Time course for urethral neuromuscular reestablishment and its facilitated recovery by transcutaneous neuromodulation after simulated birth trauma in rats.

The aims of the study were to determine the time-course of urinary incontinence recovery after vaginal distension (VD), elucidate the mechanisms of injury from VD leading to external urethral sphincter (EUS) dysfunction, and assess if transcutaneous electrical stimulation (TENS) of the dorsal nerve of the clitoris facilitates recovery of urinary continence after VD. Rats underwent 4-h VD, 4-h sham VD (SH-VD), VD plus 1-h DNC TENS, and VD plus 1-h sham TENS (SH-TENS). TENS or SH-TENS were applied immediately and at days 2 and 4 post-VD. Micturition behavior, urethral histochemistry and histology, EUS and nerve electrophysiology, and cystometrograms were evaluated. VD induced urine leakage and significantly disrupted EUS fibers and nerve-conduction (VD vs SH-VD group; p < 0.01). Urine leakage disappeared 13 days post-VD (p < 0.001). Structural and functional recovery of EUS neuromuscular circuitry started by day 6 post-VD, but did not fully recover by day 11 post-VD (p > 0.05). TENS significantly decreased the frequency of urine leakage post-VD (days 5-7; p < 0.01). We conclude that rat urinary continence after VD requires 2 weeks to recover, although urethra structure is not fully recovered. TENS facilitated urinary continence recovery after VD. Additional studies are necessary to assess if TENS could be used in postpartum women.

Brain derived neurotrophic factor mediates accelerated recovery of regenerative electrical stimulation in an animal model of stress urinary incontinence.

OBJECTIVE: Stress urinary incontinence (SUI) is prevalent among older women and can result from insufficient regeneration of the pudendal nerve (PN). Electrical stimulation (ES) of the PN upregulates brain derived neurotrophic factor (BDNF) and accelerates regeneration. Using tyrosine kinase B (TrkB) to reduce the availability of free BDNF, the aim of this study was to determine if BDNF is necessary for accelerated recovery via ES in a model of SUI. METHODS: Our SUI model consists of Female Sprague-Dawley rats, whose PNs were crushed bilaterally twice for 30 s, followed by insertion of a modified Foley catheter into the vagina with balloon inflation for 4 h. These rats were divided into 4 groups: 1) Sham PN crush and sham vaginal distension without electrode implantation and with saline treatment (sham injury); 2) SUI with sham stimulation and saline treatment (SUI); 3) SUI and ES with saline treatment (SUI&ES); and 4) SUI and ES with TrkB treatment (SUI&ES&TrkB). Animals underwent ES or sham stimulation four times a week for two weeks. Four weeks after injury, animals underwent functional testing consisting of leak point pressure (LPP) with simultaneous external urethral sphincter (EUS) electromyography (EMG) and pudendal nerve recordings. Data was analyzed using ANOVA with Holm-Sidak posthoc test (p < 0.05). EUS and PN specimen were sectioned and stained to semi-quantitatively evaluate morphology, regeneration, and reinnervation. RESULTS: LPP and EUS EMG firing rate were significantly increased in the sham injury and SUI&ES groups compared to the SUI and SUI&ES&TrkB groups. EUS of SUI rats showed few innervated neuromuscular junctions compared to sham injured rats, while both treatment groups showed an increase in reinnervated neuromuscular junctions. CONCLUSION: ES accelerates functional recovery via a BDNF-mediated pathway in a model of SUI. These findings suggest ES could be used as a potential regenerative therapy for women with SUI.

Effectiveness of electroacupuncture for female stress urinary incontinence: a systematic review and Meta-analysis.

OBJECTIVE: To evaluate the effectiveness of electroacupuncture (EA) for female stress urinary incontinence (SUI). METHODS: We searched 12 databases electronically from inception to November 2018 without language restrictions. We included randomized controlled trials (RCTs) involving women with SUI, but excludd other types of urinary incontinence or studies that were not RCTs. Two independent reviewers extracted study characteristics, with disagreements resolved by consensus. Data were pooled and expressed as mean difference (MD) for continuous outcomes and relative risk (RR) for dichotomous outcomes, with 95% confidence intervals (CI). This study was registered with the International Prospective Register of Systematic Reviews (number CRD42018089734). RESULTS: We found very low to high level evidence that EA improved the effective rate (RR = 2.03, 95%CI: 1.40, 2.95; P = 0.0002) and reduced urine leakage as measured by the 1-hour pad test (MD = 3.33, 95%CI: 0.89, 5.77; P = 0.008), International Consultation on Incontinence Questionnaire Short Form score (MD = 3.14, 95%CI: 2.42, 3.85; P < 0.00001), and 72-hour incontinence episodes (MD = 1.17, 95%CI: 0.56, 1.78; P = 0.0002) compared with sham electroacupuncture (SA), pelvic floor muscle training, and medication. CONCLUSION: The effectiveness and safety of EA for key outcomes for women with SUI are statistically significantly better than those of SA, but most available evidence is very low or low quality. More well-designed RCTs are needed to confirm these findings.

Effect of Pelvic Floor and Hip Muscle Strengthening in the Treatment of Stress Urinary Incontinence: A Randomized Clinical Trial.

OBJECTIVE: To investigate the effectiveness of strengthening the hip muscles in addition to strengthening the pelvic floor muscles (PFM) in the treatment of stress urinary incontinence. METHODS: This study used a prospective, assessor-blind, randomized clinical trial with parallel groups. We randomly allocated 47 individuals with stress urinary incontinence to 2 groups: 1 performing only pelvic floor strengthening exercises (PF, n = 21) and the other performing pelvic floor strengthening exercises plus exercises for the gluteus maximus and medius and hip adductor muscles (PFH, n = 22). Four individuals did not complete the study. Frequency of urine leakage was the primary outcome (3-day voiding diary and a follow-up voiding diary). Secondary outcomes were pelvic floor muscle strength (Ortiz scale, PERFECT scheme [Oxford Scale], and perineometry) and quality of life (QoL; International Consultation on Incontinence Questionnaire-Short Form and King's Health Questionnaire), which were evaluated by a blinded assessor before and after 20 sessions over 10 weeks. RESULTS: Regarding the daily frequency of urine loss evaluated by the follow-up voiding diary, an effect of group was observed (P < .001), with the PFH group showing a significant decrease in daily loss frequency, although no significant differences were found in the comparison between groups for the 3-day voiding diary, QoL, or functional assessment of the PFM. CONCLUSION: Strengthening the PFM together with the hip synergic muscles showed better results for frequency of daily urine loss throughout the sessions, although there was no accompanying superiority in improvement of strength, perineometry, or QoL over the group that performed only PFM-strengthening exercises.

Assessment of the Effectiveness of Pelvic Floor Muscle Training (PFMT) and Extracorporeal Magnetic Innervation (ExMI) in Treatment of Stress Urinary Incontinence in Women: A Randomized Controlled Trial.

OBJECTIVE: The purpose of this study is to assess the effectiveness of pelvic floor muscle training and extracorporeal magnetic innervation in treatment of urinary incontinence in women with stress urinary incontinence. METHODS: The randomized controlled trial enrolled 128 women with stress urinary incontinence who were randomly allocated to either one out of two experimental groups (EG1 or EG2) or the control group (CG). Subjects in the experimental group 1 (EG1) received 12 sessions of pelvic floor muscle training, whereas subjects in the experimental group 2 (EG2) received 12 sessions of extracorporeal magnetic innervation. Subjects in the control group (CG) did not receive any therapeutic intervention. The following instruments were used to measure results in all study groups at the initial and final assessments: Revised Urinary Incontinence Scale (RUIS), Beck Depression Inventory (BDI-II), General Self-Efficacy Scale (GSES), and King's Health Questionnaire (KHQ). RESULTS: In both experimental groups, a statistically significant decline in depressive symptoms (BDI-II) and an improvement in urinary incontinence severity (RUIS) and quality of life (KHQ) were found in the following domains: "social limitations," "emotions," "severity measures," and "symptom severity scale." Moreover, self-efficacy beliefs (GSES) improved in the experimental group that received ExMI (EG2). No statistically significant differences were found between all measured variables in the control group. Comparative analysis of the three study groups showed statistically significant differences at the final assessment in the quality of life in the following domains: "physical limitations," "social limitations," "personal relationships," and "emotions." Conclusion. Pelvic floor muscle training and extracorporeal magnetic innervation proved to be effective treatment methods for stress urinary incontinence in women. The authors observed an improvement in both the physical and psychosocial aspects.

Electromyographic characteristics of pelvic floor muscles in women with stress urinary incontinence following sEMG-assisted biofeedback training and Pilates exercises.

The aim of this study was to compare the effect of pelvic floor muscle training with surface electromyographic (sEMG) biofeedback (BF group) and Pilates exercises (P group) on the bioelectrical activity of pelvic floor muscles in women with stress urinary incontinence. The other aim aim was to compare changes in voiding diaries and scores on quality of life questionnaire against baseline values and between the groups. Women in the BF group (n = 18) participated in pelvic floor muscle training with sEMG biofeedback; the P group (n = 13) participated in basic level Pilates workouts. Both protocols were continued for eight weeks. Voiding diary, quality of life and electromyographic characteristics of the pelvic floor muscles were assessed at the three-time points: at baseline, after eight weeks' training, and at month six post-training. The sEMG activity of the pelvic floor muscles was tested during five trials in two positions. There was no marked improvement in bioelectrical activity of the pelvic floor muscles during contraction following training with sEMG biofeedback or Pilates exercises. Following eight weeks of sEMG biofeedback training, a decrease was noted in resting bioelectrical activity of pelvic floor muscles and during relaxation after sustained contraction but only in supine-lying. No such effect was observed in the Pilates group. In the BF group, the number of incontinence episodes after end of treatment (timpepoints: 1vs. 2) and at six month follow-up (timpepoints: 1vs. 3) decreased by 68.5% and 89.3%, respectively. The respective values in the P group were 78.6%, and 86.4%. The intergroup differences did not reach the level of statistical significance. As regards the quality of life, the questionnaire demonstrated that Pilates exercises had significantly better effects compared to biofeedback training both at the end of the eight-week exercise program and (p = 0.003) and at six month follow-up (p = 0.0009). The International Consultation on Incontinence Questionnaire-Short Form (ICIQ- SF) showed comparable efficacy of Pilates exercises and training with sEMG biofeedback. Intragroup improvements in micturition frequency, incontinence (leakage) episodes, and nocturia frequency were comparable. Alleviation of urinary incontinence symptoms was comparable in both groups, whereas the improvement in the quality of life was more notable in the Pilates group. The obtained results failed to demonstrate the superiority of any of the two methods regarding the bioelectrical activity of pelvic floor muscles in patients with stress urinary incontinence.

The effects of microenergy acoustic pulses on animal model of obesity-associated stress urinary incontinence. Part 2: In situ activation of pelvic floor and urethral striated muscle progenitor cells.

AIM: To investigate the possibility and mechanism of microenergy acoustic pulses (MAP) for activating tissue resident stem/progenitor cells within pelvic and urethral muscle and possible mechanism. METHODS: The female Zucker Lean and Zucker Fatty rats were randomly divided into four groups: ZL control, ZLMAP, ZF control, and ZFMAP. MAP was applied at 0.033 mJ/mm2 , 3 Hz for 500 pulses, and the urethra and pelvic floor muscles of each rat was then harvested for cell isolation and flow cytometry assay. Freshly isolated cells were analyzed by flow cytometry for Pax-7, Int-7α, H3P, and EdU expression. Meanwhile, pelvic floor muscle-derived stem cells (MDSCs) were harvested through magnetic-activated cell sorting, MAP was then applied to MDSCs to assess the mechanism of stem cell activation. RESULTS: Obesity reduced EdU-label-retaining cells and satellite cells in both pelvic floor muscle and urethra, while MAP activated those cells and enhanced cell proliferation, which promoted regeneration of striated muscle cells of the pelvic floor and urethral sphincter. Activation of focal adhesion kinase (FAK)/AMP-activated protein kinase (AMPK) /Wnt/ß-catenin signaling pathways by MAP is the potential mechanism. CONCLUSIONS: MAP treatment activated tissue resident stem cells within pelvic floor and urethral muscle in situ via activating FAK-AMPK and Wnt/ß-catenin signaling pathway.

External electrical stimulation compared with intravaginal electrical stimulation for the treatment of stress urinary incontinence in women: A randomized controlled noninferiority trial.

AIMS: To compare the efficacy and safety of a neuromuscular external electrical stimulation device (INNOVO; "NMES") with an FDA-approved intravaginal device (iTouch sure; "comparator device") for the treatment of stress urinary incontinence (SUI). METHODS: This prospective, single-blind, multicenter, noninferiority study randomized women with SUI to treatment with the NMES or the comparator device for 12 weeks. The primary endpoint was the proportion achieving >50% reduction in pad weight from baseline to 12 weeks in the provocative pad weight test. RESULTS: Most subjects in both groups achieved >50% reduction in pad weight in the provocative pad test at week 12 (NMES 56.3%; comparator 63.0%), although noninferiority was not established. Significant improvements in pad tests, number of incontinence episodes, and pads used per day, and incontinence quality of life score were seen with both devices at week 12, with no clinically relevant between-group differences. Adverse events were predominantly mild/moderate and there were few discontinuations due to adverse events. The incidence of urinary tract/vaginal infections was higher with the comparator device than the NMES (7.7% versus 0%). The most common device-related adverse effect with the NMES was device discomfort (9.0%), which was generally manageable by modifying the stimulation intensity. CONCLUSIONS: The NMES significantly improved objective and subjective measures of SUI, although statistical noninferiority was not established. The NMES was well tolerated and associated with fewer urinary tract infections than the comparator. The NMES provides a safe, clinically effective, conservative treatment option for female SUI and a low-risk alternative to intravaginal devices.

A User's Guide for Surgery Involving the Artificial Urinary Sphincter.

INTRODUCTION: The artificial urinary sphincter (AUS) has long been regarded as the gold standard for surgical correction of male stress urinary incontinence (SUI). Despite impressive rates of initial success for restoration of continence, durability may wane to the point of considering revision surgery. AIM: To provide a review of existing data as well as personal experience regarding patient selection, surgical technique, and postoperative troubleshooting for the AUS. METHODS: A systematic review of the peer-reviewed literature was performed to identify relevant and contemporary articles regarding perioperative and long-term management of the AUS. Additional input is presented based on clinical experience of the senior author. MAIN OUTCOME MEASURE: The main outcome measures are durability, patient satisfaction, mechanical failure, and urethral erosion. RESULTS: In addition to a thorough history and examination, preoperative screening should include office cystoscopy to rule out bladder neck contracture in patients with a history of radical prostatectomy. Perineal cuff placement appears superior to alternative approaches. Prior radiation and use of the 3.5-cm cuff are risk factors for future erosion. Newer findings suggest that subsequent recurrence of SUI may be due to restrictive encapsulation, rather than true atrophy, with implications for revision surgery. CONCLUSION: The AUS remains an excellent option for surgical correction of moderate to severe male SUI. Detailed preoperative evaluation and patient selection are critical. The challenge of downstream recurrent SUI after AUS can be effectively managed for most patients with a structured approach. Chouhan JD, Terlecki RP. A User's Guide for Surgery Involving the Artificial Urinary Sphincter. Sex Med Rev 2019;7:167-177.

Effects of magnetic stimulation on urodynamic stress incontinence refractory to pelvic floor muscle training in a randomized sham-controlled study.

OBJECTIVE: The aim of the present study was to evaluate the effect of magnetic stimulation on urodynamic stress incontinence refractory to pelvic floor muscle training in a randomized sham-controlled study. METHODS: Female patients with urodynamic stress incontinence who had not been cured by pelvic floor muscle training were randomly assigned at a ratio of 2 : 1 to either active treatment or sham treatment for 10 weeks. The randomization was made using magnetic cards for individuals indicating active or sham stimulation. The primary endpoint was changes in the number of incontinence episodes/week, with secondary endpoints of the degree of incontinence (in g/day; determined using the pad test), the total score on the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), the ICIQ quality of life (QOL) score, and the abdominal leak point pressure (ALPP) on urodynamic study. RESULTS: Although 39 patients were enrolled in the study, 9 dropped out, leaving a total patients for analysis (18 in the active treatment group, 12 in the sham treatment group). The number of incontinence episodes/week, the degree of incontinence, total ICIQ-SF score, ICIQ-QOL score, and ALPP were significantly improved after active treatment compared with baseline (all P < .05), but did not change significantly after sham treatment. There was a significant intergroup difference with regard to changes from baseline in the ICIQ-SF and ALPP in favor of the active treatment group (P < .05). There were no significant differences in any other parameters between the 2 groups. Treatment-related adverse events were not found in both groups. CONCLUSION: Magnetic stimulation was effective in treating urodynamic stress incontinence.

Electrical stimulation of the pudendal nerve promotes neuroregeneration and functional recovery from stress urinary incontinence in a rat model.

The pudendal nerve can be injured during vaginal delivery of children, and slowed pudendal nerve regeneration has been correlated with development of stress urinary incontinence (SUI). Simultaneous injury to the pudendal nerve and its target muscle, the external urethral sphincter (EUS), during delivery likely leads to slowed neuroregeneration. The goal of this study was to determine if repeat electrical stimulation of the pudendal nerve improves SUI recovery and promotes neuroregeneration in a dual muscle and nerve injury rat model of SUI. Rats received electrical stimulation or sham stimulation of the pudendal nerve twice weekly for up to 2 wk after injury. A separate cohort of rats received sham injury and sham stimulation. Expression of brain-derived neurotrophic factor (BDNF) and ßII-tubulin expression in Onuf's nucleus were measured 2, 7, and 14 days after injury. Urodynamics, leak point pressure (LPP), and EUS electromyography (EMG) were recorded 14 days after injury. Electrical stimulation significantly increased expression of BDNF at all time points and ßII-tubulin 1 and 2 wk after injury. Two weeks after injury, LPP and EUS EMG during voiding and LPP testing were significantly decreased compared with sham-injured animals. Electrical stimulation significantly increased EUS activity during voiding, although LPP did not fully recover. Repeat pudendal nerve stimulation promotes neuromuscular continence mechanism recovery possibly via a neuroregenerative response through BDNF upregulation in the pudendal motoneurons in this model of SUI. Electrical stimulation of the pudendal nerve may therefore improve recovery after childbirth and ameliorate symptoms of SUI by promoting neuroregeneration after injury.

[Outcomes of ER:YAG LASER treatment of stress urinary incontinence in women].

AIM: To evaluate the effectiveness of a new method of treatment for stress urinary incontinence in women using an ER: YAG laser in SMOOTH mode and investigate pathophysiological and pathomorphological changes induced by erbium laser. MATERIALS AND METHODS: This study comprised 98 women aged 37-63 years, who between 2014 and 2016 were diagnosed with SUI (type 1 and 2a, 2b) and grade 0-2 vaginal prolapse. The treatment was performed with a 2940 nm Er:YAG laser (Fotona, Slovenia) using a SMOOTH mode. Clinical assessment included PFIQ-7 and PISQ-12 questionnaires, uroflowmetry, laser Doppler flowmetry and biopsy of the anterior vaginal wall. The examination was carried out at baseline and 1-2 months after the treatment. RESULTS: The effectiveness of treatment was 73%. There was no deterioration after the procedure. Analysis of PFIQ-7 and PISQ-12 questionnaires showed that patients with mild incontinence had the greatest difference between pre- and posttreatment results. Uroflowmetry parameters improved in a majority of patients. Results of laser Doppler flowmetry demonstrated the improvement of blood flow in the microvascular bed. An important feature of the vaginal biopsy after laser exposure was an increase in neoangiogenesis. DISCUSSION: The findings of questionnaires and clinical evaluation of patients with SUI and vaginal prolapse before and after treatment with Er: YAG laser showed high therapeutic effectiveness of this treatment modality. CONCLUSION: Clinical effectiveness of ER: YAG laser in SMOOTH mode was 73%. Patients with type 1 and 2a SUI and mild or moderate incontinence have the best prognosis after treatment with this method.

Refined nomogram incorporating standing cough test improves prediction of male transobturator sling success.

AIMS: To develop a decision aid in predicting sling success, incorporating the Male Stress Incontinence Grading Scale (MSIGS) into existing treatment algorithms. METHODS: We reviewed men undergoing first-time transobturator sling for stress urinary incontinence (SUI) from 2007 to 2016 at our institution. Patient demographics, reported pads per day (PPD), and Standing Cough Test (SCT) results graded 0-4, according to MSIGS, were assessed. Treatment failure was defined as subsequent need for >1 PPD or further procedures. Parameters associated with failure were included in multivariable logistic models, compared by area under the receiver-operating characteristic curves. A nomogram was generated from the model with greatest AUC and internally validated. RESULTS: Overall 203 men (median age 67 years, IQR 63-72) were evaluated with median follow-up of 45 months (IQR 11-75 months). A total of 185 men (91%) were status-post radical prostatectomy and 29 (14%) had pelvic radiation history. Median PPD and SCT grade were both two. Eighty men (39%) failed treatment (use of ≥1 PPD or subsequent anti-incontinence procedures) at a median of 9 months. History of radiation (P = 0.03), increasing MSIGS (P < 0.0001) and increasing preoperative PPD (P < 0.0001) were associated with failure on univariate analysis. In a multivariable model with AUC 0.81, MSIGS, and PPD remained associated (P = 0.002 and <0.0001 respectively, and radiation history P = 0.06), and was superior to models incorporating PPD and radiation alone (AUC 0.77, P = 0.02), PPD alone (AUC 0.76, P = 0.02), and a cutpoint of >2 PPD alone (AUC 0.71, P = 0.0001). CONCLUSIONS: MSIGS adds prognostic value to PPD in assessing success of transobturator sling for treatment of SUI.

The effects of a heating pad on anxiety, pain, and distress during urodynamic study in the female patients with stress urinary incontinence.

AIMS: Although generally well tolerated, a urodynamic study is an unpleasant and stressful procedure for some patients. This study evaluated the effects of a heating pad on anxiety, pain, and distress during urodynamic studies in female patients with stress urinary incontinence. METHODS: A total of 74 female patients with stress urinary incontinence who underwent a urodynamic study between May 2015 and October 2015 were randomized to either the experimental group using a heating pad (n = 37) or control group (n = 37). In the experimental group, a heating pad was applied on the patient's sacrum during the urodynamic study. All patients completed the State-Trait Anxiety Inventory (20-80) before and after the procedure and assessed their degree of pain and distress after the procedure by the visual analog scale (0-10). Systolic and diastolic blood pressure and pulse rate were also checked before and after the procedure. RESULTS: Demographic characteristics, mean age, procedure duration, pre and post-procedural systolic, and diastolic blood pressures, and pulse rate were statistically similar between the experimental and control groups. The mean State-Trait Anxiety Inventory was significantly lower in the experimental group than in the control group (30.9 ± 7.5 vs 42.5 ± 10.1, P < 0.001). The experimental group showed significantly lower pain and distress scores (Visual Analog Scale, 2.7 ± 1.5, 3.0 ± 1.5) compared with the control group (4.0 ± 1.6, 4.7 ± 2.0, both P < 0.001). CONCLUSIONS: Using a heating pad for female patients with stress urinary incontinence during a urodynamic study is a simple, economical, and effective therapy that enhances patient comfort and decreases anxiety, pain, and distress.

Male synthetic sling versus artificial urinary sphincter trial for men with urodynamic stress incontinence after prostate surgery (MASTER): study protocol for a randomised controlled trial.

BACKGROUND: Stress urinary incontinence (SUI) is a frequent adverse effect for men undergoing prostate surgery. A large proportion (around 8% after radical prostatectomy and 2% after transurethral resection of prostate (TURP)) are left with severe disabling incontinence which adversely effects their quality of life and many are reliant on containment measures such as pads (27% and 6% respectively). Surgery is currently the only option for active management of the problem. The overwhelming majority of surgeries for persistent bothersome SUI involve artificial urinary sphincter (AUS) insertion. However, this is expensive, and necessitates manipulation of a pump to enable voiding. More recently, an alternative to AUS has been developed - a synthetic sling for men which elevates the urethra, thus treating SUI. This is thought, by some, to be less invasive, more acceptable and less expensive than AUS but clear evidence for this is lacking. The MASTER trial aims to determine whether the male synthetic sling is non-inferior to implantation of the AUS for men who have SUI after prostate surgery (for cancer or benign disease), judged primarily on clinical effectiveness but also considering relative harms and cost-effectiveness. METHODS/DESIGN: Men with urodynamic stress incontinence (USI) after prostate surgery, for whom surgery is judged appropriate, are the target population. We aim to recruit men from secondary care urological centres in the UK NHS who carry out surgery for post-prostatectomy incontinence. Outcomes will be assessed by participant-completed questionnaires and 3-day urinary bladder diaries at baseline, 6, 12 and 24 months. The 24-h urinary pad test will be used at baseline as an objective assessment of urine loss. Clinical data will be completed at the time of surgery to provide details of the operative procedures, complications and resource use in hospital. At 12 months, men will also have a clinical review to evaluate the results of surgery (including another 24-h pad test) and to identify problems or need for further treatment. DISCUSSION: A robust examination of the comparative effectiveness of the male synthetic sling will provide high-quality evidence to determine whether or not it should be adopted widely in the NHS. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Registry: Number ISRCTN49212975 . Registered on 22 July 2013. First patient randomised on 29 January 2014.

Responsiveness of the Golombok Rust Inventory of Sexual Satisfaction in couples with incontinent partners.

OBJECTIVE: In order for a measure to reliably evaluate treatment efficacy, it is important that the measure used has adequate responsiveness. However, the responsiveness of the Golombok Rust Inventory of Sexual Satisfaction (GRISS) questionnaire, a highly recommended questionnaire by the International Consultation of Incontinence to assess sexual function in patients with incontinence, has not been established. To enable the use of GRISS to measure change in sexual function following incontinence treatment, we evaluated the short- and long-term responsiveness of the GRISS in couples with female stress urinary incontinence partners. STUDY DESIGN: Forty-eight couples with female stress urinary incontinence partners were included in the study. The GRISS, a 28-item multidimensional measure, comprises two sets of questionnaires to assess sexual function in both male and female partners. Responsiveness was investigated using data from our recent randomized controlled trials evaluating efficacy of pulsed magnetic stimulation for treatment of female patients with stress urinary incontinence. Effect size index and standardized response mean were used to measure responsiveness of the English and Chinese versions of GRISS. RESULTS: For short-term responsiveness, the overall female and male GRISS scores had effect sizes and standardized response means ranging from 0.60 to 0.83 and 0.44 to 0.78 respectively. For long-term responsiveness, the overall female and male GRISS scores had effect sizes and standardized response means ranging from 0.59 to 0.77 and 0.48 to 0.79 respectively. CONCLUSION: In conclusion, the English and Chinese versions of GRISS had adequate responsiveness for use in couples with incontinent partners. The GRISS can be a useful measure to detect change in sexual function of couples following treatment of females with stress urinary incontinence.

Which outcome measures should be used in stress urinary incontinence trials?

OBJECTIVE: To review measures used in recent randomised controlled trials (RCTs) evaluating stress urinary incontinence (SUI) treatments and to propose the most relevant outcome measure that should be included in future trials. MATERIALS AND METHODS: We identified RCTs for SUI interventions published between January 2015 and July 2017. We listed the objective and subjective outcome measures used in eligible trials in the literature search. Using data from our RCT conducted from 2013 to 2016 evaluating pulsed magnetic stimulation for SUI, we analysed the correlation between all measures. RESULTS: A total of 45 RCTs were included; 28 (62%) involved surgical interventions. The most frequently used objective and subjective measures were the cough stress test and International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), respectively. In all, 24 different validated questionnaires were administered in the 42 studies that used subjective outcome measure. Analyses of measures used in our trial showed that all measures were significantly correlated with each other except for pelvic floor muscle function. The ICIQ-UI SF showed the highest correlation coefficients (0.587-0.733) with all outcome measures. CONCLUSION: The outcome measures used in recent trials were inconsistent. The ICIQ-UI SF had the highest correlation with all measures in our trial; however, further studies evaluating correlation of measures in other patient cohorts are needed to corroborate our present results. We propose the use of ICIQ-UI SF, as the most relevant outcome measure, in future trials evaluating efficacy of SUI interventions.

The TiLOOP® Male Sling: Did We Forejudge.

INTRODUCTION: To evaluate the safety and efficacy of the TiLOOP® male sling (pfm medical, Cologne, Germany) used in the treatment for male stress urinary incontinence (SUI). MATERIAL AND METHODS: We retrospectively evaluated a total of 34 patients with a TiLOOP® male sling. Perioperative complication rates were assessed and validated questionnaires were prospectively evaluated to assess quality of life and satisfaction rate. Outcome and complication rates were analysed by using descriptive statistics. Correlation of continence outcome and risk factors was performed with the chi-square test. A p value below 0.05 was considered statistically significant. RESULTS: The majority of patients (70.6%) were diagnosed with mild or moderate male SUI. During surgery, one instance (2.9%) of intraoperative urethral injury was observed. There were no immediate postoperative complications. The mean follow-up time was 44.6 months. An improvement of male SUI was reported by 61.9% of the patients and 38.1% reported no change according the Patient Global Impression of Improvement. The mean perineal pain score was 0.5 according to the international index of pain. CONCLUSIONS: The TiLOOP® is a safe treatment option for male SUI in our cohort with a low complication rate. However, the functional outcome of the TiLOOP® was inferior when compared to the outcome of the AdVance® male sling.

High-power Magnetotherapy: A New Weapon in Urinary Incontinence?

OBJECTIVE: Urinary incontinence (UI) is one of the most common urinary system diseases that mostly affects women but also men. We evaluated the therapeutic efficacy of functional magnetic stimulation (FMS) as potential UI treatment with improvements in the pelvic floor musculature, urodynamic tests and quality of life. METHODS: A total of 20 UI patients (10 females and 10 men, mean age 64, 14 years), including 10 with stress UI, four with urgency UI and six with mixed UI, were treated with FMS (20 min/session) twice a week for 3 weeks. The patients' impressions, records in urinary diaries, and scores of three life stress questionnaires (overactive bladder symptom questionnaire [OAB-q], urogenital distress inventory questionnaire-short form [UDI-6], incontinence impact questionnaire-short form [IIQ-7]) were performed pre- and post-treatment. RESULTS: Significant reductions (P < 0.01) of micturition number and nocturia after magnetic treatment were evidenced. The urodynamic tests recorded a significant increase in cystometric capacity (147 ± 51.3%), in maximum urethral closure pressure (110 ± 34%), in urethral functional length (99.8 ± 51.8%), and in pressure transmission ratio (147 ± 51.3%) values compared with the baseline values. CONCLUSIONS: These preliminary findings suggest that FMS with Magneto STYM (twice weekly for 3 weeks) improves the UI and may be an effective treatment for this urogenital disease.

Effect of electromyographic biofeedback as an add-on to pelvic floor muscle exercises on neuromuscular outcomes and quality of life in postmenopausal women with stress urinary incontinence: A randomized controlled trial.

AIMS: To compare the efficacy of pelvic floor muscle exercises (PFME) with and without electromyographic biofeedback (BF) in increasing muscle strength, improving myoelectric activity, and improving pre-contraction and quality of life in postmenopausal women with stress urinary incontinence. METHODS: Randomized controlled trial of 49 postmenopausal women with stress urinary incontinence. Participants were allocated across three groups: control, PFME alone, and PFME + BF. Forty-five women completed the study (14 control, 15 PFME, 16 PFME + BF; mean age 58.26 years). Outcome assessment was carried out using digital palpation (modified Oxford grading scale), electromyography, and the International Consultation Incontinence Questionnaire-Short Form (ICIQ-SF) quality of life instrument. The treatment protocol consisted of eight twice-weekly, 20-min one-on-one sessions. Controls were assessed only at baseline and after 1 month. RESULTS: The PFME and PFME + BF groups exhibited significant increases in muscle strength (Oxford scale) (P < 0.0001), precontraction while coughing (P < 0.0001), maximum voluntary contraction, duration of endurance contraction, and ICIQ-SF scores (P < 0.0001). PFME + BF was associated with significantly superior improvement of muscle strength, precontraction while coughing, maximum voluntary contraction, and duration of endurance contraction as compared to PFME alone (P < 0.05). CONCLUSIONS: This preliminary study suggests that pelvic floor muscle training, with and without biofeedback, is associated with increased muscle strength, myoelectric activity, precontraction of pelvic floor muscles, and improved quality of life in postmenopausal women with stress urinary incontinence.