E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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E.1.1.1 | Medical condition in easily understood language |
chronic pelvic pain without anatomic cause and with pelvic floor muscles hypertonicity |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal exclusion criteria |
- (wish for) Pregnancy/lactation
- Previous pelvic floor BTA treatment
- Known hypersensitivity to BTA
- History of neuromuscular or bleeding disorders
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E.5 End points |
E.5.1 | Primary end point(s) |
Decrease of chronic pelvic pain, measured with a decrease in visual analog scale score (VAS score 0-10) with 33%. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
at 4, 8, 12 and 26 weeks after injection. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial ends with the last visit of the last subject which can be 52 weeks after inclusion of the last subject. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |