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A Tunable-tension Transobturator Tape vs Standard Transobturator Midurethral Tape for Stress Urinary Incontinence

NCT03958695 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2023-05-03

No results posted yet for this study

Summary

This is the prospective randomized parallel groups trial with two participating centers (Department of Urology, Saint Petersburg State University Clinic of advanced medical technologies n.a. N.I.Pirogov, Saint Petersburg, Russia; Department of Urology, Regional Hospital №3, Chelyabinsk, Russia) designed to assess the efficacy and safety of tunable-tension transobturator tape and its ability to reduce the rate of postoperative voiding dysfunction comparing to standard transobturator midurethral sling.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Tunable-tension transobturator tape, Urosling-T (Lintex, LLC)

A transobturator mid-urethral sling with the possibility of non-invasive tuning of its tension in the early postoperative period

DEVICE

Transobturator mid-urethral tape, Urosling (Lintex, LLC)

A transobturator tension-free mid-urethral sling

Sponsors & Collaborators

  • Saint Petersburg State University, Russia

    lead OTHER

Principal Investigators

  • Dmitry Shkarupa, PhD, MD · Saint Petersburg State University, Russia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2023-01-01
Completion
2023-04-01

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 NCT03958695 on ClinicalTrials.gov