Postoperative Pain After Uterine Fibroid EmbolizationTUNESNCT07501676
Transmucosal Uterosacral Electrical Stimulation for Pelvic Pain Relief
A study testing TUNES (Transmucosal Uterosacral Electrical Stimulation) in people with Postoperative Pain After Uterine Fibroid Embolization and Uterine Fibroids (UF), run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This study will test whether gentle electrical stimulation to nerves near the uterus can reduce pelvic pain after uterine fibroid embolization. The investigators hypothesize that participants receiving active TUNES stimulation will experience lower pain levels and improved early recovery compared to those receiving… Read more about this study
- Who is it for?
- Ages 28 to 52 years, women only
- Conditions the study is for
- Postoperative Pain After Uterine Fibroid Embolization, Uterine Fibroids (UF), Uterine Fibroids
- What is being tested?
- TUNES (Transmucosal Uterosacral Electrical Stimulation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 30 Sep 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 52 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female, 28-52 years of age
- Scheduled to undergo uterine fibroid embolization (UFE) at Weill Cornell Medicine
- Able to provide informed consent
- Willing to comply with all study procedures and follow-up
- Fluent in English (for completion of study assessments)
Who cannot join
- Known or suspected pregnancy
- Active pelvic infection
- History of pelvic inflammatory disease within the past 6 months
- Implanted electrical device (e.g., pacemaker, neurostimulator)
- Current use of opioid pain medication prior to procedure
- History of chronic pelvic pain not related to fibroids
- Known allergy or sensitivity to medical-grade silicone
- Participation in another interventional study within 30 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Weill Cornell Medicine
New York, New York, 10022
Marc Schiffman, M.D., 646-962-9185, mas9252@med.cornell.edu
Maurice Hurd, M.A., mah4011@med.cornell.edu
About this study
This study will test whether gentle electrical stimulation to nerves near the uterus can reduce pelvic pain after uterine fibroid embolization. The investigators hypothesize that participants receiving active TUNES stimulation will experience lower pain levels and improved early recovery compared to those receiving sham stimulation or standard care.
Read the detailed description
Pelvic pain after uterine fibroid embolization (UFE) is common and can slow recovery and increase the need for pain medication. There is growing interest in non-pharmacologic options that may help manage this discomfort. The TUNES device delivers gentle electrical stimulation through a vaginally placed disc, targeting sensory nerves involved in pelvic pain pathways. The components and stimulation levels fall within established safety parameters for similar FDA-cleared technologies.
In this pilot study, participants will use the device for a short period after UFE under clinician supervision. The study will assess the feasibility, tolerability, and safety of this approach and explore whether this type of targeted stimulation may support improved comfort during early recovery. Findings from this work may help guide future investigation of transvaginal electrical stimulation as a potential adjunct to post-procedural pain management.
- Conditions
- Postoperative Pain After Uterine Fibroid Embolization, Uterine Fibroids (UF), Uterine Fibroids, Pelvic Pain, Pain Management
- Being tested
- TUNES (Transmucosal Uterosacral Electrical Stimulation), Sham TUNES Device
- Keywords
- Transmucosal Uterosacral Electrical Stimulation, TUNES, Uterine Fibroid Embolization, UFE, Post-UFE Pain, Electrical Stimulation Therapy, Pelvic Pain Relief, Noninvasive Neuromodulation, Weill Cornell Medicine
- Medical subject headings
- Leiomyoma, Pelvic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TUNES (Transmucosal Uterosacral Electrical Stimulation)Device
Also called Transvaginal Electrical Stimulation, TUNES Device, TUNES System
The TUNES device delivers low-amplitude transvaginal electrical stimulation (0-10 mA, 80-120 Hz, 100-200 µs pulse width) through stainless steel electrodes embedded in a modified menstrual disc. The device targets sensory nerves near the uterosacral ligaments and Frankenhauser plexus involved in pelvic pain signaling. It is powered by an FDA-cleared portable TENS unit (TENS 7000®). The stimulation is administered in 20-minute sessions each hour for up to 12 hours following uterine fibroid embolization (UFE).
Sham TUNES DeviceDevice
A non-functioning version of the TUNES device that is identical in appearance, placement, and handling but delivers no electrical stimulation. It is used to maintain blinding and control for placebo effects.
| Study group | Role | What they receive |
|---|---|---|
| Active TUNES Device | Experimental | Participants will receive the active TUNES device, which delivers low-amplitude transvaginal electrical stimulation (0-10 mA, 80-120 Hz, 100-200 µs pulse width) using a modified menstrual disc with stainless-steel electrodes. Stimulation targets the uterosacral ligaments and associated nerve plexuses involved in pelvic pain. Sessions last 20 minutes each hour for up to 12 hours after uterine fibroid embolization (UFE). Receives: Device: TUNES (Transmucosal Uterosacral Electrical Stimulation) |
| Sham TUNES Device | Sham comparator | Participants will receive an identical TUNES device that appears and feels the same as the active version but delivers no electrical current. The device will be placed for the same duration and under the same conditions as the active arm to maintain blinding and control for placebo effects. Receives: Device: Sham TUNES Device |
| Standard Care Control | No intervention | Participants will receive standard post-procedure care following uterine fibroid embolization, including access to patient-controlled analgesia (PCA) and non-opioid pain medications as clinically indicated. No TUNES device will be used in this arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of patient-controlled analgesia (PCA) activations within 12 hours after uterine fibroid embolization
The mean number of patient-controlled analgesia (PCA) pump activations (button presses) within the first 12 hours after uterine fibroid embolization will be recorded. This measure reflects the frequency of patient-initiated pain medication use and serves as a quantitative indicator of post-procedural pain intensity. The mean number of activations will be compared across the active TUNES, sham TUNES, and control arms.
Measured: Up to 12 hours post-UFE
Secondary outcomes (2)
Mean stimulation intensity over time during TUNES therapy
For participants in the active and sham TUNES arms, the average stimulation intensity (measured in mA) will be recorded hourly during the 0-12 hour period following UFE. This measure assesses tolerance, comfort, and consistency of device use throughout this post-UFE window.
Measured: 0 to 12 hours post-UFE
Mean visual analog scale (VAS) pain score within 23 hours after uterine fibroid embolization
Pain intensity will be measured using a standard 0-10 visual analog scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable. VAS scores will be collected periodically during the first 23 hours post-UFE. The mean VAS score will be compared across the active TUNES, sham TUNES, and control arms to evaluate potential differences in perceived pain.
Measured: Up to 23 hours post-UFE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain After Uterine Fibroid EmbolizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Schiffman, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501676
- Sponsor's protocol ID
- 25-10029448
- Acronym
- TUNES
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Renner RM, Nichols MD, Jensen JT, Li H, Edelman AB. Paracervical block for pain control in first-trimester surgical abortion: a randomized controlled trial. Obstet Gynecol. 2012 May;119(5):1030-7. doi: 10.1097/AOG.0b013e318250b13e.
PubMed 22525915Radtke S, Boren T, Depasquale S. Paracervical Block as a Strategy to Reduce Postoperative Pain after Laparoscopic Hysterectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2019 Sep-Oct;26(6):1164-1168. doi: 10.1016/j.jmig.2018.12.001. Epub 2018 Dec 6.
PubMed 30528725de Bernardes NO, Marques A, Ganunny C, Bahamondes L. Use of intravaginal electrical stimulation for the treatment of chronic pelvic pain: a randomized, double-blind, crossover clinical trial. J Reprod Med. 2010 Jan-Feb;55(1-2):19-24.
PubMed 20337203de Oliveira Bernardes N, Bahamondes L. Intravaginal electrical stimulation for the treatment of chronic pelvic pain. J Reprod Med. 2005 Apr;50(4):267-72.
PubMed 15916211Fuentes-Marquez P, Cabrera-Martos I, Valenza MC. Physiotherapy interventions for patients with chronic pelvic pain: A systematic review of the literature. Physiother Theory Pract. 2019 Dec;35(12):1131-1138. doi: 10.1080/09593985.2018.1472687. Epub 2018 May 14.
PubMed 29757068Mendes CF, Oliveira LS, Garcez PA, Azevedo-Santos IF, DeSantana JM. Effect of different electric stimulation modalities on pain and functionality of patients with pelvic pain: Systematic review with META-analysis. Pain Pract. 2024 Oct 14. doi: 10.1111/papr.13417. Online ahead of print.
PubMed 39400976Goodwin SC, Bradley LD, Lipman JC, Stewart EA, Nosher JL, Sterling KM, Barth MH, Siskin GP, Shlansky-Goldberg RD; UAE versus Myomectomy Study Group. Uterine artery embolization versus myomectomy: a multicenter comparative study. Fertil Steril. 2006 Jan;85(1):14-21. doi: 10.1016/j.fertnstert.2005.05.074.
PubMed 16412720Pron G, Mocarski E, Bennett J, Vilos G, Common A, Zaidi M, Sniderman K, Asch M, Kozak R, Simons M, Tran C, Kachura J; Ontario UFE Collaborative Group. Tolerance, hospital stay, and recovery after uterine artery embolization for fibroids: the Ontario Uterine Fibroid Embolization Trial. J Vasc Interv Radiol. 2003 Oct;14(10):1243-50. doi: 10.1097/01.rvi.0000092664.72261.f9.
PubMed 14551270