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

December 17, 2007 updated by: University Of Perugia

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Perugia, Italy, 06100
        • University of Perugia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Of Perugia

Investigators

  • Principal Investigator: Elisabetta Costantini, MD, University of Perugia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

December 17, 2007

First Submitted That Met QC Criteria

December 17, 2007

First Posted (Estimate)

December 18, 2007

Study Record Updates

Last Update Posted (Estimate)

December 18, 2007

Last Update Submitted That Met QC Criteria

December 17, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC_ML_001
  • EC_ML_001s

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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