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

Pelvic Pain Clinical Trial

— SEMG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03715777
• Other study ID #: SEMG
• Status: Completed
• Phase: Phase 3
• Start date: October 29, 2018
• Est. completion date: April 29, 2020

Study information

• Verified date: August 2020
• Source: Instituto de Investigacion Sanitaria La Fe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 29, 2020
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Electromyography
• ElectroPhys: Myopathy
• EMG Syndrome
• EMG: Myopathy
• Muscular Diseases
• Pelvic Floor Disorders
• Pelvic Pain
• Pelvic Pain Syndrome
• Syndrome

Intervention

Drug:
• Clostridium botulinum type A (BoNTA)
Powder and solution for solution for injection Specify total dose: 80 U Route of administration:

Locations

Country	Name	City	State
Spain	Hosptial Universitario y Politécnico La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Jose Alberola-Rubio

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   European Union Clinical Trials Register