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

University Magna Graecia

Status and phase

Withdrawn

Phase 4

Conditions

Stress Urinary Incontinence

Treatments

Procedure: Transobturator tape procedure

Procedure: Laparoscopic Burch colposuspension

Study type

Interventional

Funder types

Other

Identifiers

NCT00573703

02/2007

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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