At-Home Neuromodulation for Female Sexual Dysfunction

University of Michigan24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Female Sexual Dysfunction

Interventions

Electrical StimulationDEVICE

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.

Smart vibratorDEVICE

Subjects will use a smart vibrator at home twice a week during the study. The Lioness smart vibrator records physiological responses during use.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

RECRUITING

Outcomes

Primary Outcomes

Number of dorsal genital nerve stimulation (DGS) sessions performed

Time frame: Approximately day 22

Number of related adverse events

Study-related AEs include incidents such as device zapping, skin irritation, back cramps, or falls due to sitting for 30 minutes of stimulation.

Time frame: Up to week 9

Secondary Outcomes

Change in Female Sexual Function Index (FSFI) total scores

The FSFI is a 19-question survey assessing sexual function in 6 different domains (desire, arousal, lubrication, orgasm, satisfaction, and pain). Each question asks subjects to rate an aspect of their sexual function on a scale from 0 or 1 to 5, depending on the question. The total score for each subdomain is multiplied by a factor so that the maximum score is 6. The total score is out of 36, with the cutoff score for overall dysfunction being 26.55. Subdomain scores of 3 or less indicate dysfunction in the respective subdomain. The FSFI will be conducted before the first study visit and again within one week after completion of the at-home stimulation period in order to see if scores have changed over the course of the treatment.

Time frame: Baseline and approximately day 22

The Patient Global Impression of Change (PGIC) survey score

The Patient Global Impression of Change (PGIC) is a 1-question survey asking patients to describe the change in their condition with a number from 1 to 7. Each number is paired with a description, where 1 represents "No change (or condition is worse)" and 7 represents "A great deal better, and a considerable improvement that has made all the difference". The PGIC will be administered within one week after completion of at-home stimulation, and again 1 month later in order to assess the patient's perception of their change in symptoms.

Time frame: Up to week 9

Central Contacts

Yike Liu

CONTACT

734-647-8568 yikel@umich.edu

Tim Bruns, PhD

CONTACT

734-647-8727 bruns@umich.edu

Data from ClinicalTrials.gov

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