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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48791

Enrollment

Registered

2019-07-15

Start date

2020-01-07

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronische bekkenpijn chronic pelvic pain pelvic floor muscle hypertonicity

Interventions

The pelvic floor muscles will be injected with either 100 IU BTA or NaCl 0.9% (placebo).

botulin

hypertonicity

pelvic floor muscles

pelvic pain

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
- 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.	—

Measure

Time frame

- 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.

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)