EUCTR2017-001296-23-NL
Active, Not Recruiting
Phase 1
The efficacy of botulinum toxin A injection in pelvic floor muscles in chronic pelvic pain patients: a double-blinded randomised controlled trial
ConditionsPatients 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]
DrugsBotox
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- 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.
- Sponsor
- Radboudumc
- Enrollment
- 92
- Status
- Active, Not Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\-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
Exclusion Criteria
- •\-(wish for) Pregnancy/lactation
- •\-Previous pelvic floor BTA treatment
- •\-Known hypersensitivity to BTA
- •\-History of neuromuscular or bleeding disorders
Outcomes
Primary Outcomes
Not specified
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