Trial of Tibial Nerve Stimulation for Treating Sexual Dysfunction

Female Sexual Dysfunction Clinical Trial

Official title:

A Randomized Controlled Trial Investigating the Efficacy of Percutaneous Tibial Nerve Stimulation (PTNS) in the Treatment of Female Sexual Dysfunction (FSD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04122703
• Other study ID #: 1370654
• Status: Completed
• Phase: N/A
• Start date: September 15, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2023
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Female Sexual Dysfunction

Intervention

Device:
• percutaneous tibial nerve stimulation (PTNS)
The PTNS treatments will be given in 30 min sessions. The PTNS treatment consists of inserting a 34-gauge needle electrode approximately 5 cm cephalad to the medial malleolus and, as well as placing a PTNS surface electrode on the ipsilateral calcaneus. To keep the electrode placement consistent with the sham treatment, 2 inactive transcutaneous electrical nerve stimulation (TENS) surface electrodes are also added, 1 placed under the little toe and 1 on the top of the foot. The PTNS lead set is connected to the Urgent PC stimulator, and a current level of 0.5 to 10 mA at 20 Hz is delivered until the flexion of the big toe is observed or the patient reports a radiating sensation at the sole of the foot.
• Sham procedure
The sham treatment, involves simulating the sensation of the PTNS needle insertion at the same location using a Steritberger placebo needle. This is a blunt tip needle which simulates the sensation of a needle prick when touched to the skin, however, the blunt tip retracts into the handle when pressed into the skin. This creates the illusion of the needle entering the skin, without breaking the skin's surface. An inactive PTNS surface electrode is also placed on the ipsilateral calcaneus. The two TENS surface electrodes, placed in the same location as the PTNS treatment, are active and deliver stimulation mimicking the sensory effects of the PTNS. However, since no electrode needles were inserted near the tibial nerve, there will be no tibial nerve stimulation

Locations

Country	Name	City	State
United States	Stony Brook Medicine Women's Pelvic Health And Continence Center	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Female Sexual Function Index (FSFI)	Female Sexual Function Index (FSFI) is a 19-item questionnaire used to assess female sexual function. Minimum score is 1.2 and maximum score is 36. A score of 26.55 or lower is classified as sexual dysfunction	Baseline, at week 6 and at week 12
Secondary	Change in Arizona Sexual Experiences Scale (ASEX)	Arizona Sexual Experiences Scale (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.	Baseline, at week 6 and at week 12
Secondary	Change in Prolapse/Urinary Incontinence Sexual-12 (PISQ-12 ) Function Questionnaire (PISQ- 12)	PISQ-12 is a 12-item questionnaire used to assess sexual function in women with pelvic organ prolapse or urinary incontinence. Possible total scores range from 0 to 48, with the lower scores indicating more sexual dysfunction.	Baseline, at week 6 and at week 12
Secondary	Change in Urinary Distress Inventory (UDI-6)	Urinary Distress Inventory (UDI-6) is a 6-item questionnaire used to assess lower urinary tract symptoms in women. Possible total scores range from 0 to 18, with the higher scores indicating more urogenital distress.	Baseline, at week 6 and at week 12