Overactive BladderNCT06529198
NeuroGyn Genital Neuromodulation System for iOAB Treatment
A study testing NeuroGyn Genital Neuromodulation System in people with Overactive Bladder, run by Prof. Dr. med. Marc Possover.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- NeuroGyn Genital Neuromodulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%)
Who cannot join
- 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).
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
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).
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.
Read the detailed description
not provided
- Conditions
- Overactive Bladder
- Being tested
- NeuroGyn Genital Neuromodulation System
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroGyn Genital Neuromodulation SystemDevice
Genital Neuromodulation
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Patient are undergoing neuromodulatioon Receives: Device: NeuroGyn Genital Neuromodulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Symptoms greater than or equal to 50%
Overactive Bladder Symptom Score - OABSS
Measured: 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
Measured: 6 months - 1 year - 2 years
Secondary outcomes (2)
International Consultation on Incontinence Questionnaire
International Consultation on Incontinence Questionnaire (ICIQ)
Measured: 6 months - 1 year - 2 years
The PHQ-9 (Patient Health Questionnaire-9)
PHQ-9
Measured: 6 months - 1 year - 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Aug 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. med. Marc Possover
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. med. Marc Possover, Possover International Medical Center AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529198
- Sponsor's protocol ID
- NeuroGyn AG
- Status last verified
- Jul 2024
- First submitted
- 13 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT06529198
- Acronym / sponsor ID
- NeuroGyn AG
- Conditions
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Prof. Dr. med. Marc PossoverUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Device: NeuroGyn Genital Neuromodulation SystemPatient are undergoing neuromodulatioon |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroGyn Genital Neuromodulation SystemGenital Neuromodulation | Device | treatment |
Primary outcome
Reduction in Symptoms greater than or equal to 50%
Time frame: 6 months - 1 year - 2 years follow up
Overactive Bladder Symptom Score - OABSS
Urodynamic testing
Time frame: 6 months - 1 year - 2 years
Noninvasive uroflowmetry, followed by invasive cystometry and a pressure-flow study + concurrent electromyography (EMG) of pelvic floor muscles and urethral pressure profiles
2 secondary outcomes
International Consultation on Incontinence Questionnaire
Time frame: 6 months - 1 year - 2 years
The PHQ-9 (Patient Health Questionnaire-9)
Time frame: 6 months - 1 year - 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroGyn Genital Neuromodulation System in people with Overactive Bladder, run by Prof. Dr. med. Marc Possover.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc Possover, PhD (+41797507595, m.possover@possover.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Symptoms greater than or equal to 50% (time frame: 6 months - 1 year - 2 years follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.