Rationale and design of the validation of bladder health instrument for evaluation in women (VIEW) protocol

Background Bladder health is an understudied state and difficult to measure due to lack of valid and reliable instruments. While condition specific questionnaires assess presence, severity and degree of bother from lower urinary tract symptoms, the absence of symptoms is insufficient to assume bladder health. This study describes the methodology used to validate a novel bladder health instrument to measure the spectrum of bladder health from very healthy to very unhealthy in population based and clinical research. Methods Three samples of women are being recruited: a sample from a nationally representative general population and two locally recruited clinical center samples—women with a targeted range of symptom severity and type, and a postpartum group. The general population sample includes 694 women, 18 years or older, randomly selected from a US Postal delivery sequence file. Participants are randomly assigned to electronic or paper versions of the bladder health instrument along with a battery of criterion questionnaires and a demographic survey; followed by a retest or a two-day voiding symptom diary. A total of 354 women around 7 clinical centers are being recruited across a spectrum of self-reported symptoms and randomized to mode of completion. They complete the two-day voiding symptom diary as well as a one-day frequency volume diary prior to an in-person evaluation with a standardized cough stress test, non-invasive urine flowmetry, chemical urine analysis and post void residual measurement. Independent judge ratings of bladder health are obtained by interview with a qualified health care provider. A total of 154 postpartum women recruited around 6 of the centers are completing similar assessments within 6–12 weeks postpartum. Dimensional validity will be evaluated using factor analysis and principal components analysis with varimax rotation, and internal consistency with Cronbach’s alpha. Criterion validity will be assessed using multitrait-multimethod matrix including correlations across multiple data sources and multiple types of measures. Discussion We aim to validate a bladder health instrument to measure the degree of bladder health within the general population and among women (including postpartum) recruited from local clinical centers. Trial registration NCT04016298 Posted July 11, 2019 (https://www.clinicaltrials.gov/ct2/show/NCT04016298?cond=bladder+health&draw=2&rank=1).

Real-time assessment of the behaviour of the bladder neck and proximal urethra during urine leaking in the cough stress test (CST) in supine and standing positions using transperineal ultrasound

Introduction and hypothesis The objective was to describe the behaviour of the bladder neck and proximal urethra during urine leaking in the cough stress test (CST) in supine and standing positions using transperineal ultrasound (TPUS). Method We carried out prospective data collection and a retrospective data analysis of 102 women with stress urinary incontinence (SUI) who had a positive CST with TPUS in the supine and/or standing position. On TPUS, the behaviour of the bladder neck and proximal urethra was described by the urethral length, urethral funnelling, bladder neck descent (BND), retrovesical angle (RVA) and urethral rotation angle (URA). Differences between the ultrasound findings in the two positions were evaluated. Results In the 102 women, the mean age was 48 years and mean BMI was 23.8 kg/m2. On TPUS, urine leakage was detected in the supine or standing position in 102 women and in both positions in 81. Between the two positions, significant differences were found in the URA and RVA. In the standing position, the median RVA of 166° was significantly larger than that of 133° in the supine position (p < 0.001), and the median URA of 35° was significantly smaller than that of 64° in the supine position (p < 0.001). Conclusions TPUS in both positions can be used to detect the real-time behaviour of the bladder neck and urethra in the CST. In the standing position, less rotation and more straightening of the bladder neck and proximal urethra occurred during urine leakage.

Treating Women With Urinary Incontinence and Overactive Bladder

Introduction: Pelvic floor Muscle Training (PFMT) commonly used physical therapy for Female Overactive bladder (OAB) and stress urinary incontinence (SUI). However some women has difficulty to understand and comply to PFMT. Our aim is to evaluate the effectiveness of Transpelviner Magnetic Stimulation (TPMS) as a replacement for PFMT. Materials and Methods: A prospective observational study on 53 women with SUI or OAB, were assessed objectively using cough stress test, bladder diary, one hour pad test, perineometry and validated questionnaires. Then, all of them received 10 courses of individualized TPMS therapy over five weeks. Reassessments were done after five weeks and six months of initial treatment. The outcomes were measured by severity index, negative pad test, muscle power, numbers of leaking episodes, daytime frequency and nocturia, negative cough stress test and improvement in specific quality of life questionnaires (QOL) Results: Frequency of micturition in OAB showed reduction from 100% at baseline to 12.5%,(p=0.053) after five weeks and 25%,(p=0.345) after six months. While, SUI reducedfrom 100% to 17.2(0.052) and 27.6% (p=0.826) after six months. Urgency OAB reduced from 100% to 12.5% and SUI reduced from 100% to 41.4%. It appears that after five weeks of treatment, all participants improved in their severity index (75%) followed by OAB (55.6%). However the percentage dropped six months later which was 50% and 12.5%, respectively. These results were consistent for perineal muscles power, one hour pad test and QOL score. Conclusion: TPMS shows significant effectiveness to treat OAB and SUI. However, bigger study is required to compare it with PFMT in treating urinary symptoms.

Evaluation of per-operative cough stress test during transobturator mid-urethral sling surgery

Purpose: Currently, it is unclear how the mesh tension should be adjusted on the transobturator tape surgery (TOT) for improving continence. The aim of this study was to evaluate the effects of per-operative cough stress test on TOT. Materials and methods: Between March 2007 and December 2011, 206 women with SUI were enrolled in this study. Patients were randomly categorized to treatment with TOT (96) or TOT with cough stress test (110). The IIQ-7 and the UDI-6 were used to identify satisfaction level. At the end of 1st year, two groups were compared patient characteristics, operation time, duration of hospital stay, cure and complication rates. Results: The cure rate was 84.37% 81/96) versus 83.63% (92/110) in TOT and TOT with cough test groups, respectively. Postoperatively ten patient (10/110, 9.09%) suffered voiding difficulties (> 250 ml residual urine) in TOT with cough stress test group. Five patients were discharged with transurethral catheter, whereas, in traditional TOT group, two patients (2/96, 2.1%) had transient postoperative voiding difficulty and two patients were treated with repeated catheterization for 1 week (p < 0.05). Postoperative groin pain was present in 7/96 (8%) versus 24/110 (22%) in TOT and TOT with cough test groups, respectively (p < 0.05). TOT with cough stress test group had an higher rate of complications like, retention of urine, necessitating to cut the tape, mesh erosion and pain in groin or leg. No patient had resistant voiding difficulty or prolonged urinary retention (> 1 week) in traditional TOT group. Conclusions: We believe that per-operative cough stress test leads to overtreatment of stress urinary incontinence when the complication rates were considered.

Efficacy of the inside-out tramsobturator tension-free vaginal tape (TVT-ABBREVO) for the treatment of stress urinary incontinence after a 12-month follow-up

The aim of this study was to evaluate the efficacy of the inside-out tension-free vaginal tape transobturator approach or TVT-Obturator system (TVT-ABBREVO) in women with stress urinary incontinence (SUI). This is a prospective single arm study of women with SUI who underwent a TVT-ABBREVO procedure. The inclusion criterion was a diagnosis of SUI urodynamically proven without detrusor over activity. SUI was defined as involuntary urine leakage with stress in the absence of detrusor over activity with or without intrinsic sphincter deficiency. Before, and 12 months after surgery women received urodynamic test, pelvic examination, and a personal interview using the Urogenital Distress Inventory (UDI) and the Incontinence Impact Questionnaire (IIQ). The primary outcome was the incidence of incontinency through cough stress test during the urodynamic exam. A total of 90 women were included in the analysis. Our analysis showed that the incidence of incontinence through cough stress test during the urodynamic exam was significantly less 12 months after the intervention (100% vs 3%; P-value =0.001). Moreover, we found a significantly improvement of the quality of life measured by UDI score (13±4.5 vs 7.3±2.2 points; P-value 0.01) and IIQ score (14±5.7 vs 8.1 vs 3.1 points; P-value 0.02). No intraoperative complications were noticed. TVT-ABBREVO significantly reduced the incidence of stress urinary incontinence. In the authors’ experience, this technique resulted technically simple and provided high objective and subjective long-term efficacy, a clinically meaningful improvement in patient quality of life, and an excellent safety profile.