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Retropubic vs. Transobturator Tension-free Vaginal Tape

Retropubic vs. Transobturator Tension-free Vaginal Tape (TVT vs. TVT-O): A Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00441454
Enrollment
564
Registered
2007-03-01
Start date
2004-09-30
Completion date
2012-10-31
Last updated
2012-12-11

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

Conditions

Stress Urinary Incontinence

Keywords

stress urinary incontinence, surgery, tension-free vaginal tape, retropubic, transobturator, quality-of-life

Brief summary

The so-called tension-free vaginal tape (TVT), first described in Sweden in 1996, has become a standard operation worldwide for the treatment of women with stress urinary incontinence. This tape is placed from the vagina behind the pubic bone and exits through the skin of the lower abdomen, just above the pubic bone. In 2001 a urologist in France proposed passing a similar tape laterally (as opposed to behind the pubic bone). This tape is passed through a window of the pelvic bones (the so-called obturator foramen), by what is called a transobturator approach. It is passed through the skin of the thigh (as opposed to the lower abdomen). The reason for this modification was to avoid injuring the bladder and, possibly, provide a more physiologic restoration of the continence mechanism. However, it is unclear whether the lateral (so-called transobturator approach) is as good as or better than the initial approach behind the pubic bone. The purpose of the present study is to compare the standard (retropubic) and the newer (transobturator) approach for the placement of a tape for treating women with stress urinary incontinence.

Detailed description

After informed consent women scheduled for surgery for stress urinary incontinence are randomized to receive a tension-free vaginal tape either by the retropubic or the transobturator approach.

Interventions

DEVICETransobturator Tension-free vaginal tape (TVT-O)

tension-free vaginal tape (TVT)

DEVICERetropubic Tension-free vaginal tape (TVT)

Retropubic Tension-free vaginal tape (TVT)

Sponsors

Austrian Urogynecology Working Group (AUWG)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Planned surgery for primary stress incontinence (positive stress test at bladder filling of 300 ml) without concomitant prolapse surgery or hysterectomy * Patient able and willing to participate in follow-up * Informed consent

Exclusion criteria

´ * Detrusor overactivity, predominant complaint overactive bladder (OAB) * Major concomitant surgery * Prolapse beyond introitus or any prolapse necessitating surgery * Previous incontinence surgery other than colporrhaphy * Residual urine \>100 ml * Neurologic disease * Allergy to local anesthetic agents * Coagulation disorders

Design outcomes

Primary

MeasureTime frame
Continence5 years

Secondary

MeasureTime frame
Quality of life5 years

Countries

Austria

Outcome results

None listed

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