Michael Baboudjian1, Marc Fourmarier2, Christophe Clement3, Arnaud Cherasse4, Jean-Pierre Graziana5, Youssef Bentaleb6, Yohann Rouscoff7, Sylvain Ducrocq8, Bastien Gondran-Tellier9, Christian Saussine10. 1. Department of Urology and Kidney Transplantation, La Conception Hospital, Aix-Marseille University, APHM, Marseille, France. Michael.BABOUDJIAN@ap-hm.fr. 2. Department of Urology, CH Aix-Pertuis, Aix-en-Provence, France. 3. Department of Urology, Clinique Rhône Durance, Avignon, France. 4. Department of Urology, Clinique du Val d'Ouest, Ecully, France. 5. Department of Urology, Clinique Mutualiste de la Porte de L'Orient, Lorient, France. 6. Department of Urology, CH Jean Rougier, Cahors, France. 7. Department of Urology, Clinique Saint George, Nice, France. 8. Department of Urology, CH Notre Dame de la Miséricorde, Ajaccio, France. 9. Department of Urology and Kidney Transplantation, La Conception Hospital, Aix-Marseille University, APHM, Marseille, France. 10. Department of Urology, NHC, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.
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.
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.
Authors: Heather Payne; Andrew Adamson; Amit Bahl; Jonathan Borwell; David Dodds; Catherine Heath; Robert Huddart; Rhona McMenemin; Prashant Patel; John L Peters; Andrew Thompson Journal: BJU Int Date: 2013-11 Impact factor: 5.588