Clinical trial · Interventional
Transmucosal Uterosacral Electrical Stimulation for Pelvic Pain Relief
NCT07501676CI-TRIAL-00106689TUNESnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pain Management | — | UNRESOLVED | — |
| Pelvic Pain | — | UNRESOLVED | — |
| Postoperative Pain After Uterine Fibroid Embolization | — | UNRESOLVED | — |
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
| Uterine Fibroids (UF) | Uterine Corpus Leiomyoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sham TUNES Device | Device | — | UNRESOLVED |
| TUNES (Transmucosal Uterosacral Electrical Stimulation) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Active TUNES Device
- description
- 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).
- interventionNames
- Device: TUNES (Transmucosal Uterosacral Electrical Stimulation)
- type
- SHAM_COMPARATOR
- label
- Sham TUNES Device
- description
- 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.
- interventionNames
- Device: Sham TUNES Device
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 28 Years
- Maximum age
- 52 Years
Show eligibility criteria text
Inclusion Criteria: * 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) Exclusion Criteria: * 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
References
Publications (8)
- BACKGROUNDRenner 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. PMID 22525915
- BACKGROUNDRadtke 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. PMID 30528725
- BACKGROUNDde 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. PMID 20337203
- BACKGROUNDde Oliveira Bernardes N, Bahamondes L. Intravaginal electrical stimulation for the treatment of chronic pelvic pain. J Reprod Med. 2005 Apr;50(4):267-72. PMID 15916211
- BACKGROUNDFuentes-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. PMID 29757068
- BACKGROUNDMendes 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. PMID 39400976
- BACKGROUNDGoodwin 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.