Treatment of Urinary Stress Incontinence During or Following Correction of Pelvic Organ Prolapse

NCT ID: NCT00697489

Last Updated: 2013-04-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30

Brief Summary

The incidence of pelvic organ prolapse (POP) in parous women is estimated over 50%. A variety of urinary, bowel and sexual symptoms may be associated with POP. Moreover, a proportion of women who underwent a surgical correction of POP may occur post-surgical urinary incontinence and, thus, if this last presents as genuine stress-type or mixed-type, a second surgical intervention may be required. At this proposal, with the aim to reduce the incidence of postoperative urinary incontinence, the addition of a preventive continence procedure to a POP repair intervention has been widely proposed, but the potential benefits needs to be balanced against potential disadvantages.

Based on these considerations, the aim of this trial will be to compare two different surgical strategies for women with POP without urinary stress incontinence. Specifically, the efficacy to associate and to follow a preventive continence procedure to the correction of POP will be compared.

Detailed Description

Women with POP not associated to urinary stress incontinence will be enrolled and randomized in two arms(groups A and B). Patients of group A will be treated with unique surgery (correction of POP plus preventive continence procedure), whereas in patients of group B POP will be surgically corrected and, in case of stress or mixed postoperative incontinence, a further intervention for urinary stress incontinence will be tailored.

All patients eligible will undergo baseline assessment consisting of anthropometric, clinical, hormonal, ultrasonographic and urodynamic evaluations. During the study, the clinical outcomes, and the adverse experience 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.

Conditions

Pelvic Organ Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

unique surgery

Group Type: ACTIVE_COMPARATOR

correction of POP plus preventive continence procedure

Intervention Type: PROCEDURE

2

Double surgery

Group Type: ACTIVE_COMPARATOR

POP surgery followed by eventual incontinence procedure

Intervention Type: PROCEDURE

Interventions

correction of POP plus preventive continence procedure

Intervention Type: PROCEDURE

POP surgery followed by eventual incontinence procedure

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Pelvic organ prolapse stage 2-3
• Absence of subjective urinary stress incontinence

Exclusion Criteria

• pregnancy
• <12 months postpartum
• systemic disease known to affect bladder function
• current chemotherapy or radiation therapy
• urethral diverticulum, augmentation cytoplasty, or artificial sphincter
• recent pelvic surgery
• patient age under 18 and over 80
• any previous pelvic surgery, diabetes mellitus and collagen disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Magna Graecia

OTHER

Sponsor Role: lead

Responsible Party

Stefano Palomba

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefano Palomba, MD

Role: PRINCIPAL_INVESTIGATOR

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

Fulvio Zullo, MD

Role: STUDY_CHAIR

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

Locations

"Pugliese" Hospital

Catanzaro, Catanzaro, Italy

Countries

Italy

Other Identifiers

01/2008

Identifier Type: -

Identifier Source: org_study_id