Pelvic Organ Prolapse Repair With or Without Concomitant Burch Colposuspension in Patients With Urinary Incontinence - Full Text View

Sponsored by:	University Of Perugia
Information provided by:	University Of Perugia
ClinicalTrials.gov Identifier:	NCT00576004

Purpose

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

Condition	Intervention
Pelvic Organ Prolapse Urinary Incontinence	Procedure: Pelvic organ prolapse repair and Burch colposuspension

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Pelvic Organ Prolapse Repair With or Without Concomitant Burch Colposuspension in Patients With Urinary Incontinence: A Randomised Surgical Trial

Further study details as provided by University Of Perugia:

Primary Outcome Measures:

changes in the incontinence rate as shown by a bladder diary, number of daily pads and the stress test. [ Time Frame: 2002-2006 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

changes in subjective symptoms and Quality of Life (QoL) as measured by questionnaires [ Time Frame: 2002-2206 ] [ Designated as safety issue: No ]

Enrollment:	67
Study Start Date:	January 2002
Study Completion Date:	December 2006

Arms	Assigned Interventions
group A: Active Comparator Pelvic organ prolapse repair plus concomitant Burch Colposuspension	Procedure: Pelvic organ prolapse repair and Burch colposuspension Abdominal pelvic organ prolapse repair and retropubic Burch colposuspension
group B: Active Comparator Pelvic organ prolapse without Burch colposuspension	Procedure: Pelvic organ prolapse repair and Burch colposuspension Abdominal pelvic organ prolapse repair and retropubic Burch colposuspension

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576004

Locations

Italy
University of Perugia
Perugia, Italy, 06100

Sponsors and Collaborators

University Of Perugia

Investigators

Principal Investigator:

Elisabetta Costantini, MD

University Of Perugia

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology
Study ID Numbers:	EC_ML_001, EC_ML_001s
Study First Received:	December 17, 2007
Last Updated:	December 17, 2007
ClinicalTrials.gov Identifier:	NCT00576004
Health Authority:	Italy: Ministry of Health

Keywords provided by University Of Perugia:

Pelvic organ prolapse, Urinary incontinence, Burch colposuspension, surgery

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Signs and Symptoms
Digestive System Diseases
Urologic Diseases
Gastrointestinal Diseases
Urination Disorders

Urinary Incontinence
Intestinal Diseases
Rectal Diseases
Prolapse
Rectal Prolapse

Additional relevant MeSH terms:

Urological Manifestations

ClinicalTrials.gov processed this record on January 16, 2009