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

Primary Purpose

Urinary Incontinence

Status

Unknown status

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Solifenacin Succinate

Neuro-Muscular Stimulators (NMS)

About this trial

This is an interventional other trial for Urinary Incontinence focused on measuring Hyperactive Bladder Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Hospital Clínico Universtario Virgen de la Arrixaca

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Medical device: Transcutaneous electrical neurostimulation

Solifenacin

Arm Description

Medical device 4 weeks with daily sessions of 30 minutes

10 mg tablet daily during 75 days maximum

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03468465

First Posted

February 20, 2018

Last Updated

August 1, 2018

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT03468465

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

May 4, 2018 (Actual)

Primary Completion Date

March 2019 (Anticipated)

Study Completion Date

March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Incontinence

Keywords

Hyperactive Bladder Syndrome

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Medical device: Transcutaneous electrical neurostimulation

Arm Type

Experimental

Arm Description

Medical device 4 weeks with daily sessions of 30 minutes

Arm Title

Solifenacin

Arm Type

Active Comparator

Arm Description

10 mg tablet daily during 75 days maximum

Intervention Type

Drug

Intervention Name(s)

Solifenacin Succinate

Other Intervention Name(s)

Vesicare

Intervention Description

10 mg tablet daily during 75 days maximum

Intervention Type

Device

Intervention Name(s)

Neuro-Muscular Stimulators (NMS)

Other Intervention Name(s)

T-PTNS

Intervention Description

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

Primary Outcome Measure Information:

Title

Description

3- day voiding diary

Time Frame

12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: