NeuroGyn Genital Neuromodulation System for iOAB Treatment (NCT06529198) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
NeuroGyn Genital Neuromodulation System for iOAB Treatment
150 participantsStarted 2025-08-01
Plain-language summary
The NeuroGyn study is designed to evaluate the safety and effectiveness to the NeuroGyn Genital Neuromodulation System as an aid in the treatment of the symptoms of idiopathic overactive bladder in patients who have failed or could not tolerate more conservative treatments.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion Criteria:
* 18 years of age and older (adult and older adult, all sexes)
* Diagnosed (urodynamic testing) with idiopathic overactive bladder (iOAB)
* Symptoms of urinary urgency, frequency, and/or urge incontinence for at least 6 months
* Failed conservative treatments (e.g., lifestyle modifications, medications)
* Willing and capable of providing informed consent
* Capable of participating in all testing associated with this clinical investigation
* Patients have already undergo a successful GNS-test phase with adhesive electrodes (reduction symptoms greater equal or more than 50%)
Exclusion Criteria:
* History of pelvic surgery affecting the pubic bone or genital nerves
* Current urinary tract infection
* Neurological conditions affecting bladder function (neurogenic OAB)
* Pregnancy or planning to become pregnant during the study period
* Contraindications to local anesthesia or surgery
* Female patients with significant prolapse (i.e., prolapse beyond the introitus).
* Patients with primary stress incontinence and primary pelvic pain symptoms.
* Patients with less than 12 months from last intravesical botulinum toxin A therapy
* Patients with mechanical infravesical obstruction and/or Interstitial Cystitis.
* Vulnerable patients with co-morbid conditions should be excluded from this study. These co-morbid conditions include all pathologies of the cardiovascular system (Angina Pectoris, Infarct, Thrombose, Embolie, Hypertonia), pulmonary system (asthma, COPD, …
What they're measuring
1
Reduction in Symptoms greater than or equal to 50%