Laparoscopic Burch Colposuspension Versus Transobturatory Tape for the Treatment of Female Urinary Stress Incontinence - Full Text View

Sponsored by:	University Magna Graecia
Information provided by:	University Magna Graecia
ClinicalTrials.gov Identifier:	NCT00573703

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 IV

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Comparison Between Laparoscopic Burch Colposuspension and Transobturatory Tape (TOT) for the Treatment of Female Urinary Stress Incontinence

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 ]

Study Start Date:

September 2007

Arms	Assigned Interventions
Group A: Active Comparator	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.
Group B: Experimental	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

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

Contacts

Contact: Stefano Palomba, MD

stefanopalomba@tin.it

Locations

Italy
"Pugliese" Hospital	Recruiting
Catanzaro, Italy, 88100
Contact: Ingrid Tomaino, MD +39-0961-883234 angela.falbo@libero.it

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:	University "Magna Graecia" of Catanzaro ( Stefano Palomba )
Study ID Numbers:	02/2007
Study First Received:	December 12, 2007
Last Updated:	December 13, 2007
ClinicalTrials.gov Identifier:	NCT00573703 History of Changes
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

Study placed in the following topic categories:

Signs and Symptoms
Urinary Incontinence, Stress
Urologic Diseases

Urination Disorders
Stress
Urinary Incontinence

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Pathologic Processes
Urinary Incontinence, Stress

Urologic Diseases
Urination Disorders
Stress
Urinary Incontinence

ClinicalTrials.gov processed this record on May 07, 2009