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In this clinical trials the sponsor want to assess a self-controlled-energo-neuroadaptative-regulation in patient with urge incontinence
In this clinical trials the sponsor want to assess a self-controlled-energo-neuroadaptative-regulation in patient with urge incontinence and mixted incontinence
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | The Neuro-Adaptative Regulation will be carried out in the regime of switched off power supply in vulvo-perineal and sacral area. |
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| Experimental | Experimental | The neuro-adaptative regulation will be carried out in vulvo-perineal and sacarl area. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCENAR 1NT-02.2 | Device | The neuro-adaptative regulation will be carried out in vulvo-perineal and sacral area |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Intervals between voiding | time between voiding | 2 years |
| Frequency of nocturia | Frequency of nocturia | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alvaro Zapico-Goñi, MD | Contact | 918878100 | azapicog1@gmail.com | |
| Diana Barreira, Ph | Contact | 918878100 | dbarreirahdez@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Álvaro Zapico-Goñi | Recruiting | Madrid | 28805 | Spain |
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| ID | Term |
|---|---|
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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A randomized, single blind placebo controlled clinical trial.
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| 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 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |