← Back to Search

Behavioural Intervention

percutaneous tibial nerve stimulation (PTNS) for Female Sexual Dysfunction

N/A

Waitlist Available

Led By Jason Kim, MD

Research Sponsored by Stony Brook University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, at week 6 and at week 12

Awards & highlights

Study Summary

This trial will test whether PTNS is an effective treatment for female sexual dysfunction syndrome, compared to a placebo.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, at week 6 and at week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, at week 6 and at week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, at week 6 and at week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Female Sexual Function Index (FSFI)

Secondary outcome measures

Change in Arizona Sexual Experiences Scale (ASEX)

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

Change in Urinary Distress Inventory (UDI-6)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Percutaneous tibial nerve stimulation (PTNS)Experimental Treatment1 Intervention

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

Group II: Transcutaneous electrical nerve stimulation (TENS)Placebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

percutaneous tibial nerve stimulation (PTNS)

2019

N/A

~70

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Stony Brook UniversityLead Sponsor

215 Previous Clinical Trials

39,861 Total Patients Enrolled

Jason Kim, MDPrincipal Investigator - Stony Brook Medicine

Stony Brook University Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are being recruited to take part in this trial?

"This hypothesis-driven experiment is actively recruiting, as indicated on clinicaltrials.gov. It was initially posted in September of 2019 and last modified in October of the same year. The trial aims to get 66 enrollees from a single site."

Answered by AI

Is enrollment still possible for this research endeavor?

"Data from clinicaltrials.gov confirms that this medical study continues to seek participants, with its initial posting on September 15th 2019 and most recent modifications made October 8th of the same year."

Answered by AI

Recent research and studies

Journal of UrologyJournal

Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus Sham Efficacy in the Treatment of Overactive Bladder Syndrome: Results from the Sumit Trial

Peters, Kenneth M., Donna J. Carrico, Ramon A. Perez-Marrero, Ansar U. Khan, Leslie S. Wooldridge, Gregory L. Davis, and Scott A. MacDiarmid. 2010. “Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus Sham Efficacy in the Treatment of Overactive Bladder Syndrome: Results from the Sumit Trial”. Journal of Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.juro.2009.12.036.

Neuromodulation: Technology at the Neural InterfaceJournal

Transcutaneous Electrical Nerve Stimulation to Improve Female Sexual Dysfunction Symptoms: A Pilot Study

Zimmerman, Lauren L., Priyanka Gupta, Florence O’Gara, Nicholas B. Langhals, Mitchell B. Berger, and Tim M. Bruns. 2018. “Transcutaneous Electrical Nerve Stimulation to Improve Female Sexual Dysfunction Symptoms: A Pilot Study”. Neuromodulation: Technology at the Neural Interface. Elsevier BV. doi:10.1111/ner.12846.

clinicaltrials.govStudy

Trial of Tibial Nerve Stimulation for Treating Sexual Dysfunction

Jason Kim 2019. "Trial of Tibial Nerve Stimulation for Treating Sexual Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04122703.