Prostatic Obstruction Investigation Team Multicenter Study (POInT)

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)

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.

Study Overview

• Status: Unknown
• Conditions: Lower Urinary Tract Symptoms
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 11500

Contacts and Locations

• Study Contact: Name: Qi-Xiang Song, MD, PhD; Phone Number: 086-15021223013; Email: rex_song918@qq.com
• Study Contact Backup: Name: Wei Xue, MD, PhD; Phone Number: 086-13801931604; Email: uroxuewei@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Recruiting
      • Changhai Hospital
      • Contact: Qi-Xiang Song, MD; Phone Number: 8615021223013; Email: rex_song918@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Chinese male, 45 year or elder, presenting lower urinary tract symptoms.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: Shanghai Zhongshan Hospital; RenJi Hospital; Huashan Hospital; Southwest Hospital, China; First Affiliated Hospital of Fujian Medical University; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; Beijing Hospital; Zhujiang Hospital; Third Affiliated Hospital, Sun Yat-Sen University; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Zhongda Hospital; Zhejiang University; Xinqiao Hospital of Chongqing; Tianjin Medical University Second Hospital; Zhejiang Provincial People's Hospital; Daping Hospital and the Research Institute of Surgery of the Third Military Medical University; Shanghai Changzheng Hospital; The Second Hospital of Nanjing Medical University; Jiangsu Provincial People's Hospital; First Affiliated Hospital of Suzhou Medical College; The First Affiliated Hospital of Beijing University; The Third Affiliated Hospital of Beijing University
• Investigators: Principal Investigator: Wei Xue, MD, PhD, Renji Hospital; Principal Investigator: Qi-Xiang Song, MD,PhD, Changhai Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: January 8, 2018
• First Posted (Actual): January 9, 2018

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 11, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: comorbidities; male; surgical treatment; urodynamics; lower urinary tract symptoms; medical therapy; chronic kidney diseases
• Additional Relevant MeSH Terms: Urological Manifestations; Lower Urinary Tract Symptoms
• Other Study ID Numbers: POINT-2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No