De effectiviteit van botuline toxine A als injectie in de bekkenbodemspier bij patiënten met chronische bekkenpijn: een dubbel-geblindeerde, gerandomiseerde studie.
- Conditions
- chronic pelvic pain with pelvic floor hypertonicity
- Registration Number
- NL-OMON20966
- Lead Sponsor
- Radboudumc, Nijmegen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 92
Inclusion Criteria
Female, >18 years
-Chronic pelvic pain according to the ICS with or without dyspareunia
Exclusion Criteria
-(wish for) Pregnancy/lactation during study period
-Previous pelvic floor BTA treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method decrease of chronic pelvic pain, measured with a decrease in visual analog scale score (VAS score 0-10) with 33% and the PGI-I of 6 or 7 (better or much better).
- Secondary Outcome Measures
Name Time Method „ÒQuality of life measured with validated questionnaires: pelvic floor distress inventory (PFDI-20), pelvic floor impact questionnaire (PFIQ-7), quality of life (EQ-5D), paindetect, pain catastrophizing scale (PCS), hospital anxiety and depression scale (HADS), sexual function (PISQ-IR).<br /><br>„ÒDecrease of pelvic floor hypertonicity measured by the MAPLe device<br /><br>„ÒPatient preference study: evaluating patient preferences in maximal treatment effect at cost of possible side-effects and if pretest expectations influences trial results.<br>