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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00271102
Other study ID # 2005-0193
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2006
Est. completion date August 2011

Study information

Verified date September 2019
Source Geisinger Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether vaginal repair or abdominal repair is the procedure of choice for the surgical management of a prolapsed bladder.


Description:

It is not known whether anterior vaginal repair (colporrhaphy) or abdominal paravaginal defect repair is the procedure of choice for the treatment anterior vaginal wall prolapse. This randomized prospective study will attempt to answer this question by assessing the change in the stage of prolapse before and after surgery, patient satisfaction through quality of life and sexual function questionnaires before and after surgery, and peri-operative complication rates. Patients enrolled into the study will be followed up for up to 2 years after surgery.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date August 2011
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Women over the age of 18 seen at the urogynecology clinic at Geisinger with primary or recurrent pelvic organ prolapse including an anterior vaginal wall relaxation with or without urinary incontinence who are scheduled to have pelvic reconstructive surgery will be eligible to participate in the trial.

Exclusion Criteria:

- Patients with at least 2 previous prolapse surgeries

- Patients who are pregnant or planning to have a pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
anterior vaginal repair (colporrhaphy)
vaginal repair
abdominal paravaginal defect repair
abdominal repair

Locations

Country Name City State
United States Geisinger Health System Danville Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Geisinger Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery POP-Q (pelvic organ prolapse quantification) as measured after surgery at one year or more after surgery. If one year data not available, then the last post-op measure is reported. 4 years
Secondary The Difference in Intra-operative and Post-operative Complications. Patient Satisfaction Before and One Year After Surgery Based on Quality of Life and Sexual Function Questionnaires Specifically Designed for Patients With Pelvic Organ Prolapse. 4 years
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