Genital Nerve Stimulation - GNS - for Treatment of Non-neurogenic OAB (GNS)

The Genital Nerve Stimulation - GNS - consists of a two-step procedure with a preoperative non-surgical test-phase and a final surgical implantation of the neuroprothesis. In contrast to the classical technique of transcutaneous lead electrode implantation for sacral or pudendal nerve stimulation, the GNS-test-phase does not require any interventional procedure: because the genital nerves are located just few millimeter below the skin, test-stimulation can be achieved using skin surface or needle electrodes. Stimulation is achieved using a battery powered hand-held stimulator . The effect of the stimulation can be tested by the patient in their daily, home and professional environment, or at the practice under urodynamic testing, or if required other electrophysio-logical testing. After confirmation of the effectiveness of GNS, implantation of a permanent neuroprothesis can be planned. The procedure is performed either under general or spinal anesthesia or using only local anesthesia with IV-sedation as in the classical tension-free vaginal tape procedure (TVT). Because the GNS does not require two surgical procedures for both the test- and the final-implantation but rather only one for the final implantation, the presented protocol allows considerable cost reduction in comparison to the usual procedures for sacral or pudendal nerve stimulation.

Study Overview

• Status: Unknown
• Conditions: Bladder, Overactive
• Intervention / Treatment: Device: Genital Nerve Stimulation

Detailed Description

Pelvic organ dysfunctions are complex and difficult to treat. These conditions affect a substantial portion of the population, especially with increasing age. The two most frequent pelvic dysfunctions are the idio-pathic overactive bladder (IOAB) and erectile dysfunction (ED).

In pelvic dysfunctions, sacral nerve stimulation was the first technique for pelvic nerves stimulation that typically involves electrical stimulation of the nerve via a dorsal transformational technique of implantation. SNS evolved as a widely used treatment for OAB but does not completely resolve symptoms in the majority of patients. Because PNS reach more "sphincter-vesico-anal" fibers than SNM, PNS has been proposed for patients who have failed to respond to sacral neuromodulation. The good effects of PNS in neurogenic and in some non-neurogenic disorders. However, the implantation of a lead to the PN is not easily accomplished and the risk for lead migration with implantation below the pelvic floor is increased. So there is definitively a need for a more suitable alternative for selective stimulation within the pelvic cavity, a method that cannot only be reserved for experts in this field but for all gynecologists dealing with patients suffering from functional disorders of the bladder in daily clinical practice. The stimulation of the dorsal nerve of the pe-nis/clitoris - GNS - emerges as a very attractive alternative that might result in great outcomes for controlling urinary and fecal disorders.

Because part of the DNP 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. This application is however limited, due to intolerance to required high stimulation amplitude. Surface electrodes have limitations such as difficulties in proper daily placement and issues related to hygiene as well as a lack of acceptance in some patients. Implanted electrodes are more suitable. However, implanted electrodes in the penis or near the clitoris, must endure the mechanical stress of penile erections and external pressure, carrying the risk of the cable/electrode breaking or being dislocated.

The GNS consists of a two-step procedure with a preoperative non-surgical test-phase and a final surgical implantation of the neuroprothesis. In contrast to the classical technique of transcutaneous lead electrode implantation for sacral or pudendal nerve stimulation, the GNS-test-phase does not require any interventional procedure: because the genital nerves are located just few millimeter below the skin, test-stimulation can be achieved using skin surface or needle electrodes. Stimulation is achieved using a battery powered hand-held stimulator . The effect of the stimulation can be tested by the patient in their daily, home and professional environment, or at the practice under urodynamic testing, or if required other electro-physiological testing. After confirmation of the effectiveness of GNS, implantation of a permanent neuroprothesis can be planned. The procedure is performed either under general or spinal anesthesia or using only local anesthesia with IV-sedation as in the classical tension-free vaginal tape procedure (TVT). Because the GNS does not require two surgical procedures for both the test- and the final-implantation but rather only one for the final implantation, the presented protocol allows considerable cost reduction in comparison to the usual procedures for sacral or pudendal nerve stimulation.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marc Possover, PhD, MD; Phone Number: +41 44 520 3600; Email: m.possover@possover.com
• Study Contact Backup: Name: Fiona Muir; Phone Number: +41 44 520 3604; Email: f.muir@possover.com

Study Locations

• Switzerland
  • Zürich, Switzerland, 8008
    • Possover
    • Contact: Marc Possover, MD, PhD; Phone Number: +41 44 520 3600; Email: m.possover@possover.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• women >18y
• suffering form intractable iOAB
• proved iOAB by urodynamic testing
• non pregnant
• good health
• patients demanding for therapy of iOAB and willing taking part to the study
• >6-9 months from last therapy with botulinum toxine A

Exclusion Criteria:

• pregnancy
• patients affected by a neurogenic condition
• any health condition being a contraindication for the procedure

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
Other: Genital Nerve Stimulation; Stimulation of the DNP	Device: Genital Nerve Stimulation; Implantation the vaginal way a stimulation's electrode to the dorsal nerve of the clintoris in local anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of bladder voiding	Patient's report on frequency of micturition	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the GNS procedure	Record of all pre- and postoperative complications	6 months

Collaborators and Investigators

• Sponsor: Prof. Dr. med. Marc Possover
• Investigators: Principal Investigator: Marc Possover, PhD, MD, PIMC

Publications and helpful links

General Publications

• Farag FF, Martens FM, Rijkhoff NJ, Heesakkers JP. Dorsal genital nerve stimulation in patients with detrusor overactivity: a systematic review. Curr Urol Rep. 2012 Oct;13(5):385-8. doi: 10.1007/s11934-012-0273-x.
• Martens FM, Heesakkers JP, Rijkhoff NJ. Surgical access for electrical stimulation of the pudendal and dorsal genital nerves in the overactive bladder: a review. J Urol. 2011 Sep;186(3):798-804. doi: 10.1016/j.juro.2011.02.2696. Epub 2011 Jul 23.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): July 31, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: October 18, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (Actual): November 13, 2019

Study Record Updates

• Last Update Posted (Actual): November 13, 2019
• Last Update Submitted That Met QC Criteria: November 8, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: GNS1

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
• product manufactured in and exported from the U.S.: No