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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:
Information provided by:
University Of Perugia
ClinicalTrials.gov Identifier:
NCT00576004
First received: December 17, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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
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

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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: December 17, 2007
Last Updated: December 17, 2007
Health Authority: Italy: Ministry of Health

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

Additional relevant MeSH terms:
Prolapse
Urinary Incontinence
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
 Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013