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

Primary Purpose

Electromyography, EMG: Myopathy, EMG Syndrome

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Clostridium botulinum type A (BoNTA)
Sponsored by
Jose Alberola-Rubio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Electromyography focused on measuring BoNTA, Electromyography, EMG, Pelvic Pain, Pelvic Pain Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hosptial Universitario y Politécnico La Fe

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BoNTA Injection

Arm Description

Patients diagnosed with chronic pelvic floor pain, without contraindications for the administration of BoNTA. Name of each active substance (INN or proposed INN if available): Botulinum toxin type A Clostridium botulinum type A (BoNTA) Pharmaceutical form (use standard terms): Powder and solution for solution for injection Route of administration (relevant to the maximum dose): Intramuscular use Specify total dose : 80 U

Outcomes

Primary Outcome Measures

Visual Analog Scale for Pain (VAS)
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.

Secondary Outcome Measures

SF-12
Although Short Form (SF)-12 × 2® has been extensively studied and used as a valid measure of health-related quality of life in a variety of population groups, no systematic studies have described the reliability of the measure in patients with behavioral conditions or serious mental illness (SMI).
Index of Female Sexual Function (IFSF)
The Index of Female Sexual Function (IFSF) is a brief questionnaire measure of sexual functioning in women. It was developed for the specific purpose of assessing domains of sexual functioning (e.g. sexual arousal, orgasm, satisfaction, pain) in clinical trials.
The Patient Global Impression of Improvement (PGI-I)
The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). It is a simple, direct, easy to use scale that is intuitively understandable to clinicians
The Clinical Global Impressions Scale (CGI-I)
The Clinical Global Impressions scale (CGI) consists of three different global measures: Severity of illness: (CGI-S); Global Improvement (CGI-I); Efficacy index The CGI-I score generally tracks with the CGI-S such that improvement in one follows the other; CGI-S and CGI-I scores can occasionally be dissociated
Electromyography of pelvic floor
Electromyography (EMG) is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles

Full Information

First Posted
October 18, 2018
Last Updated
August 10, 2020
Sponsor
Jose Alberola-Rubio
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1. Study Identification

Unique Protocol Identification Number
NCT03715777
Brief Title
Electromyographic Study for the Help and Guidance of BoNTA Administration in the Treatment of Chronic Pelvic Floor Pain
Acronym
SEMG
Official Title
Electromyographic Study for the Help and Guidance of BoNTA Administration in the Treatment of Chronic Pelvic Floor Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 29, 2018 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
April 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jose Alberola-Rubio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Electromyography, EMG: Myopathy, EMG Syndrome, Pelvic Pain, Pelvic Floor Disorders, Pelvic Pain Syndrome, ElectroPhys: Myopathy
Keywords
BoNTA, Electromyography, EMG, Pelvic Pain, Pelvic Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BoNTA Injection
Arm Type
Experimental
Arm Description
Patients diagnosed with chronic pelvic floor pain, without contraindications for the administration of BoNTA. Name of each active substance (INN or proposed INN if available): Botulinum toxin type A Clostridium botulinum type A (BoNTA) Pharmaceutical form (use standard terms): Powder and solution for solution for injection Route of administration (relevant to the maximum dose): Intramuscular use Specify total dose : 80 U
Intervention Type
Drug
Intervention Name(s)
Clostridium botulinum type A (BoNTA)
Other Intervention Name(s)
BoNTA, Clostridium botulinum type A
Intervention Description
Powder and solution for solution for injection Specify total dose: 80 U Route of administration:
Primary Outcome Measure Information:
Title
Visual Analog Scale for Pain (VAS)
Description
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
Time Frame
Week 0 - 12 - 24
Secondary Outcome Measure Information:
Title
SF-12
Description
Although Short Form (SF)-12 × 2® has been extensively studied and used as a valid measure of health-related quality of life in a variety of population groups, no systematic studies have described the reliability of the measure in patients with behavioral conditions or serious mental illness (SMI).
Time Frame
Week 0 - 12 - 24
Title
Index of Female Sexual Function (IFSF)
Description
The Index of Female Sexual Function (IFSF) is a brief questionnaire measure of sexual functioning in women. It was developed for the specific purpose of assessing domains of sexual functioning (e.g. sexual arousal, orgasm, satisfaction, pain) in clinical trials.
Time Frame
Week 0 - 12 - 24
Title
The Patient Global Impression of Improvement (PGI-I)
Description
The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). It is a simple, direct, easy to use scale that is intuitively understandable to clinicians
Time Frame
Week 0 - 12 - 24
Title
The Clinical Global Impressions Scale (CGI-I)
Description
The Clinical Global Impressions scale (CGI) consists of three different global measures: Severity of illness: (CGI-S); Global Improvement (CGI-I); Efficacy index The CGI-I score generally tracks with the CGI-S such that improvement in one follows the other; CGI-S and CGI-I scores can occasionally be dissociated
Time Frame
Week 0 - 12 - 24
Title
Electromyography of pelvic floor
Description
Electromyography (EMG) is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles
Time Frame
Week 0 - 12 - 24

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fco Jose FJ Nohales, MD, phD
Organizational Affiliation
Hospital Universitario La Fe
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hosptial Universitario y Politécnico La Fe
City
Valencia
ZIP/Postal Code
46017
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-000642-22/ES
Description
European Union Clinical Trials Register

Learn more about this trial

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

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