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

NCT00576004 | Completed

• 2 other identifiers: EC_ML_001EC_ML_001s
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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

Conditions

Pelvic Organ Prolapse; Urinary Incontinence

Keywords

Pelvic organ prolapse, Urinary incontinence, Burch colposuspension, surgery

Outcome Measures

Primary Outcomes (1)

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

  2002-2006

Secondary Outcomes (1)

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

  2002-2206

Study Arms (2)

group A

ACTIVE COMPARATOR

Pelvic organ prolapse repair plus concomitant Burch Colposuspension

Procedure: Pelvic organ prolapse repair and Burch colposuspension

group B

ACTIVE COMPARATOR

Pelvic organ prolapse without Burch colposuspension

Procedure: Pelvic organ prolapse repair and Burch colposuspension

Interventions

Pelvic organ prolapse repair and Burch colposuspension PROCEDURE

Abdominal pelvic organ prolapse repair and retropubic Burch colposuspension

group A; group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Of Perugia: lead

Study Sites (1)

University of Perugia

Perugia, Perugia, 06100, Italy

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pelvic Organ Prolapse; Urinary Incontinence

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Study Officials

• Elisabetta Costantini, MD

  University Of Perugia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 17, 2007
• First Posted: December 18, 2007
• Study Start: January 1, 2002
• Study Completion: December 1, 2006
• Last Updated: December 18, 2007

Record last verified: 2007-12

Locations

IT (1)