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Search / Trial NCT06019091

Optimal Frequency Used in Transcutaneous Electrical Nerve Stimulation (TENS) for Treating Pelvic Pain in Adults

Launched by ALBANY MEDICAL COLLEGE · Aug 24, 2023

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Chronic Pelvic Pain Chronic Primary Pelvic Pain Syndrome Posterior Tibial Nerve Stimulation Transcutaneous Electrical Nerve Stimulation Neuromodulation

ClinConnect Summary

This clinical trial is studying the best way to use a treatment called Transcutaneous Electrical Nerve Stimulation (TENS) to help people with chronic pelvic pain. TENS uses small electrical impulses delivered through the skin to relieve pain, but researchers want to find out which frequency, measured in Hertz (Hz), works best—specifically, 20Hz, 50Hz, or 100Hz. Participants will first go through a two-week period without TENS, where they will track their pain levels. After that, they will use the TENS unit for 30 minutes each day at their most painful time for two weeks. Participants can also choose to keep using TENS for up to three more months to see how well it works for them over time.

To join this trial, participants need to have been experiencing chronic pelvic pain for at least three months and should have tried other treatments that didn’t work. They must be able to consent to the study and complete the necessary steps. However, people with certain medical conditions, recent treatments, or who are pregnant cannot participate. Throughout the study, participants will fill out questionnaires to share their pain levels and how well the TENS treatment is working for them. This study aims to improve the care and treatment options available for individuals suffering from chronic pelvic pain.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Presenting with chronic pelvic pain (chronic/persistent pain that has been continuous or recurrent for at least three months (in accordance with EAU Guidelines).
  • 2. Unsuccessful initial interventions based on initial assessments
  • 3. Ability to provide informed consent and complete study requirements
  • 4. Ability to complete a comprehensive history (including with an interpreter)
  • Exclusion Criteria:
  • 1. Participants who have previously tried a new pharmacologic treatment for pelvic pain, neuromodulation or other alternative therapy for urologic disorders within the past 30 days
  • 2. Inability to work a TENS unit
  • 3. Any contraindications to usage of a TENS unit (pacemaker or other implantable device, lymphedema, pregnancy, malignancy, bleeding or clotting disorders, unhealthy tissue, seizure disorders, impaired cognition)
  • 4. Any history of electrophysiologic heart disease or complications
  • 5. Source of pain being an obvious anatomic issue requiring alternative treatment - for example urethral diverticulum, distal ureteric stone.
  • 6. Participant who is pregnant
  • 7. Participant with adhesive allergy either reported by the participant or upon chart review

About Albany Medical College

Albany Medical College is a leading academic institution dedicated to advancing medical education, research, and healthcare delivery. As a prominent sponsor of clinical trials, the college focuses on innovative research initiatives that aim to improve patient outcomes and enhance understanding of various medical conditions. With a commitment to scientific excellence and ethical standards, Albany Medical College collaborates with experienced researchers and healthcare professionals to conduct rigorous clinical studies that contribute to the advancement of medical knowledge and the development of new therapeutic interventions.

Locations

Albany, New York, United States

Patients applied

0 patients applied

Trial Officials

Elise De, MD

Principal Investigator

Urologist at Albany Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported