Nabiximols oromucosal spray in patients with multiple sclerosis-related bladder dysfunction: A prospective study.

Background: Spasticity and urinary disturbances can profoundly impact the daily lives of persons with multiple sclerosis (pwMS). Cannabis has been associated with improvement in sphincteric disturbances. To our knowledge, few studies have evaluated the effect of nabiximols oromucosal spray (Sativex®) on urinary disturbances by instrumental methods.
Objectives: This longitudinal study was conducted to assess the effect of nabiximols oromucosal spray on urinary disturbances by clinical and urodynamic evaluation in pwMS.
Materials and Methods: Neurological, spasticity, and quality of life (QoL) assessments were performed before (T0), and at one (T1) and six (T6) months after the start of nabiximols treatment. At these same time points, patients were assessed for urinary disturbances by the International Prostatic Symptoms Score (IPSS) and a urodynamic test evaluating maximum detrusor pressure (P _det ), bladder filling capacity (CC _max ), uninhibited detrusor contractions (UDC), bladder volume at first desire (BVFD), post-void residual volume (PVR) and voluntary abdominal pressure (PA).
Results: Of 31 pwMS enrolled in the study, 25 reached T1 and 18 reached T6. Mean IPSS total score, its subscores, and IPSS QoL decreased significantly from T0 to T6 (p = 0.000), with no differences according to sex, age, MS type, disease duration and disability at baseline. P _det improved significantly from T0 to T6 (p = 0.0171), and CC _max changed only marginally (p = 0.0494); results were similar in patient subgroups naïve to or previously exposed to urological treatment. All patients with overactive bladder showed improvement in their urodynamic assessment based on significant reduction of P _det (p = 0.0138). In patients with mainly hypotonic bladder, mean P _det decreased from T0 to T6 without reaching statistical significance; most urodynamic parameters showed a trend to improve. Mean numerical scale scores for MS spasticity, and for spasms, pain and tremors, decreased significantly from T0 to T6. The mean 'physical health composite' score of the MS Quality of Life-54 questionnaire increased significantly from T0 to T6 (p = 0.0126).
Discussion and Conclusion: Our data suggest that nabiximols has an appreciable effect on ameliorating subjective perception of urinary disturbances and appears to have a positive effect on objective urodynamic parameters, particularly in patients with hyperactive bladder.
Competing Interests: Declaration of Competing Interest Valentina Torri Clerici has acted as an Advisory Board member for Almirall, Merck, Novartis, Roche and Sanofi; has received funding for traveling and honoraria for speaking or writing from Almirall, Biogen, Bristol-Meyers Squibb, Novartis, Sanofi, and Teva; has received support for research projects from Almirall; is involved as principal investigator in clinical trials for FISM, Merck, Novartis, and Sanofi. Laura Brambilla has received honoraria for speaking from Novartis and Sanofi, and for traveling from Coloplast, Merck, Roche, and Sanofi. She has acted as an Advisory Board member for Biogen, Merck, Novartis, and Sanofi. She is involved as principal investigator in clinical trials for Merck and Roche. Simone Tonietti has received honoraria for lecturing from Sanofi and Teva; for writing from Teva; for participation in advisory boards from Biogen and Merck; and for travel expenses to attend congresses and meetings from Biogen, Merck, Novartis, Sanofi, and Teva. Marco Ronzoni has acted as an Advisory Board member for Biogen, Roche and Sanofi; has received honoraria for speaking from Sanofi and for traveling from Biogen, Mylan and Novartis. Sebastiano Crisafulli has received travel grants from Merck and Novartis. Carlo Antozzi has received honoraria for Advisory Board participation from Momenta Pharmaceuticals, and for meeting participation from Biogen and Sanofi. Paolo Confalonieri has received honoraria for speaking or consultation fees from Biogen, Novartis, and Roche; has received funding for travel to attend scientific events or speaker honoraria from Biogen, Merck, Mylan, Roche, and Teva; has received institutional research support from Merck, Mylan, Novartis, and Roche. He is also involved as principal investigator in clinical trials for Biogen, Merck, and Roche. Paolo Luca Politi, Federica Viggiani, Simone Mercurio, Irene Tramacere and Chiara Redemagni have nothing to disclose.
(Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)