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

David Scheiner

Status: Terminated

Conditions: Stress Urinary Incontinence

Treatments: Procedure: midurethral sling procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT00642109

slingrnd06

Details and patient eligibility

About

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

Enrollment: 160 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 3 patient groups

TVT

Other group

Description:

Tension-free Vaginal Tape (TVT)

Treatment:

Procedure: midurethral sling procedure

TOT

Other group

Description:

Transobturator Tape outside-in (TOT Monarc)

Treatment:

Procedure: midurethral sling procedure

TVT-O

Other group

Description:

Transobturator Tape inside-out (TVT-O)

Treatment:

Procedure: midurethral sling procedure