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

Urinary Incontinence Clinical Trial

— SOLITENS  

Official title:

Peripheral Transcutaneous Neuromodulation of the Post-tibial Nerve (T-PTNS) for Solifenacin 10 mg. in the Treatment of Hyperactive Bladder Syndrome: no Inferiority Phase IV Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03468465
• Other study ID #: FFIS/2017/01/SLT
• Secondary ID: 2017-000605-20
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 4, 2018
• Est. completion date: March 2019

Study information

• Verified date: August 2018
• Source: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Hyperkinesis
• Urinary Bladder, Overactive
• Urinary Incontinence

Intervention

Drug:
• Solifenacin Succinate
10 mg tablet daily during 75 days maximum

Device:
• 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

Locations

Country	Name	City	State
Spain	Hospital Clínico Universtario Virgen de la Arrixaca	El Palmar	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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