THC/CBD oromucosal spray in patients with multiple sclerosis overactive bladder: a pilot prospective study
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Lower urinary tract dysfunctions (LUTDs) are commonly reported in multiple sclerosis (MS) patients and are mainly related to neurogenic overactive bladder (OAB). The aim of this observational study was to assess the effect of a tetrahydrocannabinol-cannabidiol (THC/CBD) oromucosal spray on resistant OAB by means of clinical and instrumental tools. Twenty-one MS patients were screened, and 15 cases have been evaluated. They underwent a specific clinical assessment (overactive bladder symptom score, OABSS) and a urodynamic assessment evaluating the maximal cystometric capacity (CCmax), bladder compliance (Qmax), maximum detrusor pressure (Pdet max), detrusor pressure at the first desire (Pdet first), bladder volume at the first desire (BVFD), leakage volume (LV), and post-void residual volume (PVR), before and after 4 weeks of THC/CBD administration. A complete neurological evaluation, including the assessment of their spasticity using the Modified Ashworth Scale (MAS) and the spasticity 0–10 numerical rating scale (NRS), was performed at the same times. Mobility was evaluated through the 25-ft walking-time test (T25-WT). The THC/CBD treatment successfully reduced the OAB symptoms (p = 0.001). Regarding the urodynamic findings after the end of treatment, PVR was significantly reduced (p = 0.016). Regarding the urodynamic findings after the end of treatment, PVR was significantly reduced (p = 0.016), while BVFD and CCmax were increased although the difference was not statistically significant. THC/CBD oromucosal spray has shown to be effective in improving overactive bladder symptoms in MS patients demonstrating a favorable impact on detrusor overactivity.
KeywordsMultiple sclerosis Spasticity Cannabinoids Nabiximols Sativex LUTDs
Compliance with ethical standards
Conflicts of interest
Giorgia Teresa Maniscalco received personal compensation from Novartis, Genzyme, Biogen, Merck Serono, and TEVA for public speaking and advisory boards.
Roberto Aponte does not have disclosures.
Dario Bruzzese does not have disclosures.
Giovanni Guarcello does not have disclosures.
Massimo Napolitano does not have disclosures.
Valentino Manzo does not have disclosures.
Ornella Moreggia does not have disclosures.
Francesco Chiariello does not have disclosure.
Ciro Florio received personal compensation from Merk Serono, Biogen, and TEVA for public speaking and advisory boards.
- 8.Zecca C, Riccitelli GC, Disanto G, Singh A, Digesu GA, Panicari L, Puccini F, Mattioli M, Tubaro A, Gobbi C (2016) Urinary incontinence in multiple sclerosis: prevalence, severity and impact on patients’ quality of life. Eur J Neurol 23(7):1228–1234. https://doi.org/10.1111/ene.13010 CrossRefPubMedGoogle Scholar
- 9.Ghezzi A, Carone R, Del Popolo G, Amato MP, Bertolotto A, Comola M, Del Carro U, Di Benedetto P, Giannantoni A, Lopes de Carvalho ML, Montanari E, Patti F, Protti A, Rasia S, Salonia A, Scandellari C, Sperli F, Spinelli M, Solaro C, Uccelli A, Zaffaroni M, Zipoli V, Multiple Sclerosis Study Group, Italian Society of Neurology (2011) Recommendations for the management of urinary disorders in multiple sclerosis: a consensus of the Italian multiple sclerosis study group. Neurol Sci 32(6):1223–1231. https://doi.org/10.1111/ene.13010 CrossRefPubMedGoogle Scholar
- 11.Novotna A, Mares J, Ratcliffe S, Novakova I, Vachova M, Zapletalova O, Gasperini C, Pozzilli C, Cefaro L, Comi G, Rossi P, Ambler Z, Stelmasiak Z, Erdmann A, Montalban X, Klimek A, Davies P, Sativex Spasticity Study Group (2011) A randomized, double-blind, placebo-controlled, parallel-group, enriched-design study of nabiximols* (Sativex(®) ), as add-on therapy, in subjects with refractory spasticity caused by multiple sclerosis. Eur J Neurol 18(9):1122–1231. https://doi.org/10.1111/j.1468-1331.2010.03328.x CrossRefPubMedGoogle Scholar
- 16.Collin C, Ehler E, Waberzinek G, Alsindi Z, Davies P, Powell K, Notcutt W, O'Leary C, Ratcliffe S, Nováková I, Zapletalova O, Piková J, Ambler Z (2010) A double-blind, randomized, placebo-controlled, parallel-group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis. Neurol Res 32(5):451–459. https://doi.org/10.1179/016164109X12590518685660 CrossRefPubMedGoogle Scholar
- 20.Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O'Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS (2011) Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol 69(2):292–302. https://doi.org/10.1002/ana.22366 CrossRefPubMedPubMedCentralGoogle Scholar
- 21.Farrar JT, Troxel AB, Stott C, Duncombe P, Jensen MP (2008) Validity, reliability, and clinical importance of change in a 0-10 numeric rating scale measure of spasticity: a post hoc analysis of a randomized, double-blind, placebo-controlled trial. Clin Ther 30(5):974–985. https://doi.org/10.1016/j.clinthera.2008.05.011 CrossRefPubMedGoogle Scholar
- 28.Patti F, Messina S, Solaro C, Amato MP, Bergamaschi R, Bonavita S, Bruno Bossio R, Brescia Morra V, Costantino GF, Cavalla P, Centonze D, Comi G, Cottone S, Danni M, Francia A, Gajofatto A, Gasperini C, Ghezzi A, Iudice A, Lus G, Maniscalco GT, Marrosu MG, Matta M, Mirabella M, Montanari E, Pozzilli C, Rovaris M, Sessa E, Spitaleri D, Trojano M, Valentino P, Zappia M, on behalf of the SA.FE. study group (2016) Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity. J Neurol Neurosurg Psychiatry 87(9):944–951. https://doi.org/10.1136/jnnp-2015-312591 CrossRefPubMedPubMedCentralGoogle Scholar