NCT03715777: SEMG

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

Completed Phase 3 Last updated 11 August 2020

What this trial tests

Phase 3 trial testing Clostridium botulinum type A (BoNTA) in Electromyography in 25 participants. Completed in 29 April 2020.

Timeline

29 October 2018

Primary endpoint
1 April 2019

29 April 2020

Quick facts

Lead sponsor	Jose Alberola-Rubio
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	29 October 2018
Primary completion	1 April 2019
Estimated completion	29 April 2020
Sites	1 location across Spain

Drugs / interventions tested

• Clostridium botulinum type A (BoNTA) — full drug profile →

Conditions studied

• Electromyography — all drugs for Electromyography →
• EMG: Myopathy — all drugs for EMG: Myopathy →
• EMG Syndrome — all drugs for EMG Syndrome →
• Pelvic Pain — all drugs for Pelvic Pain →

Sponsor

Jose Alberola-Rubio — full company profile →

Who can join

Adults 18 to 75, female only, with Electromyography or EMG: Myopathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Characterization of Pelvic Floor Activity in Healthy Subjects and with Chronic Pelvic Pain: Diagnostic Potential of Surface Electromyography.
   Albaladejo-Belmonte M, Tarazona-Motes M, Nohales-Alfonso FJ, De-Arriba M, et al · · 2021 · cited 14× · PMID 33806717 · DOI 10.3390/s21062225
2. Effect of BoNT/A in the Surface Electromyographic Characteristics of the Pelvic Floor Muscles for the Treatment of Chronic Pelvic Pain.
   Albaladejo-Belmonte M, Nohales-Alfonso FJ, Tarazona-Motes M, De-Arriba M, et al · · 2021 · cited 8× · PMID 34300408 · DOI 10.3390/s21144668
3. Treatment of Dyspareunia with Botulinum Neurotoxin Type A: Clinical Improvement and Influence of Patients' Characteristics.
   Tarazona-Motes M, Albaladejo-Belmonte M, Nohales-Alfonso FJ, De-Arriba M, et al · · 2021 · cited 6× · PMID 34444532 · DOI 10.3390/ijerph18168783