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

University Of Perugia67 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pelvic Organ Prolapse Urinary Incontinence

Interventions

Pelvic organ prolapse repair and Burch colposuspensionPROCEDURE

Abdominal pelvic organ prolapse repair and retropubic Burch colposuspension

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Perugia

Perugia, Perugia, Italy

Outcomes

Primary Outcomes

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

Time frame: 2002-2006

Secondary Outcomes

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

Time frame: 2002-2206

Data from ClinicalTrials.gov

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