TVT-ABBREVO Versus SERASIS for the Treatment of Female Urinary Stress Incontinence: 1 Year Outcomes of a Comparative Study With 2 Trans-obturator Sub Mid Urethral Slings
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|ClinicalTrials.gov Identifier: NCT02867748|
Recruitment Status : Unknown
Verified November 2017 by Western Galilee Hospital-Nahariya.
Recruitment status was: Active, not recruiting
First Posted : August 16, 2016
Last Update Posted : October 5, 2018
Urinary Stress Incontinence (USI)- is a discomforting condition that negatively affects the quality of life of many female individuals and frequently treated by surgical intervention. The incontinence curative operations revolutionized at 1995, with the introduction of the first retro-pubic sub-mid urethral synthetic sling, firstly named Intra-Vaginal Sling-plasty (IVS) and then Tension Free Vaginal Tape (TVT), by Ulmsten and Petros. This was later proposed to be done trans-obturatorly (TOT), for avoiding operative bladder injuries.
Among other peri-operative complications attributed to the commonly used anti-incontinence TOT are the thigh and groin pain. These pains are subjects of concern for patients and physicians worldwide. Another, rare yet very disturbing post-operative complication is erosion of the polypropylene tape into the vagina. TOT palpation at vaginal examination was claimed to be a predictive sign for future erosion of the polypropylene tape into the vaginal cavity.
This current study aims to compare TVT-Abbrevo procedure (12 cm polypropylene tape, Ethicon J&J Somerville, NJ, USA ) to Serasis procedure (softly knitted monofilament non-absorbable polypropylene, Serag-Wiessner, Naila, Germany) for the cure of USI. The purpose of this study is to evaluate the feasibility, the safety and the cure rate of both procedures, as well as documenting the post-operative immediate, and long term thigh and groin pain levels, and dyspareunia. This study is aimed to evaluate the palpability of the implanted tapes at vaginal examination and the possible relation of this to further vaginal tape exposure.
Investigators hypothesized that using Serasis tape, which is made of a softer polypropylene material than rather rigid TVT-Abbrevo polypropylene tape might result in lower pain levels at the short and long term post-operative course, as well as to reduced tape palpability and exposure to the vaginal cavity. investigators believe that favorable results for this study might improve patients' post-operative quality of life and overall satisfaction.
Keywords: Serasis, TVT-Abbrevo, USI, pain, groin, thigh, dyspareunia, safety, urinary stress incontinence, sub mid urethral sling, trans-obturator, TOT, Intra-Vaginal-Sling plasty.
|Condition or disease||Intervention/treatment||Phase|
|Urinary Stress Incontinence||Procedure: TVT-Abbrevo Procedure: Serasis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||September 2016|
|Actual Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||March 2019|
- urinary stress incontinence cure [ Time Frame: one year follow up ]
Primary outcome measure will be the cure of urinary stress incontinence subjective as reported by the patient in percentage of postoperative residual leak vs preoperative leak.
Objective cure rate will be the leakage at physical examination cough test with full bladder (200-400ml) verified by US
- Safety, intra and postoperative adverse effects [ Time Frame: 1 year follow up ]the ability to palpate the sling at vaginal examination (yes/no)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867748
|Western Galilee MC|
|Nahariya, Israel, 65432|
|Tel Aviv, Israel, 45320|