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

NCT03715777 | Completed Phase 3 DMC

• 1 other identifier: SEMG
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Electromyography; EMG: Myopathy; EMG Syndrome; Pelvic Pain; Pelvic Floor Disorders; Pelvic Pain Syndrome; ElectroPhys: Myopathy

Keywords

BoNTA; Electromyography; EMG; Pelvic Pain; Pelvic Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

BoNTA Injection

EXPERIMENTAL

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)

Interventions

Clostridium botulinum type A (BoNTA) DRUG

Powder and solution for solution for injection Specify total dose: 80 U Route of administration:

Also known as: BoNTA, Clostridium botulinum type A

BoNTA Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jose Alberola-Rubio: lead

Study Sites (1)

Hosptial Universitario y Politécnico La Fe

Valencia, 46017, Spain

Location

Related Links

• European Union Clinical Trials Register

MeSH Terms

Conditions

Beckwith-Wiedemann Syndrome; Pelvic Pain; Pelvic Floor Disorders

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Fco Jose FJ Nohales, MD, phD

  Hospital Universitario La Fe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSc, PhD

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 23, 2018
• Study Start: October 29, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 29, 2020
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)