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

NCT00697489 | Withdrawn Phase 4 DMC

• 1 other identifier: 01/2008
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic organ prolapse; Urinary incontinence; Mesh

Outcome Measures

Primary Outcomes (1)

• efficacy (cure rate)

  12 months

Secondary Outcomes (6)

• intra-operative complication rate

  one day

• postoperative complications rate

  12 months

• sexual function

  12 months

• quality of life

  12 months

• Failure rate

  12 months

Study Arms (2)

1

ACTIVE COMPARATOR

unique surgery

Procedure: correction of POP plus preventive continence procedure

2

ACTIVE COMPARATOR

Double surgery

Procedure: POP surgery followed by eventual incontinence procedure

Interventions

correction of POP plus preventive continence procedure PROCEDURE

1

POP surgery followed by eventual incontinence procedure PROCEDURE

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

"Pugliese" Hospital

Catanzaro, Catanzaro, 88100, Italy

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse; Urinary Incontinence

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Study Officials

• Stefano Palomba, MD

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

  PRINCIPAL INVESTIGATOR

• Fulvio Zullo, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 12, 2008
• First Posted: June 16, 2008
• Study Start: June 1, 2008
• Primary Completion: August 1, 2010
• Last Updated: April 8, 2013

Record last verified: 2013-04

Locations

IT (1)