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

Jose Alberola-Rubio

Status and phase: Completed; Phase 3

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

Treatments: Drug: Clostridium botulinum type A (BoNTA)

Study type: Interventional

Funder types: Other

Identifiers

NCT03715777

SEMG

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

BoNTA Injection

Experimental group

Description:

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

Treatment:

Drug: Clostridium botulinum type A (BoNTA)