Prostatic Obstruction Investigation Team Multicenter Study

Lower Urinary Tract Symptoms Clinical Trial

— POInT  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03394651
• Other study ID #: POINT-2017
• Status: Recruiting
• Start date: April 1, 2018
• Est. completion date: April 1, 2022

Study information

• Verified date: November 2018
• Source: Changhai Hospital
• Contact: Qi-Xiang Song, MD, PhD
• Phone: 086-15021223013
• Email: rex_song918[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 11500
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms

Intervention

Drug:
• Oral medications to treat lower urinary tract symptoms
Patients in this group will receive oral medication(s) depending on doctors' prescriptions.

Procedure:
• Minimal invasive transurethral prostate procedures
Patients in this group will receive surgical treatment.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (23)

Lead Sponsor

Collaborator

Changhai Hospital

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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), ß2-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.
Secondary	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.
Secondary	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.
Secondary	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.