Evidence map›Paper›PMID 41729249›Full record

Observational studyInternational urogynecology journal2026

Impact of Revi® Implantable Tibial Neuromodulation on Quality of Life in Patients with Urgency Urinary Incontinence.

Suzette E Sutherland, John P F A Heesakkers, Kimberly L Ferrante, Roger R Dmochowski

Abstract readObservational Study
In one paragraph

Observational study in International urogynecology journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Suzette E SutherlandArizona Urology Specialists - United Urology Group, Scottsdale, AZ, USA. suzette.sutherland@gmail.com.
John P F A HeesakkersDepartment of Urology, Maastricht UMC, Maastricht, The Netherlands.
Kimberly L FerranteKaiser Permanente, San Diego, CA, USA.
Roger R DmochowskiVanderbilt University Medical Center, Nashville, TN, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introduction and hypothesisThe objective was to evaluate quality-of-life (QoL) improvements following Revi® implantable tibial neuromodulation (ITNM) in patients with urgency urinary incontinence (UUI).

methodsThis prospective, multicenter study evaluated the Revi® System, an ITNM device that allows for at-home therapy using an external, battery-operated unit. The primary efficacy and safety endpoints were assessed at 6 and 12 months; thereafter, participants either exited the study or consented to extend follow-up. This completers analysis evaluated QoL outcomes using the Overactive Bladder Questionnaire (OAB-q) and the total transformed Health-Related QoL (HRQL) score through 24 months.

resultsSubfascial implantation of the Revi System was performed in 151 participants. Primary efficacy and safety endpoints were met and no device- or procedure-related serious adverse events occurred. Consistent QoL benefits were seen throughout 24 months, with clinically significant (≥ 10-point change) and sustainable improvements in symptom severity in all domains of the OAB-q and HRQL scores. Additionally, 96.8% reported treatment benefit, 96.7% reported satisfaction, and 100% reported a willingness to continue therapy at 24 months. Notably, among participants who did not meet the primary efficacy endpoint at 24 months (n = 20; 20.6%), appreciable therapeutic benefit was still noted; 83.3% reported treatment benefit, 66.7% reported satisfaction, and 100% reported a willingness to continue this therapy.

conclusionsRevi is an effective and safe intervention for UUI. Two-year results of the Revi System demonstrate clinically meaningful and sustainable improvements to bladder-related and overall health-related QoL, including those whose objective benefit did not meet the primary efficacy endpoint.

Indexed as

Electric Stimulation TherapyQuality of LifeTibial NerveUrinary Incontinence, UrgeAdultAgedClinical Trials as TopicFemaleHumansMiddle AgedMulticenter Studies as TopicPatient SatisfactionProspective StudiesSurveys and QuestionnairesTreatment OutcomeClinical trialImplantable neurostimulatorsOveractiveQuality of lifeRevi SystemSafety and efficacyTibial nerve stimulationUrgency urinary incontinence

Identifiers

PMID41729249
PMCPMC13486121

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.