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

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Arm Study to Assess the Safety and Efficacy of a Single Treatment of BOTOX®, Followed by an Optional Open-Label Treatment with BOTOX®, in Female Subjects with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

Date Added
January 29th, 2024
PRO Number
Pro00120543
Researcher
Eric Rovner

List of Studies


Keywords
Bladder
Summary

The purpose of this study is to investigate the safety (what side effects the study treatment may have) and effectiveness (how well the study treatment works to relieve symptoms) of BOTOX when injected into the bladder of adult females for the treatment of Interstitial Cystitis/ Bladder Pain Syndrome. Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a chronic and debilitating urological condition characterized by symptoms of bladder pain or discomfort and accompanied by lower urinary tract symptoms such as frequent toilet visits, often also during bedtime. BOTOX might be able to temporarily reduce bladder pain/discomfort and improve your accompanying urinary symptoms. There will be a total of 9 study visits over a period of approximately 28 weeks which includes up to 28 days (4 weeks of screening), a treatment visit, and 24 weeks of follow-up if you receive only one treatment. If you choose to receive a second treatment (which will be BOTOX), you could have a total of up to 13 visits and be in the study for an additional 12 weeks for a total of up to 44 weeks (depending on when you request retreatment) which includes the 28 days (4 weeks of screening). If you are already
receiving treatment for IC-BPS, after you have signed the informed consent, you may have to washout of your medication prior to screening and throughout your study participation. If you have a urinary tract infection [UTI] that requires treatment, an additional 14-day extension is allowed to receive Treatment 2 for total study
participation of up to 46 weeks. You may need to attend additional unscheduled visits for safety or other reasons.

Institution
MUSC
Recruitment Contact
Jessica Jenkins
8438760630
jenkijn@musc.edu



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