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

Randomized Controlled Study Comparing Two Types of Suburethral Slings for the Surgical Treatment of Female Stress Incontinence : TVT and TVT-O.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00135616

Enrollment

180

Registered

2005-08-26

Start date

2005-03-31

Completion date

2008-03-31

Last updated

2007-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence, Stress

Keywords

urinary incontinence, stress incontinence, urethra, gynaecologic surgical procedures, suburethral sling

Brief summary

The purpose of this study is to compare efficacy and morbidity following the placement of two types of suburethral slings in women presenting with stress urinary incontinence: TVT and TVT-O.

Detailed description

Urinary stress incontinence (USI) is a frequent pathology in women. Surgical treatment is required in 30 to 50% of women presenting with USI. Several surgical techniques are currently available. At the present time, the placement of suburethral slings is one of the most efficient techniques. Furthermore, the placement of a suburethral sling is known to be associated with a low rate of complications. Currently, two approaches are available for the placement of a suburethral sling: retropubic approach (TVT) and trans-obturator approach (TVT-O). The efficacy of these two approaches seem equivalents. However, the morbidity related to these two techniques is probably different. In retrospective studies, the retropubic approach is associated with a higher rate of bladder perforation. On the other hand, the trans-obturator approach is supposed to be associated with a higher rate of post-operative pain. Thus, the purpose of this study is to compare efficacy and morbidity following the placement of two types of suburethral slings in women presenting with stress urinary incontinence: TVT and TVT-O.

Interventions

DEVICEsurgical placement of a suburethral sling tvt or tvt-o

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 95 Years

Healthy volunteers

Inclusion criteria

* Woman over 18 years old * Clinical diagnosis of stress urinary incontinence requiring surgical management * Must be able to read and sign the consent

Exclusion criteria

* Pregnancy * Anti-coagulant treatment * Isolated overactive bladder syndrome * Genital prolapse requiring surgical treatment * Concomitant hysterectomy

Design outcomes

Primary

Measure	Time frame
pre operative complication: rate of bladder perforation	—
post operative complication: rate of post-operative pain	—

Secondary

Measure	Time frame
efficacy: disparation of urinary incontinence	—
safety: sexual behaviour	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026