Urge Incontinence
Conditions
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
Interventions
DEVICESCENAR 1NT-02.2
The neuro-adaptative regulation will be carried out in vulvo-perineal and sacral area
Sponsors
Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
A randomized, single blind placebo controlled clinical trial.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Intervals between voiding | 2 years | time between voiding |
| Frequency of nocturia | 2 years | Frequency of nocturia |
| Duration of the response to treatment | 2 years | the duration of the response to treatment |
| 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. |
Countries
Spain
Contacts
Primary ContactAlvaro Zapico-Goñi, MD
Backup ContactDiana Barreira, Ph
Outcome results
None listed