The Role of Protopine Associated With Nuciferine (Protoves M1® Syrup) in Controlling Adverse Event During HIVEC® Instillations
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- OAB-q SF 13
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intermediate-and high-risk NMIBC (non-muscle invasive bladder cancer) patients.
- •Therapeutic program of HIVEC® (Recirculant hyperthermic IntraVEsical chemotherapy).
- •Must be able to drink a syrup.
排除标准
- •Uncontrolled underlying diseases (ASA III or IV)
- •Post void residual urine ≥ 100 ml
- •Bleeding tendency
- •Drug abuse
- •Chronic pelvic pain
- •Urinary tract infection
- •Neurological disease
- •Bladder lithiasis
- •Renal or liver failure
- •Tachycardia and heart failure.
- •Male patients with lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH)with abnormal values of uroflowmetry
- •Male patients with lower urinary tract symptoms (LUTS) that assume medical treatment for BPH.
结局指标
主要结局
OAB-q SF 13
时间窗: 1 and 6 weeks
The OAB-q SF 6 is a questionnaire developed to evaluate the overactive bladder symptom and health-related quality of life.
VAS scale
时间窗: 1 and 6 weeks
Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions.
OAB-q SF 6
时间窗: 1 and 6 weeks
The OAB-q SF 6 is a questionnaire developed to evaluate the overactive bladder symptom and health-related quality of life.
PPIUS
时间窗: 1 and 6 weeks
The PPIUS is a questionnaire developed to evaluate the patient perception of intensity of urgency
PGI-1
时间窗: 1 and 6 weeks
PGI-I is a validated tool to estimate the improvement or the deterioration associated to the treatment.
IPSS total
时间窗: 1 and 6 weeks
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.
次要结局
- Qmax(1 and 6 weeks)
- Volume voided(1 and 6 weeks)
- RPM(1 and 6 weeks)
研究者
Francesco Chiancone
Assistant Medical Director, Principal Investigator
Cardarelli Hospital