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

NCT03468465 | Unknown Phase 4

• 2 other identifiers: FFIS/2017/01/SLT2017-000605-20
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Keywords

Hyperactive Bladder Syndrome

Outcome Measures

Primary Outcomes (1)

• Evaluate whether treatment with T-PTNS is not less than 3 months compared to the current standard pharmacological treatments regarding the episodes of urgency, urinary frequency, incontinence and nocturia, all measured with the 3-day voiding diary

  3- day voiding diary

  12 weeks

Study Arms (2)

Medical device: Transcutaneous electrical neurostimulation

EXPERIMENTAL

Medical device 4 weeks with daily sessions of 30 minutes

Device: Neuro-Muscular Stimulators (NMS)

Solifenacin

ACTIVE COMPARATOR

10 mg tablet daily during 75 days maximum

Drug: Solifenacin Succinate

Interventions

Solifenacin Succinate DRUG

10 mg tablet daily during 75 days maximum

Also known as: Vesicare

Solifenacin

Neuro-Muscular Stimulators (NMS) 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

Also known as: T-PTNS

Medical device: Transcutaneous electrical neurostimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia: lead

Study Sites (1)

Hospital Clínico Universtario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• José David Jiménez Parra, MD

  Hospital Rafael Méndez (Lorca, Murcia. SPAIN)

  PRINCIPAL INVESTIGATOR

• María Luisa María Luisa, MD

  Hospital Clínica Universitario Virgen de la Arrixaca (SPAIN)

  PRINCIPAL INVESTIGATOR

• José Felix Escudero Bregante, MD

  Hospital Clínico Universitario Virgen de la Arrixaca (SPAIN)

  PRINCIPAL INVESTIGATOR

• Julián Oñate, MD

  Hospital General Universitario Reina Sofía (SPAIN)

  PRINCIPAL INVESTIGATOR

• Ana Isabel López López, MD

  Hospital Clínico Universitario San Juan (SPAIN)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: March 16, 2018
• Study Start: May 4, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: August 2, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)