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

NCT ID: NCT00576004

Last Updated: 2007-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2006-12-31

Brief Summary

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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

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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.

Conditions

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Pelvic Organ Prolapse Urinary Incontinence

Keywords

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Pelvic organ prolapse, Urinary incontinence, Burch colposuspension, surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group A

Pelvic organ prolapse repair plus concomitant Burch Colposuspension

Group Type ACTIVE_COMPARATOR

Pelvic organ prolapse repair and Burch colposuspension

Intervention Type PROCEDURE

Abdominal pelvic organ prolapse repair and retropubic Burch colposuspension

group B

Pelvic organ prolapse without Burch colposuspension

Group Type ACTIVE_COMPARATOR

Pelvic organ prolapse repair and Burch colposuspension

Intervention Type PROCEDURE

Abdominal pelvic organ prolapse repair and retropubic Burch colposuspension

Interventions

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Pelvic organ prolapse repair and Burch colposuspension

Abdominal pelvic organ prolapse repair and retropubic Burch colposuspension

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Of Perugia

OTHER

Sponsor Role lead

Responsible Party

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Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology

Principal Investigators

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Elisabetta Costantini, MD

Role: PRINCIPAL_INVESTIGATOR

University Of Perugia

Locations

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University of Perugia

Perugia, Perugia, Italy

Site Status

Countries

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Italy

Related Links

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http://www.unipg.it

Related Info

Other Identifiers

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EC_ML_001s

Identifier Type: -

Identifier Source: secondary_id

EC_ML_001

Identifier Type: -

Identifier Source: org_study_id