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

Pelvic Organ Prolapse Correction Plus Preventive Treatment of Urinary Stress Incontinence vs. Correction of Pelvic Organ Prolapse Followed by Treatment of Urinary Stress Incontinence

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.

Study Overview

• Status: Withdrawn
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: correction of POP plus preventive continence procedure; Procedure: POP surgery followed by eventual incontinence procedure

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Catanzaro, Italy, 88100
    • "Pugliese" Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; unique surgery	Procedure: correction of POP plus preventive continence procedure
Active Comparator: 2; Double surgery	Procedure: POP surgery followed by eventual incontinence procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
efficacy (cure rate)	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Recurrence rate	12 months
quality of life	12 months
Failure rate	12 months
intra-operative complication rate	one day
postoperative complications rate	12 months
sexual function	12 months

Collaborators and Investigators

• Sponsor: University Magna Graecia

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: June 12, 2008
• First Submitted That Met QC Criteria: June 13, 2008
• First Posted (Estimate): June 16, 2008

Study Record Updates

• Last Update Posted (Estimate): April 8, 2013
• Last Update Submitted That Met QC Criteria: April 5, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Urinary incontinence; Mesh; Pelvic organ prolapse
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Pathological Conditions, Anatomical; Urinary Incontinence; Prolapse; Pelvic Organ Prolapse; Urinary Incontinence, Stress
• Other Study ID Numbers: 01/2008