Pelvic Organ Prolapse Repair With or Without Concomitant Burch Colposuspension in Patients With Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
To evaluate the impact of Burch colposuspension (BC), as an anti-incontinence measure, in patients with urinary incontinence (UI) undergoing abdominal surgery for pelvic organ prolapse (POP) repair

Detailed Description
-----------------
Forty-seven women suffering from POP and UI were randomly assigned to abdominal POP repair and concomitant BC ( 24 patients; group A) or POP repair alone without any anti-incontinence procedure ( 23 patients.; group B). They were followed-up at 3, 6, and 9 months after surgery and then annually. The primary outcome measures were anatomical outcome and changes in incontinence status as indicated by a bladder diary, the number of daily pads and the stress test. Secondary endpoints were changes in subjective symptoms and Quality of Life (QoL) as measured by the Urogenital Distress Inventory (UDI-6) and the Impact Incontinence Quality of Life (IIQ-7) questionnaires.

Official Title
-----------------
Pelvic Organ Prolapse Repair With or Without Concomitant Burch Colposuspension in Patients With Urinary Incontinence: A Randomised Surgical Trial

Conditions
-----------------
Pelvic Organ Prolapse, Urinary Incontinence

Intervention / Treatment
-----------------
* Procedure: Pelvic organ prolapse repair and Burch colposuspension


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Study inclusion criteria were POP > 2, UI as was defined by ICS [2], age ≥ 18 and ≤ 75 yrs. Exclusion Criteria: Benign or malignant uterus lesion (leiomyoma, fibromyoma, cervical or endometrial carcinoma) Active pelvic inflammatory disease, Known hypersensitivity to synthetic materials (polypropylene, polythetrafloroethilene, polyethileneterephtalate, polyglactil acid or polyglycolic acid) Pregnancy or lactation Evidence of clinically significant cardiovascular, renal, hepatic or respiratory diseases; and Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group A<br>Pelvic organ prolapse repair plus concomitant Burch Colposuspension | Procedure: Pelvic organ prolapse repair and Burch colposuspension<br>* Abdominal pelvic organ prolapse repair and retropubic Burch colposuspension<br>|
| Active Comparator: group B<br>Pelvic organ prolapse without Burch colposuspension | Procedure: Pelvic organ prolapse repair and Burch colposuspension<br>* Abdominal pelvic organ prolapse repair and retropubic Burch colposuspension<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in the incontinence rate as shown by a bladder diary, number of daily pads and the stress test. |  | 2002-2006 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in subjective symptoms and Quality of Life (QoL) as measured by questionnaires |  | 2002-2206 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pelvic organ prolapse, Urinary incontinence, Burch colposuspension, surgery