Effect of Peri-Urethral Stimulation on Intra-Urethral Pressure (NCT05900570) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Peri-Urethral Stimulation on Intra-Urethral Pressure
United States20 participantsStarted 2024-02-26
Plain-language summary
The purpose of this early feasibility prospective study is to gain initial understanding of the effect of acute peri-urethral neurostimulation on the perineal nerves on intra-urethral pressure.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female aged 18 years old or older
* Capable of understanding the clinical study procedures and giving informed consent
* Willing and able to undergo the study procedure
* Diagnosis of SUI or stress predominant mixed incontinence, for at least 6 months
* Provided authorization to use and disclose information for research purposes
Exclusion Criteria:
* Predominant urge incontinence per patient report or medical record
* Active symptomatic uncontrolled bladder instability as determined by the investigator
* Regularly or intermittently used a urethral catheter
* Active bladder cancer (currently undergoing or scheduled to undergo treatment for bladder cancer).
* Previous radiation treatment in the pelvic floor
* History or symptoms of cystocele, enterocele or rectocele of grade 3 or 4. Per the medical record or as determined by the investigator
* Current infection (urethritis, cystitis or vaginitis) as determined by investigator.
* Active herpes genitalis
* Unevaluated hematuria
* Currently taking, or has taken within 4 weeks prior to the screening/baseline visit, pharmacological treatment for SUI (including but not limited to, alpha adrenergics, and tricyclic antidepressants)
* Severe or uncontrolled diabetes, (defined as being a diabetic with a hemoglobin A1c of ≥10%) per patient medical record.
* History of drug/alcohol abuse, mental dysfunction, or other factors limiting her ability to cooperate fully
* Pregnancy test with positive result during screen…
What they're measuring
1
The effect of acute peri-urethral neurostimulation on intra-urethral pressure.