Clinical trial NCT03715777: Electromyographic Study for the Help and Guidance of BoNTA Administration in the Treatment of Chronic Pelvic Floor Pain
Official title: Electromyographic Study for the Help and Guidance of BoNTA Administration in the Treatment of Chronic Pelvic Floor Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Instituto de Investigacion Sanitaria La Fe
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Visual Analog Scale for Pain (VAS)
timeFrame: Week 0 - 12 - 24
Secondary outcomes:
measure: SF-12
timeFrame: Week 0 - 12 - 24
measure: Index of Female Sexual Function (IFSF)
timeFrame: Week 0 - 12 - 24
measure: The Patient Global Impression of Improvement (PGI-I)
timeFrame: Week 0 - 12 - 24
measure: The Clinical Global Impressions Scale (CGI-I)
timeFrame: Week 0 - 12 - 24
measure: Electromyography of pelvic floor
timeFrame: Week 0 - 12 - 24
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hosptial Universitario y Politécnico La Fe
Study officials:
affiliation: Hospital Universitario La Fe
name: Fco Jose FJ Nohales, MD, phD
role: PRINCIPAL_INVESTIGATOR
References: