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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00576004
First Posted: December 18, 2007
Last Update Posted: December 18, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Of Perugia
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pelvic Organ Prolapse Repair With or Without Concomitant Burch Colposuspension in Patients With Urinary Incontinence: A Randomised Surgical Trial

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • changes in subjective symptoms and Quality of Life (QoL) as measured by questionnaires [ Time Frame: 2002-2206 ]

Enrollment: 67
Study Start Date: January 2002
Study Completion Date: December 2006
Arms Assigned Interventions
Active Comparator: group A
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
Active Comparator: group B
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

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology
ClinicalTrials.gov Identifier: NCT00576004     History of Changes
Other Study ID Numbers: EC_ML_001
EC_ML_001s
First Submitted: December 17, 2007
First Posted: December 18, 2007
Last Update Posted: December 18, 2007
Last Verified: December 2007

Keywords provided by University Of Perugia:
Pelvic organ prolapse, Urinary incontinence, Burch colposuspension, surgery

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Prolapse
Pelvic Organ Prolapse
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Pathological Conditions, Anatomical