GNS Therapy for Overactive Bladder

GNS Therapy for Overactive Bladder (OAB): A Breakthrough Neuromodulation Solution for Urge Incontinence

Introduction: GNS Therapy for Overactive Bladder – A Minimally Invasive Breakthrough in Pelvic Neuromodulation

GNS Therapy for Overactive Bladder is a minimally invasive neuromodulation technique developed by Prof. Marc Possover to treat one of the most common and challenging pelvic organ dysfunctions: idiopathic overactive bladder (iOAB). Affecting nearly 17% of women and 16% of men over the age of 40, iOAB can lead to urgent, uncontrollable urination, frequent daytime and nighttime voiding, and episodes of urge incontinence. While Sacral Nerve Modulation (SNM) and Pudendal Nerve Stimulation (PNS) have traditionally been used to address these symptoms, they remain invasive, costly, and largely inaccessible—especially for women, who represent 70–80% of patients needing pelvic neuromodulation. Gynecologists often lack training in these techniques, and many clinics are unequipped with the tools (like fluoroscopy) required for standard implantation procedures. In contrast, GNS Therapy for Overactive Bladder offers a safe, effective, and gynecology-friendly alternative. It targets the dorsal genital nerves through a precise, two-passage technique and enables both a non-invasive test phase and a permanent, subpubic implantation—making it suitable for broader use in clinical practice. As part of the field of neuropelveology, this therapy is not only transforming how we treat overactive bladder, but also improving quality of life for patients who have exhausted other options.

Is There Scientific Evidence for Genital Nerve Stimulation (GNS) in Treating Overactive Bladder (OAB)?

Absolutely – YES!

Genital nerve stimulation, specifically targeting the Dorsal Nerve of the Clitoris/Penis (DNC/P), is strongly supported by scientific research. Studies have demonstrated that DNC/P stimulation:

Significantly increases bladder capacity
Inhibits involuntary detrusor contractions
Reduces symptoms of overactive bladder (OAB)

Farag et al. (2012) conducted a systematic review confirming these effects in patients with detrusor overactivity (Curr Urol Rep). Similar findings were reported by Oliver et al. (2003) and Howard et al. (2008), showing improved bladder control and reduction of OAB symptoms with dorsal genital nerve stimulation (Neurourol Urodyn).

Additionally, GNS has shown effectiveness in treating idiopathic fecal incontinence. Worsøe et al. (2012) found that electrical stimulation of the dorsal clitoral nerve reduced incontinence episodes in patients with idiopathic fecal incontinence (Colorectal Dis).

The DNC/P also plays a crucial role in sexual function. Research supports its involvement in penile erection and clitoral stimulation. Electrical stimulation of the dorsal penile nerve can trigger reflex tonic erections, bulbospongiosus muscle activity, and even ejaculatory responses (Seftel et al. 1994; Giuliano et al. 1993). These effects relate to the cavernous nerves, which contain major genital parasympathetic fibers responsible for arousal. Interestingly, pelvic sympathetic nerve stimulation may also induce erection, despite traditionally being associated with detumescence.

Altogether, these findings confirm that GNS has a solid physiological rationale and promising clinical evidence for managing OAB, fecal incontinence, and sexual dysfunctions.

Recognizing this, Prof. Dr. Marc Possover developed a novel implantation technique that enables precise electrode placement at the genital nerves, offering an innovative and effective approach for long-term neuromodulation therapy.

What Is Genital Nerve Stimulation (GNS) Therapy?

Genital Nerve Stimulation (GNS) is an innovative therapy designed to treat pelvic dysfunctions like overactive bladder (OAB) by stimulating the dorsal genital nerves. While the concept of stimulating these nerves using adhesive electrodes has existed for decades, permanent treatment was limited by the lack of viable implantation techniques.

This challenge was solved by Prof. Dr. Marc Possover, a world leader in Neuropelveology, who developed the first surgical method allowing precise electrode placement at the genital nerves. In this minimally invasive procedure:

A thin lead is passed behind the pubic bone
The stimulation site is positioned in front of the pubic bone, directly on the genital nerves
The neurostimulator (generator) is implanted safely behind and below the pubic bone

This patented NeuroGyn Genital Nerve Stimulation® (GNS) technique is the first 24/7 genital neuromodulation therapy, offering long-term symptom relief for OAB in everyday life.

Many patients have found long-term relief through GNS Therapy for Overactive Bladder, even after other treatments failed.

How Does GNS Therapy Work?

Unlike sacral neuromodulation (SNM), which targets deep sacral nerves, GNS directly stimulates the dorsal nerve of the clitoris (in women) or the dorsal nerve of the penis (in men)—both located just beneath the skin.

Using gentle, low-intensity electrical stimulation, GNS modulates bladder function by activating key nerve fibers responsible for urination control. This targeted neuromodulation helps to:

Suppress involuntary bladder contractions (urgency)

Improve your ability to delay urination

Reduce or even eliminate episodes of urinary incontinence

TREATMENT PROCESS

Test Phase with Adhesive Skin Electrodes (Non-invasive)

Before final GNS implantation of a permanent neurostimulator, patients undergo a temporary test phase lasting 1 to 3 weeks (or longer, depending on individual needs). Because part of the DNC/P lies superficially to the skin outside the pelvis, this nerve can be stimulated using surface electrodes attached to the overlying skin of the penis or close to the clitoris

Figure 1 (Worsøe J, Fynne L, Laurberg S, Krogh K, Rijkhoff NJ. Electrical stimulation of the dorsal clitoral nerve reduces incontinence episodes in idiopathic fecal incontinent patients: a pilot study. Colorectal Dis 2012;14: 349-355. doi: 10.1111/j.1463-1318.2011.02586.x).

This test is performed at home during normal daily activities (e.g., work, errands, rest), allowing patients to assess whether the stimulation provides symptom relief in real-life settings.

Cost Advantages – A savings of €15,000 to €20,000!

For the electrical stimulation, a simple TENS device connected to two skin electrodes is used. Such adhesive electrodes and the TENS unit can easily be purchased at any pharmacy and cost less than €100. This is a major advantage compared to the surgical test phase used in sacral neuromodulation, where the costs—due to the price of the electrodes and hospital-related expenses—can amount to approximately €15,000 to €20,000 (Daikh, A., Reymond, F., Lombardo, D. et al. Retrospective study of sacral neuromodulator implantations in a French hospital center: Lifespan and hospital costs assessment. Int J Colorectal Dis 38, 273 (2023). https://doi.org/10.1007/s00384-023-04569-5).

This becomes even more significant when considering that nearly 30% of patients do not pass this test phase—meaning the health insurance covers very high costs without any benefit to the patient. This financial aspect is one of the main reasons why sacral neuromodulation is so difficult to get reimbursed by health insurance providers—especially for retired patients or those suffering from multiple chronic illnesses, who already represent a high cost for the healthcare system.

Thus, this significant cost reduction – both for patients who successfully complete the trial phase and for those who unfortunately do not—means that insurance providers will have a strong interest in covering the costs of GNS compared to those of SNM, regardless of which company’s device is used.

Trial Phase Duration and Patient Pressure: GNS vs. SNM

In the case of surgical trial phases, as with Sacral Neuromodulation (SNM), the use of extension cables, which connect the electrodes implanted near the sacral nerves to the external stimulator, inevitably leads to infection risk due to the cables exiting through the skin. For this reason, the SNM trial phase typically does not exceed 2–3 weeks. Patients are therefore under significant pressure, as they have only this limited period to determine whether SNM is effective and to decide with long-term consequences. In contrast, Genital Nerve Stimulation (GNS) uses surface adhesive electrodes, which may cause some skin irritation over time but only with long-term use over several months, but do not expose patients to infection risks. Patients are not under time pressure! They can take their time to evaluate whether GNS is effective for them and make a more considered decision. If uncertain, they can pause the test phase and restart it at any time, even weeks or months later.

Some neurourology centers already use this same method (surface stimulation) to decide whether a surgical test phase such as SNM is justified or not.

Implantation of the PosStim Neurostimulator (Permanent Solution)

If the test phase shows a positive effect, a permanent neurostimulator – PosStim – is implanted through a minimally invasive outpatient procedure, performed under local anesthesia or mild sedation.

1^st Step – Retropubic passage of the cable electrode: A sagittal vaginal/infrapubic incision about 2 mm is made approximately 1 cm below and 1cm lateral to the outer urethral meatus in female (infrapubic/infratesticular incision in male – figure 2).

Figure 2 – 1st Step – Retropubic passage of the cable electrode

No dissection is required. The curve needle driver is inserted into the incision. During the insertion, the surgeon controls the position of the inserters by palpation, as in standard TVT procedure. The tip is oriented at an angle of 5-10° from the midline, towards the symphysis. The curve needle driver is advanced contacting the inferior edge of the pubic ramus, until it transfixes the urogenital diaphragm. A straight metallic inserter helps to lateralize the urethra and bladder to the contralateral side.

The needle applicator is guided through the retropubic space along the backside of the pubic bone, through the space of Retzius, towards the suprapubic abdominal skin incision, where it is brought up.

To definitively exclude a bladder perforation during the passage of the applicator behind the pubic symphysis, a cystoscopy is performed. The applicator remains in situ, and the spear of the curve driver needle is removed. A quadripolar lead electrode with an electrode distance of 60mm is introduced retrograde into the shaft of the curve needle driver.

By retraction of the curve needle driver, the electrode lead is left with the stimulation’s poles coming out through the genital incision while the cable electrode is in deep protection of the pubic bone – Figure 3.

Figure 3 – retrograde introduction of the electrode lead in the NeuroGyn’s patented applicator

2^nd Step – Genital passage of the lead-electrode in front of the pubic bone: The purpose of this second passage is to insure a direct contact of the lead electrode to the DNC/P. As the DNC/P perforates the urogenital diaphragm laterally to the external urethral meatus at an average distance of 2.7 cm (2.4–3.0 cm) and then runs along the bulbo-spongiosus muscle for a distance of 1.9 cm (1.8–2.2 cm) before penetrating the pillars of the clitoris – Figure 4

Figure 4 – Anatomy of the DNC/P in front of the pubic bone

Through a second supraclitoral/penis incision in the midline – with sufficient distance to the clitoris/penis, the applicator with the spear is introduced from top to bottom and guided as deep as possible along the frontside of the pubic bone in direction to the fist genital incision, where it is brought up. After removing the spear, the electrode cable is inserted retrograde into the applicator again. After removing the applicator, the electrode is in place in direct contact to the DNC/P – Figure 5.

Medical Advantages of the Patented NeuroGyn GNS Procedure Compared to Classical SNM

The implantation technique for the stimulation electrode requires no dissection of nerves or subcutaneous structures. Placement of the electrode and the passage of the lead under the pubic bone are performed using a tunneling device specifically developed and patented by NeuroGyn for this purpose.
The procedure requires only two small incisions (~1 mm) at the level of the genital organs. The technique does not involve any dissection of nerves or subcutaneous tissue. The tunneling device enables the retrograde introduction of the stimulation lead—a technique not feasible without this specialized applicator. As a result, the stimulation poles are positioned in front of the pubic bone, directly in contact with the genital nerves, while the neurostimulator is implanted behind and below the pubic bone. This requires only a small incision (1–1.5 cm) above the pubis. Since neither men nor women sit directly on the vulva or penis, the subpubic lead path protects it from external trauma and lead migration, as the cable is not placed directly under the skin.
The PosStim™ stimulation electrode includes multiple stimulation poles, ensuring effective and long-term neuromodulation. PosStim is rechargeable and designed to deliver therapeutic stimulation for at least 15 years.
The implantable pulse generator is placed behind the pubic bone (retropubic), using a surgical approach similar to the TVT (tension-free vaginal tape) procedure—one of the most frequently performed interventions in gynecology (Ulmsten, U., Falconer, C., Johnson, P. et al. A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence. Int Urogynecol J 9, 210–213 (1998). https://doi.org/10.1007/BF01901606). This familiar technique reduces the surgical learning curve and makes GNS accessible to more gynecologists. Until now, neuromodulation has been performed by only a small number of gynecologists—primarily urogynecologists working in referral centers—representing only about 0.35% of all gynecologists.

This is largely due to traditional neuromodulation requiring dorsal (sacral) approaches and electrode placement near the spinal cord, which fall outside standard gynecologic training.

It is important to note that the TVT procedure is actually more invasive than sacral neuromodulation. The passage of the tape occurs near the urethra, bladder, and retropubic vessels, exposing patients to potential risks such as hemorrhage, hematoma, and urethral or bladder injury.

In contrast to the TVT, the retropubic approach used in GNS is performed approximately 2 cm lateral to the urethra, safely distant from both the urethra and the perivascular plexus of Santorini, thereby significantly reducing the risk of injury, bleeding and hematoma. The more lateral the trajectory, the lower the risk of bladder injury. Nonetheless, to ensure absolute safety, a cystoscopy is systematically performed after passing the applicator behind the pubic symphysis, to confirm that the bladder has not been perforated. If accidental entry into the bladder is detected, the applicator can simply be withdrawn and reinserted, either by adjusting the trajectory along the dorsal edge of the symphysis or by performing the implantation on the contralateral side, as genital nerves are present on both the left and right sides.

In a study, Possover introduces and assesses the feasibility of the GNS procedure (Possover M. Minimally Invasive Two-passage Electrical Genital Nerve Stimulation: A Human Cadaver Study of a New Technique. J Minim Invasive Gynecol. 2023 Jun;30(6):480-485. doi: 10.1016/j.jmig.2023.02.024. Epub 2023 Mar 15. PMID: 36924880). The procedure was performed bilaterally on five cadavers and tested by ten gynecologic surgeons at theDepartment of Anatomy, University of Bern, Switzerland. Following the procedures, anatomical dissections were performed to evaluate the course and positioning of the lead in relation to the DNC/P. In all cases, the electrode ran in close parallel alignment with the DNC/P, with a maximum distance of less than two millimeters. All participating surgeons rated the technique with ascore of 1 out of 10 for both difficulty and reproducibility, indicating that the procedure was perceived as very easy and safe to perform. In conclusion, the GNS-double-down procedure represents a new and highly accurate peripheral nerve stimulation technique that enables consistent and precise electrode placement on the DNC/P. Its simplicity and reproducibility make it well-suited for clinical application.
Because existing neurostimulators on the market were not designed for the specific anatomical and surgical requirements of the GNS procedure – particularly due to their form factor, which prevents implantation behind the pubic symphysis – a dedicated solution was needed. This was the primary motivation behind the founding ofNeuroGyn AG. In collaboration withIMEC (Eindhoven, Netherlands), NeuroGyn has developed a purpose-built neurostimulator specifically designed for GNS. This device fulfills all surgical and functional requirements of the GNS technique, including its unique retropubic implantation route, long-term reliability, and patient comfort.

Cost Comparison: Sacral Nerve Modulation (SNM) vs. Genital Nerve Stimulation (GNS)

Sacral Nerve Modulation (SNM):

Trial Phase: Requires surgical placement of a temporary lead with subcutaneous extension connected to an external stimulator.
Trial Duration: Limited to 1–3 weeks due to risk of infection from skin-externalized cables.
Setting: Both the trial phase and the final implantation typically performed in a hospital or surgical center, both under general or regional anesthesia.
Procedure Time: 30–60 minutes per lead placement for both the trial phase and final implantation.
Device Cost: High – includes leads, extensions, implantable pulse generator (IPG), and external devices.
Total Cost Estimate (Europe): €15,000–€20,000 per patient for test-phase, and further €20,000–€25,000 for final implantation, excluding revisions and complications.
Additional Costs: Frequent medical follow-ups, device programming, and potential for explantation if ineffective.

Genital Nerve Stimulation (GNS):

Trial Phase: Performed at home with surface adhesive electrodes; no surgery required.
Trial Duration: Flexible – can last several weeks or months with no infection risk.
Setting: Final implantation fully ambulatory, performed under local anesthesia in an outpatient setting.
Procedure Time: Less than 10 minutes; single minimally invasive technique.
Device Cost: Significantly lower, especially during trial phase using external surface electrodes.
Total Cost Estimate: Both Trial phase and final implantation under €25,000, both in outpatient settings.
Additional Advantages: No hospital stay, no general anesthesia, no surgical risk in the testing phase. No post-implantation device programming, much less medical follow-ups.
The patient has full control over their therapy with the option to choose between several pre-programmed settings.

While SNM is an established therapy, it is costly, surgically invasive, and time-limited due to infection risk. In contrast, GNS is designed for cost-efficiency and patient comfort: it is performed in outpatient settings under local anesthesia, involves minimal surgery, and offers flexible, extended trial periods with significantly reduced costs – potential savings of €15,000 to €20,000 per patient.

LONG-TERM NEUROMODULATION

After implantation:

The stimulation parameters are customized to the patient’s needs.
The device is programmable and adjustable via app and remote control, providing user-friendly management.

Your Benefits at a Glance

A gentle, modern therapy for OAB resistant to conventional treatments.
No general anesthesia required — performed under local anesthesia in an outpatient setting.
Non-invasive test phase helps determine success before any permanent surgery.
Cost-effective: Test phase facilitates insurance approval for permanent implantation.
User-controlled stimulation through remote or app interface.
Better sleep, fewer accidents, more freedom in daily life.
A next-generation, fully implantable neurostimulator (PosStim) is currently under final development and expected to launch within the next two years – tailored specifically to the GNS procedure and designed to meet all clinical and safety standards for long-term use.

IMPORTANT TO KNOW

GNS therapy is scientifically validated, with positive data from previous neuromodulation studies and ongoing clinical trials under Prof. Possover’s leadership.
The GNS technique was developed to overcome limitations of existing therapies like sacral or tibial nerve stimulation (e.g., invasiveness, side effects, poor access for gynecologists).
The entire GNS approach is rooted in neuropelveology – a subspecialty that focuses on diseases of the pelvic nerves.
As part of the Neuropelveology training program – www.possover-neuropelveology.com – more than 150 gynecologists from around the world have been certified in the GNS procedure. Therefore, as soon as NeuroGyn’s neurostimulator, called “PosStim,” becomes available on the international market, you will be able to benefit from this exceptional therapy for your overactive bladder – especially if you also suffer from fecal incontinence or sexual dysfunction (erectile dysfunction in men).

IS GNS RIGHT FOR YOU?

If you suffer from:

Urgent, uncontrollable urination
Frequent urination day and night
Involuntary urine leakage (urge incontinence)
and previous treatments have not helped, then GNS may be a breakthrough option for you.

WE ARE HERE FOR YOU

If you are interested in GNS therapy or would like to take part in the clinical study which will start in 2026, we would be pleased to provide personal advice and answer all your questions.

✉️ Want to learn more about GNS Therapy or join the training?

Reach out directly to Prof. Possover’s team at

m.possover@possover.com

We’re here to guide you.