EFFECTIVENESS OF THE NEUROADAPTATIVE FOR URGE INCONTINENCE

NCT ID: NCT04164589

Last Updated: 2021-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-20

Study Completion Date

2021-12-20

Brief Summary

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In this clinical trials the sponsor want to assess a self-controlled-energo-neuroadaptative-regulation in patient with urge incontinence

Detailed Description

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In this clinical trials the sponsor want to assess a self-controlled-energo-neuroadaptative-regulation in patient with urge incontinence and mixted incontinence

Conditions

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Urge Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized, single blind placebo controlled clinical trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

The Neuro-Adaptative Regulation will be carried out in the regime of switched off power supply in vulvo-perineal and sacral area.

Group Type PLACEBO_COMPARATOR

SCENAR 1NT-02.2

Intervention Type DEVICE

The neuro-adaptative regulation will be carried out in vulvo-perineal and sacral area

Experimental

The neuro-adaptative regulation will be carried out in vulvo-perineal and sacarl area.

Group Type EXPERIMENTAL

SCENAR 1NT-02.2

Intervention Type DEVICE

The neuro-adaptative regulation will be carried out in vulvo-perineal and sacral area

Interventions

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SCENAR 1NT-02.2

The neuro-adaptative regulation will be carried out in vulvo-perineal and sacral area

Intervention Type DEVICE

Other Intervention Names

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Neuro-adaptative regulation

Eligibility Criteria

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Inclusion Criteria

* Urge incontinence or mixed incontinence without urethral hypermobility
* Over 3 months of disease evolves.

Exclusion Criteria

* Severe physical limitations that might interfere with applying the treatment.
* Severe mental disorders that need pharmacology treatments that may influence in neuronal activity
* Oncological processes in the lower abdomen that had required radical surgery.
* Neurogenic bladder.
* Blockage of the bladder
* Vaginal infection
* Bladder infection or disorder of kidney function
* Have received, in the last year, botulinum toxin in bladder or pelvic organs.
* Have received pharmacological treatment for urge incontinence in the last month (before entry date in the trial)
* Be receiving pharmacological treatment for urge incontinence.
* Stress incontinence due to urethral hypermobility which was treatable with surgery.
* Pregnant women
* Patients with pacemarker
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Álvaro Zapico-Goñi

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Alvaro Zapico-Goñi, MD

Role: CONTACT

918878100

Diana Barreira, Ph

Role: CONTACT

918878100

Facility Contacts

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Alvaro Zapico-Goñi, M.D

Role: primary

918878100

Other Identifiers

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SCENAR-EC

Identifier Type: -

Identifier Source: org_study_id

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