Stress Urinary Incontinence Clinical Trial
Official title:
The Effect of Dorsal Genital Nerve Stimulation on Opening Urethral Pressure
Verified date | November 2023 |
Source | University Hospital Bispebjerg and Frederiksberg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to investigate the effect of electrical stimulation of the dorsal genital nerve on the urethral pressure in healthy women.
Status | Completed |
Enrollment | 10 |
Est. completion date | March 30, 2023 |
Est. primary completion date | March 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Zelo Phase 1 unit | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Thea Christoffersen | InnoCon Medical |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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