Duloxetine compared with placebo for the treatment of women with mixed urinary incontinence

AIMS: Evaluate duloxetine in the treatment of women with mixed urinary incontinence (MUI). MATERIALS AND METHODS: 588 women, 19-85 years old with >or=4 incontinence episodes/week were randomly assigned to duloxetine 80 mg/day (N = 300) or placebo (N = 288). Patients were classified into three symptom subgroups: stress or urge predominant MUI (SPMUI or UPMUI) or balanced MUI (BMUI) based on their responses to the validated Stress/Urge Incontinence Questionnaire. Half the population was randomly assigned to have urodynamics; SPMUI, UPMUI, and BMUI condition diagnoses were based on signs, symptoms, and urodynamic observations. The primary outcome measure was the change in incontinence episode frequency (IEF). Secondary outcome measures included the Incontinence Quality of Life (I-QOL) scores, the ICI Quality of Life (ICIQ-SF) score, and the Patient Global Impression of Improvement (PGI-I) rating. RESULTS: At baseline, women with SPMUI averaged 15.9 IEF/week (61% stress), those with UPMUI averaged 13.2 (70% urge), and those with BMUI averaged 16.5 (52% urge). Overall IEF decreases were significantly greater with duloxetine than placebo (median percent reduction 60% vs. 47%, P < 0.001); both UUI and SUI episodes were significantly decreased with duloxetine (median SUI IEF reduction 59% vs. 43%, P = 0.001; UUI IEF reduction 58% vs. 40%, P < 0.001). Duloxetine IEF decreases were significantly greater for patients with SPMUI conditions and symptoms and for those with UPMUI conditions but not symptoms. Significant benefits were also demonstrated with duloxetine for improvements in I-QOL total score (11.5 points vs. 8.1 points, P = 0.002), all three I-QOL subscale scores, and for the ICIQ-SF score (-2.6 vs. -1.7, P = 0.002) as well as for PGI-I ratings (much/very much better 44.2% vs. 27.3%, P = 0.001). CONCLUSION: Duloxetine demonstrated significant efficacy in this population of women with MUI.     

Prospective multicenter clinical trial of Uretex Sup for surgical treatment of stress urinary incontinence

AIM: To evaluate in a prospective multicenter study the efficacy and safety of the suburethral support Uretex (Sofradim, Trevoux, France) delivered by a suprapubic approach in the treatment of female stress urinary incontinence. METHODS: Between March 2002 and March 2003, 57 patients were treated for stress urinary incontinence with Uretex. Preoperative evaluation included urodynamic examination and questionnaires (symptoms and quality of life, Contilife). Forty patients had pure stress urinary incontinence and 17 mixed urinary incontinence. No associated procedure was performed. The objective cure rate was evaluated by clinical examination and pad-test, and the subjective cure rate was assessed through questionnaires at 1, 3 and 12 months. RESULTS: The mean follow-up was 13 months (range 11-24 months). During follow up, chronic urinary retention requiring a tape section occurred in one patient, and in another patient a delay of vaginal healing was followed by a sling exposure and resection at 4 months. No infection or urethral erosion was reported. The objective cure rate was 96.2%, and the subjective cure rate was 79.2%; four patients reported low leakage on stress and nine patients complained of urge incontinence (four de novo and five persistent). CONCLUSION: The suprapubic Uretex Sup procedure is a safe and effective treatment for women with stress urinary incontinence.     

Recent status of the treatment of stress urinary incontinence

The therapeutic options for management of stress urinary incontinence can be conservative, pharmacological or surgical. The treatment of patients with stress urinary incontinence should be tailored to the individual to optimize care. A multitude of surgical techniques have emerged to treat this condition in recent years. The objective of the present review was to present an overview of current practice in the management of stress urinary incontinence while considering the evidence supporting the clinical effectiveness of these procedures.     

A multicenter, prospective, randomized clinical trial comparing tension-free vaginal tape surgery and no treatment for the management of stress urinary incontinence in elderly women

AIMS: The aim of our study was to test the hypothesis that elderly women undergoing tension-free vaginal tape surgery (TVT) will have a better quality of life (QOL) and satisfaction compared to non-treated women despite age- and technique-related potential morbidity. METHODS: This multicenter, prospective, randomized, controlled trial enrolled a total of 69 women aged over 70 years who initially consented to be randomized to either undergo immediate TVT surgery or to wait for 6 months before submitting to the same surgery (control group). The main outcomes measured at every visit (pre-randomization, 8-12 weeks and 6 months) consisted of the Incontinence-Quality of Life (I-QOL) Questionnaire, the Patient Satisfaction Questionnaire and the Urinary Problems Self-assessment Questionnaire, among others. RESULTS: The analysis included 31 patients in the immediate surgery group and 27 subjects in the control group. Peri-operative complications in the immediate surgery group were bladder perforation (22.6%), urinary retention (12.9%), urinary tract infection (3.2%) and de novo urgency (3.2%). At 6 months, the mean I-QOL scores for the TVT and control groups were respectively 96.5 +/- 15.5 and 61.6 +/- 19.8 (P < 0.0001); mean Patient Satisfaction scores were respectively 8.0 +/- 2.7 and 2.0 +/- 2.4 (P < 0.0001); and mean Urinary Problems scores were respectively 4.5 +/- 4.3 and 11.6 +/- 3.5 (P < 0.0001). CONCLUSION: At 6 months post-randomization, the group of elderly women who underwent immediate TVT surgery showed a significant improvement in QOL, patient satisfaction and less urinary problems compared to the group of women waiting for the same surgery.     

Macroplastique implantation system for the treatment of female stress urinary incontinence

PURPOSE: We evaluated the 12-month followup outcome of the Macroplastique (Uroplasty, Minneapolis, Minnesota) implantation system for the treatment of stress urinary incontinence caused by intrinsic sphincter deficiency using objective and subjective measures, including quality of life impact. MATERIALS AND METHODS: A total of 21 consecutive women with a mean age of 47.4 years and a mean body mass index of 25.65 kg./m.2 in whom intrinsic sphincter deficiency was urodynamically diagnosed were enrolled in the study. Patients were preoperatively assessed by physical examination, quality of life questionnaire, Stamey grading of incontinence, pad use, pad weight test and urodynamic testing. Patients underwent periurethral injection under local anesthesia with the Macroplastique implantation system. The mean volume of silicone elastomers injected was 6.3 ml. RESULTS: As assessed by the King health questionnaire, patient quality of life improved in all domains and in most lower urinary tract symptoms. Patient satisfaction and subjective surgeon evaluation were assessed by Stamey incontinence grading. From patient point of view 12 (57.1%) considered themselves cured, 4 (19%) were improved and 5 (23.8%) had failure. According to subjective surgeon grading 8 patients (38.1%) were considered cured 6 (28.6%) were improved and 7 (33.3%) had failure. Pad use decreased from a mean of 4.38 to 1.29 units daily. According to the pad weight test 13 patients (62%) were dry, 4 (19%) were improved and 4 (19%) had failure. Urodynamic testing demonstrated that 8 patients (40%) were dry and 1 (5%) was improved. CONCLUSIONS: The Macroplastique implantation system proved to have an acceptable outcome for patient and surgeon. The procedure can be done with local anesthesia and without cystoscopic guidance.     

Tension-free vaginal tape versus transobturator tape for treatment of stress urinary incontinence: A comparative randomized clinical trial study

ObjectiveThe objective of this study is to evaluate short- and mid-term results of tension-free vaginal tape (TVT) and transobturator tape (TOT) for the treatment of female stress urinary incontinence (SUI) in Imam Reza Academic Hospital.MethodsA total of 100 women with SUI treated using TVT (n = 50) or TOT (n = 50) between March 2008 and October 2010 were included in this prospective randomized clinical trial study. Preoperative workups, including case history, clinical examination, cough test, urodynamic study with abdominal leak point pressure and postvoiding residue measurements, pad test, transvaginal scan, and evaluation with International Consultation on Incontinence Modular Questionnaire–Urinary Incontinence (ICIQ-UI) and International Consultation on Incontinence Modular Questionnaire–Quality of Life (ICIQ-QOL), were performed. During hospitalization, the type of anesthesia, operative time, hospital stay, and catheter indwelling time were recorded. Postoperatively, continence status and subjective patient satisfaction were evaluated using a cough test and in some patients by a pad test also; transvaginal scan and ICIQ-UI and ICIQ-QOL evaluations at 1, 3, 6, 12, and 18 months of follow-up were performed for all patients.ResultsThe mean age was 52.02 ± 7.37 years in the TVT group and 52.27 ± 7.34 years in the TOT group. The rate of complications was similar in both groups. The operative time was 14.50 ± 7.40 and 15.00 ± 7.48 minutes (p = 0.86), hospital stay time 1.56 ± 0.51 and 1.52 ± 0.47 days (p = 0.76), and catheter indwelling time 1.58 ± 0.41 and 1.55 ± 0.47 days (p = 0.651) in the TVT and TOT groups, respectively. At 1, 3, 6, 12, and 18 months after intervention, ICIQ-UI and ICIQ-QOL were completed for all the patients and no significant difference was found between them.ConclusionOur study results showed that TVT and TOT methods have similar efficacy and safety for SUI, although the catheter indwelling time was significantly longer in the TVT group.     

Long-term efficacy of duloxetine in women with stress urinary incontinence

OBJECTIVE

To assess the maintenance of efficacy of duloxetine beyond 3 months, using data from several long‐term, open‐label studies, as the efficacy of duloxetine 40‐mg twice daily for treating women with stress urinary incontinence (SUI) for up to 3 months has been established in several randomized, placebo‐controlled clinical trials.

PATIENTS AND METHODS

Data from 1424 patients (Cohort A) enrolled in three 12‐week, placebo‐controlled clinical trials and their uncontrolled, open‐label extensions, and in one uncontrolled, open‐label study, were used to assess long‐term continuation rates and continued efficacy based on responses to the validated Patient Global Impression of Improvement (PGI‐I) scale for up to 30 months. Data from another 2758 patients (Cohort B) enrolled in an additional placebo‐controlled study and its open‐label extension were used to assess PGI‐I ratings, reductions in incontinence episode frequency (IEF) recorded on urinary diaries, and the relationship between PGI‐I ratings and reductions in IEF for up to 72 weeks.

RESULTS

In Cohort A, the duloxetine continuation rate at 1 year was 42.5%. At 12, 24 and 30 months, most (83%, 83% and 88%, respectively) patients in Cohort A who continued treatment rated their incontinence in one of the three ‘better since starting treatment’ PGI‐I categories. Both the median IEF reductions (50–77%) and the PGI‐I ‘better’ ratings (70–88% of patients) remained fairly consistent over 72 weeks in Cohort B. Finally, IEF reductions increased with increasing PGI‐I ratings (≈46% for ‘a little better’, 75% for ‘much better’ and 95% for ‘very much better’) over the first year of treatment.

CONCLUSION

The benefits of duloxetine were maintained in patients who continued treatment for up to 30 months. However, these favourable results need to be interpreted cautiously, as many patients discontinued treatment and those with better responses are more likely to continue taking medication.     

A randomized controlled trial of duloxetine alone, pelvic floor muscle training alone, combined treatment and no active treatment in women with stress urinary incontinence

PURPOSE: We primarily compared the effectiveness of combined pelvic floor muscle training (PFMT) and duloxetine with imitation PFMT and placebo for 12 weeks in women with stress urinary incontinence (SUI). In addition, we compared the effectiveness of combined treatment with single treatments, single treatments with each other and single treatments with no treatment. MATERIALS AND METHODS: This blinded, doubly controlled, randomized trial enrolled 201 women 18 to 75 years old with SUI at 17 incontinence centers in the Netherlands, United Kingdom and United States. Women averaged 2 or more incontinence episodes daily and were randomized to 1 of 4 combinations of 80 mg duloxetine daily, placebo, PFMT and imitation PFMT, including combined treatment (in 52), no active treatment (in 47), PFMT only (in 50) and duloxetine only (in 52). The primary efficacy measure was incontinence episode frequency. Other efficacy variables included the number of continence pads used and the Incontinence Quality of Life questionnaire score. RESULTS: The intent to treat population incontinence episode frequency analysis demonstrated the superiority of duloxetine with or without PFMT compared with no treatment or with PFMT alone. However, pad and Incontinence Quality of Life analyses suggested greater improvement with combined treatment than single treatment. A completer population analysis demonstrated the efficacy of duloxetine with or without PFMT and suggested combined treatment was more effective than either treatment alone. CONCLUSIONS: The data support significant efficacy of combined PFMT and duloxetine in the treatment of women with SUI. We hypothesize that complementary modes of action of duloxetine and PFMT may result in an additive effect of combined treatment.     

Surgical treatment for stress urinary incontinence

Abstract:   The prevalence of stress urinary incontinence is quite significant with large numbers of women affected. Many of these women will not seek medical help in the belief that they will not be cured or improved. With the increasing numbers of procedures now available we present a review of both established and novel surgical techniques that is intended to help both urologists and primary care physicians in the counselling of patients complaining of stress incontinence. We compare the "gold standards" of surgical treatment for all types of stress incontinence with the newer techniques that have recently become popular among urologists and gynaecologists.     

Periurethral autologous fat injection as treatment for female stress urinary incontinence: a randomized double-blind controlled trial

PURPOSE: We evaluated the effectiveness of periurethral autologous fat injection as treatment for female stress urinary incontinence. MATERIALS AND METHODS: Women with stress incontinence were randomized in a double-blind fashion to receive periurethral injections of autologous fat (treatment group) or saline (placebo group). After injection patients were evaluated monthly for 3 months by a validated standardized incontinence questionnaire, 1-hour pad test and cough test. Patients who remained incontinent were offered repeat injection using the same initial agent to a maximum of 3 injections. Every 3 months after injection patients were assessed by a standardized questionnaire, pad test, cough test and urodynamics. Those who did not qualify for repeat injection at 3 months were then followed 6, 9, 12, 18 and 24 months or until failure. RESULTS: Of the 68 women enrolled 35 received fat and 33 received saline injections. The groups were comparable in terms of baseline parameters. A total of 56 patients completed the study, including 27 in the fat and 29 in the placebo group, for a total of 189 injections (91 fat and 98 saline). At 3 months 6 of 27 (22.2%) and 6 of 29 (20.7%) women were cured or improved in the fat and saline groups, respectively. Complications included cystitis in 9 of 189 injections, urinary retention in 6 in the fat injection group, urge incontinence in 9 of 68 patients and pulmonary fat embolism resulting in death in 1 of 189 procedures. CONCLUSIONS: In this study periurethral fat injection did not appear to be more efficacious than placebo for treating stress incontinence.     

The relationships among measures of incontinence severity in women undergoing surgery for stress urinary incontinence

PURPOSE: We assessed the relationships among severity measures of urinary incontinence in women with stress predominant symptoms enrolled in a randomized clinical trial comparing 2 surgical techniques (Burch colposuspension vs pubovaginal sling) for stress urinary incontinence. MATERIALS AND METHODS: A total of 655 women underwent a standardized preoperative assessment that included the Medical, Epidemiological and Social Aspects of Aging questionnaire, Urogenital Distress Inventory, Incontinence Impact Questionnaire, 3-day voiding diary, 24-hour pad test, a supine empty bladder stress test and Valsalva leak point pressure measurements. Correlations were estimated using Spearman correlation coefficients and 95% confidence intervals. T tests at alpha=0.05 were conducted to compare the distributions of the continuous severity measure between patients with positive and negative supine empty bladder stress test. RESULTS: Baseline mean scores on Medical, Epidemiological and Social Aspects of Aging, Urogenital Distress Inventory and Incontinence Impact Questionnaire were 25.8, 151 and 171, respectively. Mean incontinence episode frequency and pad weight were 3.2 per day and 43.5 gm, respectively. Supine empty bladder stress test was positive in 218 patients, and 428 patients had valid Valsalva leak point pressure measurements with a mean Valsalva leak point pressure of 80 cm H(2)O. Weak to moderate correlations were observed between Medical, Epidemiological and Social Aspects of Aging, incontinence episode frequency, pad weight, Incontinence Impact Questionnaire and Urogenital Distress Inventory. On the other hand, Valsalva leak point pressure correlated poorly with all variables measured. The sensitivity and specificity of the supine empty bladder stress test to predict intrinsic sphincter dysfunction were 49% and 60%, respectively. CONCLUSIONS: Urinary incontinence severity measures correlate moderately with each other at best. While Medical, Epidemiological and Social Aspects of Aging demonstrated stronger correlations with the other measures of severity and quality of life, Valsalva leak point pressure did not. Supine empty bladder stress test did not demonstrate a clinically significant association among severity measures.     

A randomized,controlled clinical trial of an intravesical pressure‐attenuation balloon system for the treatment of stress urinary incontinence in females

Aims

Evaluate the efficacy, safety, and tolerability of a novel pressure‐attenuation balloon for the treatment of female stress urinary incontinence (SUI) using a prospective, randomized, single‐blind, multi‐center design, evaluated at 3 months.

Methods

Sixty‐three females with SUI were randomized 2:1 to treatment with a balloon (N = 41) or sham procedure (N = 22). The sham (control) entailed the same procedure without the deployment of a balloon. Endpoints were evaluated at 3 months and included a composite endpoint that required both ≥10 point increase in the 22‐item Incontinence Quality of Life Survey (I‐QOL) and ≥50% decrease in provocative pad weight. Additional endpoints included incontinence episode frequency, and PGII assessment.

Results

In an ITT analysis, 63% of women in the treatment group achieved the composite endpoint, compared to 31% in the Control Group (P = 0.0200). In a per protocol analysis, 81% of women in the treatment arm had a 50% decrease in pad weight test vs. 45% in the Control Group (P = 0.0143); 41.6% of the treatment patients were dry on pad weight test (≤1gram) vs. 0% in the Control Group (P < 0.001), and 58% of treated patients reported improvement on a PGII assessment versus 25% of women in the Control Group (P = 0.025). Adverse events in the treatment group included dysuria (14.6%), gross hematuria (9.8%), and UTI (7.3%).

Conclusions

This minimally invasive treatment for female SUI with an intravesical pressure‐attenuation balloon was safe and effective. The concept of pressure attenuation as a therapy for SUI is valid and feasible for those patients that can tolerate the balloon. Neurourol. Urodynam. 35:252–259, 2016. © 2015 The Authors. Neurourology & Urodynamics published by Wiley Periodicals, Inc.     

Mobile app for treatment of stress urinary incontinence: A randomized controlled trial

Aims

To evaluate the effect of a mobile app treatment for stress urinary incontinence (SUI) in women.

Methods

Randomized controlled trial, conducted 2013‐2014 in Sweden. Community‐dwelling adult women with ≥1 SUI episode/week recruited through our website and randomized to app treatment (n = 62) or control group (postponed treatment, n = 61). One participant from each group was lost to follow‐up. Intervention was the mobile app Tät^® with a treatment program focused on pelvic floor muscle training (PFMT), and information about SUI and lifestyle factors. Primary outcomes, 3 months after randomization: symptom severity (International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form [ICIQ‐UI SF]); and condition‐specific quality of life (ICIQ Lower Urinary Tract Symptoms Quality of Life [ICIQ‐LUTSqol]).

Results

One hundred and twenty‐three women were included (mean age 44.7), with moderate/severe SUI (97.5%, 120/123), mean ICIQ‐UI SF score 11.1 (SD 2.8) and mean ICIQ‐LUTSqol score 34.4 (SD 6.1) at baseline. At follow‐up, the app group reported improvements in symptom severity (mean ICIQ‐UI SF score reduction: 3.9, 95% confidence interval 3.0‐4.7) and condition‐specific quality of life (mean ICIQ‐LUTSqol score reduction: 4.8, 3.4‐6.2) and the groups were significantly different (mean ICIQ‐UI SF score difference: ?3.2, ?4.3to ?2.1; mean ICIQ‐LUTSqol score difference: ?4.6, ?7.8 to ?1.4). In the app group, 98.4% (60/61) performed PFMT at follow‐up, and 41.0% (25/61) performed it daily.

Conclusions

The mobile app treatment was effective for women with SUI and yielded clinically relevant improvements. This app may increase access to first‐line treatment and adherence to PFMT.

     

TVT-Abbrevo术治疗女性压力性尿失禁的疗效观察

目的:探讨TVT-Abbrevo术治疗女性压力性尿失禁的疗效及并发症。方法:2012年11月~2014年2月采用TVT-Abbrevo术治疗女性压力性尿失禁患者共52例,以术后患者主观症状的改善与否作为疗效的判断标准,观察患者的临床疗效及手术相关并发症。结果:手术时间为15~25min,平均(18.7±8.2)min;术中出血量为5~25ml,平均(13.6±4.9)ml。1例术中出现血尿,经膀胱镜检查发现膀胱颈损伤,经阴道予以修补。无尿道、神经损伤,无尿潴留发生。随访3~16个月,平均12.8个月,治愈46例(88.4%),改善3例(5.8%),无效2例(3.8%),有效率达96.2%。最大尿流率(Qmax)为(18.16±6.21)ml/s。腹股沟处疼痛(Vas疼痛评分):手术当天0分9例,0~3分43例;术后第1天0分12例,0~3分40例;术后第2天0分21例,0~3分31例;术后第3天0分41例,0~3分11例;术后2周0分49例,0~3分3例;术后1个月0分52例。术后无耻骨后血肿、吊带侵蚀、排尿困难及感染等相关手术并发症。结论:TVT-Abbrevo术治疗女性压力性尿失禁是安全、有效的,且术后腹股沟疼痛发生率和疼痛程度轻。     

Comparison of the Q-tip test and voiding cystourethrogram to assess urethral hypermobility among women enrolled in a randomized clinical trial of surgery for stress urinary incontinence

PURPOSE: We compared 2 measures of urethral hypermobility, the Q-tip test and voiding cystourethrogram, preoperatively in women recruited in 1 center participating in a multicenter randomized clinical trial comparing Burch colposuspension with autologous rectus fascia sling. MATERIALS AND METHODS: Following institutional review board approval, women with stress urinary incontinence and pelvic organ prolapse stage 2 or less underwent a standardized standing voiding cystourethrogram and a Q-tip test at a 45 degree angle reclining position preoperatively. Urethral angle at rest and straining were measured with a radiological ruler (voiding cystourethrogram) or goniometer (Q-tip) by 2 different investigators blinded to each other findings. RESULTS: In 43 patients the mean urethral angle at rest and UAS were 20 degrees +/- 12 and 51 degrees +/- 20, by voiding cystourethrogram compared to 16 degrees +/- 9 and 58 degrees +/- 10 by Q-tip test, respectively. The mean angle difference (urethral angle with straining minus urethral angle at rest) was greater for the Q-tip test (42 degrees +/- 9) than that for the voiding cystourethrogram test (32 degrees +/- 17; p < 0.05). Fewer patients (14% by Q-tip, 28% by voiding cystourethrogram) had urethral hypermobility using the definition of urethral angle at rest greater than 30, while almost all patients (91% by voiding cystourethrogram, 100% by Q-tip) had urethral hypermobility using the definition of urethral angle with straining greater than 30. However, using the definition of urethral angle with straining minus urethral angle at rest greater than 30, only 58% of patients had urethral hypermobility by voiding cystourethrogram compared to 98% by Q-tip. CONCLUSIONS: The voiding cystourethrogram and the Q-tip test measure urethral hypermobility differently. This may affect which patients are classified as having urethral hypermobility, and the choice of anti-incontinence surgery.