Contributions
Abstract: EP1694
Type: Poster Sessions
Abstract Category: Therapy - Symptomatic treatment
Background: Among symptoms with great impact on pwMS (people with Multiple Sclerosis), spasticity and urinary disturbances play a relevant role. Beyond the effect on spasticity, Cannabis has been associated with improvement in sphincteric disturbances. To our knowledge, few studies have been conducted to evaluate the effect of tetrahydrocannabinol-cannabidiol (THC/CBD) on urinary disturbances by instrumental methods.
Objectives: To assess the effect of THC/CBD (Sativex) oromucosal spray on urodynamic parameters evaluated in pwMS.
Materials and methods: This is an ongoing longitudinal study with three time-points (before the beginning of Sativex treatment (T0), after one (T1), and six (T2) months. A spasticity assessment by numerical rating scale (NRS) and VAS scales for spasms, tremors and pain, the MS Quality of Life-54 questionnaire were performed at each time-point. Patients also underwent urinary diary and urodynamic assessment: amelioration in urodynamic test will be defined by the reduction in the amplitude of the maximal detrusorial contraction (P-det) of at least 20 cmH2O and by the increase of the baseline bladder filling capacity (MaxCC) of at least one third of the value at baseline.
Results: Fourteen pwMS were enrolled in the study. All the participants performed T0 and T1 evaluation, and six of them also completed T2 evaluation. All the sample referred voiding dysfunction at T0; 50% of the sample reported improvements in urinary urgency at T1 and 75% of sample at T2. From T0 to T1, P-det value decreased in 9/14 patients (64%), and of 20 centimetres or more in three patients (27%). MaxCC increased in 10/14 patients (70%) and at least one third in five patients (38.5%). P-det value decreased in all the sample at T2, but only one showed a decrease of 20 cm or more. MaxCC increased in 2/6 patients, but none of them showed an increase of one third of the initial value. The overall NRS score improved from 7.4 ± 1.3 (T0) to 5.3 ± 2.0 (T1) and to 5.2 ± 2.6 (T2).
Discussion and conclusion: Through the analysis of this preliminary data, Sativex seems to have an appreciable effect in ameliorating subjective perception of urinary urgency and objective urodynamic parameters, though the improvement in P-det and in MaxCC in our sample was weakly significant. An in-depth statistical analysis, also with the data received from the patients still in treatment, could highlight the effect of the Sativex in improving voiding dysfunction in pwMS.
Disclosure: Antozzi C. received funding for traveling from Teva, Merck and Biogen
Brambilla L. received honoraria for speaking from Novartis and for traveling from Sanofi-Genzyme and Roche; acted as an Advisory Board member of Sanofi-Genzyme; she is involved as principal investigator in clinical trials for Roche.
Confalonieri P. acted as an Advisory Board member of Biogen and Novartis; received funding for traveling from Biogen, Merck, Teva, Novartis; received honoraria for speaking or writing from Biogen and Novartis. He received support for research project by Novartis and Merk and is involved as principal investigator or co-investigator in clinical trials for Teva, Novartis, Biogen and Merk.
Studer V. received honoraria for traveling from Merck; she is involved as principal investigator in clinical trials for Novartis and Biogen.
Torri Clerici V. acted as an Advisory Board member of Sanofi-Genzyme, Novartis and Merck, received funding for traveling and honoraria for speaking or writing from Teva, Biogen, Genzyme, and Almirall. She received support for research project by Almirall. She is involved as principal investigator in clinical trials for FISM, Merck and Novartis.
Mercurio S., Tonietti S and Politi P. have nothing to disclose
Abstract: EP1694
Type: Poster Sessions
Abstract Category: Therapy - Symptomatic treatment
Background: Among symptoms with great impact on pwMS (people with Multiple Sclerosis), spasticity and urinary disturbances play a relevant role. Beyond the effect on spasticity, Cannabis has been associated with improvement in sphincteric disturbances. To our knowledge, few studies have been conducted to evaluate the effect of tetrahydrocannabinol-cannabidiol (THC/CBD) on urinary disturbances by instrumental methods.
Objectives: To assess the effect of THC/CBD (Sativex) oromucosal spray on urodynamic parameters evaluated in pwMS.
Materials and methods: This is an ongoing longitudinal study with three time-points (before the beginning of Sativex treatment (T0), after one (T1), and six (T2) months. A spasticity assessment by numerical rating scale (NRS) and VAS scales for spasms, tremors and pain, the MS Quality of Life-54 questionnaire were performed at each time-point. Patients also underwent urinary diary and urodynamic assessment: amelioration in urodynamic test will be defined by the reduction in the amplitude of the maximal detrusorial contraction (P-det) of at least 20 cmH2O and by the increase of the baseline bladder filling capacity (MaxCC) of at least one third of the value at baseline.
Results: Fourteen pwMS were enrolled in the study. All the participants performed T0 and T1 evaluation, and six of them also completed T2 evaluation. All the sample referred voiding dysfunction at T0; 50% of the sample reported improvements in urinary urgency at T1 and 75% of sample at T2. From T0 to T1, P-det value decreased in 9/14 patients (64%), and of 20 centimetres or more in three patients (27%). MaxCC increased in 10/14 patients (70%) and at least one third in five patients (38.5%). P-det value decreased in all the sample at T2, but only one showed a decrease of 20 cm or more. MaxCC increased in 2/6 patients, but none of them showed an increase of one third of the initial value. The overall NRS score improved from 7.4 ± 1.3 (T0) to 5.3 ± 2.0 (T1) and to 5.2 ± 2.6 (T2).
Discussion and conclusion: Through the analysis of this preliminary data, Sativex seems to have an appreciable effect in ameliorating subjective perception of urinary urgency and objective urodynamic parameters, though the improvement in P-det and in MaxCC in our sample was weakly significant. An in-depth statistical analysis, also with the data received from the patients still in treatment, could highlight the effect of the Sativex in improving voiding dysfunction in pwMS.
Disclosure: Antozzi C. received funding for traveling from Teva, Merck and Biogen
Brambilla L. received honoraria for speaking from Novartis and for traveling from Sanofi-Genzyme and Roche; acted as an Advisory Board member of Sanofi-Genzyme; she is involved as principal investigator in clinical trials for Roche.
Confalonieri P. acted as an Advisory Board member of Biogen and Novartis; received funding for traveling from Biogen, Merck, Teva, Novartis; received honoraria for speaking or writing from Biogen and Novartis. He received support for research project by Novartis and Merk and is involved as principal investigator or co-investigator in clinical trials for Teva, Novartis, Biogen and Merk.
Studer V. received honoraria for traveling from Merck; she is involved as principal investigator in clinical trials for Novartis and Biogen.
Torri Clerici V. acted as an Advisory Board member of Sanofi-Genzyme, Novartis and Merck, received funding for traveling and honoraria for speaking or writing from Teva, Biogen, Genzyme, and Almirall. She received support for research project by Almirall. She is involved as principal investigator in clinical trials for FISM, Merck and Novartis.
Mercurio S., Tonietti S and Politi P. have nothing to disclose