The objective of this study is to investigate whether BTA injection in the pelvic floor muscle is an effective treatment for patients with chronic pelvic pain and pelvic floor hypertonicity.
ID
Source
Brief title
Condition
- Other condition
- Muscle disorders
- Soft tissue therapeutic procedures
Synonym
Health condition
chronische bekkenpijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
- 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).
- Decrease of pelvic floor hypertonicity measured by the MAPLe device
- Patient preference study: evaluating patient preferences in maximal treatment
effect at cost of possible side-effects.
Background summary
Chronic pelvic pain is common, affecting 15% of women aged 18-50 [Mathias].
Pelvic floor muscle spasms resulting in chronic pelvic pain may occur as a
primary event or secondary to a physical, psychological or pathological factor.
First-line treatment consists of pelvic floor physiotherapy. When first-line
treatment fails, more invasive interventions can take place. One described
intervention is injection with Botulinum toxin A (BTA) in the pelvic floor
muscles. It produces a localized, partial, and reversible chemical denervation
of the muscle which results in localized muscle weakness or paralysis. The is
some evidence that injection of BTA in the hypertonic pelvic floor muscles
decreases pelvic pain in patients with therapy resistant chronic pelvic pain,
however this is not investigated in a randomized controlled trial.
Study objective
The objective of this study is to investigate whether BTA injection in the
pelvic floor muscle is an effective treatment for patients with chronic pelvic
pain and pelvic floor hypertonicity.
Study design
Double-blinded randomized placebo-controlled cross-over trial
Intervention
The pelvic floor muscles will be injected with either 100 IU BTA or NaCl 0.9%
(placebo).
Study burden and risks
Patients will undergo one of two vaginal injections with BTA or placebo. To
evaluate efficacy, questionnaires and physical examination will be performed at
baseline, t=4, 8, 12, and 26 weeks after injection. The discomfort will mainly
be during the injection, this will last for maximal 15 minutes. Risks of
injection will be bleeding or infections which are anticipated by hemostatic
pressure and antiseptic workflow and are considered minimal. Side-effects as
temporarily urinary and/or fecal incontinence will be discussed before
inclusion (0-6%).
geert grooteplein zuid 10
nijmegen 6525ga
NL
geert grooteplein zuid 10
nijmegen 6525ga
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-001296-23-NL |
| CCMO | NL61409.091.17 |