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Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00535301
First Posted: September 26, 2007
Last Update Posted: April 22, 2015
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 (Responsible Party):
Kaiser Permanente
Results First Submitted: May 4, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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
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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
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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 
Overall Participants Analyzed 
[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   [ Time Frame: perioperative ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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/Kaiser Permanente
phone: 562-657-2642
e-mail: john.n.nguyen@kp.org


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00535301     History of Changes
Other Study ID Numbers: 4348
First Submitted: September 24, 2007
First Posted: September 26, 2007
Results First Submitted: May 4, 2011
Results First Posted: July 28, 2011
Last Update Posted: April 22, 2015