NCT03715777

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Jose Alberola-Rubio · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Clostridium botulinum type A (BoNTA)	Powder and solution for solution for injection Specify total dose: 80 U Route of administration:

Timeline

• Start date: 2018-10-29
• Primary completion: 2019-04-01
• Completion: 2020-04-29
• First posted: 2018-10-23
• Last updated: 2020-08-11

Locations

1 site across 1 country: Spain