The external validation of a prediction model for anatomical cystocele recurrence after primary anterior colporrhaphy

Completed

Conditions: blaasverzakking
pelvic floor dysfunction
pelvic organ prolapse
10018188

Registration Number: NL-OMON55841

Lead Sponsor: Maastricht Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 260

Inclusion Criteria

All women who are planned for undergoing a primary anterior colporrhaphy
because of a cystocele (with a POP-Q stage of 2 and higher) in the
participating hospitals who are willing to participate in this study and give
informed consent. Women need to be able to complete the questionnaires. A
combination of a primary anterior colporrhaphy with other POP or incontinence
surgery is permitted.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- < 18 years of age
- Not capable of understanding the Dutch language or other reasons (judged by
the clinician) that make informed consent impossible.
- POP or incontinence surgery prior to index surgery
- The use of mesh or implants during surgery (vaginal or abdominal mesh for POP
surgery, tape for incontinence surgery)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary goal of this study is external validation of the prediction model<br /><br>for anatomical recurrence after primary anterior colporrhaphy. The main<br /><br>endpoint of this study is the calculated area under the curve (AUC) of the<br /><br>receiving operating curve (ROC). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secundary goal is the identification of other risk factors besides the ones<br /><br>used in the prediction model for anatomical and subjective recurrence of<br /><br>cystocele after primary anterior colporrhaphy, calculated by univariate and<br /><br>multivariate regression analysis.</p><br>