The efficacy of botulin toxin A injection in the pelvic floor muscles in the treatment of chronic pelvic pain.

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001296-23-NL

Enrollment

Registered

2017-07-07

Start date

2019-06-03

Completion date

Unknown

Last updated

2025-01-07

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

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.

Interventions

Trade Name: Botox Product Name: Botox Pharmaceutical Form: Powder and solution for solution for injection Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Intramus

Eligibility

Sex/Gender

All

Inclusion 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 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

Exclusion criteria

Exclusion criteria: - (wish for) Pregnancy/lactation - Previous pelvic floor BTA treatment - Known hypersensitivity to BTA - History of neuromuscular or bleeding disorders

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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). ? 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. ;Timepoint(s) of evaluation of this end point: at 4, 8, 12 and 26 weeks after injection.	—

Measure

Time frame

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). ? 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. ;Timepoint(s) of evaluation of this end point: at 4, 8, 12 and 26 weeks after injection.

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Countries

Netherlands

Contacts

Public ContactGynaecology department

Radboudumc

wenche.klerkx@radboudumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026