suspension. This study aimed to establish the mesh-related complications after laparoscopic lateral suspension. Study Design: We carried out a retrospective analysis of patients who underwent laparoscopic lateral suspension for symptomatic VVP at three tertiary hospitals. Cases were identified from theatre records with coding data and the universities database. Demographic features, concomitant procedures, duration of surgery, intra-operative complications, hospital stay, change in pelvic organ prolapse quantification point C, Patient Global Impression of Improvement scale records, mesh-related complications and their management are presented. Results: A total of 120 patients underwent laparoscopic lateral suspension for symptomatic vault prolapse between 2014-2019. In total, mesh complications developed in 3 women (2.5%). While two vaginal mesh exposures were successfully managed with topical estrogen, one required surgical excision. One lateral mesh arm was loosened from the skin causing pain and itching. From 110 Patient Global Impression of Improvement scores, 106 women (96%) described their prolapse as ‘very much’ or ‘much’ better, 4 patients (3.6 %) reported ‘no change’ and no one reported worsening of symptoms. Conclusions: This series suggests that laparoscopic lateral suspension has low risk of mesh-related complications. It is a safe and effective procedure for symptomatic vault prolapse with high rates of patient satisfaction.

Evaluation of duloxetine and innovative pelvic floor muscle training in women with stress urinary incontinence (DULOXING): Study protocol clinical trial (SPIRIT Compliant).

Introduction:There is a lack of published studies about the combination of duloxetine and pelvic floor muscle training (PFMT) in women with stress urinary incontinence (SUI). The aim of our work will be to evaluate the effect of this intervention by assessing whether there is a change in the incontinence episode frequency (IEF), Incontinence Quality of Life (I-QoL), Patient Global Impression of Improvement score (PGI-I) and mean time between voids (MTBV). Combined therapy with duloxetine and PFMT will be compared to duloxetine treatment alone with respect to its efficacy and side effects.Methods:This study will be a randomized intervention, parallel, multicenter study in collaboration with 45 urological outpatient clinics at the national level. Patients will be assigned in a 1:1 ratio to the experimental and control groups using simple randomization according to odd and even numbers assigned sequentially to the patients at each clinic. The experimental intervention will be 12 weeks. The experimental group will receive oral treatment with duloxetine at a daily dose of 2 × 40 mg and will be required to perform innovative PFMT. The control group will receive the same oral duloxetine treatment (2 × 40 mg a day) but will not perform PMFT. Data will be collected from both groups before intervention and after the 12-week intervention is completed.Discussion:The study protocol presents the starting points, design and randomization of an interventional multicenter study to monitor the effect of the combination of duloxetine with innovative PFMT compared to duloxetine treatment alone in women with SUI. This study may provide evidence of the efficacy of this combined treatment for SUI and highlight benefits associated with active approaches to treatment through exercise.Registration:This study was retrospectively registered in the ClinicalTrials.go NCT04140253. Protocol version 1.0. date 11.1.2019.

Trial of SAGE-217 in Patients with Major Depressive Disorder

BackgroundAltered neurotransmission of γ-aminobutyric acid (GABA) has been implicated in the pathogenesis of depression. Whether SAGE-217, an oral, positive allosteric modulator of GABA type A receptors, is effective and safe for the treatment of major depressive disorder is unknown.MethodsIn this double-blind, phase 2 trial, we enrolled patients with major depression and randomly assigned them in a 1:1 ratio to receive 30 mg of SAGE-217 or placebo once daily. The primary end point was the change from baseline to day 15 in the score on the 17-item Hamilton Depression Rating Scale (HAM-D; scores range from 0 to 52, with higher scores indicating more severe depression). Secondary efficacy end points, which were assessed on days 2 through 8 and on days 15, 21, 28, 35, and 42, included changes from baseline in scores on additional depression and anxiety scales, a reduction from baseline of more than 50% in the HAM-D score, a HAM-D score of 7 or lower, and a Clinical Global Impression of Improvement score of 1 (very much improved) or 2 (much improved) (on a scale of 1 to 7, with a score of 7 indicating that symptoms are very much worse).ResultsA total of 89 patients underwent randomization: 45 patients were assigned to the SAGE-217 group, and 44 to the placebo group. The mean baseline HAM-D score was 25.2 in the SAGE-217 group and 25.7 in the placebo group. The least-squares mean (±SE) change in the HAM-D score from baseline to day 15 was −17.4±1.3 points in the SAGE-217 group and −10.3±1.3 points in the placebo group (least-squares mean difference in change, −7.0 points; 95% confidence interval, −10.2 to −3.9; P<0.001). The differences in secondary end points were generally in the same direction as those of the primary end point. There were no serious adverse events. The most common adverse events in the SAGE-217 group were headache, dizziness, nausea, and somnolence.ConclusionsAdministration of SAGE-217 daily for 14 days resulted in a reduction in depressive symptoms at day 15. Adverse events were more common in the SAGE-217 group than in the placebo group. Further trials are needed to determine the durability and safety of SAGE-217 in major depressive disorder and to compare SAGE-217 with available treatments. (Funded by Sage Therapeutics; ClinicalTrials.gov number, NCT03000530.)

Behavioral activation therapy for depression and anxiety in cancer patients: a case series study

BackgroundBehavioral activation therapy (BAT) directly addresses activities that individuals value most highly, and may be easily applicable to cancer patients. However, there is no established evidence of the use of BAT in this population. In this study, we examined the possibility of a BAT program for depression and anxiety in cancer patients.Case presentationWe retrospectively reviewed the medical records of cancer patients with each of the following characteristics: 1) were outpatients or inpatients visiting the psycho-oncology division of the National Cancer Center Hospital in Japan; 2) met criteria for Major Depressive Disorder or Adjustment Disorders; and 3) participated in a BAT program. The primary outcome was the program completion percentage. Secondary outcomes were self-reported depression severity (Patient Health Questionnaire-9 (PHQ-9) score), anxiety disorder status (Generalized Anxiety Disorder-7 (GAD-7) score), and clinical improvement (Clinical Global Impression-Improvement (CGI-I) score) after the program. We analyzed both depression and anxiety by the matched paired t-test. Ten patients participated in the program, and nine completed it. One dropped out due to cognitive impairment secondary to brain metastasis. Both the PHQ-9 scores (pre: 14.4 (SD, 6.1); post: 5.1 (SD, 5.8)) and the GAD-7 scores (pre: 11.9 (SD, 4.9); post: 4.7 (SD, 5.5)) significantly improved after the program (PHQ-9: P = 0.0014; GAD-7: P = 0.0004). CGI-I scores ranged from 1 to 3, and all subjects except the patient who dropped out improved clinically. Among the ten patients, three distinctive cases could be observed as follows. Case 1; a 45-year-old housewife with breast cancer who did not agree to take antidepressants because of concerns about the side effects achieved remission without antidepressants and began to live an active life. Case 4; a 66-year-old housewife was so shocked after endometrial cancer diagnosis that she was absent-minded and her compliance with the assigned homework was poor, therefore, her depression did not improve much. Case 9; a 62-year-old man with laryngeal cancer who had recurrent anxiety. Increased business activity, on which he put great value, gradually allowed him to be able to live his life actively without concerns.ConclusionsThis study suggests that BAT would be effective for the depression and anxiety of cancer patients.