Pain Clinical Trial
Official title:
The Role of Protopine Associated With Nuciferine (Protoves M1® Syrup) in Controlling Adverse Event During HIVEC® Instillations
100 patients with bladder cancer whose underwent Hyperthermic Intravesical Chemotherapy (HIVEC®) will be randomized in two groups (Group A: PROTOVES M1 SYRUP, Group B: NO TREATMENT). The aim of this study will be to analyse the role of two alkaloid, Protopine and Nuciferine (Protoves-M1 ®) in the prevention and the treatment of the low and mild grade adverse events related to the use of HIVEC® instillations.
100 patients with bladder cancer whose underwent Hyperthermic Intravesical Chemotherapy
(HIVEC®) will be randomized in two groups (Group A: PROTOVES M1 SYRUP, Group B: NO
TREATMENT). The aim of this study will be to analyse the role of two alkaloid, Protopine and
Nuciferine (Protoves-M1 ®) in the prevention and the treatment of the low and mild grade
adverse events related to the use of HIVEC® instillations.
At the baseline data on demographic and anthropometric features (age, weight, height, BMI),
lifestyle characteristics (smoke, alcohol), any comorbidities (hypertension, diabetes
mellitus, etc.) will be collected. All patients will be undergone to a clinical evaluation
(comprised general, genital and urologic examination). Before starting the treatment, the
following measurements will be collected: prostate volume by transrectal ultrasound, PSA,
uroflowmetry (Qmax, Volume Voided, Post-Void Residual), IPSS (International Prostatic
Symptoms Score) questionnaire, OverActive Bladder questionnaire-short form (OABq-SF) 6 and
13, patient perception of intensity of urgency scale (PPIUS), and visual analogue scale
(VAS). PSA and IPSS will be investigated only in male pts. In addition, the patient
impression of improvement will be assessed. Improvement will be evaluated with the Patient
Global Impression of Improvement questionnaire (PGI-I), a validated tool to estimate the
improvement or the deterioration associated to the treatment.
The primary endpoint was the evaluation of the efficacy of the therapy with Protoves-M1 in
controlling of the irritative symptoms, including nocturia, urinary frequency, bladder pain,
urgency and urge incontinence related to the chemo-hyperthermia treatment. The secondary
endpoint evaluated was the influences of the treatment on the uroflowmetric parameters.
After 1 and 6 weeks of therapy all patients will be undergone to a clinical and instrumental
evaluation : Uroflow-Qmax (ml/s), Uroflow-Volume voided (ml),Uroflow-RPM (ml), IPSS total,
OAB-q SF 6, OAB-q SF 13, PPIUS, PGI-I, VAS scale will be collected.
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