Trial of Tibial Nerve Stimulation for Treating Sexual Dysfunction

Sponsor

Stony Brook University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04122703

Collaborator

(none)

Enrollment

Location

Arms

42.5

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Female Sexual Dysfunction	Device: percutaneous tibial nerve stimulation (PTNS) Device: Sham procedure	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

We will be recruiting 66 patients, who will be randomized (1:1) to either the PTNS group or the Sham group.We will be recruiting 66 patients, who will be randomized (1:1) to either the PTNS group or the Sham group.

Masking:

Double (Participant, Care Provider)

Masking Description:

Patients in both PTNS and Sham groups will come to the clinic once a week for 30 sessions, and will not know their group assignment until the end of the study. All the interventions will be performed by the sub-investigator. The care providing physician will not know the group assignment of the patients.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 15, 2019

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Percutaneous tibial nerve stimulation (PTNS) The patients in the PTNS group will receive 1 PTNS treatments per week for 12 weeks.	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 Comparator: Transcutaneous electrical nerve stimulation (TENS) The patients in the Sham group will receive one sham (TENS) treatment per week for 12 weeks	Device: 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

Arm

Intervention/Treatment

Experimental: Percutaneous tibial nerve stimulation (PTNS)

The patients in the PTNS group will receive 1 PTNS treatments per week for 12 weeks.

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 Comparator: Transcutaneous electrical nerve stimulation (TENS)

The patients in the Sham group will receive one sham (TENS) treatment per week for 12 weeks

Device: 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

Outcome Measures

Primary Outcome Measures

Change in Female Sexual Function Index (FSFI) [Baseline, at week 6 and at week 12]
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

Secondary Outcome Measures

Change in Arizona Sexual Experiences Scale (ASEX) [Baseline, at week 6 and at week 12]
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.
Change in Prolapse/Urinary Incontinence Sexual-12 (PISQ-12 ) Function Questionnaire (PISQ- 12) [Baseline, at week 6 and at week 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.
Change in Urinary Distress Inventory (UDI-6) [Baseline, at week 6 and at week 12]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stony Brook Medicine Women's Pelvic Health And Continence Center	Stony Brook	New York	United States	11733

Sponsors and Collaborators

Stony Brook University

Investigators

Principal Investigator: Jason Kim, MD, Stony Brook Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Jason Kim, Clinical Assistant Professor of Urology, Stony Brook University

ClinicalTrials.gov Identifier:

NCT04122703

Other Study ID Numbers:

1370654

First Posted:

Oct 10, 2019

Last Update Posted:

Oct 10, 2019

Last Verified:

Oct 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Jason Kim, Clinical Assistant Professor of Urology, Stony Brook University

Percutaneous Tibial Nerve Stimulation

Female Sexual Dysfunction

Sexual dysfunction

peripheral neuromodulation

Study Results

No Results Posted as of Oct 10, 2019