Skip to main content
OpenTrials
Completed

NCT Number: NCT03715777

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Electromyography Abnormalities, Multiple Beckwith-Wiedemann Syndrome Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities EMG Syndrome EMG: Myopathy ElectroPhys: Myopathy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Imprinting Disorders Male Urogenital Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Floor Disorders Pelvic Pain Pelvic Pain Syndrome Pregnancy Complications Signs and Symptoms Urogenital Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hosptial Universitario y Politécnico La Fe

Valencia, 46017, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clostridium botulinum type A (BoNTA)

Drug

Powder and solution for solution for injection Specify total dose: 80 U

Route of administration:

Other names: BoNTA, Clostridium botulinum type A

Primary outcomes

  1. Visual Analog Scale for Pain (VAS)

    Time frame: Week 0 - 12 - 24

    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 outcomes

  1. SF-12

    Time frame: Week 0 - 12 - 24

    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).

  2. Index of Female Sexual Function (IFSF)

    Time frame: Week 0 - 12 - 24

    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.

  3. The Patient Global Impression of Improvement (PGI-I)

    Time frame: Week 0 - 12 - 24

    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

  4. The Clinical Global Impressions Scale (CGI-I)

    Time frame: Week 0 - 12 - 24

    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

  5. Electromyography of pelvic floor

    Time frame: Week 0 - 12 - 24

    Electromyography (EMG) is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles

Sponsors and collaborators

Lead sponsor

Jose Alberola-Rubio

Other

Registry information

Acronym: SEMG

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Oct 23, 2018
Registry last updated
Aug 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.