Prostatic Obstruction Investigation Team Multicenter Study (POInT)

Naval Military Medical University

Status: Unknown

Conditions: Lower Urinary Tract Symptoms

Treatments: Drug: Oral medications to treat lower urinary tract symptoms; Procedure: Minimal invasive transurethral prostate procedures

Study type: Observational

Funder types: Other

Identifiers

NCT03394651

POINT-2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11,500 estimated patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

11,500 participants in 2 patient groups

Oral medication group

Description:

Patients in this group will receive oral medications to treat lower urinary tract symptoms

Treatment:

Drug: Oral medications to treat lower urinary tract symptoms

Surgical treatment group

Description:

Patients in this group receive minimal invasive transurethral prostate procedures.

Treatment:

Procedure: Minimal invasive transurethral prostate procedures