Evidence map›Paper›PMID 34550425›Full record

ArticleWorld journal of urology2022

Intravesical instillation of high molecular weight sodium hyaluronate in radiation-induced cystitis: a prospective pilot study.

Michael Baboudjian, Marc Fourmarier, Christophe Clement, Arnaud Cherasse, Jean-Pierre Graziana, Youssef Bentaleb, Yohann Rouscoff, Sylvain Ducrocq, Bastien Gondran-Tellier, Christian Saussine

Abstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in World journal of urology, 2022. 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
0.9field-weighted citation impact, top 27% of its field
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, 7 citations in OpenAlex.

  1. Article
  2. Review
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

10 authors at 5 institutions in 1 country.

Michael BaboudjianDepartment of Urology and Kidney Transplantation, La Conception Hospital, Aix-Marseille University, APHM, Marseille, France. Michael.BABOUDJIAN@ap-hm.fr.ORCID http://orcid.org/0000-0001-6935-3873
Marc FourmarierDepartment of Urology, CH Aix-Pertuis, Aix-en-Provence, France.
Christophe ClementDepartment of Urology, Clinique Rhône Durance, Avignon, France.
Arnaud CherasseDepartment of Urology, Clinique du Val d'Ouest, Ecully, France.
Jean-Pierre GrazianaDepartment of Urology, Clinique Mutualiste de la Porte de L'Orient, Lorient, France.
Youssef BentalebDepartment of Urology, CH Jean Rougier, Cahors, France.
Yohann RouscoffDepartment of Urology, Clinique Saint George, Nice, France.
Sylvain DucrocqDepartment of Urology, CH Notre Dame de la Miséricorde, Ajaccio, France.
Bastien Gondran-TellierDepartment of Urology and Kidney Transplantation, La Conception Hospital, Aix-Marseille University, APHM, Marseille, France.
Christian SaussineDepartment of Urology, NHC, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.
Aix-Marseille Université · FRCentre Hospitalier du Pays d'Aix · FRClinique de l'Yvette · FRClinique Mutualiste de l'Estuaire · FRHôpitaux Universitaires de Strasbourg · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo assess the efficacy and safety of intravesical instillation of high molecular weight sodium hyaluronate (HMW-HA) for the treatment of radiation-induced cystitis.

methodsThis prospective cohort study was conducted in seven centers in France. Eligible patients with radiation-induced cystitis were recruited between April 2020 and March 2021. A sterile disposable 50 ml prefilled solution containing 0.16% (80 mg/50 mL) HMW-HA (INSTYLAN) was instilled weekly into the bladder. The treatment consisted of 6 sessions (V1 to V6). Outcomes were assessed 1 week (V7) and 4 weeks (V8) after the last session and were compared with baseline (V0). The primary endpoint was bladder pain, evaluated by a Questionnaire with 5 closed-ended response options. Secondary endpoints included changes from baseline for hematuria, urinary frequency, and the effect of urgencies on Quality of Life (QoL). Adverse events (AEs) were graded according to the CTCAE 3.0 classification.

resultsA total of 30 participants were enrolled. The Intent-to-Treat analysis showed a significant reduction in pelvic pain intensity (- 45.81%, p < 0.001), hematuria (- 26.87%, p = 0.008), total 24 h voids (- 23.92%, p < 0.001) and the effect of urgencies on QoL (- 33.92%, p < 0.001) at V7. The improvement for each outcome remained stable during the post-therapeutic period between V7 and V8. Bladder instillation therapy was well-tolerated: two treatment-related AEs (6.6%) were reported corresponding to two grade 1 hematuria.

conclusionsIntravesical instillation of HMW-HA appears to be effective in the treatment of radiation-induced cystitis. Further comparative studies with longer follow-up are needed to confirm our preliminary results.

Indexed as

Administration, IntravesicalAgedCystitisFemaleFranceHumansHyaluronic AcidMaleMolecular WeightPilot ProjectsProspective StudiesRadiation InjuriesTreatment OutcomeHyaluronic AcidBladder painHematuriaIntravesical instillationRadiation-induced cystitisSodium hyaluronate

Identifiers

PMID34550425
OpenAlexW3200023876

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.