Transcutaneous Genital Nerves Stimulation for the Treatment of Refractory Chronic Pelvic and Genital Pain in Women.
NCT: NCT07884305 · NOT_YET_RECRUITING
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Brief 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 Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.
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