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

NCT04160793 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-11-13

No results posted yet for this study

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

Interventions

DEVICE

Genital Nerve Stimulation

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

Sponsors & Collaborators

  • Prof. Dr. med. Marc Possover

    lead OTHER

Principal Investigators

  • Marc Possover, PhD, MD · PIMC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2020-07-31
Completion
2020-08-01

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04160793 on ClinicalTrials.gov