Stress Urinary Incontinence
Conditions
Keywords
Electrical Stimulation, Urethral pressure, Neuromodulation
Brief summary
This study aims to investigate the effect of electrical stimulation of the dorsal genital nerve on the urethral pressure in healthy women.
Interventions
DEVICEDorsal genital nerve stimulation
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.
Sponsors
InnoCon Medical
Thea Christoffersen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Normal weight (Body weight 50 kg or more, Body Mass Index 18-5-30 kg/m2) * Signed an informed consent
Exclusion criteria
Any history of clinically significant diseases, unless regarded irrelevant and/or stable by the investigator * Any history or evidence of clinically significant urinary incontinence, urinary retention, overactive bladder, or other voiding dysfunction * Known or suspected nerve injuries or paraesthesia in the pelvic area * Pregnancy within six months before enrolment * Breastfeeding within three months before enrolment * Smoking or other regular use of any form of nicotine product during the study period and the previous 3 months * Current or prior participation (within 3 months before screening) in other clinical trials that might affect the results of this study (judged by the investigator) * Any systemic drug use within 2 weeks before the first study day (prescription drugs, over-the-counter drugs, herbal drugs, and/or illicit drugs), except for occasional use of paracetamol (up to 4 g/day), ibuprofen, or antihistamine, hormonal contraceptives and hormone replacement therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of burst dorsal genital nerve stimulation compared to baseline | Baseline and during dorsal genital nerve stimulation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of continuous dorsal genital nerve stimulation on resting pressure compared to baseline | Baseline and during dorsal genital nerve stimulation | 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). |
| Effect of continuous dorsal genital nerve stimulation on squeezing pressure compared to baseline | Baseline and during dorsal genital nerve stimulation | 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). |
Countries
Denmark
Outcome results
None listed