A PROSPECTIVE AND COMPARATIVE STUDY OF THE (COST) EFFECTIVENESS OF TENSION FREE VAGINAL MESH PLUS MONOCRYL (PROLIFT+MTM) VERSUS CONVENTIONAL VAGINAL PROLAPSE SURGERY IN PRIMARY PROLAPSE
Recruiting
- Conditions
- 10029903pelvic organ prolapse
- Registration Number
- NL-OMON35003
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 176
Inclusion Criteria
primary pelvic organ prolapse (anterior and/or posterior compartment) POP stage II or more
age >44 years
Exclusion Criteria
pregnancy
age < 45 years
previous prolapse surgery
blood coagulation disorders
a compromised immune system or any other conditions that would compromise healing
unwilling or unable to return for evaluation
Previous irradiation
Presence of any malignancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main outcome is the percentage of patients with objective anatomical<br /><br>success (POP stage <2) after 24 months. </p><br>
- Secondary Outcome Measures
Name Time Method <p>As secondary outcome the subjective improvement in quality of life will be<br /><br>measured by generic (EQ-5D) and disease-specific (UDI, DDI, IIQ and PFDI20)<br /><br>quality of life instrument. Sexual functioning will be measured by generic<br /><br>(FSFI) and disease specific (PISQ12) questionnaires. Complications will be<br /><br>monitored with special notice for pain (Mc Gill pain questionnaire) Recovery<br /><br>will be measured with the Recovery index 10. The economical endpoint is short<br /><br>term (2 year) incremental cost-effectiveness in terms of costs per additional<br /><br>year free of prolapse and costs per QALY gained. </p><br>