Prostatic Obstruction Investigation Team Multicenter Study (POInT)
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ClinicalTrials.gov Identifier: NCT03394651 |
Recruitment Status :
Recruiting
First Posted : January 9, 2018
Last Update Posted : November 14, 2018
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Condition or disease | Intervention/treatment |
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Lower Urinary Tract Symptoms | Drug: Oral medications to treat lower urinary tract symptoms Procedure: Minimal invasive transurethral prostate procedures |
Study Type : | Observational |
Estimated Enrollment : | 11500 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | 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) |
Actual Study Start Date : | April 1, 2018 |
Estimated Primary Completion Date : | April 1, 2019 |
Estimated Study Completion Date : | April 1, 2022 |

Group/Cohort | Intervention/treatment |
---|---|
Oral medication group
Patients in this group will receive oral medications to treat lower urinary tract symptoms
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Drug: Oral medications to treat lower urinary tract symptoms
Patients in this group will receive oral medication(s) depending on doctors' prescriptions. |
Surgical treatment group
Patients in this group receive minimal invasive transurethral prostate procedures.
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Procedure: Minimal invasive transurethral prostate procedures
Patients in this group will receive surgical treatment. |
- The changes of IPSS scores between baseline and follow-up [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
- The changes of intravesical prostate protrusion (mm) between baseline and follow-up [ Time Frame: 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 Blood pressure between baseline and follow-up [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 PSA (ng/ml) between baseline and follow-up [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394651
Contact: Qi-Xiang Song, MD, PhD | 086-15021223013 | rex_song918@qq.com | |
Contact: Wei Xue, MD, PhD | 086-13801931604 | uroxuewei@163.com |
China, Shanghai | |
Changhai Hospital | Recruiting |
Shanghai, Shanghai, China, 200433 | |
Contact: Qi-Xiang Song, MD 8615021223013 rex_song918@qq.com |
Study Chair: | Yinghao Sun, MD, PhD | Changhai Hospital | |
Principal Investigator: | Wei Xue, MD, PhD | RenJi Hospital | |
Principal Investigator: | Qi-Xiang Song, MD,PhD | Changhai Hospital |
Documents provided by Yinghao Sun, Changhai Hospital:
Responsible Party: | Yinghao Sun, Professor, Changhai Hospital |
ClinicalTrials.gov Identifier: | NCT03394651 |
Other Study ID Numbers: |
POINT-2017 |
First Posted: | January 9, 2018 Key Record Dates |
Last Update Posted: | November 14, 2018 |
Last Verified: | November 2018 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
male lower urinary tract symptoms comorbidities chronic kidney diseases |
urodynamics medical therapy surgical treatment |
Lower Urinary Tract Symptoms Urological Manifestations |