MedTrace Logo

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

NCT02867748 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2018-10-05

No results posted yet for this study

Summary

Abstract:

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.

Conditions

  • Urinary Stress Incontinence

Interventions

PROCEDURE

TVT-Abbrevo

PROCEDURE

Serasis

Sponsors & Collaborators

  • Western Galilee Hospital-Nahariya

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-09-30
Completion
2019-03-31

Countries

  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02867748 on ClinicalTrials.gov