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| Name | Class |
|---|---|
| Beijing Hospital | OTHER_GOV |
| Zhongda Hospital | OTHER |
| RenJi Hospital | OTHER |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral medication group | Patients in this group will receive oral medications to treat lower urinary tract symptoms |
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| Surgical treatment group | Patients in this group receive minimal invasive transurethral prostate procedures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral medications to treat lower urinary tract symptoms | Drug | Patients in this group will receive oral medication(s) depending on doctors' prescriptions. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Chinese male, 45 year or elder, presenting lower urinary tract symptoms.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qi-Xiang Song, MD, PhD | Contact | 086-15021223013 | rex_song918@qq.com | |
| Wei Xue, MD, PhD | Contact | 086-13801931604 | uroxuewei@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yinghao Sun, MD, PhD | Changhai Hospital | Study Chair |
| Wei Xue, MD, PhD | RenJi Hospital | Principal Investigator |
| Qi-Xiang Song, MD,PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31562145 | Derived | Song QX, Zhang Y, Ye X, Xue W, Xu C, Xu J, Abrams P, Sun Y; Prostatic Obstruction Investigation Team (POInT). Current status and progression of lower urinary tract symptoms in Chinese male patients: the protocol and rationale for a nationwide, hospital-based, prospective, multicentre study. BMJ Open. 2019 Sep 27;9(9):e028378. doi: 10.1136/bmjopen-2018-028378. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 19, 2017 | Dec 19, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
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| OTHER |
| The Second Hospital of Nanjing Medical University | OTHER |
| Shanghai Changzheng Hospital | OTHER |
| Third Affiliated Hospital, Sun Yat-Sen University | OTHER |
| First Affiliated Hospital of Suzhou Medical College | OTHER |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Zhujiang Hospital | OTHER |
| Zhejiang University | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
| Xinqiao Hospital of Chongqing | OTHER |
| Zhejiang Provincial People's Hospital | OTHER |
| Huashan Hospital | OTHER |
| Southwest Hospital, China | OTHER |
| First Affiliated Hospital of Fujian Medical University | OTHER |
| The First Affiliated Hospital of Beijing University | UNKNOWN |
| Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | OTHER |
| Tianjin Medical University Second Hospital | OTHER |
| The Third Affiliated Hospital of Beijing University | UNKNOWN |
| Jiangsu Provincial People's Hospital | OTHER |
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blood and urine
| Minimal invasive transurethral prostate procedures | Procedure | Patients in this group will receive surgical treatment. |
|
| 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 |
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. |
| Changhai Hospital |
| Principal Investigator |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |