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

December 17, 2007
December 17, 2007
January 2002
Not Provided
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 ]
Same as current
No Changes Posted
changes in subjective symptoms and Quality of Life (QoL) as measured by questionnaires [ Time Frame: 2002-2206 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pelvic Organ Prolapse Repair With or Without Concomitant Burch Colposuspension in Patients With Urinary Incontinence
Pelvic Organ Prolapse Repair With or Without Concomitant Burch Colposuspension in Patients With Urinary Incontinence: A Randomised Surgical Trial

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pelvic Organ Prolapse
  • Urinary Incontinence
Procedure: Pelvic organ prolapse repair and Burch colposuspension
Abdominal pelvic organ prolapse repair and retropubic Burch colposuspension
  • Active Comparator: group A
    Pelvic organ prolapse repair plus concomitant Burch Colposuspension
    Intervention: Procedure: Pelvic organ prolapse repair and Burch colposuspension
  • Active Comparator: group B
    Pelvic organ prolapse without Burch colposuspension
    Intervention: Procedure: Pelvic organ prolapse repair and Burch colposuspension
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
December 2006
Not Provided

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.
Female
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00576004
EC_ML_001, EC_ML_001s
No
Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology
University Of Perugia
Not Provided
Principal Investigator: Elisabetta Costantini, MD University Of Perugia
University Of Perugia
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP