A Clinical Investigation of the Adjustable Continence Therapy (ACT®) for Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency

Date Added
May 25th, 2021
PRO Number
Pro00103696
Researcher
Eric Rovner

List of Studies


Keywords
Bladder, Women's Health
Summary

This study is for females 22 years or older who have been diagnosed with stress urinary incontinence with primary intrinsic sphincter deficiency. Subjects are being invited to take part in a research study using a device called the ACT (Adjustable Continence Therapy for Women). ACT is an adjustable implantable silicone device for the treatment of unwanted loss of urine during activity (stress incontinence). The purpose of this study will be to find out if the implant of the ACT is safe and effective in reducing unwanted urine loss. The study will involve about 167 women that have unwanted urine loss. Participation is voluntary. This system is investigational which means it is not approved by the U.S Food and Drug Administration (FDA). After placement of the devices, subjects will be followed for 12 months on a regular visit schedule. Annual visits may continue for up to 5 years (subjects will only come to clinic one time a year after the first year in the study).

Institution
MUSC
Recruitment Contact
Jessica Jenkins
843-876-0630
jenkijn@musc.edu

A prospective efficacy study comparing FREquency of use and Efficacy of a personalized surgery-free wearable and personalized bladder modulation system with objective confirmation of nerve activation for use in the home by subjects with OverActive Bladder syndrome

Date Added
December 8th, 2020
PRO Number
Pro00103694
Researcher
Eric Rovner

List of Studies


Keywords
Bladder
Summary

The purpose of this research study is to compare the effectiveness of one treatment per week to three treatments per week using the non-surgical bladder modulation system for those diagnosed with OverActive bladder syndrome (OAB) in the home environment. Subjects Male or Female over the age of 18 with a diagnosis of Overactive bladder who meet all inclusion and no exclusion criteria will be eligible to enroll in a new study. This study will test a new surgey free wearable and personalized bladder modulation system.

Institution
MUSC
Recruitment Contact
Jessica Jenkins
843876-0630
jenkijn@musc.edu

OUTCOMES OF PATIENTS WITH AUTOLOGUS MID-URETHRAL SLING AFTER FAILURE OF MID-URETHRAL MESH SLING

Date Added
June 29th, 2012
PRO Number
Pro00012059
Researcher
Eric Rovner

List of Studies


Keywords
Urinary
Summary

Mid-urethral slings have been widely accepted as a treatment of choice for patients with stress urinary incontinence (SUI). Mid-Urethral sling surgery has been associated with good success rate and minimal morbidity.Minor complications are associated with these surgeries including bladder perforation, urethral injury or post operative complication such as de novo urgency and urge urinary incontinence, urinary retention or incomplete bladder emptying. Treatment approaches for complications included sling excision and urethral/bladder/ vaginal defect repair after sling intrusion or extrusion into these organs. Treatments for postoperative voiding dysfunction include clean intermittent catheterization, mid-urethral sling lysis, sling incision and formal urethrolysis. With urethrolysis, obstruction has been reported to be relieved in 65% to 93 with preservation of continence in 80% to 100% while the rate of SUI postoperative is 0 % to 19%.autologus fascial sling for relieve of obstruction with 54% of patients had no recurrence of their SUI [25]. On the other hand, there have been no published data on the use of autologus fascia lata pubovaginal sling to treat patient with recurrent SUI after incision of the mid-urethral mish slings. Urethral injection of bulking agent have been reported with 34% cure [26] and re-do mid urethral sling was reported to have only 53% success over 17 months of follow-up [9].
Our aim is to evaluate the subjective and objective outcomes of salvage treatment of failed mid-urethral mesh sling with sling incision, urethrolysis, autologus facial pubovaginal sling or other forms of diversion if needed. We also will evaluate if this procedure will help to improve in the quality of life of these patients.

Institution
MUSC
Recruitment Contact
Jessica Jenkins
843-876-0630
ude.csum@njiknej



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