EFFECTIVENESS OF THE NEUROADAPTATIVE FOR URGE INCONTINENCE

Urge Incontinence Clinical Trial

— SCENAR-EC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04164589
• Other study ID #: SCENAR-EC
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2019
• Est. completion date: December 20, 2021

Study information

• Verified date: February 2021
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
• Contact: Alvaro Zapico-Goñi, MD
• Phone: 918878100
• Email: azapicog1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: December 20, 2021
• Est. primary completion date: October 20, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Urge Incontinence
• Urinary Incontinence, Urge

Intervention

Device:
• SCENAR 1NT-02.2
The neuro-adaptative regulation will be carried out in vulvo-perineal and sacral area

Locations

Country	Name	City	State
Spain	Álvaro Zapico-Goñi	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Intervals between voiding	time between voiding	2 years
Secondary	Frequency of nocturia	Frequency of nocturia	2 years
Secondary	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
Secondary	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
Secondary	Duration of the response to treatment	the duration of the response to treatment	2 years