chronic pelvic pain with pelvic floor hypertonicity
Conditions
Interventions
The pelvic floor muscles will be injected with either 100 IU BTA or placebo.
Sponsors
Radboudumc, Nijmegen
Eligibility
Inclusion criteria
Inclusion criteria: - Female, >18 years - Chronic pelvic pain according to the ICS with or without dyspareunia - Vaginal examination with one finger possible - Pelvic floor hypertonicity measured by physical examination by registered pelvic floor physiotherapist and MAPLe - Previous physical therapy with registered physical therapist was unsuccessful - Good understanding of Dutch language - Willing to provide informed consent
Exclusion criteria
Exclusion criteria: - (wish for) Pregnancy/lactation during study period - Previous pelvic floor BTA treatment - Known hypersensitivity to BTA - History of neuromuscular or bleeding disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| „Ò Quality 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). „Ò Decrease of pelvic floor hypertonicity measured by the MAPLe device „Ò Patient preference study: evaluating patient preferences in maximal treatment effect at cost of possible side-effects and if pretest expectations influences trial results. | — |
Contacts
Public ContactWM. Klerkx
Outcome results
None listed