# paper.pdf ## Metadata - PDFFormatVersion=1.4 - Language=en-US - IsLinearized=false - IsAcroFormPresent=false - IsXFAPresent=false - IsCollectionPresent=false - IsSignaturesPresent=false - Creator=Arbortext Advanced Print Publisher 9.1.510/W Unicode - ModDate=D:20260618062153+05'30' - Producer=Acrobat Distiller 7.0 (Windows) - CreationDate=D:20260618061836+05'30' - xap:createdate=1900-01-00T00:00:303139248+05:30 - xap:creatortool=PTC Arbortext Layout Developer 12.3.6865/W-x64 - xap:metadatadate=1900-01-00T00:00:303139248+05:30 - xap:modifydate=1900-01-00T00:00:303139248+05:30 - pdfuaid:part=1 - dc:format=application/pdf - dc:title=JU-25-1629_Three-Year Efficacy and Safety of Revi Implantable Tibial Neuromodulation from the Pivotal OASIS Study - pdfaextension:schemas=PDF/UA Universal Accessibility Schemahttp://www.aiim.org/pdfua/ns/id/pdfuaidpartIntegerinternalIndicates, which part of ISO 14289 standard is followed ## Contents ### Page 1 ![Figure]() Urolithiasis/Endourology JU Insight ![Figure]() # Three-Year Efficacy and Safety of Revi Implantable TibialNeuromodulation from the Pivotal OASIS Study Cindy L. Amundsen, Suzette E. Sutherland, John P. F. A. Heesakkers, et al. Correspondence: Cindy L. Amundsen (). Full-length article available at. Study Need and Importance: Ongoing therapy is necessary for the treatment of overactive bladdersymptoms; therefore, data on long-term outcomes ofthe implantable tibial neuromodulation using theRevi System are essential when deciding on treatment options. This manuscript presents 3-year results of an implantable tibial neuromodulationsystem that is activated through an external wearable device for the treatment of urgency urinaryincontinence, highlighting its long-term efficacy,safety, tolerability, and compliance. What We Found: In total, 86% (121/140) of participants consented to extended follow-up, and 76% (90/119) had primary outcome data available at 36months. Consistent and durable therapeutic benefitswere demonstrated through 3 years (). Seventynine percent (71/90) had a therapeutic response (50% reduction in urgency urinary incontinence episodes), and 63% (57/90) had a 75% reduction inurgency urinary incontinence at 36 months. Moreover,28% (25/90) of patients were dry for 3 consecutive dayson a 3-day voiding diary. Therapy compliance washigh, with > 75% of patients reporting at least onedaily stimulation session through 36 months. Satisfaction was high (82%), and 98% were willing tocontinue therapy. Furthermore, an excellent safetyprofile continued through 3 years, with no device orprocedure-related serious events. Device-relatedadverse events remained low (< 10%) throughoutthe 36-month study with a 3% explant rate and nosurgical revisions. THE JOURNAL OF UROLOGY® Ó 2026 The Author(s). Published on behalf of the American Urological Association, Education and Research, Inc. ![Figure]() Limitations: The study was neither randomized norblinded, as participants could perceive stimulation.In addition, the long-term follow-up component ofthe study was implemented after some participantshad already exited the study, contributing to loss tofollow-up. Interpretation for Patient Care: The results demonstrate similar efficacy outcomes at 3 years topublished neuromodulation studies, with theadvantage of minimal implanted hardware, thecapability of intraoperative testing to ensure properplacement and stimulation response, and stimulation programming capabilities to enhance individualized efficacy over time. https://doi.org/10.1097/JU.0000000000005085Vol. 216, 219-229, August 2026Printed in U.S.A. j 219 ### Page 2 ![Figure]() ![Figure]() # Three-Year Efficacy and Safety of Revi Implantable TibialNeuromodulation from the Pivotal OASIS Study Cindy L. Amundsen,1 Suzette E. Sutherland,2 John P. F. A. Heesakkers,3 Philip Toozs-Hobson,4Frank Martens,5 Rebecca J. McCrery,6 Kevin Benson,7 Kevin J. Cline,8 Peter R. Rodine,9 and Roger R. Dmochowski9 - 1Department of Obstetrics and Gynecology, Division of Urogynecology and Reconstructive Pelvic Surgery, Duke University, Durham, North Carolina - 2Pelvic Health Center, Arizona Urology Specialists, Scottsdale, Arizona - 3Department of Urology, Maastricht UMC, Maastricht, the Netherlands - 4Birmingham Women’s and Children’s NHS Foundation Trust, Birmingham, United Kingdom - 5Department of Urology, Radboud University Medical Center, Nijmegen, The Netherlands - 6Adult Pediatric Urology and Urogynecology, Ohama, Nebraska - 7Department of Obstetrics and Gynecology, FPMRS Division, Sanford Health, University of South Dakota School of Medicine, Sioux Falls, South Dakota - 8Louisiana State University Medical Center, Shreveport, Louisiana - 9BlueWind Medical Inc., Salt Lake City, Utah Purpose: Revi is a novel implantable tibial neuromodulation system powered byan external, battery-operated wearable that facilitates individually tailoredstimulation to provide treatment for urgency urinary incontinence. The ReviSystem (manufactured by BlueWind Medical) is the first FDA-cleared implantable neuromodulation device that can be used in traditionally nonrefractorypatients. Three-year follow-up results from the pivotal FDA-approval trial, theOASIS Study, are presented. Materials and Methods: The Revi System was implanted in 151 women. Theprimary efficacy and safety end points were assessed at 6 and 12 months,respectively; thereafter, participants were consented to extend follow-up to 3years for assessments of long-term treatment durability and safety. Submitted September 25, 2025; accepted April 7, 2026; published April 13, 2026. Funding/Support: The OASIS Study was funded by BlueWind Medical. Conflict of Interest Disclosures: The following authors are/have been independent consultants paid by BlueWind Medical: Cindy L.Amundsen, Suzette E. Sutherland, and John P. F. A. Heesakkers. The authors declare that these relationships have not influenced the design,conduct, or reporting of the study. The remaining authors declare no conflicts of interest. Ethics Statement: This study received Institutional Review Board/Ethics Committee approval at all enrolling institutions. Data Availability: The data that support the findings of this study are available from BlueWind Medical, but restrictions apply to theavailability of these data, which were used under license for the current study, and so are not publicly available. Data are however available fromthe authors upon reasonable request and with permission of BlueWind Medical. Author Contributions: Conception and design: Heesakkers, Dmochowski. Critical revision of the manuscript for scientific and factual content: Amundsen, Sutherland, Heesakkers, Martens, McCrery, Rodine, Dmochowski, Philip Toozs-Hobson, Kevin Benson, Kevin J. Cline. Data acquisition: Amundsen, Sutherland, Heesakkers, Martens, McCrery, Dmochowski, Philip Toozs-Hobson, Kevin Benson, Kevin J. Cline.Data analysis and interpretation: Heesakkers, Rodine, Dmochowski. Drafting the manuscript: Rodine, Dmochowski. Statistical analysis: Dmochowski. Supervision: Amundsen, Sutherland, Heesakkers, Martens, McCrery, Rodine, Dmochowski, Philip Toozs-Hobson, Kevin Benson, Kevin J. Cline.Study Registration: This clinical trial has been registered with ClinicalTrials.gov under the identifier: NCT03596671. Investigational deviceexemption (IDE) #G20013. This is an open access article distributed under the terms of the, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any wayor used commercially without permission from the journal. Corresponding Author: Cindy L. Amundsen, MD, Department of Obstetrics and Gynecology, Urogynecology and Pelvic Reconstructive Surgery,Duke University, 5324 McFarland Drive, Suite 310, Durham, NC 27707 (). THE JOURNAL OF UROLOGY® Ó 2026 The Author(s). Published on behalf of the American Urological Association, Education and Research, Inc. Vol. 216, 219-229, August 2026Printed in U.S.A. ### Page 3 Results: Ninety-three percent (140/151) completed the 12-month study, and 85% (119/140) met screeningcriteria and consented to the 36-month extension study. Ninety participants (76%, 90/119) completed the 36month assessment, and 79% (71/90) were therapy responders (50% reduction in urgency urinary incontinence episodes, demonstrated on a 3-day voiding diary). Sustained therapeutic responses were reported, withdurable effectiveness between 6 and 36 months (response rates of 78% and 79%, respectively). Notably, 95%(83/87) reported therapeutic satisfaction, and 82% (74/90) reported feeling “much better” or “very muchbetter” based on the Patient Global Impression of Improvement scale. No device-related or procedure-relatedserious adverse events were reported through 36 months. Conclusions: In women with urgency urinary incontinence, Revidan implantable tibial neuromodulationsystem powered by a patient-controlled, external wearable ankle devicedshowed meaningful and durableefficacy, high patient satisfaction, and an excellent safety profile through 3 years. Key Words: clinical trials, tibial nerve, implantable neurostimulators, urinary incontinence, urge, urinarybladder, overactive, lower urinary tract symptoms URGENCY urinary incontinence (UUI) is both common and significantly bothersome, affecting thequality of life of millions worldwide.1 Treatmentoptions for UUI were once limited, but recent advancements have led to innovative options to addressthis onerous condition.2 Neuromodulation in particular has advanced from an involved, invasive surgicaloption of last-resort to a simple, minimally invasiveprocedure requiring only local anesthesia.3 Traditional sacral nerve stimulation therapieswere often associated with high rates of surgicalreintervention due to decreased efficacy over timefrom possible lead migration or breakage andimplantable pulse generator replacements due topain, infection, or battery depletion.3-5 Advances intechnology have led to fewer revisions, but these potential issues remain.3 Percutaneous tibial nervestimulation has been shown to be efficacious for mildto moderate overactive bladder (OAB) but with limitations of frequent office visits (weekly-to-monthly) toachieve and maintain clinical response.6 Implantabletibial neuromodulation, with an external batteryoperated power source, has the potential to provide long-term symptom control with convenientat-home therapy and few side effects or future needfor revisions. The Revi System is a minimally invasive implantable tibial neuromodulation system for the management of UUI with sophisticated stimulationprogramming capabilities (). This manuscript presents 3-year efficacy, safety, and tolerability of the Revi System for the treatment of UUI. ## MATERIALS AND METHODS ### Study Overview The OASIS Study is a prospective, multicenter, singlearm, open-label pivotal clinical study evaluating the effi-cacy and safety of the Revi System in women with UUI.All participating centers obtained ethics committeeapproval, and all study participants provided informedconsent (centers listed in Supplemental Table ST1,). Inclusion criteria required 9UUI episodes on a 7-day bladder diary and inadequateresponses to prior conservative treatments (key selectioncriteria are presented in Supplemental Table ST2,). Subjects on OAB or psychiatric medications were on a stable dose for at least 3 months beforebaseline and agreed to remain on that dose during thestudy. In an operating room, the Revi implant was placedsubfascially, in the medial ankle, through a small incision(w5 cm), and abutting the posterior tibial neurovascularbundle. Intraoperative testing confirmed proper placement ![Figure]() ### Page 4 (stimulation intensity is increased until the patient reportsparesthesia in the heel, sole of the foot or toe area) beforesecuring the lead to the crural fascia.7 Treatments wereinitiated w4 weeks postimplant after adequate surgicalhealing. Participants were assessed at 12 months aftertreatment activation for the primary safety end point.Participants then either consented to extend their followup or exit the study (see visit schedule, SupplementalFigure SF1,). Baseline, 6 and 12month diaries were 7 days, while all other diariesthroughout the 36 months were 3 days. Quality of life(QOL) and patient satisfaction questionnaires werecollected at 6, 12, 24, and 36 months. Adverse events were prospectively documented, andrelatedness was adjudicated by an independent ClinicalEvents Committee. An independent Data Safety Monitoring Board evaluated safety, study conduct, scientificvalidity, and data integrity of the study through 36months. ### Extended Study Follow-up The study extension allowed for longer-term efficacy andsafety data to be collected. Some participants had alreadyexited the study after their 12-month visit, before ethicsboard approval of the extended study was finalized. Attempts were made to recontact these participants andthey were re-enrolled if they successfully passed therescreening process. Participants then proceeded to thenext applicable study follow-up visit based on the timesince initiating treatment. All participants had maintained therapy before consenting to the extended study.During implementation of the extended study, participants who were followed for less than 12 months weregiven the option of continuing or exiting the study at 12months. Participants had phone assessments at 18 and 30months postactivation. Participants reported any changesto their treatment regimen, and outcome measures wereobtained. In-person visits were conducted if clinicallywarranted (ie, treatment parameter adjustment, assessadverse events/device malfunction). ### Stimulation Therapy Application Participants were to perform stimulation treatments athome for 30 minutes, twice a day ( 2 h/d) for the initial12 months. Participants in the extended study completedstimulation treatments per physician and patient discretion, but not fewer than two 30-minute treatment sessionsper week. A predefined algorithm for stimulation parameters was followed to customize treatment settings basedon participant sensation and response. Participants wereprovided multiple treatment program options. ### End Points and Statistical Testing The study end points and statistical methods have beenpreviously described (primary and secondary end pointsare listed in Supplemental Table ST3,). Therapy response was defined as a 50%reduction in UUI episodes compared with baseline.Formal hypothesis testing was conducted for the 6-monthprimary efficacy end point. A two-sided, 95% Clopper–Pearson confidence interval was constructed where thenull was rejected if the lower bound of this confidence interval was > 50%. This per-protocol analysis includedonly those subjects with an observed primary end point,and secondary end point analyses only included subjectswith an observed value on that end point. All primary andsecondary efficacy measures are summarized usingdescriptive statisticsdmean, median, SD, and 95% confi-dence intervals for continuous measures, and frequencydistributions for categorical or binary data. At 36 months, frequency of UUI (based on a 3-dayvoiding diary), incidence of device-related or procedurerelated adverse events, and QOL and patient satisfaction measures were assessed. Analyses were conductedusing SAS (SAS Analytics, Cary, NC). ## RESULTS ### Study Population and Follow-Up One hundred fifty-one participants were implantedout of the 282 patients who consented to be screenedfor participation in the initial OASIS Trial. Baselinedemographics and characteristics were previously reported7 and are briefly summarized in SupplementalTable ST4 (). Eleven participants withdrew from the study after implantation,with 140 participants (93%) completing the 12-monthvisit. As shown in, 86% (121/140) of participants consented to extended follow-up; 2 participants failed rescreening. Twenty-seven participantsprematurely discontinued the extended study; diarydata were available for analysis in 76% (90/119) ofparticipants at 36 months. Reasons for prematurediscontinuation are presented in. Therapy compliance data revealed that > 75% ofpatients reported at least one daily stimulationsession through 36 months (). The results ofusing a predefined algorithm for stimulation parameters have been presented.8 Additional analysesof outcomes based on stimulation parameters andtreatment frequencies will be published separately. ### Durable Reduction in UUI Episodes and Other OABSymptoms Therapy response was achieved in 79% (71/90) at36 months, while 63% (57/90) had a 75% reduction in UUI. Moreover, 28% (25/90) of patientswere dry for 3 consecutive days on a 3-day voidingdiary. Therapeutic response was durable over time(, Supplemental Table ST5,). Significant and sustained reductions in both UUIepisodes and large urgency-related leaks were reported through 36 months (). Participantsreported an average of 1.2 UUI leaks/day at 36months compared with 4.8/d before treatment, andsignificant reductions in large leaks. Nocturia episodes decreased from 1.28/d to 0.88/d, again withdurable benefits demonstrated through 36 months. ### Page 5 ![Figure]() ![Figure]() ![Figure]() ![Figure]() ![Figure]() Participants also reported experiencing an improvement in micturition frequency and urgency episodeswith 50% reduction in number of moderate-severeurgency episodes (patient’s perception of intensityof urgency scale degree 3, 4, or normalization of number of voids) and a response rate of 71.1% (64/90) 36 months postactivation. These results arefurther supported by the reduction in total numberof voids/day, from an average of 10.0 at baseline to8.1 at 36 months. ### Page 6 Daily treatment 12 Months(N [ 139) 24 Months(N [ 97) 36 Months(N [ 90) Frequency n (%) n (%) n (%) 0/ “not done” 72 (5.7) 0 (0) 0 (0) | < 1/patient | 2 (1.4)a | 1 (1.0)b | 21 | (23)c | | - | - | - | - | - | | choice | | 1 15 | (11) | 19 | (20) | 21 | (23) | | 2 94 | (68) | 68 | (70) | 41 | (46) | | 3 15 | (11) | 5 (5.2) | 7 (7.8) | | 4 6 (4.3) | 4 (4.1) | 0 (0) | 1 daily treatments 130 (93) 97 (100) 69 (77)Duration (minutes) n (%) n (%) n (%) | < 30/not | reported | 16 (12) | 7 (7.2) | 25 (28)d | | - | - | - | - | - | | 30 | 6 (4.3) | 6 (6.2) | 12 | (13) | | 60 | 93 | (67) | 62 | (64) | 44 | (49) | | 90-120 | 24 | (17) | 22 | (23) | 9 (10) | | 30 minutes daily | 123 | (88) | 90 | (93) | 65 | (72) | a Every other day (1), At least 2 per week (1). b Frequency unreported, 60 mind120 min daily. c 21/21 reported 1 daily treatment at 24-mo follow-up.d 24/25 reported 30 min daily at 24-mo follow-up. At least one postactivation follow-up visit wascompleted by 149 of the 151 implanted participants,with 91% of the participants (136/149) being therapyresponders. A larger proportion (> 95%) of participants reported overall treatment satisfaction andbenefit. Significantly, of the 13 participants whowere not therapy responders at any of the follow-upvisits through 36 months, 46% (6/13) of these participants subjectively reported experiencing meaningful treatment benefit and 62% (8/13) of theseparticipants reported an ongoing desire to continuetreatments (based on the BSW at the 6-month followup visit). ### Reported Improvements in Quality of Life The BSW (Benefit Satisfaction and Willingness toContinue) and PGI-I (Patient Global Impression ofImprovement) questionnaires were used to assessQoL. Of the participants completing the questionnaires, 95% (83/87) were satisfied with the therapyat 36 months with 82% (74/90) reporting feeling“much better” to “very much better.” Most participants who continued through 36 months (98%; 85/87) reported willingness to continue treatment.Clinically meaningful improvements (minimalimportant difference; MID, improvement > 10points) in all domains of the Overactive BladderQuestionnaire (OAB-q)9 were also seen (). ### Representative Results While some participants elected to discontinueparticipation in the extended study, 90 completedthe 36-month assessment; similar parameters andoutcomes were noted when compared with thecohort assessed at 6 months (n [ 144;) interms of patient demographics (age: 59.4 vs 59.0),baseline OAB parameters (UUI/day: 4.8 vs 4.8;voids/day: 9.9 vs 10.1), and treatment responserates at 6 months (79% vs 78%). In addition, owing to potential selection biasintroduced by adding the extended study after participants had already completed the 12-month visit,a last observation carried forward analysis fortherapy response was conducted. This analysisalso showed that 69.5% were treatment responders(Supplemental Table ST6,), confirming positive treatment responses frommost participants regardless of their decision tocontinue with the extended study. ![Figure]() ### Page 7 Urgency-related leaks/day Change (reduction) from baseline Baseline 6 Months 12 Months 24 Months 36 Months | N | 151 4.8 (2.9) 4.0 1.0, 17.7 2.9 3.8< 0.001 | 144 | 139 | 97 3.2 (2.5) 2.9 1.6, 14.7 3.0 4.2< 0.001 | 90 | | - | - | - | - | - | - | | Mean(SD) | 3.4 (2.6) 2.7 | 3.5 (2.8) 2.9 | 3.6 (3.0) 2.9 | | MedianMin, max | 0.2, 16.6 3.1 | 1.9, 17.0 2.7 | 1.6, 17.7 | | Lower | CI | 95% | | Upper | CI | 95% | 4.0 | 3.7 | | P-valuea | < 0.001 | < 0.001 | Large leaks/Day Change (reduction) from baseline Baseline 6 Months 12 Months 24 Months 36 Months | N | 151 | 144 | 139 | 97 0.7 (1.4) 0.3 1.2, 9.9 0.4 1.1< 0.001 | 90 | | - | - | - | - | - | - | | Mean(SD)MedianMin, max | 0.9 (1.7) 0.3 | 0.8 (1.5) 0.3 | 0.7 (1.5) 0.2 | 0.7 (1.6) 0.2 | | 0, 9.9 | 1.6, 9.5 0.5 | 0.4, 9.9 0.4 | 0.8, 9.9 | | Lower | CI | 95% | 0.5 | | Upper | CI | 95% | 1.0 | 1.0 | 1.0 | | P-valuea | < 0.001 | < 0.001 | < 0.001 | a Additional analysis - no formal hypothesis testing or type I error control. ### Safety A total of 543 adverse events were reported throughout36 months. There were 12 device-related adverse eventsin 11 participants (7.3%) and 19 surgical wound-related events occurred in 13 participants (8.6%); none wereserious. One procedure-related adverse event (infection)was reported between 12 and 24 months. Twoprocedure-related events were reported in 2 participants ![Figure]() ### Page 8 6 months (N [ 144) > 12 months (N [ 121) 36 months (N [ 54) 36 months (N [ 90) Parameter 10 end Point analysis Extended follow-up Discontinued Completed follow-up | Baseline UUIa | 4.8 | (3.0) | 4.7 | (2.9) | 4.7 | (3.0) | 4.8 | (2.9) | | - | - | - | - | - | - | - | - | - | | Baseline voids | 10.1 | (3.3) | 10.0 | (3.1) | 10.5 | (3.3) | 9.9 | (3.3) | | Baseline OABqb | 47.1 | (19.6) | 46.7 | (20) | 46.4 | (19.1) | 47.6 | (19.9) | | Age | 59.0 | (12.5) | 59.5 | (12) | 58.4 | (13.0) | 59.4 | (12.2) | | Responders at 6m | 78% | (112/144) | 74% | (90/121) | 67% (36/54) NA | 84% | (76/90) | | End point therapy responsec | 78% | (112/144) | 84% | (102/121)d | 79% | (71/90) | a Baseline Urgency Urinary Incontinence (UUI) [ Average Number of Urgency-related incontinence episodes at baseline. b OAB-q Health-related quality of life (HRQL) total transformed score. Note: Two participants were missing baseline OAB-q scores at baseline; available data has been reported.c Completers analysis. d Response at 12-mo follow-up. (1.3%) between 24 and 36 months (1 infection and 1granuloma); 7 device-related adverse events were reported in 6 participants (4.0%) between 24 and 36months (each involving pain/discomfort/burning sensations or an issue with stimulation). summarizesthe device adverse events throughout the study. Through 36 months, 3% of study participants (5/151) had surgical explants without complication.Two explants occurred within the first 12 monthspostimplant and have been described previously.10Two explants, 753 days and 1230 days postimplant,were due to painful stimulation. The other explantwas 1233 days postimplant (foot fusion surgery dueto arthritis). No device migrations occurred, and nodevice revision procedures were required. ## DISCUSSION Overactive bladder is a chronic condition withgreater prevalence in older adults, and symptomatolog that changesdoften worsensdover theyears.11 A therapy that can be adjusted to meet thepatient’s evolving needs is important for long-termsuccess. Current 2024 AUA/SUFU guidelinesrecommend a patient-centric approach to OABtreatment and recognize the efficacy and safety ofminimally invasive procedures.2 The results of this study reveal excellent anddurable effectiveness, few adverse events, and veryhigh patient satisfaction through 3 years. Willingness to continue and treatment satisfaction scoresexceeded the therapeutic response rates. Thus,although a minority may not have met the therapeutic threshold of response, the high rates ofimproved QOL measures, satisfaction, and willingness to continue are thought to be due to theobserved reductions in daily large leaks and nocturia, coupled with improvements in QOL. During the first year of treatment, participantswere required to stimulate for 30 minutes 2/day.One of the major strengths of this treatment is thatefficacy was maintained throughout the 3 years,even with the treatment flexibility afforded after thefirst year. The extended study allowed for individual flexibility, but with a minimum of two 30-minutesessions per week; however, this cohort maintained high compliance with consistent treatments. This cohort had severe baseline UUI; thus, it isunclear whether stimulation frequency might be lessfor those with milder symptoms. Participants reportedhigh compliance due to their high motivation tocontinue the level of symptom control, which wasconsistent throughout 6, 12, 24, and 36 months(response rates of 78%, 82%, 79%, and 79%, respectively). This response rate is slightly higher thanresponse rates reported in a recent meta-analysis,where UUI response rates for other implanted neuromodulation devices (eg, percutaneous tibial nervestimulation and sacral nerve stimulation) were 68%-72%.3 Although the system requires patient engagement with use of the external Revi Wearable anklecontroller, this seemingly did not deter participants asnoted by the 95% patient satisfaction rate and 98%“willingness to continue treatment.” Furthermore, itultimately provides the individual greater control overtreatment frequency, intensity, and programming,while obviating the future need for battery replacement surgeries. Device-related adverse events remained low (<10%) throughout the study and primarily consisted ofpain or stimulation-related discomfort, which eitherresolved without intervention or were resolved withchanges to the stimulation parameters, with a 3%explant rate, and no surgical revisions. The 19 (12.6%)procedure-related adverse events occurring more thanonce included mild-to-moderate severity wound complications (n [ 4), infections (n [ 2), and impairedhealing (n [ 2). This highlights that fewer implantedcomponents, direct fascia suturing, and an externalbattery reduces adverse events and the necessity forsubsequent revision surgery for issues such as leadmigration or battery depletion, setting the Revi system apart from other neuromodulation alternativescurrently available. By comparison, eCoin, anotherFDA-approved implantable tibial neuromodulationdevice, was noted 20% device-related adverse eventsat 2 years.12 ### Page 9 Total events (n, % of participants with event) Device-related events Procedure-related events | Adjudication | Adjudication | | - | - | | Period Total AEs | SAEs | Mild Moderate Severe Mild Moderate SevereSAEs | | Baselineto | 12m | 303 | 0 (0, | 0%) | 5 (5, 3.3%) | 1 (1, 0.7%) | 0 (0, 0%) | 0 (0, | 0%) | 7 (7, 4.6%) | 9 (9, | 6.0%) | 0 (0, | 0%) | | 12 | to | 24m | 121 | 0 (0, | 0%) | 0 (0,0%) | 0 (0,0%) | 0 (0,0%) | 0 (0, | 0%) | 0 (0, 0%) | 1 (1, | 0.7%) | 0 (0, | 0%) | | 24 | to | 36m | 119 | 0 (0, | 0%) | 3 (3, | 2.0%) | 3 (2, | 1.3%) | 1 (1, | 0.7%) | 0 (0, | 0%) | 1 (1, | 0.7%) | 1 (1, | 0.7%) | 0 (0, | 0%) | | Baseline to | 36m | 543 | 0 (0, | 0%) | 8 (8, | 5.3%) | 4 (3, | 2.0%) | 1 (1, | 0.7%) | 0 (0, | 0%) | 8 (8, | 5.3%) | 11 (11, | 7.3%) | 0 (0, | 0%) | Abbreviations: AE indicates Adverse Event; SAE, Serious Adverse Event. Relationship of event to device and procedure was adjudicated by the Clinical Events Committee (CEC) through 12 mo. After 12 mo, event relationship was adjudicated by site investigators.Mild [ Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Moderate [ minimal, local or noninvasive intervention indicated; limiting ageappropriate instrumental activities of daily living (ADL). Severe [ severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalizationindicated; disabling; limiting selfcare ADL. Moderate [ minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). ### Limitations and Strengths The OASIS study possesses a common limitationamong neuromodulation studies: a lack of randomization and blinding. The durability of the effects fromtreatment through 36 months decreases the likelihoodof a placebo effect. Initiation of the extended study wasafter some participants had completed the 12-monthvisit, reducing the number of participants available at 3 years. However, the proportion of participants whoprovided 3 years data was comparable with other longterm studies.4,13 A last observation carried forwardanalysis was performed to address the potential forselection bias from loss to follow-up which may haveinflated positive outcome reporting and found similarbaseline demographics and clinical outcomes betweenthe populations completing the initial 6-month assessment (n [ 144) and the 36-month assessment (n [ 90). The study includes several strengths. This was aninternational, multicenter study with numerous implanters representing a variety of expertise and experiences, and with different patient populations whichenhances the generalizability of findings. Accurateplacement was verified intraoperatively with stimulation, and participants were trained to complete at-hometreatments. In addition, both objective and patientreported outcome measures were included as part ofthe follow-up evaluations, providing a robust mixture ofoutcomes, including willingness to continue treatment. ## CONCLUSIONS The results of this 3-year study demonstrate excellent,consistent, and durable efficacy and safety over timewith the Revi system. Additional advantages include the small size of the electrode requiring minimalimplanted hardware; the capability of intraoperativetesting to ensure proper placement and stimulationresponse; the elimination of a formal “trial phase”before implantation; stimulation programming capabilities to enhance individualized efficacy over time, yetoperationally simple for the patient who is willing to beengaged in their therapy; and an external batteryoperated wearable control device, thus eliminatingfuture needs for surgical battery replacements. Neuromodulation has been a proven treatment modality forthe management of OAB and UUI for many years.Innovation today is focused on modes of stimulationdelivery and ease of patient use, while maintaining thesame excellent treatment results. These results fromthe OASIS trial further establish the Revi System asan effective and safe treatment for patients with UUI. ## ACKNOWLEDGMENTS The authors extend their sincere gratitude to allparticipating investigators and their teams (seeSupplemental Table ST1,). In addition, the authors are deeply appreciative for oversight provided by the Data and SafetyMonitoring Board members [Dr. Howard Goldman,Dr. Holly Richter, Dr. Eric Rovner and Mr. RichardKotz] for their careful review of the study data andtheir insightful recommendations throughout thetrial. The authors thank Clinical Event CommitteeMembers [Drs. Sandip Vasavada, Gary Lemack andEli Sidon] for their meticulous adjudication of clinical events and their expert guidance in interpretingthe clinical significance of our findings. ## REFERENCES - 1. Milsom I, Coyne KS, Nicholson S, Kvasz M, ChenCI, Wein AJ. Global prevalence and economicburden of urgency urinary incontinence: a systematic review. Eur Urol. 2014;65(1):79-95. doi: - 2. Cameron AP, Chung DE, Dielubanza EJ, et al.The AUA/SUFU guideline on the diagnosis andtreatment of idiopathic overactive bladder.J Urol. 2024;212(1):11-20. doi: - 3. Amundsen CL, Sutherland SE, Kielb SJ, DmochowskiRR. Sacral and implantable tibial neuromodulationfor the management of overactive bladder: a systematic review and meta-analysis. Adv Ther.2025;42(1):10-35. doi: ### Page 10 - 4. Chartier-Kastler E, Le Normand L, Ruffion A, et al.Five-year results from the prospective, multicenter,observational SOUNDS study of patients withoveractive bladder treated with the InterStim system for sacral neuromodulation. Eur Urol Focus.2023;9(5):765-772. doi: - 5. Lo CW, Wu MY, Yang SS, Jaw FS, Chang SJ.Comparing the efficacy of OnabotulinumtoxinA, sacralneuromodulation, and peripheral tibial nerve stimulation as third line treatment for the management ofoveractive bladder symptoms in adults: systematicreview and network meta-analysis. Toxins (Basel).2020;12(2):128. doi: - 6. Lee UJ, MacDiarmid S, Matthews CA, Gillespie E,Peters KM. Tibial nerve stimulation for urge urinaryincontinence and overactive bladder: narrative review of randomized controlled trials and applicabilityto implantable devices. Adv Ther. 2024;41(7):26352654. doi: - 7. Heesakkers J, Toozs-Hobson P, Sutherland SE,et al. A prospective study to assess the effectiveness and safety of the BlueWind system inthe treatment of patients diagnosed with urgencyurinary incontinence. Neurourol Urodyn.2024;43(7):1491-1503. doi: - 8. AUGS 46th annual scientific meeting. Urogynecology. 2025;31(10):S1-S542. doi: - 9. Coyne K, Revicki D, Hunt T, et al. Psychometricvalidation of an overactive bladder symptom andhealth-related quality of life questionnaire: theOAB-q. Qual Life Res. 2002;11(6):563-574. doi: - 10. Heesakkers J, Toozs-Hobson P, Sutherland SE, et al.Two-year efficacy and safety outcomes of the pivotalOASIS study using the revi system for treatment of urgency urinary incontinence. J Urol. 2025;213(3):323332. doi: - 11. Blasco P, Valdivia MI, Ona MR, Roset M, MoraAM, Hernandez M. Clinical characteristics, beliefs, and coping strategies among older patientswith overactive bladder. Neurourol Urodyn.2017;36(3):774-779. doi: - 12. Lucente V, Giusto L, MacDiarmid S. Two-year pivotalstudy analysis of the safety and efficacy ofimplantable tibial nerve stimulation with eCoin forurgency urinary incontinence. Urology. 2024;194:1723. doi: - 13. Siegel S, Noblett K, Mangel J, et al. Five-year followup results of a prospective, multicenter study ofpatients with overactive bladder treated with sacralneuromodulation. J Urol. 2018;199(1):229-236. doi: ## EDITORIAL COMMENTS It is encouraging to see tibial nerve stimulationfinally moving from the margins toward a more centralrole in the management of urgency urinary incontinence. For years, enthusiasm for neuromodulation hasbeen tempered by trade-offs involving durability vsinvasiveness and efficacy vs convenience. The emergence of implantable tibial platforms such as Revirepresents a meaningful attempt to reconcile thesecompeting priorities. The OASIS study adds to a growing body of evidence suggesting that tibial neuromodulation candeliver sustained benefit beyond the short-termhorizons that historically limited enthusiasm forpercutaneous approaches.1 More importantly, it reflects a broader shift in the field away from rigidtreatment hierarchies and toward earlier, patientcentered use of advanced therapies, consistent withevolving guideline recommendations.2 The key differentiator of the Revi System is notsimply that it is implantable, but that it reimagineswhere complexity should reside. By externalizing thepower source and enabling patient-controlled therapy,the system minimizes implanted hardware while preserving programmability and adaptability. This design has practical implications, including the potential forfewer revisions, avoidance of battery replacementsand greater flexibility as symptoms evolve over time.3 That said, this paradigm introduces a differentdependency in the form of patient engagement.Whether real-world adherence will match that seen ina motivated clinical trial population remains an openquestion. In addition, as with many neuromodulationstudies, the absence of randomization limits definitivecomparisons with established therapies. Nonetheless, this work1 reflects an inflection point.The field is no longer asking whether tibial neuromodulation works, but how best to deliver it. If durability, convenience, and safety are the metrics thatmatter most to patients, then systems such as Revimay help redefine expectations for contemporarymanagement of urgency urinary incontinence. Argy Stampas 1 and Rachel High 2 - 1Department of Physical Medicine and Rehabilitation, UTHealthHouston McGovern Medical SchoolHouston, Texas - 2Department of Urology,Houston Methodist HospitalHouston, Texas ## REFERENCES - 1. Amundsen CL, Sutherland SE, Heesakkers JPFA,et al. Three-year efficacy and safety of Reviimplantable tibial neuromodulation from thepivotal OASIS Study. J Urol. 2026;216(2):219-229.doi: - 2. Cameron AP, Chung DE, Dielubanza EJ, et al. TheAUA/SUFU guideline on the diagnosis and treatmentof idiopathic overactive bladder. J Urol. 2024;212(1):1120. doi: - 3. Amundsen CL, Sutherland SE, Kielb SJ, DmochowskiRR. Sacral and implantable tibial neuromodulation forthe management of overactive bladder: a systematicreview and meta-analysis. Adv Ther. 2025;42(1):10-35.doi: ### Page 11 This paper is an important longer-term report onimplantable tibial neuromodulation for urgencyurinary incontinence.1 The strongest findings ofthis study are that the therapy works for 3 yearswith high responder rates and excellent patientsatisfaction, and with low procedure-/devicerelated serious adverse events. Clinicians and theirpatients have great interest in this technologybecause it is minimally invasive, allows homestimulation, and is clearly effective. The 2 main strengths of this technique are thesubfascial placement of the implant with fixation tothe fascia (there was no device migration) and thatthere is an external power supply so there is nobattery to replace. With subfascial placement, thedevice is closer to the nerve, likely reducing thestimulation power required. This may be importantbecause many believe we are “underdosing” tibialnerve stimulation (dosage [ stimulation frequency/duration) and have shown that increasing the“dosage” allows patients to reach clinically signifi-cant improvement faster and may increase themagnitude of the clinical improvement. This mayprove criticaldif we find that patients have improvedoutcomes with more frequent/longer stimulation sessions, a device with an external power source wouldhave a significant advantage. However, the weaknesses are important. This wasa single-arm, open-label study without randomization, blinding, or sham control, and some attritionover time. In neuromodulation there may be a substantial placebo effect and patient expectation bias,and this cannot be overlooked. The authors arereminded that this is the perfect device to do a shamcontrolled study to help our understanding. Overall, the 3-year data are reassuring withexcellent patient outcomes and acceptable morbidity.I believe that these devices, when done in a costeffective setting, will provide a minimally invasive,safe experience that will be more effective than oralmedications, have less risk than onabotulinumtoxinA, and at increased dosage may be as effective asyet less invasive than sacral neuromodulation.Implantable tibial nerve stimulation devices shouldrevolutionize the management of urge urinaryincontinence. Larry T. Sirls1 1Corewell Health William Beaumont University HospitalRoyal Oak, Michigan ## REFERENCES 1. Amundsen CL, Sutherland SE, Heesakkers JPFA, et al. Three-year efficacy and safety of Revi implantable tibial neuromodulation from the pivotal OASIS study. J Urol.2026;216(2):219-229. doi: