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NOT YET RECRUITING
NCT07884305
NA

Transcutaneous Genital Nerves Stimulation for the Treatment of Refractory Chronic Pelvic and Genital Pain in Women.

Sponsor: Prof. Dr. med. Marc Possover

View on ClinicalTrials.gov

Summary

This study will explore whether non-invasive electrical stimulation can reduce chronic genital pain, deep pelvic pain, or both in adult women whose symptoms have persisted for at least six months despite conventional treatment. Approximately 50 women will participate at several clinical centers. After recording their pain for two weeks, participants will use a portable electrical stimulation device at home for 12 weeks. Two adhesive electrodes will be placed on intact skin beside the vulva. Stimulation will be applied for 30 minutes twice daily, at an individually adjusted, comfortable intensity. No surgery or implantation is required. The main outcome is the proportion of participants achieving at least a 30% reduction in their main pain symptom after 12 weeks. Researchers will also assess daily functioning, quality of life, pain medication use, and side effects. Follow-up assessments will take place three and six months after treatment ends. All participants will receive stimulation; there is no comparison group. This exploratory study aims to assess safety, tolerability, and preliminary signs of benefit to guide a future controlled trial.

Official title: Transcutaneous Genital Nerves Electrical Stimulation for Treatment-Refractory Chronic Genital and/or Visceral Pelvic Pain in Women: A Clinical Study

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-12-01

Completion Date

2027-08-01

Last Updated

2026-10-20

Healthy Volunteers

No

Interventions

DEVICE

Transcutaneous Genital Nerves Stimulation

Transcutaneous genital nerve stimulation (GNS) will be administered using an external electrical nerve stimulation device connected to bilateral adhesive skin electrodes positioned approximately 2-3 cm lateral to the vulva on intact perivulvar skin. Stimulation will be delivered at a frequency of 20 Hz for approximately 30 minutes twice daily. The stimulation intensity will be individually adjusted to produce a comfortable tingling sensation and then slightly reduced to maintain tolerability. Following initial instruction, participants will self-administer the treatment at home according to the study protocol. No vaginal or mucosal electrodes, surgical procedures, or implanted devices will be used.

Locations (1)

Possover International Medical Center AG

Zurich, Canton of Zurich, Switzerland