CClinicalTrials.gg
Status unknownNCT03468465SOLITENSUpdated Aug 2, 2018

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

A Phase 4 interventional study of Solifenacin Succinate and Neuro-Muscular Stimulators (NMS) in Urinary Incontinence, sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia. Status unknown at 1 site in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-02.

Sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Phase 4, Interventional, and Other

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.
Read the 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 .

02

Conditions studied

  • Urinary Incontinence

Keywords

  • Hyperactive Bladder Syndrome
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    Medical device: Transcutaneous electrical neurostimulation

    Medical device 4 weeks with daily sessions of 30 minutes

    Device: Neuro-Muscular Stimulators (NMS)

  • Active comparator
    Solifenacin

    10 mg tablet daily during 75 days maximum

    Drug: Solifenacin Succinate

Interventions

  • DrugSolifenacin Succinate

    10 mg tablet daily during 75 days maximum

    Also known as: Vesicare

  • DeviceNeuro-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

    Also known as: T-PTNS

05

What researchers measure

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

    Time frame: 12 weeks

06

Study locations

1 site
  • Hospital Clínico Universtario Virgen de la Arrixaca
    El Palmar, Murcia 30120, Spain
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03468465
Lead sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Responsible party
Sponsor
First posted
Mar 16, 2018
Start date
May 4, 2018
Primary completion
Mar 2019 (estimated)
Completion
Mar 2019 (estimated)
Last update
Aug 2, 2018

Study contacts

José David Jiménez Parra, MD
principal investigator · Hospital Rafael Méndez (Lorca, Murcia. SPAIN)
María Luisa María Luisa, MD
principal investigator · Hospital Clínica Universitario Virgen de la Arrixaca (SPAIN)
José Felix Escudero Bregante, MD
principal investigator · Hospital Clínico Universitario Virgen de la Arrixaca (SPAIN)
Julián Oñate, MD
principal investigator · Hospital General Universitario Reina Sofía (SPAIN)
Ana Isabel López López, MD
principal investigator · Hospital Clínico Universitario San Juan (SPAIN)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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