Predominant Stress Urinary Incontinence Research Articles

A Single Injection of Platelet-Rich Plasma Injection for the Treatment of Stress Urinary Incontinence in Females: A Randomized Placebo-Controlled Trial

ObjectiveTo determine the efficacy of a single injection of platelet-rich plasma into the anterior vaginal wall at the mid-urethra compared to placebo, as there is emerging evidence that platelet-rich plasma may help treat female stress urinary incontinence. MethodsThis was a single-blind, randomized, placebo-controlled clinical trial at a single institution. Females with bothersome, demonstrable stress-predominant urinary incontinence were enrolled. Participants were randomized to either injection of 5 mL autologous platelet-rich plasma or saline at the anterior vaginal wall at the mid-urethra. The primary outcome was composite treatment success at six months, defined as a negative cough stress test and an answer of “much better” or “very much better” on the Patient’s Global Impression of Improvement. ResultsFifty patients were enrolled in the study and randomized to the platelet-rich plasma group (n = 25) or the saline placebo group (n = 25). There was no statistically significant difference in the primary outcome between the two groups. Adverse events were minor, and the rate of adverse events was similar between both groups. ConclusionsIn this randomized placebo-controlled study, we were unable to demonstrate a difference in stress urinary incontinence treatment success between platelet-rich plasma and saline injections. At this time, there is insufficient evidence to offer a one-time platelet-rich plasma injection into the anterior vaginal wall for treatment of female stress urinary incontinence.

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 use of midurethral sling in the correction of low-stage cystoceles: a prospective randomized trial

Introduction and hypothesisThe objective was to assess whether midurethral slings (MUS) can improve both stress urinary incontinence (SUI) and cystoceles. MUS with anterior colporrhaphy (AC) as a treatment for SUI with cystocele is more invasive and carries greater risk than MUS alone.MethodsThis is a prospective randomized study involving women with stage 1 or 2 cystocele and SUI, who were > 21 years of age, who had had no previous surgery for SUI. Predominant SUI, symptomatic anterior pelvic organ prolapse, and informed consent were mandatory. Patients were randomized as to whether AC had been performed. The sling procedure was left to the surgeon’s discretion: pubovaginal sling, tension-free vaginal tape, or trans-obturator tape. Success was defined as a negative stress test and no evidence of cystocele upon local examination.ResultsNinety-eight patients were enrolled, 48 underwent MUS, and 50 underwent MUS and AC. Mean age ± SD was 44.96 ± 8.13 years. Baseline characteristics were similar. Operative time and blood loss were significantly higher in the MUS/AC group (p = 0.01 and 0.02 respectively). At 3 months, success was 79.1% and 77.8% in the MUS and MUS/AC groups respectively. This was maintained until 6 months (79.1% and 77.8% respectively). At 1 year, the results were comparable with success rates of 96.2% and 87.0% in the MUS and MUS and AC groups respectively. Symptom scores were comparable at 6- and 12-month evaluations.ConclusionMidurethral slings correct symptomatic stage 1 or 2 cystoceles without the need for AC, which carries the risk of a significantly longer procedure and more significant blood loss.

Three-year cost utility analysis of mini versus standard slings: A trial based economic evaluation.

To report on the cost-effectiveness of adjustable anchored single-incision mini-slings (mini-slings) compared with tension-free standard mid-urethral slings (standard slings) in the surgical management of female stress urinary incontinence (SUI). Data on resource use and quality were collected from women aged ≥18 years with predominant SUI undergoing mid-urethral sling procedures in 21 UK hospitals. Resource use and quality of life (QoL) data were prospectively collected alongside the Single-Incision Mini-Slings versus standard synthetic mid-urethral slings Randomised Control Trial (SIMS RCT), for surgical treatment of SUI in women. A health service provider's (National Health Service [NHS]) perspective with 3-year follow-up was adopted to estimate the costs of the intervention and all subsequent resource use. A generic instrument, EuroQol EQ-5D-3L, was used to estimate the QoL. Results are reported as incremental costs, quality adjusted life years (QALYs) and incremental cost per QALY. Base case analysis results show that although mini-slings cost less, there was no significant difference in costs: mini-slings versus standard slings: £-6 [95% CI -228-208] or in QALYs: 0.005 [95% CI -0.068-0.073] over the 3-year follow-up. There is substantial uncertainty, with a 56% and 44% probability that mini-slings and standard slings are the most cost-effective treatment, respectively, at a £20 000 willingness-to-pay threshold value for a QALY. At 3 years, there is no significant difference between mini-slings and standard slings in costs and QALYs. There is still some uncertainty over the long-term complications and failure rates of the devices used in the treatment of SUI; therefore, it is important to establish the long-term clinical and cost-effectiveness of these procedures.

Novel clinically meaningful scores for the ICIQ-UI-SF and ICIQ-FLUTS questionnaires in women with stress incontinence

AimTo establish, for the first time, the clinically important differences for the ICIQ-UI-SF and ICIQ-FLUTS questionnaires following surgical and conservative treatments for stress-predominant urinary incontinence in women.MethodsData from the SIMS and OPAL randomised controlled trials were analysed using an anchor-based method. Clinically important difference (CID; score change indicating a successful outcome) and minimal important difference (MID; score change indicating the smallest noticeable difference) were estimated using the PGI-I scale as the anchor.ResultsFor ICIQ-UI-SF, following surgical management, CIDs were 5.0 (95%CI 4.3, 5.6) at 1 year and 4.9 points (95%CI 4.2, 5.5) at 3 years, while following conservative management, CIDs were 4.0 (95%CI 3.4, 4.5) at 1 year and 4.6 points (95%CI 4.0, 5.2) at 2 years. For ICIQ-FLUTS, the CID was 3.4 points (95%CI 2.9, 4.0) at 1 year for both surgical and conservative management. MIDs for ICIQ-UI-SF, after surgical treatment, were 4.7 (95% CI 3.2, 6.1) at 1 year and 1.6 points (95%CI –0.2, 3.0) at 3 years, and after conservative treatment they were 1.7 (95% CI 1.0, 2.5) at 1 year and 1.9 points (95%CI 1.1, 2.7) at 2 years. For ICIQ-FLUTS, MIDs were 1.8 (95% CI 0.6, 3.1) at 1 year and 3.2 points (95%CI 2.0, 4.4) at 2 years after surgical treatment, and 1.3 (95%CI 0.6, 1.9) at 1 year and 1.9 points (95%CI 1.1, 2.6) at 2 years after conservative treatment.ConclusionOur study is the first to establish the CID for the ICIQ-UI-SF and ICIQ-FLUTS that women would associate with a successful outcome 3-years post-surgery and 2-years post-conservative treatment of stress-predominant urinary incontinence. The MID was lower following conservative compared to surgical treatment.

Management of female stress urinary incontinence with single-incision mini-sling (Altis®): 36 month multicenter outcomes.

To assess noninferiority of the safety and effectiveness of the Altis® Single Incision Sling (SIS) with standard midurethral transobturator and/or retropubic slings through 36 months in a prospective, longitudinal, nonrandomized USFood and Drug Administration (FDA) 522 cohort study. Adult females with confirmed predominant stress urinary incontinence (UI) through cough stress test (CST) or urodynamics and failed two noninvasive incontinence therapies. Effectiveness endpoints included objective dryness, negative CST, adverse events, and revision/resurgery through 36 months. The primary effectiveness endpoint was reduction from baseline in 24-h pad weight of ≥50% at 6 months, as requested by the FDA, and is included as a study point in this paper. Primary safety endpoint was rate of related serious adverse events (SAE) through 36 months. Noninferiority margins of 15% and 10% were prespecified for the effectiveness and safety endpoints. Due to the observational nature of the cohort study, a propensity methodology was conducted to assess the effect of potential confounding variables on the primary endpoints between groups. Three hundred fifty-fivewomen underwent the sling procedure (n = 184 Altis; n = 171 Comparator). One hundred fourty(76%) Altis subjects and 101 (59%) Comparator subjects completed follow-up through 36 months. At 36 months, for the effectiveness endpoint, the difference in proportions of -0.005 for Altis versus Comparator (95% confidence interval [CI]: -0.102 to 0.092) was statistically significant (p = 0.002), supporting the hypothesis that Altis is noninferior to Comparator. Furthermore, both groups demonstrated high objective efficacy; in the Altis arm n = 99 (81.8%) subjects were a success, and in the Comparator arm, n = 79 (82.3%) subjects were a success. Additionally, regarding the CST, Altis was found to be noninferior to the Comparator at every study visit, and the rate of negative CST remained above 80% for both groups (p < 0.001). At 36 months, Altis (n = 2; 1.1%) and Comparator (n = 4; 2.3%) subjects experienced a device and/or procedure-related SAE. The difference in proportions of 0.013 for Altis versus Comparator (95%CI: -0.023 to 0.048) was statistically significant (p < 0.001), demonstrating that Altis is noninferior to Comparator with respect to the primary safety endpoint throughout the study. There were 62 (36.3%) retropubic midurethral slings (RMUS), 96 (56.1%) transobturator midurethral slings (TMUS), and 13 (7.6%) SIS slings in the Comparator group. For the 36 month effectiveness endpoint, assessing the noninferiority of Altis versus RMUS and Altis versus TMUS, 99 (81.8%) Altis and 37 (90.2%) RMUS were a success, trending toward statistical significance, however, it cannot be determined to be noninferior (p = 0.092). Ninty-nine(81.8%) Altis and 33 (71.7%) TMUS were a success; this was statistically significant (p < 0.001), demonstrating Altis was noninferior to TMUS. Rates of negative CST were 122 (87.1%) Altis, 40 (93.0%) RMUS (p < 0.001), and 44 (91.7%) TMUS (p < 0.001). CST demonstrated that Altis was noninferior to RMUS and Altis was noninferior to TMUS at 36 months. Altis single-incision sling was noninferior to standard midurethral sling for treatment of stress UI, throughout the study and at 36 months. Furthermore, adverse event rates were low.

A randomized controlled pilot trial to assess the effectiveness of a specially formulated food supplement and pelvic floor muscle training in women with stress-predominant urinary incontinence

BackgroundPelvic floor muscle training (PFMT) is the first-line treatment approach for stress urinary incontinence. Creatine and leucine have been shown to improve muscle function. Our aim was to assess the effectiveness of a food supplement and PFMT in women with stress-predominant urinary incontinence.MethodsWomen with stress-predominant urinary incontinence were randomized in 1:1 ratio to receive daily oral supplementation for six weeks with either a food supplement (treatment group) or placebo (control group). Both groups were instructed to perform standardized daily PFMT. The primary outcome was the Urogenital Distress Inventory Short Form (UDI-6) score. Secondary outcomes were the Incontinence Impact Questionnaire (IIQ-7) score, Patient’s Global Impression of Severity (PGI‐S), and Biomechanical Integrity score (BI-score) measured by Vaginal Tactile Imager. To have a power of 80% and a significance level of 5% to detect a decrease of 16 points in the UDI-6 score, a sample size of 32 was needed, with 16 patients in each arm of our trial.ResultsSixteen women in the control group and sixteen in the treatment group completed the trial. Between-group analysis revealed no significant differences between the control and treatment group except for mean change (delta) in vaginal squeeze pressure [(cmH2O, mean ± SD), 5 ± 12 vs. 15 ± 15, P = 0.04] and mean change (delta) in PGI-S score [(mean ± SD), -0.2 ± 0.9 vs. -0.8 ± 0.8, P = 0.04]. Within-group analysis showed that UDI-6 and IIQ-7 scores improved significantly from baseline to six weeks in the treatment group but not in the control group [UDI-6 score (mean ± SD) 45 ± 21 vs. 29 ± 21, P = 0.02; 43 ± 18 vs. 33 ± 26, P = 0.22] [IIQ-7 score (mean ± SD) 50 ± 30 vs. 30 ± 21, P = 0.01; 48 ± 23 vs.40 ± 28, P = 0.36]. PGI-S scores only improved in the treatment group from baseline to six weeks after treatment [PGI-S score (mean ± SD) 3.1 ± 0.8 vs. 2.3 ± 0.8, P = 0.0001]. BI-score, on average, improved significantly in the treatment and control group as well [SD unit, mean, from − 1.06 to -0.58, P = 0.001; from − 0.66 to -0.42, P = 0.04].ConclusionsWomen with stress-predominant urinary incontinence receiving a specially formulated supplement in addition to daily PFMT for six weeks had significantly improved urinary symptoms (decrease in UDI-6 score and IIQ-7) and BI-score compared to their baseline.Trial registrationClinicalTrials.gov Identifier: NCT05358769. 27/04/2022.

A Randomized Controlled Trial to Assess the Effectiveness of a Specially Formulated Food Supplement and Pelvic Floor Muscle Training in Women With Stress-Predominant Urinary Incontinence [ID: 1372768

INTRODUCTION: The objective of this study was to assess the effectiveness of a creatine-leucine-based food supplement and standardized pelvic floor muscle training (PFMT) in women with stress-predominant urinary incontinence (SUI). METHODS: Women with SUI were randomized to receive daily oral supplementation for 6 weeks with either a supplement or placebo. Both groups were instructed to perform daily PFMT at an intensity of at least 75% of one repetition maximum of 45 pelvic floor muscle contractions per day. The primary outcome was the Urogenital Distress Inventory Short Form (UDI-6) score. Secondary outcomes were the Incontinence Impact Questionnaire (IIQ-7) score, Biomechanical Integrity (BI) score measured by Vaginal Tactile Imager. To have a power of 80% and a significance level of 5%, a sample size of 32 was needed. The trial was IRB approved. RESULTS: Within-group analysis showed that UDI-6 and IIQ-7 scores improved significantly from baseline to 6 weeks in the treatment group but not in the control group (UDI-6 score [mean±SD], 45±21 versus 29±21, P=.02; 43±18 versus 33±26, P=.22) (IIQ-7 score [mean±SD], 50±30 versus 30±21, P=.01; 48±23 versus 40±28, P=.36). Out of the 52 examined VTI parameters, significantly more parameters improved in the treatment group compared to the control group (11/52 versus 3/52, P=.04). BI-score, on average, improved significantly in the treatment and control group as well (SD unit, mean, from −1.06 to −0.58, P=.001; from −0.66 to −0.42, P=.04). CONCLUSION: Women with SUI receiving a specially formulated supplement in addition to daily PFMT for 6 weeks had improved urinary symptoms (significant decrease in UDI-6 and IIQ-7 scores) and better BI score compared to baseline.

The efficacy and feasibility of fractional CO2 laser therapy for the treatment of urinary incontinence: a multicentric case-control study.

Female urinary incontinence is a significant public health problem. Conservative treatments require high patient compliance, while surgery often leads to more complications and recovery time. Our aim is to evaluate the efficacy of microablative fractional CO<inf>2</inf> laser (CO<inf>2</inf>-laser) therapy in women with urinary incontinence (UI). This is a retrospective analysis of prospectively collected data on women with stress urinary incontinence (SUI) and mixed urinary incontinence (MUI) with predominant SUI subjected to four sessions of CO<inf>2</inf>-laser therapy performed once a month, between February 2017 and October 2017, with a 12-month follow-up. The subjective Visual Analogue Scale (VAS) 0-10 was used to score and variables were evaluated at baseline and at one, six and 12 months after initiation of therapy. Finally, results were compared to a control group. The cohort consisted of 42 women. The proportion of patients with vaginal atrophy among those younger than 55 years was substantially lower (3/23; 13%) than among those older than 55 years (15/19; 78.9%). CO<inf>2</inf> laser treatment was associated with a significant improvement in VAS scores recorded one-month, six-months, and one-year, after conclusion of therapy (P<0.001). VAS scores improved significantly in patients with either SUI (26/42; 61.9%) or mixed UI (16/42; 38.1%). No major post treatment complications were registered. Women with vaginal atrophy demonstrated significantly better results (P<0.001). Results confirm the efficacy and a good safety profile, for CO<inf>2</inf> laser treatment in SUI, mostly in women with postmenopausal vaginal atrophy and should be considered as a treatment option for female patients with concomitant SUI and vaginal atrophy.

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 ...

TOT in combination with solifenacin or intravaginal prasterone in postmenopausal women with mixed urinary incontinence: A retrospective analysis in 112 patients.

The aim of this study was to compare the efficacy of the transobturator tape (TOT) procedure combined with solifenacin (TOT-S) or prasterone (TOT-P) in postmenopausal women affected by mixed urinary incontinence (MUI) with a predominant stress urinary incontinence component. This is a retrospective analysis including 112 patients: 60 patients of the TOT-S group and 52 patients of the TOT-P group. Physical examination, 3-day voiding diary, urodynamic tests, and Vaginal Health Index (VHI) were compared at the beginning of the analysis and after 12 weeks of follow-up (FU). Specific questionnaires were administered to indagate the impact on women's quality of life and sexual function. After 12 weeks of FU, the detrusor's peak flow pressure was significantly different between the two groups (p= .02). Detrusor overactivity decreased only in the TOT-P group (p= .05). At the end of FU, 58 patients (96.7%) of the TOT-S group and 50 patients (96.2%) of the TOT-P group were dry at the stress test. A significative group difference was observed in urge urinary incontinence (24 h) (p= .01) but not in the mean number of voids (24 h) and urgent micturition events (24 h). VHI improved only in the TOT-P group (12.57 ± 3.80 vs. 19.75 ± 4.13, p< .0001). The questionnaires and Patient Global Index of Improvement (PGI-I) scores showed comparable improvements, while the Female Sexual Function Index improved especially in the TOT-P group (p< .001). In postmenopausal women with MUI, TOT-P demonstrated the same effectiveness as TOT-S in reducing urinary symptoms. In addition, TOT-P increased VHI and sexual function scores compared with TOT-S.

Transobturator Versus Single-Incision Sling for Predominant Stress Urinary Incontinent (SUI) Women: A Randomized Controlled Trial

<h3>Study Objective</h3> To assess whether single-incision sling (SIS) is non-inferior to transobturator (TOT) sling regarding efficacy for treating women with confirmed stress-predominant urinary incontinence (SUI). <h3>Design</h3> Prospective, parallel, non-blinded, multicenter, randomized controlled study. <h3>Setting</h3> Two tertiary, academic hospitals. <h3>Patients or Participants</h3> Ninety-nine patients were followed 6 and 12 months after surgery. <h3>Interventions</h3> Mid-urethral TOT sling (Obtryx II® – Halo; n=50) with regional anesthesia or SIS (Solyx®; n=49) with local anesthesia. Intention-to-treat analysis was performed. <h3>Measurements and Main Results</h3> The primary outcome was improvement in the Patient Global Improvement (PGI-I) and Kings Health Questionnaire (KHQ) instruments after treatment. Secondary outcomes were subjective improvement (improved/cured), number of reoperations, estimated blood loss (EBL), operative room (OR) time, post-op complications. Both groups were homogeneous (p=NS) regarding age(p=0.728), race(p=0.112), body mass index(p=0.082), menopausal status(p=0.359), vaginal deliveries(p=0.839), tobacco use(p=0.385) and sexual activity(p=0.605). There was no difference in the PGI after 6(p=0.067) and 12 months(p=0.128) of treatment between the groups. KHQ scores were better improved in the TOT group for the following domains: role limitations(p=0.049), physical limitations(p=0.0105) and severity measures(p=0.0416). The other domains (general health, incontinence impact, personal relationships, emotions, sleep/energy) were not different between the groups. After 12 months, TOT group was only superior to SIS in the general health domain(p=0.0189). However, the TOT group presented higher subjective improvement after 6 months (93.62 vs 75%; p=0.013) than SIS group, with no significant difference after 12 months. Six patients from the SIS group were reoperated versus three from the TOT group(p=0.309). The SIS group presented a smaller EBL (17.95 vs 33.9 ml; p=<0.005) and shorter OR time (16 vs 40.3 min; p<0.005) than the TOT group. Erosion rate was higher in the SIS group(p=0.059). No major complications occurred in both groups. <h3>Conclusion</h3> TOT and SIS groups were equally effective after 6 and 12 months after treatment according to the PGI-I and KHQ instruments. Subjective improvement was higher in the TOT group after 6 months, with no difference after 12 months.

Long-term outcomes of Altis® single-incision sling procedure for stress urinary incontinence.

In women with predominant stress urinary incontinence (SUI), recent data are still controversial regarding the short-term outcomes of mini-slings and there is a lack of evidence about the outcomes in the long term. Our aim was to evaluate the long-term effectiveness and complication rates of Altis® (Coloplast). A total of 145 women with clinical SUI were implanted with an Altis® sling between April 2012 and December 2015. Women completed the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) before the intervention and in the following consultations. A telephone interview was performed in January 2021 and 131 women (90%) were available for re-evaluation. The main outcome was treatment success, defined as no self-reported SUI symptoms and no reintervention. Secondary outcomes included response to ICIQ-SF (cure defined as ICIQ-SF = 0) and Patient Global Impression of Improvement (PGI-I) questionnaires, de novo overactive bladder (OAB) symptoms and adverse events. The overall treatment success was 73.3% at a median follow-up of 8years. The ICIQ-SF cure rate was 66.1%. In the PGI-I, 70.4% answered that they were much better or very much better. Later postoperative complications included 2 cases (1.5%) of vaginal extrusion (requiring surgical removal of the eroded mesh segment), 3 (2.3%) cases of infravesical obstruction (which led to sling section), de novo urgency in 20 patients (15.3%), and mild dyspareunia in 2 (1.5%) patients. The Altis® sling was safe and effective in a long-term follow-up, improving the quality of life in patients with SUI.

Randomized trial comparing efficacy of pelvic floor muscle training with a digital therapeutic motion-based device to standard pelvic floor exercises for treatment of stress urinary incontinence (SUV trial): An all-virtual trial design

ObjectiveTo compare the efficacy of an Intravaginal Motion-Based Digital Health System (PDHS) compared to standardized Pelvic Floor Muscle Training (PFMT) for the treatment of stress or stress-predominant urinary incontinence (SUI). MethodsThis is a virtually conducted prospective randomized controlled trial. The primary outcomes are change in urinary incontinence episodes by 3-day bladder diary and change in Urogenital Distress Inventory-6 score, measured at 8 weeks. Secondary outcomes include: Patient Global Impression of Severity (PGI-S), PGI-Improvement (PGI-I), Pelvic Floor Distress Inventory-20(PFDI-20), Pelvic Floor Impact Questionnaire-7(PFIQ-7), Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire (PISQ-IR), Short Form-2 (SF-20), and assessment of adverse event (AE). Subjects are randomized 1:1 to an intervention group using leva PDHS for PFMT or a control group, using a home Kegel exercise program. Sample size needed to identify a 60% difference in incontinence episodes from baseline to 8 weeks post-randomization using alpha = 0.05, and a power of 0.8 is 156 subjects. To identify a 30% difference in the UDI-6 score from Baseline to Week 8 (alpha = 0.05, power = 0.8, using a one-tailed t-test) the needed sample size is 278, and allowing for an attrition rate of 15%, will require approximately 350 subjects, providing power to detect differences in both primary outcomes. ResultsRecruitment was initiated September 2020 and is on target to date. The trial is projected to be complete in 2021and is registered at clinicaltrials.govNCT04508153. ConclusionThis novel virtual recruitment approach may provide more efficient recruitment of large numbers of subjects and provide input into the use of app-based management of pelvic floor interventions.

Multicenter Randomized Controlled Trial of Pelvic Floor Muscle Training with a Motion-based Digital Therapeutic Device versus Pelvic Floor Muscle Training Alone for Treatment of Stress-predominant Urinary Incontinence.

To determine whether use of an intravaginal motion-based digital therapeutic device for pelvic floor muscle training (PFMT) was superior to PFMT alone in women with stress-predominant urinary incontinence (SUI). A multicenter, randomized-controlled trial was conducted where women with SUI or SUI-predominant mixed urinary incontinence were treated with either PFMT using the device (intervention group) or PFMT alone (control group). Primary outcomes, measured at 8 weeks, included change in Urinary Distress Inventory, short-version and improvement in the Patient Global Impression of Improvement, defined as "much better" or "very much better." Participants also completed Pelvic Organ Prolapse and Colorectal-anal Distress Inventories, Pelvic-Floor-Impact Questionnaire and a 3-day bladder diary. Primary analysis used a modified intention-to-treat approach. Statistical analysis used Student t test and χ2 test. The trial was prematurely halted due to device technical considerations. Seventy-seven women were randomized, and final analysis included 61 participants: 29 in intervention and 32 in control group. There was no statistical difference in Urinary Distress Inventory, short-version scores between the intervention (-13.7 ± 18.7) and the control group (-8.7 ± 21.8; P = 0.85), or in Patient Global Impression of Improvement (intervention 51.7% and control group 40.6%; P = 0.47). Pelvic Organ Prolapse and Colorectal-anal Distress Inventories and Pelvic-Floor-Impact Questionnaire scores improved significantly more in the intervention group than the control group (all P < 0.05). Median number of SUI episodes decreased from baseline to 8 weeks by -1.7 per-day [(-3)-0] in the intervention group and -0.7[(-1)-0] in the control group, (P = 0.047). In this prematurely terminated trial, there were no statistically significant differences in primary outcomes; however, PFMT with this digital therapeutic device resulted in significantly fewer SUI episodes and greater improvement in symptom-specific quality of life outcomes. A larger powered trial is underway.

“Mesh free” autologous transobturator mid urethral sling placement for predominant stress urinary incontinence: A pilot study

To assess the efficacy and safety of autologous mid-urethral sling (MUS) in women with predominant stress urinary incontinence (SUI). This prospective cohort study included adult women with predominant SUI seen in our urology clinic between January 2018 and March 2019. Patients with: negative cough stress test, history of prior incontinence surgery, urogenital malignancy, pelvic radiation, neurological disease, body mass index more than 40 kg/m2 , the presence of more than Stage I pelvic organ prolapse, active urinary tract infection, maximum flow rate less than 15 ml/sec, postvoid residual urine more than 100 ml, abdominal leak point pressure less than 60 cm of H2 O, and pregnant women were excluded. Eligible patients underwent a transobturator MUS procedure using rectus fascia as a sling. Before the procedure, patients filled the International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptom (ICIQ-FLUTS) and the Female Sexual Function Index (FSFI) questionnaire. Urinary outcomes were assessed at 3- and 12-months while sexual outcomes were assessed at 12-months. Thirty patients with median age of 44.5 years were included. All patients had a negative cough stress test during follow up. A significant improvement was noted in the ICIQ-FLUTS scale, bother scale, filling and incontinence subscales at 3 and 12 month follow-up. A significant improvement was also noted in the FSFI full scale score and FSFI domains of mean sexual desire, arousal and lubrication at 12 months follow-up. Two patients developed voiding dysfunction requiring urethral dilatation. Autologous transobturator MUS surgery appears to be safe and efficacious in the short term. More research is needed to clarify its role in the surgical management of SUI in women.

Mini-Slings: Do They Stand the Test of Time? A 10-Year Cohort

Introduction: It is known that failures after midurethral slings increase with the follow-up time. Nevertheless, data concerning mini-slings are sparse. To clarify this statement, we analyze a mini-sling cohort with a median follow-up of 10 years. Although the brand used, MiniArc^®, is no longer available, an identical device, Solyx™, can still be used, which makes the analysis of the cohort clinically relevant. Material and Methods: A total of 172 women with predominant stress urinary incontinence (SUI) were consecutively treated with the mini-sling MiniArc^® from 2006 until 2013. They were reevaluated in 2018. The primary outcome, treatment success, was defined as no self-reported SUI symptoms and no reintervention. Secondary outcomes included the response to patient-reported outcomes. Adverse events were assessed. Results: After a median follow-up time of 113 months, 115 (66.9%) women were available for reevaluation. Forty-four (38.3%) women self-reported SUI. Seventeen women had been reoperated, 14 (12.2%) due to the reappearance of SUI and 3 due to complications. Altogether, MiniArc^® had an overall success rate of 47.0% at 10 years. Among those not reoperated, 63.3% stated that they were much better or very much better in Patient Global Impression of Improvement (PGI-I) and 71.4% affirmed that their continence problem was normal or mild in Patient Global Impression of Severity (PGI-S). Almost 85% would repeat the surgery. Reoperation due to complications was rare (2.6%). De novo urgency appeared in 30.6% of the patients and it was managed with anticholinergic drugs with favorable outcomes. Discussion/Conclusion: This report adds evidence to the long-term outcomes of mini-slings, confirming that they can cure or improve SUI and give patients high satisfaction rates, at the expense of low morbidity.

SC320 - Prospective randomised controlled study comparing the effects of TVT and TOT in women over 75 years with stress or stress predominant urinary incontinence

SC320 - Prospective randomised controlled study comparing the effects of TVT and TOT in women over 75 years with stress or stress predominant urinary incontinence

Prospective study of a single-incision sling versus a transobturator sling in women with stress urinary incontinence: 3-year results

Long-term safety and efficacy data on use of single-incision slings in stress urinary incontinence are limited. To determine whether the single-incision sling Solyx (Boston Scientific, Marlborough, MA) is noninferior to the transobturator sling Obtryx II (Boston Scientific) in efficacy and safety for treatment of stress urinary incontinence. This 522 post-market surveillance study has been designed in response to a Food and Drug Administration request to evaluate improvement in stress urinary incontinence at 36 months following single-incision sling compared with baseline, as well as provide an assessment of mesh-related complications and subject-reported outcomes, relative to the transobturator sling control. This prospective, nonrandomized, parallel cohort, multicenter postapproval study enrolled subjects to receive single-incision sling or transobturator sling. Study sites were assigned to a cohort group based on documented competency with the cohort device. Patient follow-up was 36 months to compare efficacy and adverse events for noninferiority. Inclusion criteria included stress predominant urinary incontinence, a positive cough stress test, and post-void residual ≤150 cc. Participants were ineligible if they had undergone previous stress urinary incontinence surgery or had a previous mesh complication. Primary endpoint was treatment success defined by composite negative cough stress test and subjective improvement in stress urinary incontinence using Patient Global Impression of Improvement at 36 months. Secondary endpoints included adverse events and indications for retreatment. Noninferiority margins of 15% and 10% were prespecified for the primary efficacy and safety endpoints. Data analysis was performed using intent-to-treat and per-protocol methods. Due to the observational nature of the study, a propensity score methodology was applied to account for differences in patient and surgeon characteristics between treatment groups. The study design and variables to be included in the propensity score model were reviewed and approved by Food and Drug Administration reviewers before outcome analyses were performed. No evidence of imbalance in baseline characteristics was observed between groups after propensity score stratification in the 281 subjects. EBL (72.3±92 vs 73.1±63.9 mL, P=.786), time to spontaneous void (1.1±2 vs 0.8±2.8 days, P=.998), and time to discharge (0.7±0.7 vs 0.6±0.6 days, P=.524) were similar between groups. At 36 months, treatment success was 90.4% in the single-incision sling group and 88.9% in the transobturator sling group (P=.93). At 36 months, mesh-related complications were similar between groups (mesh exposure: 2.8% vs 5.0%, P=.38). Serious adverse events including pain during intercourse (0.7% vs 0%, P=1.00), pelvic pain (0.7% vs 0%, P=1.00), and urinary retention (2.8% vs 4.3%, P=.54) were similar between groups. Single-incision sling was not inferior to transobturator sling for long-term treatment success of stress urinary incontinence. The rates of serious adverse events were acceptably low and similar between groups.

Randomized controlled trial comparing mini-sling with transobturator sling for the treatment of stress urinary incontinence.

Stress urinary incontinence (SUI) is the involuntary loss of urine on effort and is a condition that negatively interferes with various aspects of a woman's life. This study aimed to demonstrate the non-inferiority of the less invasive single-incision mini-sling (SIMS) method in objective and subjective cures in relation to tension-free transobturator tape (TOT) in two analyses, per protocol and intention to treat, and secondarily to evaluate complications and quality of life. This study was a randomized controlled trial (RCT). Participants in this study included 105 women with a clinical diagnosis of stress predominant urinary incontinence and urodynamic results demonstrating SUI and absence of detrusor overactivity. Patients were evaluated pre- and postoperatively through anamnesis, physical examination, urinalysis, urine culture and susceptibility testing, simplified pad test, the Urinary Incontinence-Specific Quality of Life Instrument (I-QOL) and Urogenital Distress Inventory Short Form (UDI-6). Regarding the objective cure, SIMS was non-inferior to TOT (p < 0.05). However, the same was not found for the subjective cure (p > 0.05). There were no differences in the complication rates (p > 0.05). However, in the TOT group, bladder perforation (2.4%), tape exposure (2.4%) and urinary retention occurred, lasting > 7 days (2.4%). In both groups, there was improvement in quality of life after surgery, without significant differences (p > 0.05). The non-inferiority of SIMS in relation to TOT was only demonstrated in the objective cure. There were no significant differences between groups regarding complications and quality of life.