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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55841

Enrollment

260

Registered

2017-05-01

Start date

2017-07-11

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

blaasverzakking pelvic floor dysfunction pelvic organ prolapse

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: -

Design outcomes

Primary

Measure	Time frame
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 (ROC).	—

Secondary

Measure	Time frame
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 analysis.	—

Countries

Netherlands

Outcome results