Prostatic Obstruction Investigation Team Multicenter Study

NCT ID: NCT03394651

Last Updated: 2018-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

11500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2022-04-01

Brief Summary

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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

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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.

Conditions

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Lower Urinary Tract Symptoms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Oral medication group

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

Oral medications to treat lower urinary tract symptoms

Intervention Type DRUG

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.

Minimal invasive transurethral prostate procedures

Intervention Type PROCEDURE

Patients in this group will receive surgical treatment.

Interventions

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Oral medications to treat lower urinary tract symptoms

Patients in this group will receive oral medication(s) depending on doctors' prescriptions.

Intervention Type DRUG

Minimal invasive transurethral prostate procedures

Patients in this group will receive surgical treatment.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Beijing Hospital

OTHER_GOV

Sponsor Role collaborator

Zhongda Hospital

OTHER

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role collaborator

The Second Hospital of Nanjing Medical University

OTHER

Sponsor Role collaborator

Shanghai Changzheng Hospital

OTHER

Sponsor Role collaborator

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Suzhou Medical College

OTHER

Sponsor Role collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Zhujiang Hospital

OTHER

Sponsor Role collaborator

Zhejiang University

OTHER

Sponsor Role collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role collaborator

Xinqiao Hospital of Chongqing

OTHER

Sponsor Role collaborator

Zhejiang Provincial People's Hospital

OTHER

Sponsor Role collaborator

Huashan Hospital

OTHER

Sponsor Role collaborator

Southwest Hospital, China

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Beijing University

UNKNOWN

Sponsor Role collaborator

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

OTHER

Sponsor Role collaborator

Tianjin Medical University Second Hospital

OTHER

Sponsor Role collaborator

The Third Affiliated Hospital of Beijing University

UNKNOWN

Sponsor Role collaborator

Jiangsu Provincial People's Hospital

OTHER

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yinghao Sun

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yinghao Sun, MD, PhD

Role: STUDY_CHAIR

Changhai Hospital

Wei Xue, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Qi-Xiang Song, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

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Changhai Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qi-Xiang Song, MD, PhD

Role: CONTACT

086-15021223013

Wei Xue, MD, PhD

Role: CONTACT

086-13801931604

Facility Contacts

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Qi-Xiang Song, MD

Role: primary

8615021223013

References

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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.

Reference Type DERIVED
PMID: 31562145 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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POINT-2017

Identifier Type: -

Identifier Source: org_study_id

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