The efficacy of botulin toxin A injection in the pelvic floor muscles in the treatment of chronic pelvic pain.
- Conditions
- Patients with >6 months or recurrent episodes of abdomino-perineo-pelvic pain, hypersensitivity or discomfort often associated with elimination changes, and sexual dysfunction in the absence of organic etiology (definition of the International Continence Society (ICS)) with (primary of secondary) pelvic floor muscle hypertonicity refractory to first line pelvic floor physiotherapy, willing to participate in this trial.Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2017-001296-23-NL
- Lead Sponsor
- Radboudumc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 92
-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
-Previous physical therapy with registered physical therapist was unsuccessful
-Good understanding of Dutch language
-Willing to provide informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 92
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-(wish for) Pregnancy/lactation
-Previous pelvic floor BTA treatment
-Known hypersensitivity to BTA
-History of neuromuscular or bleeding disorders
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective is to investigate wheather BTA injection in the pelvic floor muscle is an effective treatment for patients with chronic pelvic pain and pelvic floor hypertonicity.;Secondary Objective: Not applicable;Primary end point(s): Decrease of chronic pelvic pain, measured with a decrease in visual analog scale score (VAS score 0-10) with 33%.;Timepoint(s) of evaluation of this end point: 26 weeks after injection
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): ?Quality of life measured with validated questionnaires: patient global impression of improvement score (PGI-I), 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 (FSDS, FSFI).<br> ?Decrease of pelvic floor hypertonicity measured by the MAPLe device<br> ?Patient preference study: evaluating patient preferences in maximal treatment effect at cost of possible side-effects.<br> ;Timepoint(s) of evaluation of this end point: at 4, 8, 12 and 26 weeks after injection.