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De effectiviteit van botuline toxine A als injectie in de bekkenbodemspier bij patiŽnten met chronische bekkenpijn: een dubbel-geblindeerde, gerandomiseerde studie.


- candidate number27174
- NTR NumberNTR6369
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-mei-2017
- Secondary IDsABR NL61409.091.17
- Public TitleDe effectiviteit van botuline toxine A als injectie in de bekkenbodemspier bij patiŽnten met chronische bekkenpijn: een dubbel-geblindeerde, gerandomiseerde studie.
- Scientific TitleThe efficacy of botulinum toxin A injection in pelvic floor muscles in chronic pelvic pain patients: a double-blinded randomized controlled trial
- ACRONYM
- hypothesisPelvic 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 be done. 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, and possibly pain reduction
- Healt Condition(s) or Problem(s) studiedChronic pelvic pain, Pelvic floor muscles
- 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- (wish for) Pregnancy/lactation during study period
- Previous pelvic floor BTA treatment
- Known hypersensitivity to BTA
- History of neuromuscular or bleeding disorders
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2017
- planned closingdate31-dec-2018
- Target number of participants92
- InterventionsThe pelvic floor muscles will be injected with either 100 IU BTA or placebo.
- Primary outcomedecrease 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 outcomeĄ“ 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).
Ą“ Decrease of pelvic floor hypertonicity measured by the MAPLe device
Ą“ Patient preference study: evaluating patient preferences in maximal treatment effect at cost of possible side-effects and if pretest expectations influences trial results.
- Timepointsbaseline t=0, 4, 8, 12, 26 weeks after first injection, and t=30, 34, 38, 52 weeks after secondary injection
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. WM. Klerkx
- CONTACT for SCIENTIFIC QUERIESDr. WM. Klerkx
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Centre Nijmegen
- Publications
- Brief summaryChronic pelvic pain is common, affecting 15% of women aged 18-50. 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 be done. One previously published 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. There 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. This is a double-blinded randomized placebo-controlled cross-over trial in which intramuscular BTA will be compared with placebo in patients over 18 years with >6 months of chronic pelvic pain with pelvic floor muscle hypertonicity refractory to first-line pelvic floor physiotherapy, and in which no anatomical cause (such as endometriosis) was found. The main study parameters/endpoints: decrease of chronic pelvic pain, measured by 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).
- Main changes (audit trail)
- RECORD8-mei-2017 - 6-aug-2017


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