EFFECTIVENESS OF THE NEUROADAPTATIVE FOR URGE INCONTINENCE (SCENAR-EC)

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

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

Study Overview

• Status: Recruiting
• Conditions: Urge Incontinence
• Intervention / Treatment: Device: SCENAR 1NT-02.2

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 Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alvaro Zapico-Goñi, MD; Phone Number: 918878100; Email: azapicog1@gmail.com
• Study Contact Backup: Name: Diana Barreira, Ph; Phone Number: 918878100; Email: dbarreirahdez@gmail.com

Study Locations

• Spain
  • Madrid, Spain, 28805
    • Recruiting
    • Álvaro Zapico-Goñi
    • Contact: Alvaro Zapico-Goñi, M.D; Phone Number: 918878100; Email: azapicog1@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; 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; The neuro-adaptative regulation will be carried out in vulvo-perineal and sacral area; Other Names: Neuro-adaptative regulation
Experimental: Experimental; The neuro-adaptative regulation will be carried out in vulvo-perineal and sacarl area.	Device: SCENAR 1NT-02.2; The neuro-adaptative regulation will be carried out in vulvo-perineal and sacral area; 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

Collaborators and Investigators

• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2019
• Primary Completion (Anticipated): October 20, 2021
• Study Completion (Anticipated): December 20, 2021

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 13, 2019
• First Posted (Actual): November 15, 2019

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Incontinence, Urge
• Other Study ID Numbers: SCENAR-EC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No