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

Abstract

Purpose

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

Methods

This 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.

Results

A 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.

Conclusions

Intravesical 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.

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Availability of data and materials

Data are available upon request to the corresponding author.

Code availability

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Funding

The study was funded by LIDDE Therapeutics SAS.

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Affiliations

Authors

Contributions

Study concept and design: MF. Acquisition of data: MF, CC, AC, J-PG, YB, YR, SD, CS. Analysis and interpretation of data: MB, BG-T, and MF. Drafting of the manuscript: MB, MF, and CS. Critical revision of the manuscript for important intellectual content: MF and CS. Statistical analysis: BG-T.

Corresponding author

Correspondence to Michael Baboudjian.

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Conflict of interest

The authors report no conflict of interest.

Ethics approval

The study protocol and amendments were approved by the Committee for the Protection of Persons: CPP Sud-Est VI—Clermont Ferrand.

Consent to participate

Patient’s written information and participation agreement was obtained and signed from all patients.

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All authors approve the submission.

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We would like to pay tribute to the memory of Mr. Francois Schutz, chairman of LIDDE Therapeutics.

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Cite this article

Baboudjian, M., Fourmarier, M., Clement, C. et al. Intravesical instillation of high molecular weight sodium hyaluronate in radiation-induced cystitis: a prospective pilot study. World J Urol (2021). https://doi.org/10.1007/s00345-021-03837-9

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Keywords

  • Sodium hyaluronate
  • Intravesical instillation
  • Radiation-induced cystitis
  • Bladder pain
  • Hematuria