Clinical trial NCT04122703: Trial of Tibial Nerve Stimulation for Treating Sexual Dysfunction
Official title: A Randomized Controlled Trial Investigating the Efficacy of Percutaneous Tibial Nerve Stimulation (PTNS) in the Treatment of Female Sexual Dysfunction (FSD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Sexual Dysfunction
Keywords: Percutaneous Tibial Nerve Stimulation
Female Sexual Dysfunction
Sexual dysfunction
peripheral neuromodulation
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will be recruiting 66 patients, who will be randomized (1:1) to either the PTNS group or the Sham group.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to understand the efficacy of PTNS versus a placebo in the treatment of female sexual dysfunction syndrome.

Detailed description: The goal of this study is to evaluate the efficacy of PTNS in treating patients with FSD. We will be recruiting 66 patients, who will be randomized (1:1) to either the PTNS group or the Sham group. The patients in the PTNS group will receive one PTNS treatment per week for 12 weeks. The patients in the Sham group will receive one sham treatment per week for 12 weeks. Patients in both groups will be asked to complete questionnaires before the start of the treatment, as well as after 12-weeks of treatment to assess the changes in the severity of their symptoms

Aim 1: To evaluate the effect of percutaneous tibial nerve stimulation (PTNS), compared to a validated sham, on sexual functioning in women with female sexual dysfunction (FSD).

Aim 2: To compare the effect of PTNS on lower urinary tract symptoms versus sexual functioning in patient with FSD.

Eligibility criteria: Inclusion Criteria:

* Women aged 18 or older
* FSFI score of ≤ 26.55
* Patients must be sexually active within one month prior to the study and plans to continue to be sexually active for the next 12 weeks (Sexual activity can include masturbating, vaginal intercourse, caressing, and foreplay)

Exclusion Criteria:

* Patients with anatomical limitations preventing successful placement of the electrode (bleeding disorders, peripheral vascular disease, ulcers, or lower leg cellulitis)
* Patients with medical disorders precluding stimulation (cardiac pacemakers, current use of Holter monitor, known history of neuropathy)
* Pregnant women or women intending to become pregnant during the course of the study.

Primary outcomes:
measure: Change in Female Sexual Function Index (FSFI)
timeFrame: Baseline, at week 6 and at week 12
Secondary outcomes:
measure: Change in Arizona Sexual Experiences Scale (ASEX)
timeFrame: Baseline, at week 6 and at week 12
measure: Change in Prolapse/Urinary Incontinence Sexual-12 (PISQ-12 ) Function Questionnaire (PISQ- 12)
timeFrame: Baseline, at week 6 and at week 12
measure: Change in Urinary Distress Inventory (UDI-6)
timeFrame: Baseline, at week 6 and at week 12
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook Medicine Women's Pelvic Health And Continence Center
state: New York
Study officials:
affiliation: Stony Brook Medicine
name: Jason Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peters KM, Carrico DJ, Perez-Marrero RA, Khan AU, Wooldridge LS, Davis GL, Macdiarmid SA. Randomized trial of percutaneous tibial nerve stimulation versus Sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. J Urol. 2010 Apr;183(4):1438-43. doi: 10.1016/j.juro.2009.12.036. Epub 2010 Feb 20.
citation: Zimmerman LL, Gupta P, O'Gara F, Langhals NB, Berger MB, Bruns TM. Transcutaneous Electrical Nerve Stimulation to Improve Female Sexual Dysfunction Symptoms: A Pilot Study. Neuromodulation. 2018 Oct;21(7):707-713. doi: 10.1111/ner.12846. Epub 2018 Sep 3.