Electromyographic Study for the Help and Guidance of BoNTA Administration in the Treatment of Chronic Pelvic Floor Pain

Study Overview
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Brief Summary
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Chronic pelvic pain (CPP) is a common presenting complaint affecting approximately 15-40 % of women aged 18-50 in western countries and 5-43% of women in most developing countries. It is debilitating and has a large socio- economic impact, with a 45%reduction in work productivity, and a 15% increase in absence from work in women with the condition. Botulinum neurotoxin type A (BoNTA) has been suggested to improve pain in muscle spasm, its role in CPP secondary to pelvic floor spasm has gained increasing interest. However, clinicians do not have a diagnosis tool to evaluate the CPP and the BoNTA treatment results. Design and develop an efficient and simple tool for the diagnosis and detection of pelvic floor muscle (PFM) dysfunction based on superficial electromyography (EMG) and perform 25 EMG registrations sessions in healthy patients and 25 EMG sessions in patients diagnoses with PFM that will be treated with BoNTA to and study the EMG signal before and after BoNTA administration.

Official Title
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Electromyographic Study for the Help and Guidance of BoNTA Administration in the Treatment of Chronic Pelvic Floor Pain

Conditions
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Electromyography, EMG: Myopathy, EMG Syndrome, Pelvic Pain, Pelvic Floor Disorders, Pelvic Pain Syndrome, ElectroPhys: Myopathy

Intervention / Treatment
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* Drug: Clostridium botulinum type A (BoNTA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: I. Chronic pelvic floor pain (CPD) is defined as pain lasting longer than six months, with absence of proven organic cause and finding of component myofascial present that has been refractory to conventional medical treatment (NSAIDs) II. Sign Informed Consent for the administration of BoNTA III. Authorize to participate in the study IV. Patients who agree not to become pregnant during the duration of the study, using effective contraceptive methods Exclusion Criteria: I. Minor II. Pelvic active infection III. General or pelvic malignant disease IV. Psychiatric disease V. Contraindication for the administration of BoNTA VI. Patients who participate in another clinical trial and have been administered a investigational medication within 30 days prior to the planned start of the treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BoNTA Injection<br>Patients diagnosed with chronic pelvic floor pain, without contraindications for the administration of BoNTA. Name of each active substance (INN or proposed INN if available): Botulinum toxin type A Clostridium botulinum type A (BoNTA) Pharmaceutical form (use standard terms): Powder and solution for solution for injection Route of administration (relevant to the maximum dose): Intramuscular use Specify total dose : 80 U | Drug: Clostridium botulinum type A (BoNTA)<br>* Powder and solution for solution for injection Specify total dose: 80 U Route of administration:<br>* Other names: Clostridium botulinum type A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale for Pain (VAS) | The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. | Week 0 - 12 - 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-12 | Although Short Form (SF)-12 × 2® has been extensively studied and used as a valid measure of health-related quality of life in a variety of population groups, no systematic studies have described the reliability of the measure in patients with behavioral conditions or serious mental illness (SMI). | Week 0 - 12 - 24 | 
| Index of Female Sexual Function (IFSF) | The Index of Female Sexual Function (IFSF) is a brief questionnaire measure of sexual functioning in women. It was developed for the specific purpose of assessing domains of sexual functioning (e.g. sexual arousal, orgasm, satisfaction, pain) in clinical trials. | Week 0 - 12 - 24 | 
| The Patient Global Impression of Improvement (PGI-I) | The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). It is a simple, direct, easy to use scale that is intuitively understandable to clinicians | Week 0 - 12 - 24 | 
| The Clinical Global Impressions Scale (CGI-I) | The Clinical Global Impressions scale (CGI) consists of three different global measures: Severity of illness: (CGI-S); Global Improvement (CGI-I); Efficacy index The CGI-I score generally tracks with the CGI-S such that improvement in one follows the other; CGI-S and CGI-I scores can occasionally be dissociated | Week 0 - 12 - 24 | 
| Electromyography of pelvic floor | Electromyography (EMG) is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles | Week 0 - 12 - 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BoNTA, Electromyography, EMG, Pelvic Pain, Pelvic Pain Syndrome