Prostatic Obstruction Investigation Team Multicenter Study
- Conditions
- Lower Urinary Tract Symptoms
- Interventions
- Drug: Oral medications to treat lower urinary tract symptomsProcedure: Minimal invasive transurethral prostate procedures
- Registration Number
- NCT03394651
- Lead Sponsor
- Changhai Hospital
- Brief Summary
The present is a multicenter, observational study organized by the Prostatic Obstruction Investigation Team (POInT), with a main purpose of looking into the current status and symptom progression of male lower urinary tract symptoms patients in China.
- Detailed Description
Lower urinary tract symptoms (LUTS) is a common medical condition negatively affecting people's quality of life worldwide. LUTS may be caused by structural or functional abnormalities in 1 or more parts of the lower urinary tract, including bladder, prostate, internal and external urethral sphincter and distal urethra. Furthermore, evidence exists to demonstrate that LUTS is associate with lifestyle factors, systemic comorbidities and geriatric diseases, such as smoking, obesity, metabolic syndrome, chronic kidney diseases and chronic obstructive pulmonary disease etc. So far, there is lack of evidence to illustrate the symptom features and comorbidities among Chinese male LUTS patients. Therefore, this multicenter clinical study aims to investigate the present status and symptom progression among male LUTS patients in China.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 11500
- Male, 45 years or older.
- The presence of lower urinary tract symptoms, i.e. frequency, urgency, urge incontinence, dysuria, post-micturition dribble, etc.
- All participants have signed the informed consent form.
- Clinical data comes from 23 selected hospitals spread across China.
- Lower urinary tract symptoms as a result of urethral stricture, stone diseases, chronic prostatitis, space-occupying lesions etc.
- Diagnosis or suspicion of renal, ureteral, bladder, prostate, urethral or pelvic tumor.
- Known neurogenic or congenital lower urinary tract dysfunction.
- Known urinary tract, prostate or pelvic surgical history.
- Existence of anatomical abnormalities of the urinary tract (e.g. diverticulum of the bladder or urethra, ectopic ureteral orifice etc.).
- The presence of acute conditions, such as, urinary tract infection, fever, heart failure etc.
- Patients with poor compliance or cognitive competence.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Oral medication group Oral medications to treat lower urinary tract symptoms Patients in this group will receive oral medications to treat lower urinary tract symptoms Surgical treatment group Minimal invasive transurethral prostate procedures Patients in this group receive minimal invasive transurethral prostate procedures.
- Primary Outcome Measures
Name Time Method The changes of IPSS scores between baseline and follow-up Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided, or 1, 6, 18, 24 months after surgery. Measured using standard IPSS scoring system
The changes of nocturia symptoms between baseline and follow-up Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided, or 1, 6, 18, 24 months after surgery Measured using standard ICIQ-N-QoL score
The changes of erectile function between baseline and follow-up Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided, or 1, 6, 18, 24 months after surgery Measured using standard IIEF score
The changes of maximum flow rate (ml/s) between baseline and follow-up Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery Maximum flow rate will be measured using urinary flow study
The changes of detrusor pressure at maximum flow rate (cmH2O) between baseline and follow-up Measured at baseline (if surgical treatment is required) and 1, 6, 18, 24 months after surgery It will be measured using pressure-flow study
The changes of post void residual volume (ml) between baseline and follow-up Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery post void residual volume (ml) will be measured using urinary flow study
The changes of intravesical prostate protrusion (mm) between baseline and follow-up Measured at baseline and 6, 12, 18, 24, 36 months after oral medication treatment Intravesical prostate protrusion (mm) will be measured using transrectal prostate ultrasound and calculated as the distance between the tip of the prostate median lobe and bladder neck
The changes of prostate volume (ml) between baseline and follow-up Measured at baseline and 6, 12, 18, 24, 36 months after oral medication treatment Prostate volume (ml) will be measured using transrectal prostate ultrasound and calculated as: prostate volume (ml) = length (mm) \* width (mm) \* height (mm) \* 0.52
- Secondary Outcome Measures
Name Time Method The changes of Kidney function between baseline and follow-up Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery. The kidney function will be assessed using multiple serum and urine parameters, namely, serum creatinine (μmoI/L), cystatin-C (mg/L), eGRF (calculated via both CKD-EPI equation and MDRD equation), BUN (mmol/L), uric acid (μmoI/L), β2-MG (mg/L), NAG (U/L), Na (mmol/L), K (mmol/L), the degree of urine protein
The changes of WBC (/HP) between baseline and follow-up Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery. Urine WBC will be measured to detect the incidence of urinary tract infection
The changes of Blood pressure between baseline and follow-up Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery. systolic pressure/ diastolic pressure in mmHg.
The changes of Blood lipid between baseline and follow-up Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery. The blood lipid level will be assessed using multiple serum parameters, namely, cholesterol (mmol/L), triglyceride (mmol/L), high-density lipoprotein (mmol/L), low-density lipoprotein (mmol/L), lipoprotein-a (mmol/L)
The changes of Blood glucose between baseline and follow-up Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery. The blood glucose level will be assessed using multiple serum parameters, namely, fast blood-glucose (mmol/L), glycosylated hemoglobin (%), glycated albumin (%)
The changes of PSA (ng/ml) between baseline and follow-up Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery. Serum PSA level will be measured to rule out prostate cancer
The changes of RBC (/HP) between baseline and follow-up Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery. Urine RBC will be measured to detect the incidence of urinary tract infection or tumor
Trial Locations
- Locations (1)
Changhai Hospital
🇨🇳Shanghai, Shanghai, China