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

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse; Urinary Incontinence
• Interventions: Procedure: Pelvic organ prolapse repair and Burch colposuspension

• Registration Number: NCT00576004
• Lead Sponsor: University Of Perugia

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.

Study Timeline

• Study Start: 2002-01
• Study Completion: 2006-12
• Status Verified: 2007-12
• Study First Submitted: 2007-12-17
• Study First Submitted QC: 2007-12-17
• Last Update Submitted: 2007-12-17
• Study First Posted: 2007-12-18
• Last Update Posted: 2007-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 67

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group B	Pelvic organ prolapse repair and Burch colposuspension	Pelvic organ prolapse without Burch colposuspension
group A	Pelvic organ prolapse repair and Burch colposuspension	Pelvic organ prolapse repair plus concomitant Burch Colposuspension

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
changes in subjective symptoms and Quality of Life (QoL) as measured by questionnaires	2002-2206

Trial Locations

Locations (1)

University of Perugia; 🇮🇹 Perugia, Italy