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.
Study Type
OBSERVATIONAL
Enrollment
100
A combination of two alkaloid, Protopine and Nuciferine (Protoves-M1 ®)
IPSS total
The International Prostate Symptom Score (I-PSS) is based on the answers to some questions concerning urinary symptoms and one question concerning quality of life.
Time frame: 1 and 6 weeks
OAB-q SF 6
The OAB-q SF 6 is a questionnaire developed to evaluate the overactive bladder symptom and health-related quality of life.
Time frame: 1 and 6 weeks
OAB-q SF 13
The OAB-q SF 6 is a questionnaire developed to evaluate the overactive bladder symptom and health-related quality of life.
Time frame: 1 and 6 weeks
PPIUS
The PPIUS is a questionnaire developed to evaluate the patient perception of intensity of urgency
Time frame: 1 and 6 weeks
PGI-1
PGI-I is a validated tool to estimate the improvement or the deterioration associated to the treatment.
Time frame: 1 and 6 weeks
VAS scale
Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions.
Time frame: 1 and 6 weeks
Qmax
Qmax (ml/s) is the maximum flow rate at uroflowmetry
Time frame: 1 and 6 weeks
Volume voided
Volume voided (ml) at uroflowmetry
Time frame: 1 and 6 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
RPM
Post-Void residual (ml) measures the amount of urine left in the bladder after urination.
Time frame: 1 and 6 weeks