At-Home Neuromodulation for Female Sexual Dysfunction

Обзор

This pilot study investigates the regular use of non-invasive dorsal genital nerve stimulation (DGS) for the treatment of female sexual dysfunction (FSD). The researchers aim to determine whether subjects with FSD can correctly follow an at-home treatment regimen and to demonstrate that DGS can improve FSD arousal symptoms in premenopausal and postmenopausal women. Some subjects will use a smart vibrator for comparison to DGS.

Вмешательства

• Устройство Electrical Stimulation
  Electrical stimulation of the dorsal genital nerve will be accomplished using the UCon system and patch electrodes developed by InnoCon. The UCon system includes a programmable control unit; leads that connect to the control unit and electrodes; a silicone surface electrode; a reference electrode; and a remote control for quick on and off toggling of stimulation.
• Устройство Smart vibrator
  Subjects will use a smart vibrator at home twice a week during the study. The Lioness smart vibrator records physiological responses during use.

Первичные конечные точки

• Number of dorsal genital nerve stimulation (DGS) sessions performed [Срок оценки: Approximately day 22]
• Number of related adverse events [Срок оценки: Up to week 9]

Вторичные конечные точки (2)

• Change in Female Sexual Function Index (FSFI) total scores [Срок оценки: Baseline and approximately day 22]
• The Patient Global Impression of Change (PGIC) survey score [Срок оценки: Up to week 9]

Критерии участия

Критерии включения

• Capable of speaking and understanding English.
• Able to comprehend the clinical study procedures and provide informed consent.
• Identified as having female sexual dysfunction with a Female Sexual Function Index (FSFI) score of 26.55 or less and a score of 3 or less on one or more of the FSFI subdomains of lubrication, arousal, and orgasm.
• Willing and able to adhere to the study protocol
• Able to attend experimental sessions at Michigan Medicine at both the start and conclusion of the study.

Критерии исключения

• Not currently sexually active.
• Pregnant or planning to get pregnant during the study period.
• History of a neurological disorder or impairments affecting pelvic organ function, including diagnosed with dorsal genital nerve damage, lower motor dysfunction, or other related conditions.
• Implanted with a neurostimulator for bladder or bowel function.
• Have a skin condition that would predispose them to sensitivity to the stimulation electrodes.
• Female sexual dysfunction limited solely to low desire, without issues in lubrication, arousal, or orgasm.
• Clinically diagnosed bladder dysfunction, pelvic pain, or other pelvic organ symptoms; or a score of 8 or higher on the American Urological Association Symptom Index (AUASI).
• Unable or unwilling to adhere to the study protocol
• Simultaneously participating in another research study that may affect the results of this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT06932302 · HUM00265573

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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