An observational study in Bladder Cancer, LUTS and Pain, sponsored by Cardarelli Hospital. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-01.
Sponsored by Cardarelli Hospital · Observational
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.
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's planned enrollment of 100 is below the median of 180 across 374 observational studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Cardarelli Hospital is the lead sponsor of 8 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients who referred to a general hospital to receive endoscopic treatment for bladder cancer (TURB) and then the endovescical chemioprofilaxis.
Exclusion Criteria:
A combination of two alkaloid, Protopine and Nuciferine
Dietary Supplement: Protoves M1®
Patients will not receive a treatment
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
RPM
Post-Void residual (ml) measures the amount of urine left in the bladder after urination.
Time frame: 1 and 6 weeks
No study locations are listed for this record.
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cardarelli Hospital