Clinical trial NCT00573703: Laparoscopic Burch Colposuspension Versus Transobturatory Tape for the Treatment of Female Urinary Stress Incontinence
Official title: A Comparison Between Laparoscopic Burch Colposuspension and Transobturatory Tape (TOT) for the Treatment of Female Urinary Stress Incontinence
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Stress Urinary Incontinence
Keywords: Laparoscopic Burch colposuspension
Stress incontinence
Surgery
TOT
Treatment
Predominant or genuine stress urinary incontinence
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2007-12-14
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective/subjective symptoms improvements
timeFrame: 12 months
Secondary outcomes:
measure: Intra-operative complication rate
timeFrame: one day
measure: Postoperative complications rate
timeFrame: 12 months
measure: Failure rate
timeFrame: 12 months
measure: Recurrence rate
timeFrame: 12 months
measure: Quality of life
timeFrame: 12 months
measure: Sexual function
timeFrame: 12 months
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: "Pugliese" Hospital
Study officials:
affiliation: Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
name: Stefano Palomba, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
name: Fulvio Zullo, MD
role: STUDY_CHAIR
References: