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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TUNES (Transmucosal Uterosacral Electrical Stimulation) | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 hours post-UFE |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0 to 12 hours post-UFE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maurice Hurd, M.A. | Contact | 646-962-8690 | mah4011@med.cornell.edu | |
| Marc Schiffman, M.D. | Contact | 646-962-9185 | mas9252@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Marc Schiffman | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10022 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22525915 | Background | 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. | |
| 30528725 | Background | Radtke 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. |
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Participants and investigators are blinded to treatment allocation. Only the unblinded device technician will know whether the device is active or inactive.
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| Sham TUNES Device | Device | 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. |
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| 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. | Up to 23 hours post-UFE |
| 20337203 | Background | de 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. |
| 15916211 | Background | de Oliveira Bernardes N, Bahamondes L. Intravaginal electrical stimulation for the treatment of chronic pelvic pain. J Reprod Med. 2005 Apr;50(4):267-72. |
| 29757068 | Background | Fuentes-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. |
| 39400976 | Background | Mendes 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. |
| 16412720 | Background | Goodwin 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. |
| 14551270 | Background | Pron 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. |
| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D017699 | Pelvic Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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