Trial of Tibial Nerve Stimulation for Treating Sexual Dysfunction

NCT04122703 | Completed FDA Device

• 1 other identifier: 1370654
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Sexual Dysfunction

Keywords

Percutaneous Tibial Nerve Stimulation; Female Sexual Dysfunction; Sexual dysfunction; peripheral neuromodulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Arizona Sexual Experiences Scale (ASEX)

  Baseline, at week 6 and at week 12

• Change in Prolapse/Urinary Incontinence Sexual-12 (PISQ-12 ) Function Questionnaire (PISQ- 12)

  Baseline, at week 6 and at week 12

• Change in Urinary Distress Inventory (UDI-6)

  Baseline, at week 6 and at week 12

Study Arms (2)

Percutaneous tibial nerve stimulation (PTNS)

EXPERIMENTAL

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

Device: percutaneous tibial nerve stimulation (PTNS)

Transcutaneous electrical nerve stimulation (TENS)

SHAM COMPARATOR

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

Device: Sham procedure

Interventions

percutaneous tibial nerve stimulation (PTNS) DEVICE

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.

Percutaneous tibial nerve stimulation (PTNS)

Sham procedure DEVICE

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

Transcutaneous electrical nerve stimulation (TENS)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook Medicine Women's Pelvic Health And Continence Center

Stony Brook, New York, 11733, United States

Location

Related 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.

  PMID: 20171677 BACKGROUND

• 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.

  PMID: 30247794 BACKGROUND

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Jason Kim, MD

  Stony Brook Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor of Urology

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

Study Record Dates

• First Submitted: October 6, 2019
• First Posted: October 10, 2019
• Study Start: September 15, 2019
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)