The efficacy of botulinum toxin A injection in pelvic floor muscles in chronic pelvic pain patients: a double-blinded randomised controlled trial

Phase 3

Recruiting

Conditions: chronische bekkenpijn
chronic pelvic pain
pelvic floor muscle hypertonicity
10028302
10041297

Registration Number: NL-OMON48791

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 94

Inclusion Criteria

- Female, >16 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
- Previous physical therapy with registered physical therapist was unsuccessful
- Good understanding of Dutch language
- Willing to provide informed consent

Exclusion Criteria

- (wish for) Pregnancy/lactation during study period
- Previous pelvic floor botox treatment
- Known hypersensitivity to botox
- History of neuromuscular or bleeding disorders

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Decrease of chronic pelvic pain, measured with a decrease in visual analog<br /><br>scale score (VAS score 0-10) with 33% and the PGI-I of 6 or 7 (better or much<br /><br>better).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Quality of life measured with validated questionnaires: patient global<br /><br>impression of improvement score (PGI-I), pelvic floor distress inventory<br /><br>(PFDI-20), pelvic floor impact questionnaire (PFIQ-7), quality of life (EQ-5D),<br /><br>paindetect, pain catastrophizing scale (PCS), hospital anxiety and depression<br /><br>scale (HADS), sexual function (FSDS, FSFI).<br /><br>- Decrease of pelvic floor hypertonicity measured by the MAPLe device<br /><br>- Patient preference study: evaluating patient preferences in maximal treatment<br /><br>effect at cost of possible side-effects.</p><br>