Clinical study about changes of bladder disorders in patients with multiple sclerosis treated with Sativex , using clinical examination and urodynamic evaluation.

Clinical and Urodynamic Evaluation of Bladder dysfunction in multiple sclerosis patients treated with Sativex - CUEBS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000840-32-IT

Enrollment

Registered

2021-06-22

Start date

2016-06-24

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis patients treated with nabiximols (Sativex¿, Almirall) MedDRA version: 21.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1 Level: LLT Classification code 10039720 Term: Sclerosis multiple System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: SATIVEX - SPRAY PER MUCOSA ORALE 3 FLACONI NEBULIZZATORI CON POMPA DOSATRICE DA 10 ML - 90 EROGAZIONI Product Name: SATIVEX Pharmaceutical Form: Oromucosal spray

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients who will start therapy with Sativex according to the judgment of the physician, and who are eligible to the treatment following AIFA guidelines - Patients aged 18 - 75 years (inclusive) - Patients with a diagnosis of Relapsing-Remittent, Secondary Progressive and Primary Progressive MS, according to the revised McDonald criteria for MS diagnosis 2010 [18] - Kurtzke EDSS score = 8.0 [19] - Patients with anamnestic report of urinary disturbances - Patients able to give valid informed consent to take part in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - Male patients affected by benign prostatic hypertrophy - Presence of urinary infection at baseline or any other contraindications to urodynamic examination - Hypersensitivity to any active ingredient in Sativex product or to any of the excipients listed in the local Sativex product information

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the possible improvement of urinary dysfunction using the urodynamic evaluation in MS patients affected by urinary disturbances and eligible to the treatment with Sativex;Secondary Objective: 1.to evaluate the improvement of urinary disturbances by means of self-reported scales 2.to correlate subjective amelioration of bladder dysfunction to parameters at the urodynamic tests 3.to evaluate improvement in spasticity and its related disorders (spasms, pain) and its correlation with amelioration of urodynamic parameters 4.to assess the possible correlation between the changes in urinary symptoms and the motor performance (evaluated by means of the Timed 10-Meters Walk Test) [14] 5.to assess the possible correlation between the improvement of bladder dysfunction and cannabinoids doses ;Primary end point(s): Improvement in urodynamic parameters between pre- and post-treatment evaluations: amelioration of urodynamic test will be defined as the combination of the reduction of at least 20 cmH2O in the amplitude of the maximal detrusorial contraction plus the increase of at least one third of the baseline bladder filling capacity.;Timepoint(s) of evaluation of this end point: (T=0; T=1 30 +/-7d; T=6 180+/-7d)	—

Measure

Time frame

Main Objective: To assess the possible improvement of urinary dysfunction using the urodynamic evaluation in MS patients affected by urinary disturbances and eligible to the treatment with Sativex;Secondary Objective: 1.to evaluate the improvement of urinary disturbances by means of self-reported scales 2.to correlate subjective amelioration of bladder dysfunction to parameters at the urodynamic tests 3.to evaluate improvement in spasticity and its related disorders (spasms, pain) and its correlation with amelioration of urodynamic parameters 4.to assess the possible correlation between the changes in urinary symptoms and the motor performance (evaluated by means of the Timed 10-Meters Walk Test) [14] 5.to assess the possible correlation between the improvement of bladder dysfunction and cannabinoids doses ;Primary end point(s): Improvement in urodynamic parameters between pre- and post-treatment evaluations: amelioration of urodynamic test will be defined as the combination of the reduction of at least 20 cmH2O in the amplitude of the maximal detrusorial contraction plus the increase of at least one third of the baseline bladder filling capacity.;Timepoint(s) of evaluation of this end point: (T=0; T=1 30 +/-7d; T=6 180+/-7d)

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Secondary

Measure	Time frame
Secondary end point(s): Improvement in self-reported scales about urinary disturbances (urinary diary), in particular frequency of micturitions, episodes of diurnal and nocturnal incontinence, episodes of nocturnal micturition, micturial hesitation ; Correlation between changes in urinary disturbances evaluated by urodynamic evaluation and spasticity evaluated by Numerical Rating Scale (NRS) [15], and motor improvement evaluated by the Timed 10-Meters Walk Test; Correlation between changes in urinary symptoms evaluated by urinary diary and spasticity evaluated by NRS, and motor improvement evaluated by the Timed 10-Meters Walk Test; Amelioration of spasticity, evaluated by means of and by means of the Ashworth Scale [16]; Amelioration of motor performance evaluated by means of the Timed 10-Meters Walk Test; Improvement of VAS scales for: spasms, tremors and pain [17]; Correlation between the whole number of puffs taken from baseline to T1 and from T1 to T6 and: changes in urodynamic parameters, amelioration of urinary symptoms evaluated by means of the urinary diary, results at the NRS and the Timed 10-Meters Walk Test, evaluated at the same time points;Timepoint(s) of evaluation of this end point: (T=0; T=1=30 +/-7d; T=6=180+/-7d); (T=0; T=1=30 +/-7d; T=6=180+/-7d); (T=0; T=1=30 +/-7d; T=6=180+/-7d); (T=0; T=1=30 +/-7d; T=6=180+/-7d); (T=0; T=1=30 +/-7d; T=6=180+/-7d); (T=0; T=1=30 +/-7d; T=6=180+/-7d); (T=0; T=1=30 +/-7d; T=6=180+/-7d)	—

Measure

Time frame

Secondary end point(s): Improvement in self-reported scales about urinary disturbances (urinary diary), in particular frequency of micturitions, episodes of diurnal and nocturnal incontinence, episodes of nocturnal micturition, micturial hesitation ; Correlation between changes in urinary disturbances evaluated by urodynamic evaluation and spasticity evaluated by Numerical Rating Scale (NRS) [15], and motor improvement evaluated by the Timed 10-Meters Walk Test; Correlation between changes in urinary symptoms evaluated by urinary diary and spasticity evaluated by NRS, and motor improvement evaluated by the Timed 10-Meters Walk Test; Amelioration of spasticity, evaluated by means of and by means of the Ashworth Scale [16]; Amelioration of motor performance evaluated by means of the Timed 10-Meters Walk Test; Improvement of VAS scales for: spasms, tremors and pain [17]; Correlation between the whole number of puffs taken from baseline to T1 and from T1 to T6 and: changes in urodynamic parameters, amelioration of urinary symptoms evaluated by means of the urinary diary, results at the NRS and the Timed 10-Meters Walk Test, evaluated at the same time points;Timepoint(s) of evaluation of this end point: (T=0; T=1=30 +/-7d; T=6=180+/-7d); (T=0; T=1=30 +/-7d; T=6=180+/-7d); (T=0; T=1=30 +/-7d; T=6=180+/-7d); (T=0; T=1=30 +/-7d; T=6=180+/-7d); (T=0; T=1=30 +/-7d; T=6=180+/-7d); (T=0; T=1=30 +/-7d; T=6=180+/-7d); (T=0; T=1=30 +/-7d; T=6=180+/-7d)

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Countries

Italy

Contacts

Public ContactSevizio Ricerca e Sviluppo Clinico

Fondazione IRCCS Istituto Neurologico Carlo Besta

crc@istituto-besta.it0223942321

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026