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| Name | Class |
|---|---|
| InnoCon Medical | INDUSTRY |
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This study aims to investigate the effect of electrical stimulation of the dorsal genital nerve on the urethral pressure in healthy women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dorsal genital nerve stimulation | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dorsal genital nerve stimulation | Device | Two types of stimulation electrodes will be used: UCon Patch Electrodes (InnoCon Medical ApS, Denmark) and ValuTrodes/EconoStim Electrodes (5x5 cm, Axelgaard Manufacturing Co. Ltd., United States). The UCon Patch Electrode acts as a cathode and will be placed on the clitoris. The ValuTrode/EconoStim acts as an anode and will be placed on the lower abdomen. The continuous stimulation consists of a train of single pulses provided continuously with a frequency of 20 Hz and a pulse duration of 200 μs. The burst stimulus pattern consists of a train of bursts. The length of the train is 10 s and will consist of 20-30 bursts/s. One burst consists of 5 identical square pulses (monophasic). The inter-pulse interval is 4 ms (time between the onset of 2 consecutive pulses) while a pulse duration of 200 μs will be used. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of burst dorsal genital nerve stimulation compared to baseline | The difference in mean opening urethral pressure (in cmH20) measured with urethral pressure reflectometry during electrical burst stimulation of dorsal genital nerve (reflex-induced pelvic floor contraction) compared to mean baseline opening urethral pressure during squeezing condition | Baseline and during dorsal genital nerve stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of continuous dorsal genital nerve stimulation on resting pressure compared to baseline | The difference in mean opening urethral pressure (in cmH20) measured with urethral pressure reflectometry during maximal tolerated continuous dorsal genital nerve stimulation compared to mean baseline OUP (resting condition). | Baseline and during dorsal genital nerve stimulation |
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Inclusion Criteria:
Exclusion Criteria:
Any history of clinically significant diseases, unless regarded irrelevant and/or stable by the investigator
Gender identidy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zelo Phase 1 unit | Copenhagen | 2400 | Denmark |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Effect of continuous dorsal genital nerve stimulation on squeezing pressure compared to baseline | The difference in mean opening urethral pressure (in cmH20) measured with urethral pressure reflectometry during maximal tolerated continuous dorsal genital nerve stimulation compared to mean baseline opening urethral pressure (squeezing condition). | Baseline and during dorsal genital nerve stimulation |
| 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 |