Laparoscopic Burch Colposuspension Versus Transobturatory Tape for the Treatment of Female Urinary Stress Incontinence

Phase 4

Withdrawn

• Conditions: Stress Urinary Incontinence
• Interventions: Procedure: Laparoscopic Burch colposuspension; Procedure: Transobturator tape procedure

• Registration Number: NCT00573703
• Lead Sponsor: University Magna Graecia

Brief Summary

Transobturatory tape (TOT) procedure is a minimally invasive approach to urinary stress incontinence owing to the category of the sling-adopting procedures. Its efficacy and safety, also in comparison with similar procedures have been demonstrated. The benefits of the sling- adopting procedures in comparison to laparoscopic Burch colposuspension, which has been considered as the gold standard treatment, have been showed. But these comparisons did not included the TOT procedure in the experimental arms. Based on this considerations the aim of this trial will be to compare TOT and laparoscopic Burch colposuspension in women with urinary stress incontinence.

Detailed Description

Women with predominant and genuine stress urinary incontinence will be enrolled and randomized in two groups (groups A and B). Patients of group A will be treated with laparoscopic Burch colposuspension, whereas patients of group B will be treated with TOT procedure.

All patients eligible will undergo baseline assessment consisting of anthropometric, clinical, hormonal, urodynamic, and ultrasonographic evaluations. During the study, the surgical outcomes, the clinical subjective and objective efficacy data, and the adverse experiences will be evaluated in each patient.

Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2007-12
• Study First Submitted: 2007-12-12
• Study First Submitted QC: 2007-12-13
• Study First Posted: 2007-12-14
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-05
• Last Update Posted: 2013-04-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Predominant or genuine stress urinary incontinence by self report,examination and test
• Urethral hypermobility
• Eligible for both surgical procedures
• Ambulatory

Exclusion Criteria

• Pregnancy
• <12 months post-partum
• Systemic disease and/or drugs known to affect bladder function
• Current chemotherapy or radiation therapy
• Urethral diverticulum, augmentation cytoplasty, or artificial sphincter
• Recent pelvic surgery
• Severe genuine stress incontinence (loss of urine with minimal physical activity) with associated prolapse equal to or more than second degree
• Previous pelvic or anti-incontinence surgery
• History of severe abdominopelvic infections
• Known extensive abdominopelvic adhesions
• Detrusor instability and/or intrinsic sphincter dysfunction
• Other gynaecologic pathologies (eg, fibroids, ovarian cysts)
• BMI >30

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Laparoscopic Burch colposuspension	-
Group B	Transobturator tape procedure	-

Primary Outcome Measures

Name	Time	Method
Objective/subjective symptoms improvements	12 months

Secondary Outcome Measures

Name	Time	Method
Failure rate	12 months
Recurrence rate	12 months
Quality of life	12 months
Sexual function	12 months
Intra-operative complication rate	one day
Postoperative complications rate	12 months

Trial Locations

Locations (1)

"Pugliese" Hospital; 🇮🇹 Catanzaro, Italy