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

NCT03715777 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-08-11

No results posted yet for this study

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

Interventions

DRUG

Clostridium botulinum type A (BoNTA)

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

Sponsors & Collaborators

  • Jose Alberola-Rubio

    lead OTHER

Principal Investigators

  • Fco Jose FJ Nohales, MD, phD · Hospital Universitario La Fe

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-29
Primary Completion
2019-04-01
Completion
2020-04-29

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03715777 on ClinicalTrials.gov