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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00576004
• Other study ID #: EC_ML_001
• Secondary ID: EC_ML_001s
• Status: Completed
• Phase: N/A
• First received: December 17, 2007
• Last updated: December 17, 2007
• Start date: January 2002
• Est. completion date: December 2006

Study information

• Verified date: December 2007
• Source: University Of Perugia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Urinary Incontinence

Intervention

Procedure:
• Pelvic organ prolapse repair and Burch colposuspension
Abdominal pelvic organ prolapse repair and retropubic Burch colposuspension

Locations

Country	Name	City	State
Italy	University of Perugia	Perugia

Sponsors (1)

Lead Sponsor	Collaborator
University Of Perugia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in the incontinence rate as shown by a bladder diary, number of daily pads and the stress test.		2002-2006	No
Secondary	changes in subjective symptoms and Quality of Life (QoL) as measured by questionnaires		2002-2206	No

External Links

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