The external validation of a prediction model for anatomical cystocele recurrence after primary anterior colporrhaphy
Recruiting
- Conditions
- Pelvic Organ ProlapseRecurrencePrediction modelExternal validation
- Registration Number
- NL-OMON25627
- Lead Sponsor
- Maastricht University Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 250
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
- < 18 years of age
- Not capable of understanding the Dutch language or other reasons (judged by the clinician) that make informed consent impossible.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary goal of this study is external validation of the prediction model for anatomical recurrence after primary anterior colporrhaphy. The main endpoint of this study is the calculated area under the curve (AUC) of the receiving operating curve<br>(ROC).
- Secondary Outcome Measures
Name Time Method The secundary goal is the identification of other risk factors besides the ones used in the prediction model for anatomical and subjective recurrence of cystocele after primary anterior colporrhaphy, calculated by univariate and multivariate regression<br>analysis.