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

Primary Purpose

Pelvic Organ Prolapse, Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Pelvic organ prolapse repair and Burch colposuspension
Sponsored by
University Of Perugia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Pelvic organ prolapse, Urinary incontinence, Burch colposuspension, surgery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Perugia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group A

group B

Arm Description

Pelvic organ prolapse repair plus concomitant Burch Colposuspension

Pelvic organ prolapse without Burch colposuspension

Outcomes

Primary Outcome Measures

changes in the incontinence rate as shown by a bladder diary, number of daily pads and the stress test.

Secondary Outcome Measures

changes in subjective symptoms and Quality of Life (QoL) as measured by questionnaires

Full Information

First Posted
December 17, 2007
Last Updated
December 17, 2007
Sponsor
University Of Perugia
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1. Study Identification

Unique Protocol Identification Number
NCT00576004
Brief Title
Pelvic Organ Prolapse Repair With or Without Concomitant Burch Colposuspension in Patients With Urinary Incontinence
Official Title
Pelvic Organ Prolapse Repair With or Without Concomitant Burch Colposuspension in Patients With Urinary Incontinence: A Randomised Surgical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Of Perugia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse, Urinary Incontinence
Keywords
Pelvic organ prolapse, Urinary incontinence, Burch colposuspension, surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Active Comparator
Arm Description
Pelvic organ prolapse repair plus concomitant Burch Colposuspension
Arm Title
group B
Arm Type
Active Comparator
Arm Description
Pelvic organ prolapse without Burch colposuspension
Intervention Type
Procedure
Intervention Name(s)
Pelvic organ prolapse repair and Burch colposuspension
Intervention Description
Abdominal pelvic organ prolapse repair and retropubic Burch colposuspension
Primary Outcome Measure Information:
Title
changes in the incontinence rate as shown by a bladder diary, number of daily pads and the stress test.
Time Frame
2002-2006
Secondary Outcome Measure Information:
Title
changes in subjective symptoms and Quality of Life (QoL) as measured by questionnaires
Time Frame
2002-2206

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabetta Costantini, MD
Organizational Affiliation
University Of Perugia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Perugia
City
Perugia
ZIP/Postal Code
06100
Country
Italy

12. IPD Sharing Statement

Links:
URL
http://www.unipg.it
Description
Related Info

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

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