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Trial of Tibial Nerve Stimulation for Treating Sexual Dysfunction

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ClinicalTrials.gov Identifier: NCT04122703
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Jason Kim, Stony Brook University

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : September 15, 2019
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

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




Primary Outcome Measures :
  1. Change in Female Sexual Function Index (FSFI) [ Time Frame: 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 :
  1. Change in Arizona Sexual Experiences Scale (ASEX) [ Time Frame: 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.

  2. Change in Prolapse/Urinary Incontinence Sexual-12 (PISQ-12 ) Function Questionnaire (PISQ- 12) [ Time Frame: 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.

  3. Change in Urinary Distress Inventory (UDI-6) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122703


Contacts
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Contact: Sina Mehraban Far, BSc (631) 444-1919 Sina.mehrabanfar@stonybrookmedicine.edu

Locations
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United States, New York
Stony Brook Medicine Women's Pelvic Health And Continence Center Recruiting
Stony Brook, New York, United States, 11733
Contact: Sina Mehraban Far, B.Sc.       sina.mehrabanfar@stonybrookmedicine.edu   
Principal Investigator: Jason Kim, M.D.         
Sub-Investigator: Sina Mehraban Far, B.Sc.         
Sponsors and Collaborators
Stony Brook University
Investigators
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Principal Investigator: Jason Kim, MD Stony Brook Medicine

Publications:
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Responsible Party: Jason Kim, Clinical Assistant Professor of Urology, Stony Brook University
ClinicalTrials.gov Identifier: NCT04122703     History of Changes
Other Study ID Numbers: 1370654
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Jason Kim, Stony Brook University:
Percutaneous Tibial Nerve Stimulation
Female Sexual Dysfunction
Sexual dysfunction
peripheral neuromodulation