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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Pain; Pelvic Floor Disorders; Pelvic Pain Syndrome; Electromyography; EMG Syndrome; EMG: Myopathy; ElectroPhys: Myopathy
• Intervention / Treatment: Drug: Clostridium botulinum type A (BoNTA)

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46017
    • Hosptial Universitario y Politécnico La Fe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jose Alberola-Rubio
• Investigators: Principal Investigator: Fco Jose FJ Nohales, MD, phD, Hospital Universitario La Fé

Publications and helpful links

Helpful Links

• European Union Clinical Trials Register

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2018
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 29, 2020

Study Registration Dates

• First Submitted: October 18, 2018
• First Submitted That Met QC Criteria: October 19, 2018
• First Posted (Actual): October 23, 2018

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: EMG; Electromyography; Pelvic Pain; BoNTA; Pelvic Pain Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Musculoskeletal Diseases; Neuromuscular Diseases; Pregnancy Complications; Abnormalities, Multiple; Chromosome Disorders; Syndrome; Muscular Diseases; Pelvic Floor Disorders; Pelvic Pain; Beckwith-Wiedemann Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; incobotulinumtoxinA
• Other Study ID Numbers: SEMG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No