EFFECTIVENESS OF THE NEUROADAPTATIVE FOR URGE INCONTINENCE

Not Applicable

• Conditions: Urge Incontinence
• Interventions: Device: SCENAR 1NT-02.2

• Registration Number: NCT04164589
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias

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

Study Timeline

• Study Start: 2019-02-20
• Study First Submitted: 2019-11-13
• Study First Submitted QC: 2019-11-13
• Study First Posted: 2019-11-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-02
• Primary Completion: 2021-10-20
• Study Completion: 2021-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	SCENAR 1NT-02.2	The Neuro-Adaptative Regulation will be carried out in the regime of switched off power supply in vulvo-perineal and sacral area.
Experimental	SCENAR 1NT-02.2	The neuro-adaptative regulation will be carried out in vulvo-perineal and sacarl area.

Primary Outcome Measures

Name	Time	Method
Resultant value achieved in the assessment scale of urge incontinence.	2 years	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.
Sandvik Test for Urinary Incontinence	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Intervals between voiding	2 years	time between voiding
Satisfaction with the treatment (Visual analogue scale.)	2 years	Visual analogue scale. Minimun values: 0, máximum values: 10. Higher score means a high satisfaction with the treatment received.
Quality of life index (Potenziani-14-CI-IO-QOL-2000 index)	2 years	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.
Duration of the response to treatment	2 years	the duration of the response to treatment
Frequency of nocturia	2 years	Frequency of nocturia

Trial Locations

Locations (1)

Álvaro Zapico-Goñi; 🇪🇸 Madrid, Spain