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Midurethral Synthetic Tape With Tension Control Mechanism Versus Midurethral Free Tape

NCT04101279 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-09-24

No results posted yet for this study

Summary

This is a prospective, comparative randomized controled trial. The general purposes of this study is to compare the efficacy and safety of midurethral synthetic tape with tension control mechanism and conventional midurethral tension free tape as surgical treatment for female urinary stress incontinence.

Conditions

  • Urinary Stress Incontinence

Interventions

PROCEDURE

surgical management of stress urinary incontinence with midurethral tension free tape.

Standard protocol for the surgical treatment of stress urinary incontinence using a transobturator approach.

PROCEDURE

surgical management of stress urinary incontinence with synthetic tape with tension control mechanism.

Standard protocol for the surgical treatment of stress urinary incontinence using a transobturator approach. A absorbing gasket attached to the middle of the tape provides tension control.

Sponsors & Collaborators

  • Moscow State University of Medicine and Dentistry

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2019-10-31
Completion
2019-12-31

Countries

  • Russia

Study Locations

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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 NCT04101279 on ClinicalTrials.gov