EFFECTIVENESS OF THE NEUROADAPTATIVE FOR URGE INCONTINENCE

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

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

Official Title
-----------------
EFFECTIVENESS OF THE NEUROADAPTATIVE REGULATION TECHNIQUE FOR THE TREATMENT OF URGE INCONTINENCE AND MIXED INCONTINENCE

Conditions
-----------------
Urge Incontinence

Intervention / Treatment
-----------------
* Device: SCENAR 1NT-02.2


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized, single blind placebo controlled clinical trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>The Neuro-Adaptative Regulation will be carried out in the regime of switched off power supply in vulvo-perineal and sacral area. | Device: SCENAR 1NT-02.2<br>* The neuro-adaptative regulation will be carried out in vulvo-perineal and sacral area<br>* Other names: Neuro-adaptative regulation;|
| Experimental: Experimental<br>The neuro-adaptative regulation will be carried out in vulvo-perineal and sacarl area. | Device: SCENAR 1NT-02.2<br>* The neuro-adaptative regulation will be carried out in vulvo-perineal and sacral area<br>* Other names: Neuro-adaptative regulation;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resultant value achieved in the assessment scale of urge incontinence. | Resultant value achieved in the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF). The ICIQ-UI Short Form is a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence. Question items: Frequency or urinary incontinence; Amount of leakage; Overall impact of urinary incontinence; Self-diagnostic ítem. Scoring scale: 0-21. Higher score mean a worse outcome. | 2 years | 
| Sandvik Test for Urinary Incontinence | It is a severity indez score of symptoms to calculate severity of urinary incontinence in women. Scores are from 0 to 12. The higher score: the more severe the urinary incontinence. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervals between voiding | time between voiding | 2 years | 
| Frequency of nocturia | Frequency of nocturia | 2 years | 
| Quality of life index (Potenziani-14-CI-IO-QOL-2000 index) | Impact of incontinence on quality of life. Scores are from 0 to 28. Slight impact in quality of life = 0-14. Higher impact in quality of life = 15-28. | 2 years | 
| Satisfaction with the treatment (Visual analogue scale.) | Visual analogue scale. Minimun values: 0, máximum values: 10. Higher score means a high satisfaction with the treatment received. | 2 years | 
| Duration of the response to treatment | the duration of the response to treatment | 2 years |