1-hour Pad Test Research Articles

This Month in Adult Urology

No AccessJournal of UrologyThis Month in Adult Urology1 Jun 2018This Month in Adult Urology Joseph A. SmithMD Joseph A. SmithJoseph A. Smith More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.02.076AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail References 1 : Incidence of extraprostatic extension at radical prostatectomy with pure Gleason score 3 + 3 = 6 (Grade Group 1) cancer: implications for whether Gleason score 6 prostate cancer should be renamed “not cancer” and for selection criteria for active surveillance. J Urol2018; 199: 1482. Link, Google Scholar 2 : Complications of recognized and unrecognized iatrogenic ureteral injury at time of hysterectomy: a population based analysis. J Urol2018; 199: 1540. Link, Google Scholar 3 : Worse urinary, sexual and bowel function cause emotional distress and vice versa in men treated for prostate cancer. J Urol2018; 199: 1464. Link, Google Scholar 4 : Detrusor acontractility after acute spinal cord injury—myth or reality?. J Urol2018; 199: 1565. Link, Google Scholar 5 : Development of a nationally representative coordinated registry network for prostate ablation technologies. J Urol2018; 199: 1488. Link, Google Scholar 6 : Effect of starting penile rehabilitation with sildenafil immediately after robot-assisted laparoscopic radical prostatectomy on erectile function recovery: a prospective randomized trial. J Urol2018; 199: 1600. Link, Google Scholar 7 : Comparing outcomes of robotic and open inguinal lymph node dissection in patients with carcinoma of the penis. J Urol2018; 199: 1518. Link, Google Scholar 8 : Purified protein derivative skin test prior to bacillus Calmette-Guérin therapy may have therapeutic impact in patients with nonmuscle invasive bladder cancer. J Urol2018; 199: 1446. Link, Google Scholar 9 : Impact of comorbidities on functional recovery from partial nephrectomy. J Urol2018; 199: 1433. Link, Google Scholar 10 : A randomized comparative study evaluating various cough stress tests and 24-hour pad test with urodynamics in the diagnosis of stress urinary incontinence. J Urol2018; 199: 1557. Link, Google Scholar 11 : Neoadjuvant dose dense MVAC versus gemcitabine and cisplatin in patients with cT3-4aN0M0 bladder cancer treated with radical cystectomy. J Urol2018; 199: 1452. Link, Google Scholar © 2018 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 199Issue 6June 2018Page: 1367-1369 Advertisement Copyright & Permissions© 2018 by American Urological Association Education and Research, Inc.MetricsAuthor Information Joseph A. Smith More articles by this author Expand All Advertisement PDF downloadLoading ...

МОДИФИЦИРОВАННЫЙ PAD-TEST В ДИАГНОСТИКЕ МИНИМАЛЬНОГО НЕДЕРЖАНИЯ МОЧИ ПРИ НАПРЯЖЕНИИ У ЖЕНЩИН

Background. Difficulties in the diagnosis of stress urinary incontinence (SUI) occur with minimal volumes of involuntarily lost urine. The aim was to develop a method for documenting diagnosis of minimal forms of SUI in women. Material and methods. We modified the well-known 1-hour Pad test by the intravenous injecting of a solution of indigo carmine and an iodine-containing contrast agent before the test. Results. The main advantage of the modification is the ability to visually confirm the fact of involuntary loss of minimal volumes of urine by detecting a spot of indigo carmine on the sanitary pad and a contrast stain on the x-ray film of the pad after the 1-hour Pad test. A colored spot on the pad and a contrasting shadow on the roentgenogram of the pad is a documentary confirmation of the involuntary loss of the contents of the bladder which is a sign of SUI. The procedure was used in 21 patients who were suspected to have minimal SUI. Minimal SUI was documented in 19 (90%) and excluded in 2 (10%) patients. Conclusions. The method allows confirming and documenting the minimum amount of involuntarily lost urine.

Impact of total fascia preservation on early recovery of urinary continence after radical prostatectomy

The objective was to investigate the effect of preserving the total fascia surrounding the prostate (lateral pelvic fascia (LPF) and posterior musculofascial plate) on the early return of urinary continence after three-dimensional laparoscopic radical prostatectomy (3D-LRP). Data from 70 consecutive patients who underwent 3D-LRP from April 2015 to February 2017 were collected prospectively and analyzed retrospectively. Patients were categorized into two groups: with or without LPF preservation; each group consisted of 35 consecutive patients. The rates of urinary continence within 12 weeks (no pad and no urinary leakage) were compared between groups using a 24-hour pad test and questionnaires of the Expanded Prostate Cancer Index Composite (EPIC). Immediately after Foley catheter removal, accumulated recovery rates of continence with the Kaplan–Meier method were 65.7% (23/35) and 14.3% (5/35) for LPF preservation and non-preservation groups, respectively. Four weeks after surgery, continence rates increased to 80% (28/35) and 20% (7/35), respectively. A log-rank test showed a statistical difference between groups ( p < 0.001). The hazard ratio (HR) was 3.341 (95% confidence interval, 1.772–6.301). Our results demonstrated the effectiveness of total fascia preservation for the early recovery of urinary continence after radical prostatectomy. Level of evidence: Not applicable for this multicenter audit.

Electroacupuncture for women with stress urinary incontinence: Protocol for a systematic review and meta-analysis.

Stress urinary incontinence (SUI) is a widespread complaint in the adult women. Electroacupuncture has been widely applied in the treatment of SUI. But its efficacy has not been evaluated scientifically and systematically. Therefore, we provide a protocol of systematic evaluation to assess the effectiveness and safety of electroacupuncture treatment on women with SUI. The retrieved databases include 3 English literature databases, namely PubMed, Embase, and Cochrane Library, and 3 Chinese literature databases, namely Chinese Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), and Wanfang Database. The randomized controlled trials (RCTs) of the electroacupuncture treatment on women with SUI will be searched in the above-mentioned databases from the time when the respective databases were established to December 2017. The change from baseline in the amount of urine leakage measured by the 1-hour pad test will be accepted as the primary outcomes. We will use RevMan V.5.3 software as well to compute the data synthesis carefully when a meta-analysis is allowed. This study will provide a high-quality synthesis to assess the effectiveness and safety of electroacupuncture treatment on women with SUI. The conclusion of our systematic review will provide evidence to judge whether electroacupuncture is an effective intervention for women with SUI. PROSPERO CRD42017070947.

A Randomized Comparative Study Evaluating Various Cough Stress Tests and 24-Hour Pad Test with Urodynamics in the Diagnosis of Stress Urinary Incontinence

The cough stress test is a common and accepted tool to evaluate stress urinary incontinence but there is no agreement on how the test should be performed. We assessed the diagnostic ability of different cough stress tests performed when varying patient position and bladder volume using urodynamic stress urinary incontinence as the gold standard. The 24-hour pad test was also evaluated. We recruited women who presented to specialty outpatient clinics with the complaint of urinary incontinence and who were recommended to undergo urodynamic testing. A total of 140 patients were randomized to 4 cough stress test groups, including group 1-a comfortably full bladder, group 2-an empty bladder, group 3- a bladder infused with 200 cc saline and group 4-a bladder filled to half functional capacity. The sequence of standing and sitting was randomly assigned. The groups were compared by 1-way ANOVA or the generalized Fisher exact test. The κ statistic was used to evaluate agreement between the sitting and standing positions. The 95% CIs of sensitivity and specificity were calculated using the Wilson method. ROC analysis was done to evaluate the performance of the 24-hour pad test. The cough stress test performed with a bladder filled to half functional capacity was the best performing test with 83% sensitivity and 90% specificity. There was no statistically significant evidence that the sensitivity or specificity of 1 cough stress test differed from that of the others. The pad test had no significant predictive ability to diagnose urodynamic stress urinary incontinence (AUC 0.60, p = 0.08). Cough stress tests were accurate to diagnose urodynamic stress urinary incontinence. The 24-hour pad test was not predictive of urodynamic stress urinary incontinence and not helpful when used in conjunction with the cough stress test.

Three-Layer Two-Step Posterior Reconstruction Using Peritoneum During Robot-Assisted Radical Prostatectomy to Improve Recovery of Urinary Continence: A Prospective Comparative Study

We present our experience with a novel three-layer two-step posterior reconstruction (PR) technique using peritoneum during robot-assisted radical prostatectomy (RARP) to improve recovery of postoperative urinary continence. Forty-eight patients with localized prostate cancer were enrolled in this study and were divided randomly into two groups, which were treated by the standard PR technique (standard PR group; n = 24) or the three-layer PR technique using peritoneum (three-layer PR group; n = 24) during RARP. We prospectively analyzed the continence rate by the 1-hour pad test. All patients underwent urethrocystography at 6 days postoperatively to evaluate position of vesicourethral junction. Pelvic MRI was also performed at 6 months postoperatively for anatomical evaluation. Four weeks after RARP, the urinary continence rate was significantly higher in the three-layer PR group (57%) than in the standard PR group (26%, p = 0.036). Urethrocystography demonstrated that the postoperative craniocaudal distance from the symphysis pubis to the level of the vesicourethral junction was significantly shorter in the three-layer PR group than in the standard PR group (p < 0.01), suggesting that there was less tension on the vesicourethral anastomosis after three-layer PR. MRI confirmed that three-layer PR provided firmer reinforcement of the structures, supporting the posterior aspect of the urethral sphincter complex. This prospective comparative study might suggest that three-layer two-step PR using peritoneum during RARP is a simple and feasible method seeming to improve early recovery of postoperative continence compared with standard two-step PR, although larger multicenter randomized controlled trials will be needed.

Long-term outcomes of I-Stop TOMS™ male sling implantation for post-prostatectomy incontinence management

To report long-term outcomes after I-Stop TOMS™ implantation for PPI. A retrospective evaluation was conducted in three tertiary reference centers. All consecutive patients implanted with an I-Stop TOMS™ sling between 2007 and 2012 for mild to moderate PPI (24-hour Pad test<400g) without history of pelvic radiation therapy were included. Evaluation had been conducted preoperatively, at one and six months postoperative and yearly thereafter. The main outcome criterion was the number of pads per day. Secondary criteria were International Consultation on Incontinence Questionnaire (ICIQ), SF-36 questionnaire, and complications. A hundred patients were evaluated with a median follow-up of 58months [19-78]. Pad use was significantly reduced and quality of life improved at last follow-up (P<0.0001). The percentage of patients dry and socially continent (0 or 1 pad) were 40% and 77% at 1 year, then dropped to 15% and 22%, respectively after 5years. Twelve patients were treated by artificial urinary sphincter implantation, five by ProACT™ balloons and one by a re-do I-Stop TOMS™. No severe complications were recorded at last follow-up. I-Stop TOMS™ implantation is a safe and effective option in the short-term for mild to moderate PPI management. However, a significant trend to recurrence of leakage has been established after long-term follow-up. If confirmed by further studies, these results may substantially impact patient information before male sling implantation. 4.

Sequential treatment with ProACT™ device implantation after male sling failure for male urinary incontinence

There is no strong evidence for second line therapy after male sling failure for post-prostatectomy urinary incontinence (PPUI). We report the outcomes after periurethral balloons implantation for persistence or recurrence of mild PPI symptoms after male sling implantation. All patients implanted of a ProACT™ device (Uromedica, Inc., MN, USA) following I-STOP transobturator male sling (TOMS) failure, in a tertiary reference center between 2009 and 2016, were included. Patients were evaluated by 24-hour pad-test before and after implantation, and after each balloon repressurizing procedure. PGI-I and Likert scale patient satisfaction were estimated during a telephone interview conducted in 2016. Objective and subjective cure of urinary incontinence were defined by a 24-hour pad-test<8g and the use of zero or one pad per day, respectively. Fourteen patients were included. Median follow-up was 34months [4-89]. Objective and subjective cure were 29% (n=4) and 57% (n=8), respectively. Median pad-test decreased from 95g [IQR: 130] to 34g [IQR: 83] (P=0.022). ProACT™ significantly decreased median pad-test by a factor 2.73 [1.19-6.29]. Eighty-eight percent patients were feeling a little better, much better or very much better and 77% were satisfied or very satisfied at the end of follow-up. Reoperation rate was 28% (n=4): 3 balloons were changed for caudally migration (n=2) or deflation (n=1) and 1 had a urinary sphincter implanted for severe UI. ProACT™ is a safe and efficient treatment that can be used in second line therapy after TOMS failure for PPUI. 4.

Five-Year Outcome of MiniArc Single-Incision Sling Used in the Treatment of Primary Urodynamic Stress Incontinence

Study ObjectiveTo evaluate the effectiveness and safety of the MiniArc single-incision sling in the treatment of urodynamic stress incontinence (USI) through 5 years. DesignRetrospective observational study (Canadian Task Force classification II-2). SettingTertiary referral center. PatientsEighty-five patients with USI without needing concurrent procedures who underwent anti-incontinence surgery using the MiniArc SIMS from February 2010 to December 2011. InterventionsAnti-incontinence surgery. Measurements and Main ResultsObjective cure was defined as no demonstrable leakage of urine on the cough stress test and 1-hour pad test weight <2 g. Subjective cure was based on negative response to Urinary Distress Inventory question 3, no leakage on coughing, sneezing, or laughing. Most patients were postmenopausal, overweight, and multiparous. Postoperative USI significantly improved (p < .001) through 3 years, and the 1-hour pad test showed significant improvement through 5 years (p < .001). Although 13 patients had recurrence of USI, no repeat surgery was done. The cumulative cure rates may show a declining trend of cure, yet subjective cure was 80.0% and objective cure 84.7%, with age as a significant risk factor for sling failure. ConclusionMiniArc maintains its effectiveness and safety in treatment of USI through 5 years with high objective and subjective cure rates and low incidence of complications.

An in-house Composix™-based pubovaginal sling trial for female stress urinary incontinence: Five-year comparative followup to tension-free and transobturator vaginal tapes.

We compared the efficacy of three slings in the long-term treatment of stress urinary incontinence (SUI): tension-free vaginal tape (TVT), vaginal tape-obturator (TVT-O), and an in-house two-layered polypropylene mesh with a submicronic polytetrafluoroethylene (Composix™). Our primary endpoint was the objective measurement of continence (24-hour pad test). Secondarily, we measured the satisfaction and complication rates. This prospective, non-randomized study included 128 patients with SUI. Preoperative evaluation included medical history, physical exam, 24-hour pad test, Urinary Incontinence Quality of Life Scale (IQOL), FPSUND, and global satisfaction questionnaires. Patients were followed at one month postoperative, biannually for two years, and then annually for a total of five years. Followup visits included a focused questionnaire, physical exam, satisfaction questionnaire, 24-hour pad test, IQOL, and FPSUND questionnaires. Composix, TVT, and TVT-O groups included 60, 34, and 34 patients, respectively. No significant differences were found in baseline characteristics except for the pad test. Length of catheterization was the only immediate operative significant parameter (Composix 4.7 days vs. TVT 1.1 days vs. TVT-O 2.6 days; p=0.03). The entire cohort had significant improvements in their IQOL, FPSUND, and pad test at one and four years (p<0.01). The cohort-wide 24-hour pad test average weight was 30.4 g preoperatively vs. 5 g at 12 months (p<0.00001) (Composix 37 to 5 g, TVT 83 to 4 g, and TVT-O 55 to 5 g). The Composix group had a higher number of minor complications (Clavien I, II) and secondary procedures. This single-surgeon cohort with five-year followup demonstrated a large improvement and maintenance of continence in all three surgical groups. The Composix-based sling provided comparable continence outcomes at a fraction of the cost; however, its increased morbidity and higher complication rate raise concerns over future use.

Effect of Electroacupuncture on Urinary Leakage Among Women With Stress Urinary Incontinence: A Randomized Clinical Trial.

Electroacupuncture involving the lumbosacral region may be effective for women with stress urinary incontinence (SUI), but evidence is limited. To assess the effect of electroacupuncture vs sham electroacupuncture for women with SUI. Multicenter, randomized clinical trial conducted at 12 hospitals in China and enrolling 504 women with SUI between October 2013 and May 2015, with data collection completed in December 2015. Participants were randomly assigned (1:1) to receive 18 sessions (over 6 weeks) of electroacupuncture involving the lumbosacral region (n = 252) or sham electroacupuncture (n = 252) with no skin penetration on sham acupoints. The primary outcome was change from baseline to week 6 in the amount of urine leakage, measured by the 1-hour pad test. Secondary outcomes included mean 72-hour urinary incontinence episodes measured by a 72-hour bladder diary (72-hour incontinence episodes). Among the 504 randomized participants (mean [SD] age, 55.3 [8.4] years), 482 completed the study. Mean urine leakage at baseline was 18.4 g for the electroacupuncture group and 19.1 g for the sham electroacupuncture group. Mean 72-hour incontinence episodes were 7.9 for the electroacupuncture group and 7.7 for the sham electroacupuncture group. At week 6, the electroacupuncture group had greater decrease in mean urine leakage (-9.9 g) than the sham electroacupuncture group (-2.6 g) with a mean difference of 7.4 g (95% CI, 4.8 to 10.0; P < .001). During some time periods, the change in the mean 72-hour incontinence episodes from baseline was greater with electroacupuncture than sham electroacupuncture with between-group differences of 1.0 episode in weeks 1 to 6 (95% CI, 0.2-1.7; P = .01), 2.0 episodes in weeks 15 to 18 (95% CI, 1.3-2.7; P < .001), and 2.1 episodes in weeks 27 to 30 (95% CI, 1.3-2.8; P < .001). The incidence of treatment-related adverse events was 1.6% in the electroacupuncture group and 2.0% in the sham electroacupuncture group, and all events were classified as mild. Among women with stress urinary incontinence, treatment with electroacupuncture involving the lumbosacral region, compared with sham electroacupuncture, resulted in less urine leakage after 6 weeks. Further research is needed to understand long-term efficacy and the mechanism of action of this intervention. clinicaltrials.gov Identifier: NCT01784172.

Résultats fonctionnels à long terme de la bandelette sous-urétrale rétropubienne TVT (tension-free vaginal tape) pour le traitement de l’incontinence urinaire d’effort féminine : étude monocentrique prospective

To evaluate the long-term functional outcomes after retropubic tension-free vaginal tape (TVT) placement to treat female stress urinary incontinence (SUI). From September 1998 to September 2000, we prospectively enrolled all consecutive women in our center suffering SUI caused by urethral hypermobility. All women had a retropubic TVT inserted by the same surgeon. Patients were evaluated at 1, 3, 6 and 12 months postoperatively, and annually thereafter. Postoperative assessment included a measurement of post-voiding residual volume, urinalysis, a 1-hour pad test, a urinary symptom questionnaire, and an assessment of quality-of-life. Objective continence (defined as no urine leakage at clinical examination) and subjective continence (defined as no urine leakage, whatever the mechanism, reported by the patient) were reported. Overall, 58 consecutive women (median age 59; IQR 49-67; min 21-max 78) were evaluated. Median follow-up was 10.2years (IQR 1.4-16.0; min 1-max 13.2). At the last follow-up, objective and subjective continence rates were 93% and 78%, respectively and remained stable in the long run. Pad tests, urinary symptom questionnaire scores and quality-of-life were significantly improved. Self-intermittent catheterisation was required by three women. A section of one TVT and removal of another tape was undertaken in two women with chronic pelvic pain. One patient had a chronic urinary infection. Rate of de novo urgency was 10%. TVT implantation offered good and stable functional long-term outcomes. This procedure enhanced quality-of-life and had low morbidity. 3.

STRES ÜRİNER İNKONTİNANSLI KADINLARDA PELVİK TABAN KAS EĞİTİMİNE EK OLARAK UYGULANAN ELEKTROMYOGRAFİK BİOFEEDBACK EĞİTİMİNİN ETKİNLİĞİNİN İNCELENMESİ

Aim: The aim was to investigate the effects of electromyography biofeedback training applied in addition to pelvic floor muscle training on the quality of life, amount of urine leakage and pelvic floor muscle strength in women with stress urinary incontinence. Materials and Methods: 52 women with stress urinary incontinence included in the study. The patients were divided into two groups. First group received pelvic floor muscle training (n= 27) and the other group received electromyography biofeedback training in addition to pelvic floor muscle training (n= 25). The perceived quality of life and dryness sensation of the women were assessed by using a visual analog scale. The pelvic floor muscle strength was evaluated by a vaginal pressure manometer. Their amount of urine leakage was evaluated by a 1-hour pad test. The evaluations were performed before the treatment and after an 8 weeks treatment. Results: Pelvic floor muscle training and electromyographic biofeedback training in addition to pelvic floor muscle training showed improvement in dryness sensation, perceived quality of life, pelvic floor muscle strength and amount of urine leakage before and after treatment in intra-group analyzes (p<0.05). The assessments showed that there was no difference between the groups (p>0.05) . Discussion and Conclusion: The electromyography biofeedback training in addition to pelvic floor muscle training did not show an additional healing effect in the treatment of women with stress urinary incontinence.

MP40-03 WHAT IS THE IMPACT OF COITAL INCONTINENCE ON WOMEN SEXUALITY AND SEXUAL FUNCTION?

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Female Incontinence: Therapy I1 Apr 2017MP40-03 WHAT IS THE IMPACT OF COITAL INCONTINENCE ON WOMEN SEXUALITY AND SEXUAL FUNCTION? Mariana Felippe, Marcia Eli Girotti, Maira dos Santos, Monique Rodrigues, Tatiana Rodarte, and Fernando Almeida Mariana FelippeMariana Felippe More articles by this author , Marcia Eli GirottiMarcia Eli Girotti More articles by this author , Maira dos SantosMaira dos Santos More articles by this author , Monique RodriguesMonique Rodrigues More articles by this author , Tatiana RodarteTatiana Rodarte More articles by this author , and Fernando AlmeidaFernando Almeida More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.1250AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES To determine the impact of coital incontinence on women sexual activity. METHODS Between May 2013 and July 2014, we performed a cross-sectional study to evaluated sexual active women with and without coital incontinence. All patients were evaluated by means of anamnesis, physical examination, self-answered questionnaires, including World Health Organization for Quality of Life (WHOQOL-BREF), International Consultation on Incontinence Questionnaire-short form (ICIQ-SF; score ranges from 0 to 21; the greater the values the greater the incontinence severity), Overactive Bladder Questionnaire (OAB Short-Form; patients with overactive bladder are those with cumulative scores greater than 8) and 1-hour pad test. We evaluated the sexuality by means of Sexuality Quotient – Female Version (SQ-F). The SQ-F consists of 10 questions, the overall score ranges from 0 to 100. Women with scores under 62 were considered as sexual dysfunctional. RESULTS It was evaluated 108 women (mean age: 52.6±9.35 and range: 30-70 years-old). Out of them, 52 women (48.1%) self-reported coital incontinence. Patients with and without coital incontinence had similar age (p=0.405), BMI (p=0.104), marital status (p=0.518), deliveries (p=0.805), educational level (p=0.392), 1 hour pad test weight (p=0.287), intercourse frequency (p=0.675) and similar scores in all WHOQoL-Brief domains. Women with coital UI had higher scores (more symptomatic) on ICIQ-SF and OAB-q (Table 1). There was not any difference in SQ-F questionnaire between the two groups. The prevalence of sexual dysfunction was similar in both groups. Questionnaire’s data are shown in Table 2. CONCLUSIONS Women with more severe urinary incontinence symptoms seems to be more predisposed to present coital incontinence. The presence of coital incontinence did not have significant impact on sexuality or sexual function. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e523-e524 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Mariana Felippe More articles by this author Marcia Eli Girotti More articles by this author Maira dos Santos More articles by this author Monique Rodrigues More articles by this author Tatiana Rodarte More articles by this author Fernando Almeida More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

PD50-08 AUTOLOGOUS MUSCLE DERIVED CELLS FOR URINARY SPHINCTER REPAIR FOR RECURRENT OR PERSISTENT STRESS URINARY INCONTINENCE AFTER CONTINENCE SURGERY

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Female Incontinence: Therapy II1 Apr 2017PD50-08 AUTOLOGOUS MUSCLE DERIVED CELLS FOR URINARY SPHINCTER REPAIR FOR RECURRENT OR PERSISTENT STRESS URINARY INCONTINENCE AFTER CONTINENCE SURGERY Lesley Carr, Le Mai Tu, Magali Robert, David Quinlan, Kevin Carlson, Sender Herschorn, Roger Dmochowski, Kenneth Peters, Melissa Kaufman, Ron Jankowski, and Michael Chancellor Lesley CarrLesley Carr More articles by this author , Le Mai TuLe Mai Tu More articles by this author , Magali RobertMagali Robert More articles by this author , David QuinlanDavid Quinlan More articles by this author , Kevin CarlsonKevin Carlson More articles by this author , Sender HerschornSender Herschorn More articles by this author , Roger DmochowskiRoger Dmochowski More articles by this author , Kenneth PetersKenneth Peters More articles by this author , Melissa KaufmanMelissa Kaufman More articles by this author , Ron JankowskiRon Jankowski More articles by this author , and Michael ChancellorMichael Chancellor More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.2220AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES We describe the effect of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) on women with recurrent or persistent stress urinary incontinence (SUI) after continence surgery. METHODS Analysis includes data from women enrolled in Cook MyoSite-sponsored SUI studies who underwent prior continence surgery (e.g., urethral sling, bladder neck suspension) and presented with incontinence episode frequency (IEF) of ≥3 stress leaks over 3 days and ≥3 g 24-hour pad test. Twenty-one women who received 1 treatment of 10 (n=5), 50 (n=2), 100 (n=4), or 200 x 106 (n=10) AMDC-USR were treated in open-label studies (NCT00847535, NCT01008943) and 17 women who were randomized 2:1 to receive 150 x 106 AMDC-USR (n=11) or placebo (n=6) and 1:1 for 1 or 2 treatments were treated in a double-blind trial (RCT, NCT01382602). SUI was assessed by 3-day diaries at baseline and 1, 3, 6, and 12 months for all studies and at 2 years in the RCT. RCT patients were unblinded after 12-month visits. RESULTS Median baseline stress IEF per 3 days was 12 leaks for open-label studies, and 11 leaks for AMDC-USR and 27.5 leaks for placebo in the RCT. In the RCT, the AMDC-USR group tended to be younger (51 yr vs. 64 yr), had a lower percentage with stage 1-2 pelvic organ prolapse (9% vs. 67%), and better 24-hour pad tests (45 g vs. 76 g) than placebo. In open-label studies, 18 women completed 12-month visits; 67% (12/18) had ≥50% IEF reduction, 44% (8/18) had ≥75% IEF reduction, and 39% (7/18) reported ≤1 leak over 3 days. Similarly, 12-month responder rates for the RCT AMDC-USR group were 73% (8/11) for ≥50% IEF reduction, 64% (7/11) for ≥75% IEF reduction, and 36% (4/11) for ≤1 leak per 3 days. During the RCT, a higher percentage of the AMDC-USR group met IEF reduction endpoints than placebo (Figure). Eight AMDC-USR RCT patients completed 2-year diaries; 100% (6/6) of women with ≥50% IEF reduction at 12 months also met the endpoint at 2 years. All (6/6) RCT placebo patients elected to receive open-label AMDC-USR after unblinding; at final follow-up, 3 patients had ≥50% IEF reduction compared to 12-month diaries. No AMDC-USR safety signals were identified. CONCLUSIONS AMDC-USR may be a novel, safe, durable therapy for the challenging patient population with recurrent or persistent SUI after continence surgery. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e982 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Lesley Carr More articles by this author Le Mai Tu More articles by this author Magali Robert More articles by this author David Quinlan More articles by this author Kevin Carlson More articles by this author Sender Herschorn More articles by this author Roger Dmochowski More articles by this author Kenneth Peters More articles by this author Melissa Kaufman More articles by this author Ron Jankowski More articles by this author Michael Chancellor More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

PNFBA-03 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF AUTOLOGOUS MUSCLE DERIVED CELLS FOR URINARY SPHINCTER REPAIR

You have accessJournal of UrologyPlenary: Next Frontier1 Apr 2017PNFBA-03 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF AUTOLOGOUS MUSCLE DERIVED CELLS FOR URINARY SPHINCTER REPAIR Lesley Carr, Le Mai Tu, Magali Robert, David Quinlan, Kevin Carlson, Sender Herschorn, Roger Dmochowski, Ron Jankowski, and Michael Chancellor Lesley CarrLesley Carr More articles by this author , Le Mai TuLe Mai Tu More articles by this author , Magali RobertMagali Robert More articles by this author , David QuinlanDavid Quinlan More articles by this author , Kevin CarlsonKevin Carlson More articles by this author , Sender HerschornSender Herschorn More articles by this author , Roger DmochowskiRoger Dmochowski More articles by this author , Ron JankowskiRon Jankowski More articles by this author , and Michael ChancellorMichael Chancellor More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.3222AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES This multicenter study (NCT01382602) assessed the safety and efficacy of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) in women with stress urinary incontinence (SUI). METHODS Women with predominant SUI who experienced ≥3 stress leaks over 3 days were randomized 2:1 to receive intrasphincteric injection of 150 x 106 AMDC-USR or vehicle placebo and 1:1 to receive 1 or 2 treatments. Second treatments were administered 6 months after first treatments. At baseline and follow-up, SUI was monitored by 3-day diaries of stress incontinence episode frequency (IEF), 24-hour pad tests, in-office pad tests, and quality of life (QOL) questionnaires. The primary composite efficacy endpoint was the percentage of patients with ≥50% IEF reduction or ≥50% reduction in either pad test 12 months post-treatment. Patients were unblinded after completing 12-month visits, and patients who received placebo could opt to receive an open-label AMDC-USR treatment. Patients were followed for 2 years after initial treatment. RESULTS Overall, 143 patients were treated (50 placebo; 93 AMDC-USR), 141 patients completed 12-month visits (50 placebo, 91 AMDC-USR), 127 patients completed 2-year visits, and 3 patients remain in follow-up. Both placebo and AMDC-USR groups had similar baseline characteristics. No AMDC-USR safety signals were identified and no urinary retention was reported. Due to an unexpectedly high placebo responder rate with the composite endpoint, which included pad tests, enrollment was halted at 61% (150/246) of the planned study size. In post hoc analyses, IEF reduction correlated with QOL score improvement and suggested that ≥50% IEF reduction, ≥75% IEF reduction, and ≤1 leak per 3 days may be clinically meaningful endpoints. With these alternate endpoints, placebo rates were reduced and a potential treatment effect was detected (Figure). Further, 84% (37/44) of AMDC-USR patients with ≥50% IEF reduction at 12 months and available 2-year diaries also met this endpoint at 2 years. At final follow-up, 56% (20/36) of patients who received open-label AMDC-USR and had ≥3 stress leaks at 12 months had ≥50% IEF reduction compared to the 12-month diary collected before unblinding. CONCLUSIONS In women with SUI, AMDC-USR is safe and may provide durable reduction in IEF. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e609-e610 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Lesley Carr More articles by this author Le Mai Tu More articles by this author Magali Robert More articles by this author David Quinlan More articles by this author Kevin Carlson More articles by this author Sender Herschorn More articles by this author Roger Dmochowski More articles by this author Ron Jankowski More articles by this author Michael Chancellor More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

A New Implanted Posterior Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome: 3-Month Results of a Novel Therapy at a Single Center

This study was designed to investigate the safety and performance of a new implantable system for tibial nerve stimulation for overactive bladder symptoms. A battery-free stimulation device for tibial nerve stimulation (BlueWind Medical, Herzliya, Israel) was implanted in 15 patients. Safety and efficacy assessments were done at 3 months after activation with a 3-day bladder diary, a 24-hour pad test and 2 quality of life questionnaires. Two males and 13 females were enrolled in the study. Mean age was 54 years (range 19 to 72). Five of 15 patients were previously treated with percutaneous tibial nerve stimulation and 12 experienced urgency urinary incontinence. Median operative time was 34 minutes. At 3 months of followup a significant change was seen in 24-hour frequency from a mean ± SD of 11.8 ± 3.5 to 8.1 ± 2.0 times per day (p = 0.002), the number of severe urinary urgency episodes from 6.5 ± 5.1 to 2.0 ± 2.1 times per day (p = 0.002), the number of severe incontinence episodes from 2.8 ± 5.2 to 0.3 ± 0.4 episodes per day (p = 0.017), urinary loss per day from 243 ± 388 to 39 ± 55 gm (p = 0.038) and improvement in quality of life. After implantation, 3 patients received prolonged antibiotic treatment and 3 received pain medication for 1 week. In 1 patient the device was explanted due to pain and swelling suspicious for infection, although tissue cultures did not reveal a bacterial infection. This novel posterior tibial nerve stimulator is safe and easy to implant with good clinical results.

Efficacy of Electrical Pudendal Nerve Stimulation versus Transvaginal Electrical Stimulation in Treating Female Idiopathic Urgency Urinary Incontinence

We compared the efficacy of electrical pudendal nerve stimulation vs transvaginal electrical stimulation to treat female idiopathic urgency urinary incontinence. A total of 120 female patients with idiopathic urgency urinary incontinence refractory to medication were randomized at a ratio of 2:1 to group 1 of 80 patients and group 2 of 40. Groups 1 and 2 were treated with electrical pudendal nerve stimulation and transvaginal electrical stimulation, respectively. To perform electrical pudendal nerve stimulation long acupuncture needles were deeply inserted into 4 sacrococcygeal points and electrified to stimulate pudendal nerves. Outcome measures were the 24-hour pad test and a questionnaire to measure the severity of symptoms and quality of life in women with urgency urinary incontinence. The median severity of symptoms and quality of life score on the urgency urinary incontinence questionnaire (urgency urinary incontinence total score) was 13 (range 7 to 18.75) in group 1 and 11 (range 8 to 16) in group 2 before treatment, which decreased to 2 (range 0 to 6.75) in group 1 and 6.5 (range 3.25 to 10.75) in group 2 (both p <0.01) after the completion of treatment. At the end of treatment in group 1 complete symptom resolution was noted in 34 patients (42.5%), with a 50% or greater symptom improvement rate in 70.1%. In group 2 complete symptom resolution was noted in 1 patient (2.5%) with a 50% or greater symptom improvement rate in 45.0%. The posttreatment urgency urinary incontinence total score was lower and the therapeutic effect was better in group 1 than in group 2 (both p <0.01). Electrical pudendal nerve stimulation is more effective than transvaginal electrical stimulation in treating drug refractory, female idiopathic urgency urinary incontinence.

Use of a postoperative pad test to identify continence status in women after obstetric vesicovaginal fistula repair: a prospective cohort study.

Determine whether a 1-hour pad test at discharge can identify continence status within 120days of obstetric vesicovaginal fistula (VVF) repair. Prospective cohort study. Fistula Care Centre in Lilongwe, Malawi. Women with VVF who underwent repair between January 2012 and December 2014. Data on demographics, obstetric history, physical exam findings, operative management, postoperative findings, and follow up evaluations were collected on women with VVF repair. Sensitivity, specificity, positive and negative predictive values (PPV and NPV), and a receiver operating curve (ROC) were calculated to assess the utility of using a discharge pad test at three thresholds to identify women likely to be continent at follow up. After VVF repair, 346 women had a 1-hour pad test performed at the time of hospital discharge and completed follow up within 120days of repair. Of these, 79.8% (n=276) were completely continent, whereas 20.2% (n=70) had some degree ofincontinence. The sensitivity and specificity of a negative 1-hour pad test at predicting continence is 68.1% and 82.9%, respectively. With this prevalence, a negative pad test at a 1.5-g threshold demonstrates a high predictive value (PPV=94.0%, 95% CI 90.0-96.9) in detecting women with continence after repair. At the 1.5-g threshold, a negative pad test at discharge identifies 94% of women who will remain continent after VVF repair. Adding the pad test to fistula care can identify women who are likely to remain continent and may not need further therapies in settings where resources are limited and follow up after repair is difficult. A negative pad test after repair is associated with continued continence at follow up.

What Is the Real Impact of Urinary Incontinence on Female Sexual Dysfunction? A Case Control Study.

IntroductionUrinary incontinence (UI) has been associated with negative effects on women's sexuality. Women's sexuality and sexual function are a complex issue, and the role of UI is not completely clear.AimTo assess the impact of UI on female sexual function by comparing this population with a control group of continent women.MethodsWe performed a case-control study from August 2012 to September 2013. We evaluated continent and incontinent women (age range = 30–70 years) for their sexuality.Main Outcome MeasuresAll patients were evaluated by anamnesis, physical examination, and self-report quality-of-life questionnaires. In addition, incontinent women underwent a 1-hour pad test. Patients without sexual activity were evaluated for the role of UI in their sexual abstinence. Sexual abstinence was defined as the absence of sexual activity for more than 6 months. All sexually active women completed the self-report Sexuality Quotient–Female Version (SQ-F) questionnaire.ResultsA total of 356 women were included in the study (incontinent, n = 243; continent, n = 113). Sexual abstinence was found in 162 women (45%). Incontinent women presented a higher prevalence (P < .001) of sexual abstinence than their counterparts (129 [53%] and 33 [29.2%], respectively). Age, marital status, and UI were found to be isolated predictive factors for more sexual abstinence in incontinent women. Sexually active women (incontinent, n = 114; continent, n = 80) presented similar demographic data. Despite a similar frequency of sexual activity, incontinent women had less sexual desire, foreplay, harmony with a partner, sexual comfort, and sexual satisfaction than their counterparts. Women with greater urinary leakage during the 1-hour pad test (weight > 11 g) had the worst sexual function (SQ-F) score.ConclusionWomen with UI were more likely to be sexual abstinent than continent women. Furthermore, women with UI showed less sexual desire, sexual comfort, and sexual satisfaction than their counterparts despite having a similar frequency of sexual activity.