E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic pelvic pain |
Dolor cronico de suelo pélvico |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic pelvic pain |
Dolor cronico de suelo pélvico |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
El objetivo principal del proyecto de investigación es diseñar y desarrollar una herramienta eficaz y sencilla para la localización de la zona más adecuada para la administración de la neurotoxina botulínica tipo A (BoNTA), basada en electromiografía |
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E.2.2 | Secondary objectives of the trial |
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. |
1. Diseñar, crear e implementar un sistema confortable, y robusto para el registro de la señal de EMG de suelo pélvico para uso clínico con electrodos de aguja y superficiales. 2. Cuantificar y caracterizar la actividad electrofisiológica asociada al dolor pélvico crónico y normal 3. Comparar, identificar y evaluar la actividad electrofisiológica de la musculatura de suelo pélvico una vez tratada con BoNTA. 4. Desarrollar técnicas de procesado de señal para la sustitución de los electrodos de aguja por electrodos desechables superficiales para la localización de las unidades motoras. 5. Evaluar la respuesta en las pacientes de acuerdo a los test clínicos que empleamos en la práctica clínica. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients diagnosed with chronic pelvic floor pain, without contraindications for the administration of BoNTA. |
Pacientes diagnosticadas con dolor crónico de suelo pélvico, sin contraindicaciones para la administración de BoNTA. |
|
E.4 | Principal exclusion criteria |
Minor Age and/or Contraindication for BoNTA administration |
Menor de edad y/o Contraindicación para la administración de BoNTA |
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E.5 End points |
E.5.1 | 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 |
R.1. Validación y testeo del sistema de registro de EMG R.2. Registros electrofisiologicos y base de datos de los parámetros clínicos de EMG de Suelo Pélvico R.3. Parametrización electrofisiológica de EMG de Suelo Pélvico. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 12 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |