Electromyographic Study for the Help and Guidance of BoNTA Administration in the Treatment of Chronic Pelvic Floor Pain
Overview
- Phase
- Phase 3
- Intervention
- Clostridium botulinum type A (BoNTA)
- Conditions
- Electromyography
- Sponsor
- Jose Alberola-Rubio
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale for Pain (VAS)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Jose Alberola-Rubio
MSc, PhD
Instituto de Investigacion Sanitaria La Fe
Eligibility Criteria
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.
Arms & Interventions
BoNTA Injection
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
Intervention: Clostridium botulinum type A (BoNTA)
Outcomes
Primary Outcomes
Visual Analog Scale for Pain (VAS)
Time Frame: Week 0 - 12 - 24
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.
Secondary Outcomes
- SF-12(Week 0 - 12 - 24)
- Index of Female Sexual Function (IFSF)(Week 0 - 12 - 24)
- The Patient Global Impression of Improvement (PGI-I)(Week 0 - 12 - 24)
- The Clinical Global Impressions Scale (CGI-I)(Week 0 - 12 - 24)
- Electromyography of pelvic floor(Week 0 - 12 - 24)