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

NCT00573703 | Withdrawn Phase 4 DMC

• 1 other identifier: 02/2007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence

Keywords

Laparoscopic Burch colposuspension; Stress incontinence; Surgery; TOT; Treatment; Predominant or genuine stress urinary incontinence

Outcome Measures

Primary Outcomes (1)

• Objective/subjective symptoms improvements

  12 months

Secondary Outcomes (6)

• Intra-operative complication rate

  one day

• Postoperative complications rate

  12 months

• Failure rate

  12 months

• Recurrence rate

  12 months

• Quality of life

  12 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

Procedure: Laparoscopic Burch colposuspension

Group B

EXPERIMENTAL

Procedure: Transobturator tape procedure

Interventions

Laparoscopic Burch colposuspension PROCEDURE

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.

Group A

Transobturator tape procedure 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.

Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

"Pugliese" Hospital

Catanzaro, Catanzaro, 88100, Italy

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefano Palomba, MD

  Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

  PRINCIPAL INVESTIGATOR

• Fulvio Zullo, MD

  Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 14, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2007
• Last Updated: April 8, 2013

Record last verified: 2013-04

Locations

IT (1)