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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
Sponsor:
Collaborators:
Beijing Hospital
Zhongda Hospital
RenJi Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
The Second Hospital of Nanjing Medical University
Shanghai Changzheng Hospital
Third Affiliated Hospital, Sun Yat-Sen University
The First Affiliated Hospital of Suzhou University
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Zhujiang Hospital
Zhejiang University
Shanghai Zhongshan Hospital
Xinqiao Hospital of Chongqing
Zhejiang Provincial People’s Hospital
Huashan Hospital
Southwest Hospital, China
First Affiliated Hospital of Fujian Medical University
The First Affiliated Hospital of Beijing University
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Tianjin Medical University Second Hospital
The Third Affiliated Hospital of Beijing University
Jiangsu Provincial People's Hospital
Information provided by (Responsible Party):
Yinghao Sun, Changhai Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Lower Urinary Tract Symptoms Drug: Oral medications to treat lower urinary tract symptoms Procedure: Minimal invasive transurethral prostate procedures

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.

Study Design
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Oral medication group
Patients in this group will receive oral medications to treat lower urinary tract symptoms
 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.
 Procedure: Minimal invasive transurethral prostate procedures
Patients in this group will receive surgical treatment.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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 (%)

  4. 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

  5. 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

  6. 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

  7. 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
blood and urine

Eligibility Criteria
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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
Study Population
Chinese male, 45 year or elder, presenting lower urinary tract symptoms.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Qi-Xiang Song, MD, PhD 086-15021223013 rex_song918@qq.com
Contact: Wei Xue, MD, PhD 086-13801931604 uroxuewei@163.com

Locations
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China, Shanghai
Changhai Hospital Recruiting
Shanghai, Shanghai, China, 200433
Contact: Qi-Xiang Song, MD    8615021223013    rex_song918@qq.com   
Sponsors and Collaborators
Changhai Hospital
Beijing Hospital
Zhongda Hospital
RenJi Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
The Second Hospital of Nanjing Medical University
Shanghai Changzheng Hospital
Third Affiliated Hospital, Sun Yat-Sen University
The First Affiliated Hospital of Suzhou University
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Zhujiang Hospital
Zhejiang University
Shanghai Zhongshan Hospital
Xinqiao Hospital of Chongqing
Zhejiang Provincial People’s Hospital
Huashan Hospital
Southwest Hospital, China
First Affiliated Hospital of Fujian Medical University
The First Affiliated Hospital of Beijing University
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Tianjin Medical University Second Hospital
The Third Affiliated Hospital of Beijing University
Jiangsu Provincial People's Hospital
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Yinghao Sun, Changhai Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] December 19, 2017

More Information
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Responsible Party: Yinghao Sun, Professor, Changhai Hospital
ClinicalTrials.gov Identifier: NCT03394651     History of Changes
Other Study ID Numbers: POINT-2017
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yinghao Sun, Changhai Hospital:
male
lower urinary tract symptoms
comorbidities
chronic kidney diseases
 urodynamics
medical therapy
surgical treatment
Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms