Evidence map›Paper›PMID 41644939›Full record

ArticleInternational urology and nephrology2026

A prospective, multicenter, real-world effectiveness and safety study of high molecular weight sodium hyaluronate for interstitial cystitis/bladder pain syndrome.

Robert Stoica, Jose Medina-Polo, Rustom P Manecksha, Christine Kolb, Melanie Emmeluth, Hans Christian Kuhl, Tarek Hassan, Claus R Riedl

Abstract readMulticenter Study
In one paragraph

Article in International urology and nephrology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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.

Robert StoicaFundeni Clinical Institute, University of Medicine and Pharmacy Carol Davila, Bucharest, Romania.ORCID http://orcid.org/0000-0002-3895-3574
Jose Medina-PoloDepartment of Urology, Hospital Universitario 12 de Octubre and UCM, Madrid, Spain.ORCID http://orcid.org/0000-0003-3626-8669
Rustom P ManeckshaDepartment of Surgery, Tallaght University Hospital, Dublin, Ireland.ORCID http://orcid.org/0000-0003-3437-744X
Christine KolbMEDA Pharma GmbH and Co. KG (A Viatris Company), Bad Homburg, Germany.ORCID http://orcid.org/0009-0003-2249-3459
Melanie EmmeluthMEDA Pharma GmbH and Co. KG (A Viatris Company), Bad Homburg, Germany.
Hans Christian KuhlMEDA Pharma GmbH and Co. KG (A Viatris Company), Bad Homburg, Germany.ORCID http://orcid.org/0009-0001-2696-1358
Tarek HassanViatris Inc, Canonsburg, PA, USA.ORCID http://orcid.org/0000-0001-9427-363X
Claus R RiedlDepartment of Urology, LKH Baden, Waltersdorfer Straße 75, 2500, Baden, Austria. claus.riedl@baden.lknoe.at.ORCID http://orcid.org/0000-0001-5544-9540

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe aim of the present study was to evaluate the performance and safety of high molecular weight (HMW) sodium hyaluronate (40 mg/50 mL) for interstitial cystitis/bladder pain syndrome (IC/BPS) in real-world clinical practice.

methodsThis prospective, multicenter European study was conducted in patients with the clinical diagnosis of IC/BPS. Participants received weekly intravesical instillations for 12 weeks. The primary endpoint was responder rate at end of treatment/week 12, defined as any improvement in IC/BPS symptoms on the 7-point Patient Global Assessment (PGA) scale. Secondary endpoints included changes in bladder symptoms and quality of life assessed by visual analog scales (VAS), questionnaires, and voiding diaries at week 12 and 24.

resultsSeventy-one (N = 74) patients enrolled were part of the full analysis set (mean [SD] age: 51.8 [16.9] years; 98.6% female) and 73/74 patients were in the safety set (mean [SD] age: 51.9 [17.2] years; 98.6% female). Total responder rate was 90.1% (90% CI: 82.3, 95.3) at week 12 and 78.9% (90% CI: 69.4, 86.5) at week 24. Significant improvements from baseline were observed in VAS scores for urinary urgency and bladder pain at week 12 (-42.0; -39.3) and week 24 (-49.2; -49.2). Quality of life scores also improved significantly (+ 17.1; + 27.2, all P < .0001). Twenty patients (27.4%) reported 37 adverse events (AEs), including seven treatment-related AEs (incidents). No treatment-related serious AEs occurred and all incidents were resolved.

conclusionsIntravesical HMW sodium hyaluronate improved IC/BPS symptoms and quality of life through week 24 in most patients with a favorable safety profile.

Indexed as

Cystitis, InterstitialHyaluronic AcidAdministration, IntravesicalAdultAgedFemaleHumansMaleMiddle AgedMolecular WeightPain MeasurementProspective StudiesQuality of LifeTreatment OutcomeHyaluronic AcidBladder painInterstitial cystitisIntravesical sodium hyaluronatePerformanceReal-worldSafety

Identifiers

PMID41644939
PMCPMC13375820

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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.