Clinical trial NCT06932302: At-Home Neuromodulation for Female Sexual Dysfunction
Official title: At-Home Neuromodulation for Female Sexual Dysfunction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Female Sexual Dysfunction
Keywords: dorsal genital nerve stimulation
neuromodulation
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of dorsal genital nerve stimulation (DGS) sessions performed
timeFrame: Approximately day 22
measure: Number of related adverse events
timeFrame: Up to week 9
Secondary outcomes:
measure: Change in Female Sexual Function Index (FSFI) total scores
timeFrame: Baseline and approximately day 22
measure: The Patient Global Impression of Change (PGIC) survey score
timeFrame: Up to week 9
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Tim Bruns, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Priyanka Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References: