Recruiting NCT06932302
At-Home Neuromodulation for Female Sexual Dysfunction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electrical Stimulation, Smart vibrator.
- Who it may be relevant to
- Registry conditions: Female Sexual Dysfunction. Basic parameters: 18 years — 85 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Interventions
- Device 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. - Device 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.
Primary outcome measures
- Number of dorsal genital nerve stimulation (DGS) sessions performed [Time frame: Approximately day 22]
- Number of related adverse events [Time frame: Up to week 9]
Secondary outcome measures (2)
- Change in Female Sexual Function Index (FSFI) total scores [Time frame: Baseline and approximately day 22]
- The Patient Global Impression of Change (PGIC) survey score [Time frame: Up to week 9]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Michigan — Ann Arbor
Identifiers
NCT: NCT06932302 · HUM00265573