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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Stefano Palomba, University Magna Graecia
ClinicalTrials.gov Identifier:
NCT00573703
First received: December 12, 2007
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Stress Urinary Incontinence
Procedure: Laparoscopic Burch colposuspension
Procedure: Transobturator tape procedure
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison Between Laparoscopic Burch Colposuspension and Transobturatory Tape (TOT) for the Treatment of Female Urinary Stress Incontinence

Resource links provided by NLM:


Further study details as provided by University Magna Graecia:

Primary Outcome Measures:
  • Objective/subjective symptoms improvements [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intra-operative complication rate [ Time Frame: one day ] [ Designated as safety issue: Yes ]
  • Postoperative complications rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Failure rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Recurrence rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Sexual function [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A 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.
Experimental: Group B Procedure: 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.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573703

Locations
Italy
"Pugliese" Hospital
Catanzaro, Italy, 88100
Sponsors and Collaborators
University Magna Graecia
Investigators
Principal Investigator: Stefano Palomba, MD Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Study Chair: Fulvio Zullo, MD Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
  More Information

No publications provided

Responsible Party: Stefano Palomba, Associate Professor, University Magna Graecia
ClinicalTrials.gov Identifier: NCT00573703     History of Changes
Other Study ID Numbers: 02/2007
Study First Received: December 12, 2007
Last Updated: April 5, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University Magna Graecia:
Laparoscopic Burch colposuspension
Stress incontinence
Surgery
TOT
Treatment
Predominant or genuine stress urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence, Stress
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014