MiniArc Study: Long-Term Effectiveness Trial for AMS Sling Systems
Stress Urinary Incontinence in WomenMulti-center, prospective, single arm study. Qualify patients will receive treatment for stress urinary incontinence by implantation of an AMS Sling System. The study is a long-term evaluation of effectiveness and safety associated with AMS sling systems.
To Evaluate the Use of Bioresorbable Tephaflex™ Sling for Stress Urinary Incontinence
Stress Urinary IncontinenceUrinary incontinence (UI) is a major public health issue affecting up to 25-50% of all women and has a detrimental impact on patient quality of life. Stress urinary incontinence (SUI) is the most common form of urinary incontinence and is defined as the leakage of urine, which occurs during physical activity of exertion or on sneezing or coughing. It has been reported that the prevalence of SUI is 25 to 45% of the female population. If pelvic floor exercises are not effective, mid-urethral slings (MUS) are widely used as a first-line surgical treatment. Subjective and objective cure rates of 91% and 85% respectively have been reported for retropubic midurethral slings. Midurethral slings are commonly made of polypropylene (PP). Although the polypropylene products are effective and have relatively low rates of adverse events, the adverse events that do occur, like exposure and pain, have been related to the fact that a permanent synthetic mesh is implanted. Mesh-related complications are difficult to manage and may even involve partial or complete removal of the implant. Clinically, there is a need to investigate whether mid-urethral sling surgery can be performed with a non-permanent mesh made from a resorbable biomaterial, as an alternative for PP. Non-permanent meshes may be associated with fewer complications and better quality of life. However, before non-permanent and permanent mesh procedures can be compared, there is a need to first establish the feasibility of using a mesh in a mid-urethral sling procedure. The investigators hypothesize that a retropubic mid-urethral sling procedure to treat stress urinary incontinence, can be successfully performed using an implant made of poly-4-hydroxybutyrate (P4HB).
Surgical Consent Process for Trans-obturator Tape Slings.
Urinary IncontinenceStressThe purpose of this study is to determine if addition of a handout to the standard consent process for the trans-obturator tape (TOT) mid-urethral sling procedure will improve patients' understanding, recall and satisfaction with their procedure. The information provided in the handout will include the procedure details, the accompanying risks and benefits, as well as the expectations and alternatives to the TOT procedure. The aim of the investigators is to improve and standardize the current process for surgical consent for patients undergoing a mid-urethral sling procedure, specifically the TOT. The investigators hypothesize that addition of a handout will improve patient's preoperative comprehension by an absolute value of 10% compared to the standard consent process. The investigators further hypothesize that the handout will improve patient satisfaction and recall of the surgical procedure details post operatively.
The Effect of Diuresis During 20-minute Pad Test on the Estimation of the Severity of Stress Urinary...
Lower Urinary Tract SymptomsThe aim of this study is to estimate the amount of extra urine produced by natural diuresis during 20-minute pad test, and assess the effect of diuresis on the accuracy of using 20-minute pad test to estimate the severity of SUI. Besides, the above results may be used for further refinement of the amount of water infusion used for the 20-minute pad test.
Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery
Pelvic Organ ProlapseUrinary Incontinence,Stress1 moreThis study is a randomized controlled trial designed to assess the rate of failure of voiding trials in the early and late post-operative period within patients who underwent outpatient pelvic floor surgery that failed initial same day voiding trials.
Mid Term Safety and Efficacy of ALTIS® Single Incision Sling for Female Stress Urinary Incontinence...
Urinary Incontinence,StressProspective, single-arm, non-sponsored, observational single centre trial in a cohort of patients undergoing stress urinary incontinence surgery with ALTIS® procedure. All patients were diagnosed according to clinical reports, physical exploration and urodynamics. Body mass index(BMI) was categorized according to World Health Organization classification. Valsalva leak point pressure was categorized in three groups <60 cmH2O, 60-90 cmH2O and >90 cmH2O). Participants were evaluated post-operatively at 1, 6, 12 and 24 months with physical examination, ICIQ-SF, visual scale of satisfaction(SVS)(0-10). Adverse events were reported in each visit. Multivariate analysis for risk factors of surgery failure was performed.
What is the Effect of Prolapse Surgery on Voiding?
Pelvic Organ ProlapseStress Urinary Incontinence3 moreThe aim of our study is to examine the effect of prolapse surgery on voiding. Our study is the very first one to combine several innovative low-invasive and low-cost methods to analyse the amelioration or deterioration of voiding function after surgery for pelvic organ prolapse using 3D/4D translabial ultrasound, home-uroflowmetry and patient reported quality of life outcomes.
Male Stress Urinary Incontinence and Sexual Health
Prostate CancerThe purpose of this study if to demonstrate if post-prostatectomy incontinence is a barrier to sexual satisfaction/frequency/desire and if surgical correction of incontinence will improve these aspects of sexual health.
The Effect of Pelvic Floor Physiotherapy on Vaginal Elasticity
Stress Urinary IncontinenceWomen suffering from stress urinary incontinence are offered pelvic floor physiotherapy as an optional treatment. Strengthening of the pelvic floor is measured to date by manual examination and lacks precise evaluation. The vaginal tactile imager assists in evaluation of the changes in the pelvic floor after physiotherapy.
Serial Changes in Micturition Symptoms, Urine Flow and Bladder Voiding Efficiency Following Transobturator...
Stress Urinary IncontinenceThe aim of this study was to identify the serial changes in lower urinary tract symptoms (LUTS), urine flow and bladder voiding efficiency after transobturator tape (TOT) surgery for treatment of female stress urinary incontinence.