Peripheral Transcutaneous Neuromodulation of the Post-tibial Nerve for Solifenacin 10 mg. Hyperactive Bladder Syndrome

NCT ID: NCT03468465

Last Updated: 2018-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-04
• Study Completion Date: 2019-03-31

Brief Summary

• To determine if the T-PTNS is not inferior in the short term (3 months) to one of the usual pharmacological treatments (Solifenacin) in the treatment of hyperactive bladder syndrome and with respect to the percentage of patients that improve 50% any of the 3 signs (Urinary frequency, diurnal / nocturnal frequency, urgency and urinary incontinence).
• To determine prognostic factors associated with insufficient improvement (less than 50% in the 3 main signs of hyperactive bladder syndrome (urinary frequency, urgency and urinary incontinence frequency) after treatment with T-PTNS and Solifenacin.

Detailed Description

Patients will be randomized to receive the usual standard treatment with Solifenacin or treatment based on peripheral unilateral transcutaneous neuromodulation of the posterior tibial nerve .

Conditions

Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Medical device: Transcutaneous electrical neurostimulation

Medical device 4 weeks with daily sessions of 30 minutes

Group Type: EXPERIMENTAL

Neuro-Muscular Stimulators (NMS)

Intervention Type: DEVICE

Treatment with T-PTNS will include a first induction period of 4 weeks with daily sessions of 30 minutes duration and performed at each subject's home (Monday through Friday, resting weekends) and a second recall period of 2 additional months, with a session every 4 weeks that will be held at the healthcare center. In total there will be 20 sessions in the induction period and 2 in the recall period

Solifenacin

10 mg tablet daily during 75 days maximum

Group Type: ACTIVE_COMPARATOR

Solifenacin Succinate

Intervention Type: DRUG

10 mg tablet daily during 75 days maximum

Interventions

Solifenacin Succinate

10 mg tablet daily during 75 days maximum

Intervention Type: DRUG

Neuro-Muscular Stimulators (NMS)

Treatment with T-PTNS will include a first induction period of 4 weeks with daily sessions of 30 minutes duration and performed at each subject's home (Monday through Friday, resting weekends) and a second recall period of 2 additional months, with a session every 4 weeks that will be held at the healthcare center. In total there will be 20 sessions in the induction period and 2 in the recall period

Intervention Type: DEVICE

Other Intervention Names

Vesicare; T-PTNS

Eligibility Criteria

Inclusion Criteria

• Women> 18 years, diagnosed with hyperactive bladder syndrome for at least 6 months of evolution and who have taken Beta 3 agonists

Exclusion Criteria

• Patients who can contribute biased information: have previously consumed and abandoned anticholinergic drugs due to lack of efficacy or side effects; Suffering from hyperactive bladder of neurogenic origin (multiple sclerosis, Parkinson's, spinal cord injury); Present cystocele or any pelvic organ prolapse> 2 according to Pelvic Organ Prolapse-Q classification
• Patients who may become worse with the interventions envisaged in the study: being a implantable automatic defibrillators; With cutaneous alterations in lower extremities that prevent the placement of electrodes on the surface; Women who are pregnant or who may be pregnant during the duration of the clinical trial (prior and at each evaluation visit urine Bhcg will be requested to rule out pregnancy) or patients who are not able to manage transcutaneous electrical neurostimulation on an outpatient basis ) Or patients in whom Solifenacin is contraindicated: urinary retention, severe gastrointestinal disorders (including toxic megacolon), myasthenia gravis, or narrow-angle glaucoma, and in patients at risk of these conditions as hypersensitive at first Active or to any of the excipients, undergoing hemodialysis, with moderate hepatic insufficiency or severe renal insufficiency or in simultaneous treatment with a potent inhibitor of CYP3A4, eg ketoconazole.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

José David Jiménez Parra, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Rafael Méndez (Lorca, Murcia. SPAIN)

María Luisa María Luisa, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínica Universitario Virgen de la Arrixaca (SPAIN)

José Felix Escudero Bregante, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico Universitario Virgen de la Arrixaca (SPAIN)

Julián Oñate, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital General Universitario Reina Sofía (SPAIN)

Ana Isabel López López, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico Universitario San Juan (SPAIN)

Locations

Hospital Clínico Universtario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Countries

Spain

Other Identifiers

2017-000605-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FFIS/2017/01/SLT

Identifier Type: -

Identifier Source: org_study_id