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

NCT04160793 | Unknown

• 1 other identifier: GNS1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder, Overactive

Outcome Measures

Primary Outcomes (1)

• Frequency of bladder voiding

  Patient's report on frequency of micturition

  6 months

Secondary Outcomes (1)

• Safety of the GNS procedure

  6 months

Study Arms (1)

Genital Nerve Stimulation

OTHER

Stimulation of the DNP

Device: Genital Nerve Stimulation

Interventions

Genital Nerve Stimulation DEVICE

Implantation the vaginal way a stimulation's electrode to the dorsal nerve of the clintoris in local anesthesia

Genital Nerve Stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Prof. Dr. med. Marc Possover: lead

Study Sites (1)

Possover

Zurich, 8008, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 22865209 RESULT

• 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.

  PMID: 21788054 RESULT

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc Possover, PhD, MD

  PIMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Possover, PhD, MD

CONTACT

+41 44 520 3600; m.possover@possover.com

Fiona Muir

CONTACT

+41 44 520 3604; f.muir@possover.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Model Details: Prospective unblinded interventional study

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: November 13, 2019
• Study Start: January 1, 2020
• Primary Completion: July 31, 2020
• Study Completion: August 1, 2020
• Last Updated: November 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)