Electromyographic study for the help and guidance of Botox administration in the treatment of chronic pelvic floor pain

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000642-22-ES

Enrollment

Unknown

Registered

2017-04-07

Start date

2017-07-19

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic pelvic pain

Interventions

Trade Name: Botox Pharmaceutical Form: Powder and solution for solution for injection INN or Proposed INN: Botulinum toxin type A CAS Number: 93384-43-1 Other descriptive name: BOTULINUM TOXIN TYPE A

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients diagnosed with chronic pelvic floor pain, without contraindications for the administration of BoNTA. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 64 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Minor Age and/or Contraindication for BoNTA administration

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the research project is design and develop an effective and simple tool for locating the most suitable area for the administration of botulinum neurotoxin type A (BoNTA), based on electromyography;Secondary Objective: 1. Design, create and implement a comfortable, robust system for recording the EMG signal of pelvic floor for clinical use with needle and surface electrodes. 2. Quantify and characterize the electrophysiological activity associated with chronic and normal pelvic pain 3. Compare, identify and evaluate the electrophysiological activity of the musculature of Pelvic floor once treated with BoNTA. 4. Develop signal processing techniques for replacing needle electrodes with disposable surface electrodes for locating motor units. 5. Evaluate the response in patients according to the clinical tests we use in clinical practice.;Primary end point(s): R.1. EMG registration system tested and validated. R.2. Electrophysiological recordings and clinical parameters of Pelvic Floor EMG database R3. Electrophysiological parametrization of Pelvic Floor EMG;Timepoint(s) of evaluation of this end point: N/A	—

Measure

Time frame

Main Objective: The main objective of the research project is design and develop an effective and simple tool for locating the most suitable area for the administration of botulinum neurotoxin type A (BoNTA), based on electromyography;Secondary Objective: 1. Design, create and implement a comfortable, robust system for recording the EMG signal of pelvic floor for clinical use with needle and surface electrodes. 2. Quantify and characterize the electrophysiological activity associated with chronic and normal pelvic pain 3. Compare, identify and evaluate the electrophysiological activity of the musculature of Pelvic floor once treated with BoNTA. 4. Develop signal processing techniques for replacing needle electrodes with disposable surface electrodes for locating motor units. 5. Evaluate the response in patients according to the clinical tests we use in clinical practice.;Primary end point(s): R.1. EMG registration system tested and validated. R.2. Electrophysiological recordings and clinical parameters of Pelvic Floor EMG database R3. Electrophysiological parametrization of Pelvic Floor EMG;Timepoint(s) of evaluation of this end point: N/A

—

Secondary

Measure	Time frame
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A	—

Countries

Spain

Contacts

Public ContactClinical Trials

Instituto de Investigación Sanitaria Hospital Univ. & Politc. La Fe de Valencia

palberola.rubio@gmail.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026