Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair

This study has been completed.
Sponsor:
Information provided by:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00535301
First received: September 24, 2007
Last updated: August 1, 2011
Last verified: August 2011
Results First Received: May 4, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Cystocele
Uterine Prolapse
Urinary Incontinence
Interventions: Device: grafted anterior prolapse repair
Procedure: sutured anterior vaginal prolapse repair

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from the Female Pelvic Medicine and Reconstructive Surgery Clinic at Kaiser Permanente Bellflower Medical Center between January 2005 and April 2006.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Exclusion criteria were less than stage II anterior vaginal prolapse, current or future pregnancy, prior grafted anterior prolapse repair, impaired wound healing, known hypersensitivity to polypropylene, unable or unwilling to give valid informed consent or if scheduled to undergo concomitant Burch colposuspension or pubovaginal sling.

Reporting Groups
  Description
Anterior Colporrhaphy Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
Perigee Anterior vaginal prolapse repair with graft

Participant Flow:   Overall Study
    Anterior Colporrhaphy     Perigee  
STARTED     38     38  
COMPLETED     33     33  
NOT COMPLETED     5     5  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Anterior Colporrhaphy Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
Perigee Anterior vaginal prolapse repair with graft
Total Total of all reporting groups

Baseline Measures
    Anterior Colporrhaphy     Perigee     Total  
Number of Participants  
[units: participants]
  38     38     76  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     26     28     54  
>=65 years     12     10     22  
Age  
[units: years]
Mean ± Standard Deviation
  59  ± 9.5     61  ± 10.5     60  ± 10.5  
Gender  
[units: participants]
     
Female     38     38     76  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     38     38     76  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Recurrent Stage II or Greater Anterior Vaginal Prolapse   [ Time Frame: three years ]

2.  Secondary:   Operative Time - From First Incision to Closure of Last Incision   [ Time Frame: perioperative ]

3.  Secondary:   Vaginal Mesh Exposure   [ Time Frame: perioperative ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
-Small number of subjects, Single surgeon, Medium follow-up, Limited ability to detect uncommon adverse events and small differences in quality of life and sexual symptom scores, Concurrent pelvic reconstructive and anti-incontinence procedures


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: John N. Nguyen, MD
Organization: SCPMG
phone: 562-657-2642
e-mail: john.n.nguyen@kp.org


Publications:
Publications automatically indexed to this study:

Responsible Party: John N. Nguyen, MD, SCPMG
ClinicalTrials.gov Identifier: NCT00535301     History of Changes
Other Study ID Numbers: 4348
Study First Received: September 24, 2007
Results First Received: May 4, 2011
Last Updated: August 1, 2011
Health Authority: United States: Institutional Review Board