A Comparison of the Retropubic (TVT) With the Transobturator Sling Operation in the Treatment of Female Stress Urinary Incontinence or Stress Dominated Mixed Urinary Incontinence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2010-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The midurethral tension-free vaginal tape (a macroporous polypropylene mesh) procedure is a well established technique for treating female stress urinary incontinence in patients with (hyper)mobile urethra. Postoperative continence rates are achieved in up to 95%. Currently, several anatomical approaches are developed and investigated to simplify this minimal invasive technique and make it safer. While the retropubic approach consists of the passage of the needles from under the midurethra up behind the pubic bone through the cavum retzii, the transobturator technique traverses the foramina obturatoria. Intraoperative complications like bladder perforation (in 4%) can be treated conservatively, while postoperative complications like voiding dysfunction (urinary outlet obstruction in up to 16% or urinary retention) are troublesome, impair the quality of life and require occasionally surgical sling release (transection of the sling). The aim of this study is to compare quality of life, postoperative voiding dysfunction, success rates and tape position after retropubic and transobturator sling procedure.

* Trial with surgical intervention

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Patient-reported Outcome After Sling Insertion Using the Incontinence Outcome Questionnaire (IOQ)

NCT01042275

Stress Urinary Incontinence

COMPLETED

Randomized, Multicenter Trial Comparing TVT With TVT-O for Treatment of Female Urinary Incontinence

NCT00379314

Urinary Stress Incontinence

UNKNOWN PHASE3

Complications of Mesh Procedures for Stress Urinary Incontinence

NCT02850120

Urinary Incontinence Stress

COMPLETED

TVT-Secur Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures

NCT00676273

Stress Urinary Incontinence

UNKNOWN PHASE4

Treatment of Female Stress Urinary Incontinence: Study Comparing Two Suburethral Slings, Retropubic Approach (TVT) and Trans-Obturator (TVT-O) Approach

NCT00135616

Urinary Incontinence, Stress

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stress Urinary Incontinence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TVT

Tension-free Vaginal Tape (TVT)

Group Type OTHER

midurethral sling procedure

Intervention Type PROCEDURE

quality of life, voiding dysfunction

TOT

Transobturator Tape outside-in (TOT Monarc)

Group Type OTHER

midurethral sling procedure

Intervention Type PROCEDURE

quality of life, voiding dysfunction

TVT-O

Transobturator Tape inside-out (TVT-O)

Group Type OTHER

midurethral sling procedure

Intervention Type PROCEDURE

quality of life, voiding dysfunction

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

midurethral sling procedure

quality of life, voiding dysfunction

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Urodynamic stress urinary incontinence or stress dominated mixed urinary incontinence with mobile urethra
* With or without concomitant surgery for pelvic organ prolapse
* With or without hysterectomy

Exclusion Criteria

* No informed consent
* No preoperative urodynamic investigation
* Mixed urinary incontinence with predominant overactive bladder
* Recurrent stress urinary incontinence after sling procedure
* Begin of treatment of overactive bladder less then a month ago or non stable condition
* Pregnancy
* Desires future childbearing
* Concomitant incontinence procedure like intravesikal injection of Botulinumtoxin
* Preoperative postvoid residual urinary volume exceeding 100cc
* Coagulopathies

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No