View clinical trials related to Pelvic Floor Disorders.
Filter by:Demonstrate and compare the 3D morphology of the bladder wall in full and drained states with 2 different kinds of bladder catheters in place. (Foley Catheter vs. Cystosure Catheter)
Background: The risk of ureteric injury at the time of pelvic reconstructive surgery can be as high as 3% and the American College of Obstetricians and Gynecologists has stated that intraoperative cystoscopy should be done after all such procedures. Intravenous indigo carmine was routinely given during surgery to colour the urine bright blue and allow for assessment of ureteric integrity. In 2014, indigo carmine was no longer available worldwide and since then, surgeons have been searching for suitable alternatives. Vitamin B is a water soluble vitamin that colours the urine bright yellow and can be given immediately before surgery to help with ureteric visualization. Alternatively, 5% dextrose in water (D5W) can be used as the instillation fluid during cystoscopy to allow for urine jet visualization due to the difference in fluid viscosity. Both agents have been shown to be better than instillation with normal saline and are affordable and accessible in Canada. Objective: To identify which agent is superior for intraoperative ureteric visualization at the time of cystoscopy by determining the difference in detection rate of both ureteric jets using either preoperative oral vitamin B or intraoperative cystoscopic distension with D5W. Methods: This study will be a three-site (Mount Sinai Hospital, Sunnybrook Health Sciences Centre, Women's College Hospital), double-blinded, randomized control trial whereby female patients undergoing pelvic reconstructive surgery will be randomized to receive either preoperative vitamin B or intraoperative D5W cystoscopic instillation fluid. Parameters measured during surgery will include whether both ureteric jets were seen, time to visualization of both ureters, colour of jets, and surgeon satisfaction. Patients will also be seen at one week after surgery to assess for urinary tract infection. Sample size calculation based on previous studies demonstrated a need for 119 patients per study arm. Anticipated Clinical Significance: The findings of this study will be relevant to all surgeons performing intraoperative cystoscopy where ureteric visualization is required. The investigators believe the outcome of this study will help make cystoscopy shorter and more efficient for surgeons who often feel the pressure of time constraints within the operating room setting. In turn, decreasing the time of cystoscopy may reduce operating times which will benefit both the patient and hospital.
An open-label long-term evaluation of a novel intravaginal device in female patients experiencing sexual and bladder function issues.
The lifetime risk for a woman to undergo surgery for either vaginal prolapse or urinary incontinence is high. There are many different surgical techniques for treatment of prolapse, but there is a lack of knowledge about factors that contribute to objective result and patient satisfaction after surgery. The aim of the study is to investigate factors that could be related to patient satisfaction and objective result such as pelvic floor muscle contractility/strength and muscle injury, objective measures of prolapse and women's symptoms. This study will investigate whether systematic pelvic floor exercise and life style advise before surgery can improve outcomes after surgery for either vaginal prolapse. Another aim is to determine an ultrasound scale for measure of pelvic floor muscle contraction.
Pregnancy and vaginal delivery are considered as the main risk factors for damage to the pelvic floor. There are various ways to measure the strength of the pelvic floor and to evaluate functional problems. Manual mobilization of the pelvic floor is a well-known treatment modality, however, ample knowledge exists on the efficacy of physiotherapy and exercise for improvement of pelvic floor function and strength. The aim of this study is to analyze the influence of pelvic floor fascial mobilization (PFFM) technique on the function and strength of the pelvic floor muscles as well as parameters presumed to be influenced by the strength of the pelvic floor in pregnant women.
The investigators are trying to determine if using a bladder scanner (type of ultrasound) to check how much urine is left in the bladder is the same as checking that volume with a catheter (tube that goes into your bladder to drain urine). After urogynecologic surgery, the investigators perform a voiding trial. Water is put into the participant's bladder through the catheter (tube draining your bladder). The catheter is then removed and the participant is asked to empty their bladder. After that, the investigators will use the bladder scanner (ultrasound) to see how much urine is left in the participant's bladder. After the ultrasound, the investigators will pass a very small catheter (tube) into the bladder to take out the remaining urine. The investigators will then compare the amount obtained from the catheter to the ultrasound amount. This will also help the investigators to figure out if they need to check how much urine is left in a patient's bladder after the voiding trial.
Levator trauma (ballooning) often occurs after vaginal delivery. Platelet rich plasma injection after delivery showed reduced hiatal area and maintain levator muscle strength.
The bladder flap at the time of cesarean delivery is the term used to describe the separation of the bladder from the lower uterine segment by sharply incising the vesico-uterine peritoneum or serosa and using blunt and/or sharp dissection to develop this potential space which facilitates placement of a retractor, known as the bladder blade. Creating a bladder flap at the time of cesarean delivery is largely based on individual practice patterns and practitioners are divided in their use of this step. While creating a bladder flap has a theoretical advantage of protecting the bladder from injury, it is unknown whether this step has an effect on postoperative bladder function. The purpose of this study was to evaluate whether the omission or creation of a bladder flap results in a change in urinary symptoms as measured by the UDI-6 component of the PFDI-20.
Interobserver variation in measuring the anovaginal distance (AVD) with perineal ultrasound
The OPTIONs study is a randomized controlled, non-inferiority study to evaluate postoperative care using outpatient clinic visits versus telephone calls for women undergoing surgery for pelvic floor disorders. The primary outcome is patient satisfaction using the Surgical-Consumer Assessment of Healthcare Providers and Systems (S-CAHPS) questionnaire provided by the Agency for Healthcare Research and Quality (AHRQ). Secondary outcomes include safety and cost analysis for patients' direct and indirect medical costs. Women who speak and understand either English or Spanish and planning to undergo an elective surgery for a pelvic disorder will be recruited. Baseline demographics, satisfaction, and cost analysis questionnaires will be acquired pre-operatively. Randomization will be assigned at the time of discharge from the hospital. Patients will either have scheduled clinic visits at 1-2 weeks, 6 weeks, and 3 months or telephone calls by a registered nurse at these same intervals. Questionnaires will be completed at 3 months for satisfaction and cost analysis.