ong-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
Recruiting
- Conditions
- recurrent pelvic organ prolapse10029903
- Registration Number
- NL-OMON40299
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 190
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
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Effectiveness of surgery 7 and 10 years after conventional surgery compared<br /><br>with tension free vaginal mesh.<br /><br>Success is defined as a *composite outcome*: pelvic organ prolapse POPQ ,<br /><br>leading edge < hymen and no bulge symptoms and no re-operation for POP.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Long-term complications of both techniques, with special interest in pain and<br /><br>(de novo)-dyspareunia and re-operation. </p><br>