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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Stefano Palomba, University Magna Graecia
ClinicalTrials.gov Identifier:
NCT00697489
First received: June 12, 2008
Last updated: April 5, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Pelvic Organ Prolapse
 Procedure: correction of POP plus preventive continence procedure
Procedure: POP surgery followed by eventual incontinence procedure
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pelvic Organ Prolapse Correction Plus Preventive Treatment of Urinary Stress Incontinence vs. Correction of Pelvic Organ Prolapse Followed by Treatment of Urinary Stress Incontinence

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Magna Graecia:

Primary Outcome Measures:
  • efficacy (cure rate) [ 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 ]
  • sexual function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Failure rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Recurrence rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: June 2008
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697489

Locations
Italy
"Pugliese" Hospital
Catanzaro, Italy, 88100
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: Stefano Palomba, Associate Professor, University Magna Graecia
ClinicalTrials.gov Identifier: NCT00697489     History of Changes
Other Study ID Numbers: 01/2008
Study First Received: June 12, 2008
Last Updated: April 5, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University Magna Graecia:
Pelvic organ prolapse
Urinary incontinence
Mesh

Additional relevant MeSH terms:
Prolapse
Urinary Incontinence, Stress
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Urinary Incontinence
 Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013