Prostatic Obstruction Investigation Team Multicenter Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Current Status and Progression of Symptoms and Comorbidities Among Male Lower Urinary Tract Symptoms Patients in China: a Multicenter Study From Prostatic Obstruction Investigation Team (POInT)

Conditions
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Lower Urinary Tract Symptoms

Intervention / Treatment
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* Drug: Oral medications to treat lower urinary tract symptoms
* Procedure: Minimal invasive transurethral prostate procedures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oral medication group<br>Patients in this group will receive oral medications to treat lower urinary tract symptoms | Drug: Oral medications to treat lower urinary tract symptoms<br>* Patients in this group will receive oral medication(s) depending on doctors' prescriptions.<br>|
| Surgical treatment group<br>Patients in this group receive minimal invasive transurethral prostate procedures. | Procedure: Minimal invasive transurethral prostate procedures<br>* Patients in this group will receive surgical treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of IPSS scores between baseline and follow-up | Measured using standard IPSS scoring system | Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided, or 1, 6, 18, 24 months after surgery. | 
| The changes of nocturia symptoms between baseline and follow-up | Measured using standard ICIQ-N-QoL score | Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided, or 1, 6, 18, 24 months after surgery | 
| The changes of erectile function between baseline and follow-up | Measured using standard IIEF score | Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided, or 1, 6, 18, 24 months after surgery | 
| The changes of maximum flow rate (ml/s) between baseline and follow-up | Maximum flow rate will be measured using urinary flow study | Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery | 
| The changes of post void residual volume (ml) between baseline and follow-up | post void residual volume (ml) will be measured using urinary flow study | Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery | 
| The changes of detrusor pressure at maximum flow rate (cmH2O) between baseline and follow-up | It will be measured using pressure-flow study | Measured at baseline (if surgical treatment is required) and 1, 6, 18, 24 months after surgery | 
| The changes of prostate volume (ml) between baseline and follow-up | Prostate volume (ml) will be measured using transrectal prostate ultrasound and calculated as: prostate volume (ml) = length (mm) * width (mm) * height (mm) * 0.52 | Measured at baseline and 6, 12, 18, 24, 36 months after oral medication treatment | 
| The changes of intravesical prostate protrusion (mm) between baseline and follow-up | 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 | Measured at baseline and 6, 12, 18, 24, 36 months after oral medication treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of Blood pressure between baseline and follow-up | systolic pressure/ diastolic pressure in mmHg. | Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery. | 
| The changes of Blood lipid between baseline and follow-up | 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) | Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery. | 
| The changes of Blood glucose between baseline and follow-up | The blood glucose level will be assessed using multiple serum parameters, namely, fast blood-glucose (mmol/L), glycosylated hemoglobin (%), glycated albumin (%) | Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery. | 
| The changes of Kidney function between baseline and follow-up | 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 | Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery. | 
| The changes of PSA (ng/ml) between baseline and follow-up | Serum PSA level will be measured to rule out prostate cancer | Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery. | 
| The changes of RBC (/HP) between baseline and follow-up | Urine RBC will be measured to detect the incidence of urinary tract infection or tumor | Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery. | 
| The changes of WBC (/HP) between baseline and follow-up | Urine WBC will be measured to detect the incidence of urinary tract infection | Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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male, lower urinary tract symptoms, comorbidities, chronic kidney diseases, urodynamics, medical therapy, surgical treatment