Evidence map›Paper›PMID 39693268›Full record

Trial reportThe Journal of urology2025

Gene Therapy With URO-902 (pVAX/

Ekene A Enemchukwu, Susan Kalota, Kaiser Robertson, Sijian Ge, Jingmei Lu, Hanh Badger, Salim Mujais, Kenneth M Peters

Abstract readClinical Trial, Phase IIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in The Journal of urology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
  2. Review
  3. 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

8 authors.

Ekene A EnemchukwuDepartment of Urology, Stanford University School of Medicine, Stanford, California.ORCID 0000-0001-6224-6207
Susan KalotaArizona Urology Specialists, Tucson, Arizona.
Kaiser RobertsonChesapeake Urology, Hanover, Maryland.
Sijian GeSumitomo Pharma America, Inc, Marlborough, Massachusetts.
Jingmei LuSumitomo Pharma America, Inc, Marlborough, Massachusetts.
Hanh BadgerSumitomo Pharma America, Inc, Marlborough, Massachusetts.
Salim MujaisSumitomo Pharma America, Inc, Marlborough, Massachusetts.
Kenneth M PetersOakland University William Beaumont School of Medicine, Rochester, Michigan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe assessed efficacy and safety of URO-902, an investigational gene therapy expressing the α subunit of the large-conductance Ca MATERIALS AND

methodsWomen, age 40 to 79 years, with OAB and urge urinary incontinence who were refractory to OAB medications were randomized to single-dose URO-902 24 and 48 mg or placebo administered by intradetrusor injection via cystoscopy under local anesthesia. Efficacy end points included change from baseline to week 12 in mean daily micturitions, urgency episodes, urge urinary incontinence episodes, and patient-reported outcomes. Safety assessments included adverse events and postvoid residual urine volume.

resultsOf 80 patients randomized (URO-902 24 mg, n = 26; URO-902 48 mg, n = 27; placebo, n = 27), 74 received treatment, and 67 reached week 24. At week 12, URO-902 24 and 48 mg were associated with significant improvement vs placebo in daily micturitions (least-squares mean change from baseline, -2.3 and -2.4 vs -0.8, respectively; least-squares mean difference [95% CI], ‒1.5 [‒2.7 to ‒0.3] and ‒1.6 [‒2.8 to ‒0.4], nominal

conclusionsIn this phase 2a trial, treatment with URO-902 was associated with improvements vs placebo in efficacy and patient-reported outcomes and was safe and well tolerated.

Indexed as

Genetic TherapyUrinary Bladder, OveractiveUrinary Incontinence, UrgeAdultAgedDouble-Blind MethodFemaleHumansMiddle AgedTreatment Outcomecalcium activated potassium channelgene therapyoveractive bladderoveractive detrusorurinary incontinence

Identifiers

PMID39693268
PMCPMC12708029

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.