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

Primary Purpose

Stress Urinary Incontinence

Status

Withdrawn

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

Laparoscopic Burch colposuspension

Transobturator tape procedure

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Laparoscopic Burch colposuspension, Stress incontinence, Surgery, TOT, Treatment, Predominant or genuine stress urinary incontinence

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

"Pugliese" Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A

Group B

Arm Description

Outcomes

Primary Outcome Measures

Objective/subjective symptoms improvements

Secondary Outcome Measures

Intra-operative complication rate

Postoperative complications rate

Failure rate

Recurrence rate

Quality of life

Sexual function

Full Information

NCT ID

NCT00573703

First Posted

December 12, 2007

Last Updated

April 5, 2013

Sponsor

University Magna Graecia

1. Study Identification

Unique Protocol Identification Number

NCT00573703

Brief Title

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

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Withdrawn

Study Start Date

September 2007 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Magna Graecia

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stress Urinary Incontinence

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Active Comparator

Arm Title

Group B

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic Burch colposuspension

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Transobturator tape procedure

Intervention Description

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.

Primary Outcome Measure Information:

Title

Objective/subjective symptoms improvements

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Intra-operative complication rate

Time Frame

one day

Title

Postoperative complications rate

Time Frame

12 months

Title

Failure rate

Time Frame

12 months

Title

Recurrence rate

Time Frame

12 months

Title

Quality of life

Time Frame

12 months

Title

Sexual function

Time Frame

12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stefano Palomba, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Fulvio Zullo, MD

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

"Pugliese" Hospital

City

Catanzaro

ZIP/Postal Code

88100

Country

Italy

12. IPD Sharing Statement

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

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