Long-term follow-up of the prospective and comparative study of the performance of tension free vaginal mesh (ProliftTM) versus conventional pelvic organ prolapse surgery in recurrent prolapse

Long-term follow-up of the prospective and comparative study of the performance of tension free vaginal mesh (ProliftTM) versus conventional pelvic organ prolapse surgery in recurrent prolapse - VROUW 1 follow-up

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40299

Enrollment

190

Registered

2014-04-28

Start date

2014-11-02

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

recurrent pelvic organ prolapse

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: a. The study population is already selected and randomisation and surgery already have taken place (Withagen 2011, Vrouw 1 trial). b. Subject is willing to return for follow-up evaluation and/or QoL questionnaires completion at 7 years and/or 10 years after surgery.

Exclusion criteria

Exclusion criteria: a. Subject is unwilling or unable to complete questionnaire and/or return for evaluation b. Presence or treatment of malignancy in the pelvis / lower abdomen

Design outcomes

Primary

Measure	Time frame
Effectiveness of surgery 7 and 10 years after conventional surgery compared with tension free vaginal mesh. Success is defined as a composite outcome: pelvic organ prolapse POPQ , leading edge	—

Secondary

Measure	Time frame
Long-term complications of both techniques, with special interest in pain and (de novo)-dyspareunia and re-operation.	—

Countries

Netherlands

Outcome results