NeuroGyn Genital Neuromodulation System for iOAB Treatment

Prof. Dr. med. Marc Possover

Status

Not yet enrolling

Conditions

Overactive Bladder

Treatments

Device: NeuroGyn Genital Neuromodulation System

Study type

Interventional

Funder types

Other

Identifiers

NCT06529198

NeuroGyn AG

Details and patient eligibility

About

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.

Full description

not provided

Enrollment

150 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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