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

NCT03958695 | Completed

• 1 other identifier: TTTvsTOT
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

midurethral sling; stress urinary incontinence; urinary incontinence; voiding dysfunction

Outcome Measures

Primary Outcomes (1)

• Objective cure of stress urinary incontinence

  Objective cure is defined as the absence of urinary leakage during ICS-Uniform Cough Stress Test (ICS-UCST) in the absence of the bladder outlet obstruction

  36 months (3 years)

Secondary Outcomes (7)

• Observed postoperative bladder outlet obstruction

  Measured postoperatively at intervals of 1, 6, 12, 24 and 36 months postoperatively (3 years in total)

• Subjective cure of stress urinary incontinence

  Measured postoperatively at intervals of 1, 6, 12, 24 and 36 months postoperatively (3 years in total)

• Observed postoperative voiding dysfunction

  Measured postoperatively at intervals of 1, 6, 12, 24 and 36 months postoperatively (3 years in total)

• Observed complications

  Measured postoperatively at intervals of 1, 6, 12, 24 and 36 months postoperatively (3 years in total)

• The assessment of the impact of treatment on the quality of life: Urogenital Distress Inventory (UDI-6) questionnaire

  Measured postoperatively at intervals of 12, 24 and 36 months postoperatively (3 years in total)

Study Arms (2)

Tunable-tension transobturator tape (TTT)

ACTIVE COMPARATOR

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

Transobturator mid-urethral tape (TOT)

ACTIVE COMPARATOR

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

Interventions

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

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

Tunable-tension transobturator tape (TTT)

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

A transobturator tension-free mid-urethral sling

Transobturator mid-urethral tape (TOT)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is a woman with stress urinary incontinence or urodynamic mixed urinary incontinence with predominate SUI
• The subject is at least 18 years of age
• The subject has failed conservative treatment for at least 6 months
• The subject gave written consent to participate in the study,

You may not qualify if:

• The subject has an active urinary tract infection or skin infection in the region of surgery
• The subject has pelvic organ prolapse (POP) stage 2 or higher according to Pelvic Organ Prolapse Quantification system (POP-Q)
• The subject had prior surgery for SUI or POP
• The subject has predominate urge urinary incontinence
• The subject has a urogenital fistula, anatomical defect, stricture, diverticulum, new growth or any kind of abnormalities of the urethra
• The subject has chronic pelvic pain
• The subject has a system neurological disease, such as Parkinson's disease, Alzheimer disease and other dementias, multiple sclerosis, epilepsy etc
• The subject has pelvic cancer or the subject has undergone radiotherapy for treating pelvic cancer
• The subject has post void residual (PVR) \>50 ml
• The subject has dysfunctional voiding and average flow rate (Qave) \< 12 ml/s
• The subject is pregnant or disagrees to abstain from the pregnancy during the study
• The subject has any mental disorders affecting his ability to evaluate the risks of the treatment and make an independent decision on participation in the study
• The subject has an allergy on local anesthetics

Sponsors & Collaborators

• Saint Petersburg State University, Russia: lead

Study Sites (2)

Regional Clinic Hospital №3

Chelyabinsk, 454021, Russia

Location

Saint Petersburg State University Clinic of advanced medical technologies n.a. N.I.Pirogov

Saint Petersburg, 190103, Russia

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dmitry Shkarupa, PhD, MD

  Saint Petersburg State University, Russia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D., Deputy Director for medical care, Chief Urologist of Saint Petersburg State University Clinic of advanced medical technologies n.a. N.I.Pirogov.

Study Record Dates

• First Submitted: May 5, 2019
• First Posted: May 22, 2019
• Study Start: April 1, 2020
• Primary Completion: January 1, 2023
• Study Completion: April 1, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)