Patient Global Impression Of Improvement Score Research Articles

658 Treatment Outcomes Among Patients with Recurrent Urinary Tract Infections Using a Multidisciplinary Management approach in a Complex UTI Clinic: A 20-Months’ Experience

Abstract Aim Our aim was to assess the treatment outcomes among patients with recurrent UTIs managed in a novel multidisciplinary complex UTI clinic started by Department of Urology at a single tertiary care centre, over a 20-month period. Method In view of persistently increasing burden and prevalence of antibiotic resistance associated with UTIs, a multidisciplinary complex UTI clinic, is started by Urologists supported by specialist nurses and microbiologists was started in April 2021. A prospectively maintained database of 176 patients {(median age 57.4 years (14-89 years) and (Male:Female ratio of 1:10)} who were referred to our clinic, within a 20-month period was reviewed. Patient demographics, urine culture results (causative bacterial organism and antibiotic sensitivities), investigations performed, and treatment outcomes were recorded. Pre-treatment QoL (Quality of Life) and post-treatment PGI-I (Patient global impression of improvement Scale) Score were measured. Results Escherichia Coli (69%) was identified as the most common causative organism. 30% patients had multi-resistant bacterial organism on urine culture. Abnormal Flexible cystoscopy, Renal Tract USS, CT Urogram was reported in 14%, 13% and 11% respectively. All patients received information on general cystitis prevention measures. 46 (26%) required intra-vesical treatment (Gentamicin 12%, Amikacin 1% and Glycosaminoglycans 13%). 71% patients remained infection free on follow up. Pre-treatment 64% patients reported significant impact on their QoL. 88.6% (94) of the 106 patients, followed up after the completion of treatment had good improvement on PGI-I scale (Table 1). Conclusions A dedicated complex UTI clinic service with multidisciplinary treatment approach can be efficient in managing recurrent UTIs.

(030) PATIENT-REPORTED OUTCOMES OF CORE EXCISION FOR SURGICAL MANAGEMENT OF NEUROPROLIFERATIVE VESTIBULODYNIA

Abstract Introduction Among patients with neuroproliferative vestibulodynia (NPV) experiencing pain on cotton-tip swab testing at the 1:00-11:00 vestibule prior to complete vestibulectomy surgery, a subset also had pain at the 12:00 vestibule. Excision of the 12:00 core region may be performed concomitantly or after healing from the vestibulectomy. Given that a vaginal flap cannot be advanced to this area, only a core excision is removed and closed using surrounding 12:00 tissue. Differences between the post-operative improvement in the 1:00-11:00 and the 12:00 regions have not been examined to date. To better understand the success of core excision of the 12:00 region, we assessed post-operative patient-reported outcomes specifically of this vestibular region. Objective To characterize patients who underwent 12:00 excision as well as assess Patient Global Impression of Improvement (PGI-I) specifically regarding 12:00 core excision in individuals with NPV. Methods We performed a retrospective chart review of patients from one clinic who had undergone a 12:00 core excision. Preoperative baseline assessments included Vulvar Pain Functional Questionnaire (V-Q), Female Sexual Function Index (FSFI), Short Form McGill Pain Questionnaire (SF-MPQ), cotton-tip swab test results. Dimensions of the excised tissue as determined by pathology report, responses to the PGI-I scale at > 6 months post-op, and any adverse events were collected. Descriptive statistics were conducted to analyze the PGI-I scores and other outcomes. Results The majority of patients (67%, n=21), with an average age of 26, rated their 12:00 pain as “much improved” or “very much improved” on the PGI-I scale. Mean duration of follow up since surgery was one year and five months, with a minimum follow up of 9 months. Most patients (90%) did not have regrets about having the 12:00 region removed. Most patients (83%) would recommend this surgery to other patients who have 12:00 pain. There were no significant post-operative adverse events with 12:00 excision. Mean dimensions of the excised specimen were 1.01 cm x 0.60 cm x 0.21 cm, 3% of the size of the 1:00-11:00 vestibule excised. Preoperatively, patient reported mean FSFI pain domain was 0.67, SF-MPQ 16.80, affective 5.15 and PPI 3.42. Mean V-Q prior to surgery was 11.68, mean cotton-tip swab test result for the 12:00 region was 6.15. Conclusions Performing core excision of a very small volume of tissue during surgery in patients with 12:00 pain is associated with an improved PGI-I score in 67% of patients. Further research with larger sample sizes and longer follow-up periods is warranted to confirm these findings and optimize the management of vestibulodynia. In patients who fail 12:00 core excision surgery, buccal mucosal grafting of the entire 12:00 vestibule may be a future option. Disclosure No.

(084) PERSISTENT GENITAL AROUSAL DISORDER/GENITO-PELVIC DYSESTHESIA (PGAD/GPD) SECONDARY TO TARLOV CYST-INDUCED SACRAL RADICULOPATHY

Abstract Introduction Persistent Genital Arousal Disorder/Genito-Pelvic Dysesthesia (PGAD/GPD) is characterized by persistent, unwanted genital arousal and/or other dysesthesia, including burning, itch and/or pain in the genito-pelvic area such as clitoris, vulva, perineal region and/or peri-anal region (pudendal nerve), umbilicus, urethra, bladder, vagina, and/or rectum (pelvic nerve) and also including the lower extremity buttock, thigh, calf, foot (sciatic nerve). Patients with PGAD/GPD are significantly bothered/distressed, and catastrophization and suicidal ideation are common. In 2012 Komisaruk reported that PGAD/GPD could result from Tarlov cyst-induced sacral radiculopathy. We developed a multidisciplinary step-care management algorithm with specialists in sexual medicine, spine surgery, sex therapy, physical therapy, and neurophysiology to diagnose and treat Tarlov cyst-induced sacral radiculopathy. Objective To utilize a multidisciplinary step-care management algorithm to identify PGAD/GPD patients with Tarlov cyst-induced sacral radiculopathy who could benefit from Tarlov cyst spine surgery and to evaluate long-term safety and efficacy of the surgery. Methods Clinical data were collected on PGAD/GPD patients who underwent Tarlov cyst spine surgery between 2016 and 2020 with at least 1-year follow-up. The management algorithm used to identify and treat Tarlov cyst-induced sacral radiculopathy involves: detailed psychosocial assessment and medical history; non-invasive diagnostic assessments for sacral radiculopathy; sacral MRI with Tarlov cyst protocol; targeted diagnostic caudal epidural injection; and if appropriate, Tarlov cyst spine surgery using minimally invasive surgery techniques. Treatment outcome was based on the validated Patient Global Impression of Improvement (PGI-I) measured at regular intervals post-operatively. Results Ten patients (8 women, 2 men), mean age 40 years (range 19-66), met inclusion criteria. Patients were discharged the same day or following morning post-operatively. No serious complications occurred. Follow-up was >12 months (range 13-22 months). Seven (70%) patients reported post-operative clinical improvement on PGI-I at last follow up: two patients reported “very much better”, three patients reported “much better” and two patients reported “little better”. Two patients had no improvement. Only one patient was much worse, however we believe that the PGI-I score of 6 reflected the worsening of the PGAD/GPD condition and not specifically the result of the surgical procedure. Conclusions Distressing PGAD/GPD symptoms can be caused by Tarlov cyst-induced sacral radiculopathy. A multidisciplinary step-care management algorithm allows selection of appropriate surgical candidates. To the best of our knowledge, this is the largest case series of patients with PGAD/GPD treated with Tarlov cyst spine surgery with at least 1 year follow-up. Using minimally invasive spine surgery techniques, spine surgery on the Tarlov cyst was associated with clinical improvement in 70% of select patients. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Elliquence.

The Outcomes of the Manchester Procedure Versus Sacrospinous Ligament Hysteropexy for Uterine Prolapse: A Study of the British Society of Urogynaecology Database.

The Manchester procedure (MP) and sacrospinous ligament hysteropexy (SSHP) have long been established as effective conservative surgeries for treating uterine prolapse. However, there have been limited studies on outcomes comparing these two techniques. This was a prospective cohort study of the British Society of Urogynaecology database between February 2007 and 2023 of MP and SSHP outcomes from 90 centres in the UK. The primary outcome was the Patient Global Impression of Improvement (PGI-I). The other outcomes compared were the absence of pelvic organ prolapse beyond the hymen in any compartment evaluated by the Pelvic Organ Prolapse Quantification (POP-Q), complications, and the incidence of reported symptomatic prolapse within 1 year after the operation. There were 718 women who underwent MP and 2,384 who had SSHP. The PGI-I score was significantly better in the MP group (p value <0.001). The rates of symptomatic prolapse within 1 year (odds ratio [OR] 0.36, 95% confidence interval [CI] 0.18-0.69; p value 0.001), recurrence of prolapse beyond the hymen (OR 0.13, 95% CI 0.03-0.53; p value 0.001) and apical recurrence (OR 0.09, 95% CI 0.01-0.65; p value 0.003) during follow-up examination were lower in the MP group. The combined peri-operative and post-operative complications reported in both groups were comparatively similar. The symptom improvement was better and recurrence was lower with the MP than with SSHP at short-term follow-up.

(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.

(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.

Flat Magnetic Stimulation for Urge Urinary Incontinence.

Background and Objectives: Strategies for overactive bladder syndrome (OAB) management involve, among others, strengthening the bladder outlet to suppress urgency and neuromodulating the sacral roots. Magnetic stimulation (MS) is a technology that involves an extracorporeal device that is able to provide an electromagnetic field specifically designed to interact with pelvic floor neuromuscular tissue. The resulting tissue electrical activity induces contraction of the pelvic muscle and neuromodulation of the S2-S4 sacral roots. Flat Magnetic Stimulation (FMS) is a relevant advancement involving homogeneous electromagnetic fields, which are able to optimize the effect on the entire pelvic area. However, the benefits of this new technology for OAB syndrome are poorly known. Consequently, the aim of our study is to analyze the outcomes and quality of life (QoL) impact of FMS with Dr. Arnold (DEKA, Calenzano, Italy) in women suffering from OAB syndrome associated with urinary incontinence. Materials and Methods: This prospective study included patients with OAB, urge urinary incontinence, and no ongoing OAB treatments. At baseline (T0), the Incontinence Impact Questionnaire (IIQ-7), the Female Sexual Function Index (FSFI-19), and the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) were collected. Patients underwent 8 FMS sessions of 25 min each in one month. At the termination of the therapy (T1), women repeated the ICIQ-UI SF, FSFI-19, and IIQ-7 tools. Moreover, the Patient Global Impression of Improvement (PGI-I) questionnaire was collected to evaluate the cure rate. Results: Our study enrolled a total of 57 consecutive patients. Most women had at least one second- or third-line treatment before FMS, while the remaining naive patients had contraindications to pharmacological treatments. No women reported adverse effects during the treatment. After the treatment, we observed a decrease in the IIQ-7 (p < 0.001) and ICIQ-UI SF scores (p < 0.001) and an improvement in sexual function (p < 0.001) evaluated with FSFI-19. According to PGI-I scores, 42 (73.7%) women referred to some kind of improvement, scoring ≤ 3 points. Specifically, 8.7% of patients considered themselves very much improved, 29.8% much improved, 35.1% minimally improved, and 26.3% found no changes. FMS was effective in treating OAB symptoms without any adverse effects. The mechanism is supposed to be related to suppressing the initiation of micturition. This makes FMS a promising device for treating naive and refractory urge urinary incontinence. Conclusions: The new FMS represents a promising non-pharmacological option for the treatment of naive and refractory OAB.

Efficacy of a Diode Vaginal Laser in the Treatment of the Genitourinary Syndrome of Menopause.

Genitourinary syndrome of menopause (GSM) and vulvovaginal atrophy (VVA) are the most frequent menopause-related clinical entities and are consistently included in the definition of pelvic floor disorders (PFDs). Nonhormonal therapies, such as lubricants and moisturizers, are indicated as first-line treatments, while the "gold standard'' is represented by topical estrogen products; however, in cancer survivors hormonal treatment is not indicated. For this reason, energy-based therapeutic approaches-for instance, through laser technologies-may be employed as alternative options in this kind of patient; however, there are no studies evaluating the efficacy of a pure diode vaginal laser in the treatment of GSM. As a consequence, with our study, we aimed to evaluate outpatient nonablative diode laser treatment in sexually active women, with contraindications, no response, or refusal of local estrogenic therapy. This prospective study included patients with GSM, aged ≥ 18 years old, with contraindications, or refusal of local estrogen therapies. Women were evaluated via the use of their Vaginal Health Index (VHI) scores, which consists of five measures: elasticity, fluid volume, pH, epithelial integrity, and moisture. Moreover, the intensity of VVA symptoms (vaginal burning, vaginal itching, vaginal dryness, dyspareunia, and dysuria) was measured using a 10 cm visual analog scale (VAS), where the left extreme of the scale (score = 0) indicated "absence of symptom" and the right indicated "symptom as bad as it could be" (score = 100). Sexual function was evaluated with the Female Sexual Function Index (FSFI-19) questionnaire. The treatment was performed using a Leonardo Dual diode laser (Biolitec Italia Srl, Milano, Italy). The laser treatment consisted of three sessions, one per month. One month after the third session, the VHI, symptom VAS, and FSFI-19 were re-evaluated. In addition, the Patient Global Impression of Improvement (PGI-I) questionnaire was collected. Our study enrolled a total of 26 consecutive patients. All patients were either in menopause or under treatment with gonadotropin-releasing hormone (GnRH). None of the patients reported adverse effects after laser treatment. In total, 19 (73.1%) patients referred improvements of their symptoms according to PGI-I scores. All domains of the FSFI-19 questionnaire, significantly improved after the diode laser treatment. The mean VHI score increased by 3.2 points, from 12.2 to 15.4 (p < 0.001). Additionally, we documented a significant improvement in symptoms affecting the VAS score, from 69.2 to 43.5 points (p < 0.001). A diode vaginal laser is an effective and easily tolerated ambulatory procedure for vaginal functional restoration in the treatment of GSM and VVA.

Comparison of laparoscopic pectopexy with the standard laparoscopic sacropexy for apical prolapse: an exploratory randomized controlled trial

To compare laparoscopic pectopexy with the standard laparoscopic sacropexy in women with symptomatic apical prolapse. An interim analysis of an exploratory randomized controlled trial with the primary objective of comparing mesh fixation time and secondary objectives were to compare total operating time, blood loss, and intra-operative and post-operative complications. Additionally, patients completed the Prolapse Quality of Life (P-QOL) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) questionnaires before surgery and during six months follow-up visit to evaluate the overall improvement in quality of life and sexual function. Patient Global Impression of Improvement (PGI-I) score was calculated on the 7-10th day post-operatively and then at six months to assess the level of improvement. The study included 30 patients; 15 underwent laparoscopic sacropexy, and 15 underwent laparoscopic pectopexy. Baseline characteristics were comparable in both groups. The mean duration of mesh fixation was significantly less with laparoscopic pectopexy (45.00±11.34 minutes) than laparoscopic sacropexy (54.67±9.35 minutes) (p=0.019). The total operating time and blood loss tended to be less in the pectopexy group, but not significantly so. Only one patient in the pectopexy group had a bladder injury. No patient in either group had any post-operative complications. One case in each group had a relapse of apical prolapse. All the domains of PISQ-12, P-QOL, and PGI-I scores improved significantly after both procedures. Laparoscopic pectopexy is a safe, feasible, and comfortable alternative procedure to the standard sacropexy for apical prolapse. We noted significantly less mesh fixation time and less operating time, while blood loss tended to be less with laparoscopic pectopexy than with laparoscopic sacropexy. Post-operative parameters were comparable between techniques. Both corrective techniques for prolapse improved the PGI-I, P-QOL, and PISQ-12 scores.

Efficacy and safety of the TENSI+ device for posterior tibial nerve stimulation: A multicenter, retrospective study.

Transcutaneous posterior tibial nerve stimulation (TC-PTNS) is a validated option for lower urinary tract symptoms (LUTS) management, with a short-term success rate of around 60% and few adverse events. Our goal was to report the efficacy and safety results of TC-PTNS using the newly issued device TENSI+ for LUTS management. A multicenter, retrospective study was conducted in 7 urology departments in France. All patients treated with TC-PTNS for LUTS using the TENSI+ device between September 2021 and February 2022 were included. All patients received supervised at-home training by a specialized nurse. All patients were asked to do daily, 20minutes sessions of TC-PTNS. Patient demographics, history, initial symptoms and previous treatment were collected at inclusion. A follow-up visit was scheduled at 3 months. Efficacy was evaluated through treatment persistence at 3 months and PGI-I (Patient Global Impression of Improvement) score. Adverse events were recorded. One hundred and three patients (86 women and 17 men) were included. All patients had overactive bladder symptoms, 64 suffered from urgency incontinence, and 24 had associated voiding symptoms. Eighteen patients had neurogenic background, and 30 previously received anticholinergics. After a median follow-up of 12 [10-21]weeks, 70 patients were still using the device (68%). PGI-I score reflected an improvement in 70.9% and was 1, 2 and 3 in 28, 26 and 19 patients respectively, while 24 were unchanged and 6 were worse. No clinical baseline parameter was predictive of success. Adverse events included pain at stimulation site (two cases) and pelvic pain (two patients), which rapidly resolved after treatment interruption. TC-PTNS with TENSI+ device is an effective option for LUTS management, with results that seem similar to other TC-PTNS approaches. Adverse events were mild and reversible after treatment interruption.

(134) Development of a Multidisciplinary Step-Care Management Algorithm and Surgical Outcomes of PGAD/GPD Patients with Tarlov Cyst-Induced Sacral Radiculopathy

Abstract Introduction Persistent Genital Arousal Disorder/Genito-Pelvic Dysesthesia (PGAD/GPD) is characterized by persistent, unwanted genital arousal and/or other genito-pelvic dysesthesia, including burning, itch, pain in the clitoris/penis, mons pubis, vulva/scrotum, vagina, urethra, perineal region, bladder, and/or rectum. Patients with PGAD/GPD are significantly bothered/distressed and catastrophization and suicidal ideation are common. In 2012 Komisaruk reported that PGAD/GPD could be mediated by Tarlov cyst-induced sacral radiculopathy. In 2016 we developed a multidisciplinary step-care management algorithm with specialists in sexual medicine, spine surgery, sex therapy, physical therapy, and neurophysiology to diagnose Tarlov cyst-induced sacral radiculopathy. Objective To utilize a novel multidisciplinary step-care management algorithm to identify PGAD/GPD patients with Tarlov cyst-induced sacral radiculopathy who could benefit from Tarlov cyst spine surgery, and to evaluate the long-term safety and efficacy of the surgery. Methods Clinical data were collected on PGAD/GPD patients who underwent Tarlov cyst spine surgery between 2016 and 2020 with at least 1-year follow-up. The management algorithm used to identify and treat Tarlov cyst-induced sacral radiculopathy involves: detailed psychosocial assessment and medical history; non-invasive assessments for sacral radiculopathy; targeted diagnostic caudal epidural injection that results in temporary clinically significant reduction of PGAD/GPD symptoms; and surgical intervention with Tarlov cyst spine surgery. Treatment outcome was based on the validated patient global impression of improvement (PGI-I) measured at intervals post-operatively. Results Ten patients (8 women, 2 men), mean age 40 years (range 19 - 66), met inclusion criteria. Patients were discharged the same day or following morning post-operatively. No serious complications occurred. Follow-up was &amp;gt;12 months (range 13 - 22 months). Seven (70%) patients reported post-operative clinical improvement on PGI-I at last follow up: two patients reported “very much better”, three patients reported “much better” and two patients reported “little better”. Two patients had no improvement. Only one patient was much worse, however we believed that the PGI-I score of 6 reflected the worsening of the PGAD/GPD condition and not a specific result of the surgical procedure. Conclusions Distressing PGAD/GPD symptoms can be caused by Tarlov cyst-induced sacral radiculopathy. This case series with long-term follow-up demonstrates that spine surgery effectively treats PGAD/GPD patients with Tarlov cyst-induced sacral radiculopathy established by a multidisciplinary step-care management algorithm. Imbricating the Tarlov cyst using minimally invasive spine surgery techniques was associated with clinical improvement in 70% of these select patients. Disclosure No

MP37-16 A NOVEL DEVICE FOR SELECTIVE EXTRACORPOREAL MAGNETIC INNERVATION: RESULTS ON WOMEN WITH STRESS URINARY INCONTINENCE

You have accessJournal of UrologyCME1 Apr 2023MP37-16 A NOVEL DEVICE FOR SELECTIVE EXTRACORPOREAL MAGNETIC INNERVATION: RESULTS ON WOMEN WITH STRESS URINARY INCONTINENCE Serena Maruccia, Marta Barba, Alice Cola, Silvia Volontè, Giuseppe Marino, Tomaso Melocchi, Desirè de Vicari, Stefano Terzoni, and Matteo Frigerio Serena MarucciaSerena Maruccia More articles by this author , Marta BarbaMarta Barba More articles by this author , Alice ColaAlice Cola More articles by this author , Silvia VolontèSilvia Volontè More articles by this author , Giuseppe MarinoGiuseppe Marino More articles by this author , Tomaso MelocchiTomaso Melocchi More articles by this author , Desirè de VicariDesirè de Vicari More articles by this author , Stefano TerzoniStefano Terzoni More articles by this author , and Matteo FrigerioMatteo Frigerio More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003275.16AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The international guidelines include conservative and surgical treatments for stress urinary incontinence on women. Extracorporeal magnetic stimulation (EMS) is a conservative option for pelvic floor disorders. MS is a non-invasive therapeutic device that interacts with the neuromuscular tissue through an electromagnetic field, thus inducing intense contractions that stimulate pelvic floor muscles. Recently, the TOP Flat Magnetic Stimulation (TOP FMS) has been developed as new generation of traditional magnetic chairs. This new technology generates electromagnetic fields with a homogenous profile optimized for the stimulation of the pelvic area, allowing greater recruitment of muscle fibres without creating areas of uneven stimulation intensity. We sought to assess the short-term outcomes, both subjective and objective, in women suffering from SUI. METHODS: In this non-randomized trial, a clinical interview was performed to investigate the presence of isolated or predominant stress urinary incontinence (SUI), subsequently confirmed by a stress test. Urogenital examination was used to exclude significant prolapse (POP-Q stage >2 or higher). Patients could choose to receive the new treatment (eight sessions of 25 minutes of TOP FMS in one month) or home-based, unsupervised, non-personalized pelvic floor muscles training (PFMT) according to the International Urogynecological Association leaflets for one month. At baseline (T0) and at the end of the treatments (T1) the International Consultation on Incontinence Questionnaire-Short Form questionnaire (ICIQ-SF) and the Incontinence Impact Questionnaire (IIQ-7- SF) were administered. The stress test was performed again after treatment and the Patient Global Impression of Improvement (PGI-I) questionnaire was administered. RESULTS: 50 patients were enrolled (1:1 allocation ratio). Improved PGI-I scores were reported by 72% intervention patients vs 20% controls (p<0.001) after 1 month. According to the stress test at T1 (1 month), the objective cure rate resulted 40% for TOP FMS and 0% for PFMT (p<0.001). Significant improvements were observed in the TOP FMS, IIQ-7 and ICIQ-SF scores (p<0.05) but not in the FSFI-19 scores. No adverse events were reported either with TOP FMS or PFMT. CONCLUSIONS: The TOP FMS appears promising in patients with isolated or predominant SUI, compared to than unsupervised, non-individualized PFMT, in treating SUI in women. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e520 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Serena Maruccia More articles by this author Marta Barba More articles by this author Alice Cola More articles by this author Silvia Volontè More articles by this author Giuseppe Marino More articles by this author Tomaso Melocchi More articles by this author Desirè de Vicari More articles by this author Stefano Terzoni More articles by this author Matteo Frigerio More articles by this author Expand All Advertisement PDF downloadLoading ...

Factors associated with polyacrylamide hydrogel outcomes in women with stress urinary incontinence.

Knowledge of factors associated with superior outcomes in women treated with urethral bulking agents for stress urinary incontinence (SUI) remains limited. The aim of this study was to examine associations between post-treatment outcomes in women who had undergone polyacrylamide hydrogel injections for SUI, and physiological and self-reported variables captured during pre-treatment clinical evaluation. A cross-sectional study was undertaken in female patients treated for SUI with polyacrylamide hydrogel injections by a single urologist between January 2012 and December 2019. Post-treatment outcome data were gathered in July 2020 using the Patient Global Impression of Improvement (PGI-I), Urinary Distress Inventory-short form (UDI-6), Incontinence Impact Questionnaire (IIQ7), and International Consultation on Incontinence Questionnaire Short Form (ICIQ SF). All other data were gathered from women's medical records including pre-treatment patient-reported outcomes. Associations between post-treatment outcomes and pre-treatment physiological and self-reported variables were investigated using regression models. One hundred seven of the 123 eligible patients completed post-treatment patient-reported outcome measures. Mean age was 63.1 years (range 25-93 years), and median time between first injection and follow-up was 51 months (inter-quartile range 23.5-70 months). Fifty-five (51%) women had a successful outcome based on PGI-I scores. Women with type 3 urethral hypermobility pre-treatment were more likely to report treatment success (PGI-I). Poor bladder compliance pre-treatment was associated with greater urinary distress, frequency and severity (UDI-6 and ICIQ) post-treatment. Older age was associated with worse urinary frequency and severity (ICIQ) post-treatment. Associations between patient-reported outcomes and time between first injection and follow-up were trivial and not statistically significant. Severity of pre-treatment incontinence impact (IIQ-7) was associated with worse incontinence impact post-treatment. Type 3 urethral hypermobility was associated with a successful outcome, whereas pre-treatment incontinence impact, poor bladder compliance and older age were associated with poorer self-reported outcomes. Long-term efficacy appears to hold in those who responded to initial treatment.

Medium Term Outcomes of TVT-Abbrevo for the Treatment of Stress Urinary Incontinence: Efficacy and Safety at 5-Year Follow-Up.

Background and objectives: Stress urinary incontinence (SUI) is the most common type of urinary incontinence, affecting approximately 46% of adult women. After failure of conservative treatment, the mid-urethral sling (MUS) is considered the most effective and safe surgical procedure for SUI. In 2012, Waltregny et al. introduced a new trans-obturator tension-free vaginal tape (TVT) procedure, named TVT-abbrevo (TVT-A). The aim of the present study is to evaluate the efficacy and safety of the TVT-A procedure in women with pure SUI at 5-year follow-up. Materials and Methods: All women who complained of pure SUI symptoms with concomitant urodynamic stress incontinence (USI) were prospectively enrolled and treated with the TVT-A procedure. Postoperative subjective outcome measures included: International Consultation on Incontinence Questionnaire–Short Form (ICI-Q SF), Patient Global Impression of Improvement (PGI-I) scale, and patient degree of satisfaction scale. A PGI-I score ≤ 2 and a patient-satisfaction score ≥8 were used to define subjective success. Objective success was defined as the absence of urine leakage during a cough stress test. Adverse events were collected according to the Clavien–Dindo classification during follow-up. Results: Univariable analysis was used to investigate outcomes. Fifty women who met the inclusion criteria underwent TVT-A implantation. At 5 years after TVT-A implantation, 38 out of 45 (84.4%) patients were subjectively cured (p for trend 0.05), and 40 out of 45 (88.9%) patients were objectively cured (p for trend 0.04). A significant trend of de novo OAB symptoms was reported (22.2% [10/45]) at the 5-year follow-up. No serious early or late complications such as urethral/bladder injury, persistent groin-thigh pain, and sexual dysfunction that required mesh removal were detected. The univariate analysis did not reveal any risk factors (i.e., age, body mass index (BMI), menopause, obstetric factors, and preoperative ICIQ- SF questionnaire) statistically associated with failure of the TVT-A procedure. Conclusions: In conclusion, the 5-year follow-up results of this study demonstrated that TVT-A is a safe and effective option for treatment of SUI with a very low rate of post-operative groin–thigh pain

Is artificial urinary sphincter surgery safe and effective in elderly males aged 70 years and above?

To evaluate the clinical outcomes and patient satisfaction rate between men aged under and over 70 years who underwent artificial urinary sphincter (AUS) surgery. A prospective review of all men who received AUS between January 2008 and January 2018 was undertaken with a minimum 24-month review. All patient demographics and surgical outcomes including data on the Incontinence Impact Questionnaire, Patient Global Impression of Improvement (PGI-I) and National Surgical Quality Improvement Program Frailty Index (NSQIP-FI) scores, as well as patient satisfaction rates, were recorded. Of the 245 AUS implanted, 60 patients were aged ≥70 years with 45 virgin cases and 15 revision AUS. Reduction in mean pad use and weight over 24 hours were significant at 0.21 (0-1) pads and 8 (0-30) g in both groups with no significant difference (P=0.76). Kaplan-Meier estimates of AUS survival showed no significant difference between men aged ≥ and <70 years at 1 year (98% versus 96%; P=0.44). The multivariate logistic regression model showed that radiation (adjusted odds ratio [OR] 3.8, 95% CI 1.4-6.8; P < 0.01) was a significant predictor of AUS revision, while age ≥ 70 years (adjusted OR 1.0, 95% CI 0.8-8.8; P=0.14) and frailty (NSQIP-FI ≥ 0.27 adjusted OR 0.9, 95% CI 0.2-7.6; P=0.82) were not. There were no significant differences in PGI-I scores (P=0.43) and overall satisfaction rate (83% versus 84%; P=0.44) between the two groups. Men aged ≥70 years reported similar clinical efficacy as men aged <70 years in terms of device survival and satisfaction rates following AUS surgery.

Botulinum toxin A injection to the external urethral sphincter for voiding dysfunction in females: A tertiary center experience.

The aim of this study is to examine the functional outcomes of ona-botulinum toxin A (BTX-A) injection into the external urethral sphincter (EUS) for female patients with nonneurogenic nonrelaxing sphincter as the underlying cause of voiding dysfunction (VD). A retrospective analysis was performed for all the patients with the urodynamic findings of higher than expected maximum urethral closure pressure (MUCP) who received their first injection during the study period. All patients were evaluated with preoperative videourodynamic study and urethral pressure profilometry and received 100 U of EUS BTX-A. Patients aged less than 18 years and those with neurogenic bladder were excluded. All patients were followed up with the free flow, postvoid residuals (PVR), and patient global impression of improvement (PGI-I) scale at 6 weeks and then at 3 monthly intervals. We identified 35 female patients with a mean age of 37.5 ± 15 years (range 18-72 years) with a mean follow-up of 20 months. More than 50% of patients had a history of prior surgical intervention and 28 (80%) patients were catheter dependent, a suprapubic catheterization, or clean intermittent self-catheterization. Mean MUCP was 97.1 ± 22 cm of water. After treatment with BTX-A, 21 (60%) patients were able to void per urethral (p = 0.02). The mean maximum flow rate (Qmax) improved from 8.8 to 11 mls/s and the mean PVRdecreased from 200 to 149 mls (p &lt; 0.05). On multivariate analysis, we identified high preoperative PVR, high preoperative actualMUCP, and previous surgical intervention (urethral dilatation, sacral neuromodulation, and pelvic surgery) as predictors of successful voiding restoration. The mean duration of response was 4.7 months, 46% of patients requested repeat injection, and 29% were established on maintenance injections. On the 5-point PGI-I score, 13 (37%), 12 (34%), and 10 (29%) patients reported good, some, and no improvement, respectively. Quality of life was also improved in 60% of patients. Two patients had transient stress urinary incontinence (for&lt;6 weeks) and there were no significant long-lasting adverse events. EUS BTX-A is a valid treatment option for VD considering therapeutic options are limited. The patient must be made aware of the need for repeat treatments.

Long-term outcomes of polyacrylamide hydrogel treatment in women with stress urinary incontinence.

Long-term outcomes of polyacrylamide hydrogel treatment in women with stress urinary incontinence.

Comparison of outcomes between pessary use and surgery for symptomatic pelvic organ prolapse: A prospective self-controlled study.

PurposeWe compared the degree of pelvic floor symptom improvement between pessary use and prolapse surgery.Materials and MethodsPessary-naïve women who elected prolapse surgery were enrolled and used a pessary preoperatively (for ≥7 days and ≤30 days). Pelvic floor symptoms were assessed at baseline, after pessary use, and at 3 months postoperatively. The primary outcome was concordance in the degree of symptoms improvement between pessary use and surgery, as assessed by Patient Global Impression of Improvement (PGI-I). Secondary outcomes were related to prolapse specific symptoms on validated questionnaires (POPDI-6, PFIQ-7). The McNemar test was used for comparisons of discordant pairs for comparisons of the PGI-I ratings after pessary use and surgery.ResultsSixty-one participants were enrolled (March 2016 through April 2019) and 58 patients used a pessary. Mean±standard deviation age was 60.7±10.7 years; 24.1% had prior hysterectomy, and 13.8% had prior prolapse surgery. While both treatments demonstrated symptomatic improvement, concordance in the degree of overall improvement on the PGI-I score was poor (n=40); responses significantly favored more improvement postoperatively (p<0.001). Pessary use and surgery were associated with significant improvements in prolapse symptoms from baseline on POPDI-6 (both p<0.001) and POPIQ-7 (pessary, p=0.002; surgery, p<0.001). The degree of improvement was larger postoperatively compared to post-pessary use on POPDI-6 (p<0.001) and PFIQ-7 (p=0.004).ConclusionsBoth pessary use and surgery significantly improved pelvic floor symptoms from baseline. However, concordance in degrees of improvement between these treatments was poor, with more favorable outcomes after surgery for prolapse symptoms.

Intralesional collagenase Clostridium histolyticum vs. verapamil injections in males with Peyronie's Disease: A prospective, matched-pair, non-blinded, randomised clinical study comparing clinical outcomes and patient satisfaction rates.

PurposeTo compare clinical outcomes and patient satisfaction rates between intralesional verapamil (ILV) and collagenase Clostridium histolyticum (CCH) injections in males with Peyronie’s disease (PD).Materials and MethodsFollowing ethics approval, PD patients were prospectively enrolled in this open-label non-blinded study. Patients were randomised to receive ILV or CCH injections with penile remodelling every fortnightly for 6 courses. Patient demographics, change in penile curvature, International Index of Erectile Function-15 and Peyronie’s Disease Questionnaire (PDQ) scores as well as overall patient satisfaction and Patient Global Impression of Improvement (PGI-I) scores were recorded at pre-treatment and 6-, 12- and 24-month post-treatment.ResultsA total of 50 males were recruited and divided into ILV (n=25) and CCH (n=25) groups. The mean changes in penile curvature were -16.8 (standard deviation [SD] 7.65) degrees in ILV and -28.2 (SD 11.5) degrees in CCH groups (p<0.01). Patients in the CCH group scored better than the ILV group on the PDQ psychosexual symptoms (-2.14 vs. -2.9; p<0.01) and symptom bother score (-3.88 vs. -4.16; p=0.08). Minor treatment-related adverse events were more common in the CCH group. The overall satisfaction rate on a 5-point scale was 4.1 in ILV and 4.5 in CCH groups, and there was no statistically significant difference in the PGI-I scores between the 2 groups (p=0.14).ConclusionsCCH therapy is more effective than ILV to treat a carefully selected group of males with PD, with a reasonable safety profile and a higher high level of patient satisfaction rate in the short term.

Long-term outcomes of transvaginal mesh surgery for pelvic organ prolapse: a retrospective cohort study

BackgroundThe objective of this study was to evaluate the overall outcomes and complications of transvaginal mesh (TVM) placement for the management of pelvic organ prolapse (POP) with different meshes with a greater than 10-years of follow-up.MethodsWe performed a retrospective review of patients with POP who underwent prolapse repair surgery with placement of transvaginal mesh (Prolift kit or self-cut Gynemesh) between January 2005 and December 2010. Baseline of patient characteristics were collected from the patients’ medical records. During follow-up, the anatomical outcomes were evaluated using the POP Quantification system, and the Patient Global Impression of Improvement (PGI-I) was used to assess the response of a condition to therapy. Overall postoperative satisfaction was assessed by the following question: “What is your overall postoperative satisfaction, on a scale from 0 to 10?”. Relapse-free survival was analyzed using Kaplan–Meier curves.ResultsIn total, 134 patients were included. With a median 12-year (range 10–15) follow-up, 52 patients (38.8%) underwent TVM surgery with Prolift, and Gynemesh was used 82 (61.2%). 91% patients felt that POP symptom improved based on the PGI-I scores, and most satisfied after operation. The recurrence rates of anterior, apical and posterior compartment prolapse were 5.2%, 5.2%, and 2.2%, respectively. No significant differences in POP recurrence, mesh-associated complications and urinary incontinence were noted between TVM surgery with Prolift versus Gynemesh.ConclusionsTreatment of POP by TVM surgery exhibited long-term effectiveness with acceptable morbidity. The outcomes of the mesh kit were the same as those for self-cutmesh.