N/A N=16 Randomized Treatment

Surface Stimulation for Female Sexual Dysfunction

Female Sexual Dysfunction

Bottom Line

View on ClinicalTrials.gov: NCT02692417 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2019

Primary outcome: Primary: 6 Weeks - Total FSFI Score — 26.0; 17.4 score on a scale — p=0.109

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Transcutaneous Electrical Nerve Stimulation (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Timothy Bruns
Primary completion: Mar 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY 6 Weeks - Total FSFI Score	26.0; 17.4	0.109
PRIMARY 12 Weeks - Total FSFI Score	27.8; 18.7	0.109
PRIMARY 18 Weeks - Total FSFI Score	26.2; 18.8	0.109

Summary

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02692417). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.