Clinical trial NCT06529198: NeuroGyn Genital Neuromodulation System for iOAB Treatment
Official title: The NEUROGYN-GNS Pivotal Clinical Study to Assess the Safety and Efficacy of the Neurogyn Genital Neuromodulation System, a Genital Nerves Neuromodulation Device Used to Treat Idiopathic Overactive Bladder (iOAB).
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Overactive Bladder
Lead sponsor: Possover International Medical Center AG
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

Brief 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.

Detailed description: not provided

Eligibility criteria: 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, chr. Bronchitis), intestinal system (morbus Crohn, diverticulitis..) and any malignant disease. These co-morbid conditions also include neurologic diseases (i.e., stroke, multiple sclerosis, spinal cord injury), sacral dermal pathological conditions, congenital or other anatomical sacral anomalies (e.g. spina bifida, sacral agenesis, trauma sequelae), mobility deficits, medically complicated/uncontrolled diabetes, fecal motility disorders (fecal incontinence/constipation), chronic pelvic pain, history of recurrent urinary tract infections (UTIs), gross hematuria, prior pelvic/vaginal surgeries (incontinence/prolapse surgeries), pelvic cancer (bladder, colon, cervix, uterus, prostate), deeply infiltrating endometriosis of the pelvic plexus, sacral plexus or of the bladder, Reiter´s syndrome, and pelvic radiation.
* Patients suffering from other CNS disorders (mental disorders, severe psychological problems, cerebrovascular accident less than 6 months ago).
* Patients suffering from polydipsia/polyuria are excluded from the study. Similarly, patients suffering from diabetes insipidus (DI) and diabetes mellitus (DM) are also excluded from the study.
* A female with a positive urine pregnancy test
* A female who is breastfeeding
* Allergies again local anesthesia (Lidocain), Tranquillizers and Antibiotics

Primary outcomes:
measure: Reduction in Symptoms greater than or equal to 50%
timeFrame: 6 months - 1 year - 2 years follow up
measure: Urodynamic testing
timeFrame: 6 months - 1 year - 2 years
Secondary outcomes:
measure: International Consultation on Incontinence Questionnaire
timeFrame: 6 months - 1 year - 2 years
measure: The PHQ-9 (Patient Health Questionnaire-9)
timeFrame: 6 months - 1 year - 2 years
Other outcomes:
Locations:
Study officials:
References: