NeuroGyn Genital Neuromodulation System for iOAB Treatment

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).

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Overactive Bladder
• Intervention / Treatment: Device: NeuroGyn Genital Neuromodulation System

Detailed Description

not provided

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marc Possover, PhD; Phone Number: +41797507595; Email: m.possover@possover.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment; Patient are undergoing neuromodulatioon	Device: NeuroGyn Genital Neuromodulation System; Genital Neuromodulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Symptoms greater than or equal to 50%	Overactive Bladder Symptom Score - OABSS	6 months - 1 year - 2 years follow up
Urodynamic testing	Noninvasive uroflowmetry, followed by invasive cystometry and a pressure-flow study + concurrent electromyography (EMG) of pelvic floor muscles and urethral pressure profiles	6 months - 1 year - 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Consultation on Incontinence Questionnaire	International Consultation on Incontinence Questionnaire (ICIQ)	6 months - 1 year - 2 years
The PHQ-9 (Patient Health Questionnaire-9)	PHQ-9	6 months - 1 year - 2 years

Collaborators and Investigators

• Sponsor: Prof. Dr. med. Marc Possover

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: July 13, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder, Overactive
• Other Study ID Numbers: NeuroGyn AG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No