Surface Stimulation for Female Sexual Dysfunction
Completed · Not applicable
Conditions studied: Female Sexual Dysfunction
In brief
Female sexual dysfunction, including sexual arousal disorder, has a significant clinical impact, affecting millions of women in the United States alone. Peripheral nerve stimulation, such as posterior tibial nerve stimulation (PTNS) and dorsal genital nerve stimulation (DGNS) can modulate neural circuits for bladder and fecal continence. The investigators hypothesize that periodic DGNS and PTNS will modulate autonomic neural circuits and promote improvements in sexual function in women with sexual arousal disorder. Subjects will be randomized to receive one of the stimulation approaches. Subjects will have weekly 30-minute sessions across twelve weeks.
Key facts
- Study ID
- NCT02692417
- Run by
- Timothy Bruns
- People needed
- 16
- Starts
- 2016-02-01
- Expected to finish
- 2018-03-01
- Last updated by the study team
- 2019-04-09
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Adult women ≥ 18 years of age
- Sexually active ≥ 1 time per month (≥ 2 times per month preferred)
- Score of 19 or less on a 6-question set of the Female Sexual Function Index (FSFI) survey
- Neurologically stable
- Ambulatory
- Capable of giving informed consent
- English speaking
- Capable and willing to follow study procedures
You may not qualify if…
- Men
- Women ≤ 17 years of age
- Pregnant or planning to get pregnant during the study period
- Clinically diagnosed neurological bladder dysfunction
- Prior experience with PTNS or DGNS
- Current use of transcutaneous electrical nerve stimulation (TENS) on pelvis, back, or legs
- Implanted pacemaker, defibrillator, spinal cord stimulator, or sacral root stimulator
- Taking flibanserin
- Taking any investigational drug
- History of neurologic diseases or impairments
- Any other factors that the investigators feel would place the patient at increased risk from this study
Where it is running
- University of Michigan Health System — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.