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

Stress Urinary Incontinence Clinical Trial

Official title:

A Comparison Between Laparoscopic Burch Colposuspension and Transobturatory Tape (TOT) for the Treatment of Female Urinary Stress Incontinence

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00573703
• Other study ID #: 02/2007
• Status: Withdrawn
• Phase: Phase 4
• First received: December 12, 2007
• Last updated: April 5, 2013
• Start date: September 2007

Study information

• Verified date: April 2013
• Source: University Magna Graecia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Procedure:
• Laparoscopic Burch colposuspension
Lapaparoscopic approach. One or two nonadsorbable sutures are placed at the level of the midurethra without penetrating the vaginal mucosa and fixed to Cooper's ligament with a tension free knotting technique.
• Transobturator tape procedure
Small incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of mesh by means of needle. Application of resorbable tensioning suture that maintains the mesh and enables fine adjustments in mesh tension during the procedure and in the immediate postoperative period.

Locations

Country	Name	City	State
Italy	"Pugliese" Hospital	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective/subjective symptoms improvements		12 months	No
Secondary	Intra-operative complication rate		one day	Yes
Secondary	Postoperative complications rate		12 months	Yes
Secondary	Failure rate		12 months	No
Secondary	Recurrence rate		12 months	No
Secondary	Quality of life		12 months	No
Secondary	Sexual function		12 months	No