EFFECTIVENESS OF THE NEUROADAPTATIVE FOR URGE INCONTINENCE (SCENAR-EC)
Primary Purpose
Urge Incontinence
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
SCENAR 1NT-02.2
Sponsored by
About this trial
This is an interventional treatment trial for Urge Incontinence
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
Sites / Locations
- Álvaro Zapico-GoñiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
Experimental
Arm Description
The Neuro-Adaptative Regulation will be carried out in the regime of switched off power supply in vulvo-perineal and sacral area.
The neuro-adaptative regulation will be carried out in vulvo-perineal and sacarl area.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Intervals between voiding
time between voiding
Frequency of nocturia
Frequency of nocturia
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.
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.
Duration of the response to treatment
the duration of the response to treatment
Full Information
NCT ID
NCT04164589
First Posted
November 13, 2019
Last Updated
February 1, 2021
Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
1. Study Identification
Unique Protocol Identification Number
NCT04164589
Brief Title
EFFECTIVENESS OF THE NEUROADAPTATIVE FOR URGE INCONTINENCE
Acronym
SCENAR-EC
Official Title
EFFECTIVENESS OF THE NEUROADAPTATIVE REGULATION TECHNIQUE FOR THE TREATMENT OF URGE INCONTINENCE AND MIXED INCONTINENCE
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 20, 2019 (Actual)
Primary Completion Date
October 20, 2021 (Anticipated)
Study Completion Date
December 20, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urge Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized, single blind placebo controlled clinical trial.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
The Neuro-Adaptative Regulation will be carried out in the regime of switched off power supply in vulvo-perineal and sacral area.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
The neuro-adaptative regulation will be carried out in vulvo-perineal and sacarl area.
Intervention Type
Device
Intervention Name(s)
SCENAR 1NT-02.2
Other Intervention Name(s)
Neuro-adaptative regulation
Intervention Description
The neuro-adaptative regulation will be carried out in vulvo-perineal and sacral area
Primary Outcome Measure Information:
Title
Resultant value achieved in the assessment scale of urge incontinence.
Description
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.
Time Frame
2 years
Title
Sandvik Test for Urinary Incontinence
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Intervals between voiding
Description
time between voiding
Time Frame
2 years
Title
Frequency of nocturia
Description
Frequency of nocturia
Time Frame
2 years
Title
Quality of life index (Potenziani-14-CI-IO-QOL-2000 index)
Description
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.
Time Frame
2 years
Title
Satisfaction with the treatment (Visual analogue scale.)
Description
Visual analogue scale. Minimun values: 0, máximum values: 10. Higher score means a high satisfaction with the treatment received.
Time Frame
2 years
Title
Duration of the response to treatment
Description
the duration of the response to treatment
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alvaro Zapico-Goñi, MD
Phone
918878100
Email
azapicog1@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Barreira, Ph
Phone
918878100
Email
dbarreirahdez@gmail.com
Facility Information:
Facility Name
Álvaro Zapico-Goñi
City
Madrid
ZIP/Postal Code
28805
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alvaro Zapico-Goñi, M.D
Phone
918878100
Email
azapicog1@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
EFFECTIVENESS OF THE NEUROADAPTATIVE FOR URGE INCONTINENCE
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