Clinical trial NCT03394651: Prostatic Obstruction Investigation Team Multicenter Study
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lower Urinary Tract Symptoms
Keywords: male
lower urinary tract symptoms
comorbidities
chronic kidney diseases
urodynamics
medical therapy
surgical treatment
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Hospital
name: Zhongda Hospital
name: RenJi Hospital
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: The Second Hospital of Nanjing Medical University
name: Shanghai Changzheng Hospital
name: Third Affiliated Hospital, Sun Yat-Sen University
name: First Affiliated Hospital of Suzhou Medical College
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Zhujiang Hospital
name: Zhejiang University
name: Shanghai Zhongshan Hospital
name: Xinqiao Hospital of Chongqing
name: Zhejiang Provincial People's Hospital
name: Huashan Hospital
name: Southwest Hospital, China
name: First Affiliated Hospital of Fujian Medical University
name: The First Affiliated Hospital of Beijing University
name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: Tianjin Medical University Second Hospital
name: The Third Affiliated Hospital of Beijing University
name: Jiangsu Provincial People's Hospital
First posted: 2018-01-09
Enrollment: 11500
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese male, 45 year or elder, presenting lower urinary tract symptoms.

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.

Eligibility 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.

Primary outcomes:
measure: The changes of IPSS scores between baseline and follow-up
timeFrame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided, or 1, 6, 18, 24 months after surgery.
measure: The changes of nocturia symptoms between baseline and follow-up
timeFrame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided, or 1, 6, 18, 24 months after surgery
measure: The changes of erectile function between baseline and follow-up
timeFrame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided, or 1, 6, 18, 24 months after surgery
measure: The changes of maximum flow rate (ml/s) between baseline and follow-up
timeFrame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery
measure: The changes of post void residual volume (ml) between baseline and follow-up
timeFrame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery
measure: The changes of detrusor pressure at maximum flow rate (cmH2O) between baseline and follow-up
timeFrame: Measured at baseline (if surgical treatment is required) and 1, 6, 18, 24 months after surgery
measure: The changes of prostate volume (ml) between baseline and follow-up
timeFrame: Measured at baseline and 6, 12, 18, 24, 36 months after oral medication treatment
measure: The changes of intravesical prostate protrusion (mm) between baseline and follow-up
timeFrame: Measured at baseline and 6, 12, 18, 24, 36 months after oral medication treatment
Secondary outcomes:
measure: The changes of Blood pressure between baseline and follow-up
timeFrame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.
measure: The changes of Blood lipid between baseline and follow-up
timeFrame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.
measure: The changes of Blood glucose between baseline and follow-up
timeFrame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.
measure: The changes of Kidney function between baseline and follow-up
timeFrame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.
measure: The changes of PSA (ng/ml) between baseline and follow-up
timeFrame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.
measure: The changes of RBC (/HP) between baseline and follow-up
timeFrame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.
measure: The changes of WBC (/HP) between baseline and follow-up
timeFrame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Yinghao Sun, MD, PhD
role: STUDY_CHAIR
affiliation: RenJi Hospital
name: Wei Xue, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Changhai Hospital
name: Qi-Xiang Song, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.