Prostatic Obstruction Investigation Team Multicenter Study

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)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03394651

Acronym

POInT

Enrollment

11500

Registered

2018-01-09

Start date

2018-04-01

Completion date

2022-04-01

Last updated

2018-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Urinary Tract Symptoms

Keywords

male, lower urinary tract symptoms, comorbidities, chronic kidney diseases, urodynamics, medical therapy, surgical treatment

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.

Interventions

DRUGOral medications to treat lower urinary tract symptoms

Patients in this group will receive oral medication(s) depending on doctors' prescriptions.

PROCEDUREMinimal invasive transurethral prostate procedures

Patients in this group will receive surgical treatment.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

45 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Male, 45 years or older. 2. The presence of lower urinary tract symptoms, i.e. frequency, urgency, urge incontinence, dysuria, post-micturition dribble, etc. 3. All participants have signed the informed consent form. 4. Clinical data comes from 23 selected hospitals spread across China.

Exclusion criteria

1. Lower urinary tract symptoms as a result of urethral stricture, stone diseases, chronic prostatitis, space-occupying lesions etc. 2. Diagnosis or suspicion of renal, ureteral, bladder, prostate, urethral or pelvic tumor. 3. Known neurogenic or congenital lower urinary tract dysfunction. 4. Known urinary tract, prostate or pelvic surgical history. 5. Existence of anatomical abnormalities of the urinary tract (e.g. diverticulum of the bladder or urethra, ectopic ureteral orifice etc.). 6. The presence of acute conditions, such as, urinary tract infection, fever, heart failure etc. 7. Patients with poor compliance or cognitive competence.

Design outcomes

Primary

Measure	Time frame	Description
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 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 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 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 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

Measure	Time frame	Description
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 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 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
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 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

Countries

China

Contacts

Primary ContactQi-Xiang Song, MD, PhD

rex_song918@qq.com086-15021223013

Backup ContactWei Xue, MD, PhD

uroxuewei@163.com086-13801931604

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026