Prostatic Obstruction Investigation Team Multicenter Study

NCT03394651 | Unknown

• 1 other identifier: POINT-2017
• Study Type: observational
• Target: 11,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Urinary Tract Symptoms

Keywords

male; lower urinary tract symptoms; comorbidities; chronic kidney diseases; urodynamics; medical therapy; surgical treatment

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (7)

• The changes of Blood pressure between baseline and follow-up

  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

  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

  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

  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

  Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.

Study Arms (2)

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

Surgical treatment group

Patients in this group receive minimal invasive transurethral prostate procedures.

Procedure: Minimal invasive transurethral prostate procedures

Interventions

Oral medications to treat lower urinary tract symptoms DRUG

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

Oral medication group

Minimal invasive transurethral prostate procedures PROCEDURE

Patients in this group will receive surgical treatment.

Surgical treatment group

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Male, 45 years or older.
• The presence of lower urinary tract symptoms, i.e. frequency, urgency, urge incontinence, dysuria, post-micturition dribble, etc.
• All participants have signed the informed consent form.
• Clinical data comes from 23 selected hospitals spread across China.

You may not qualify if:

• Lower urinary tract symptoms as a result of urethral stricture, stone diseases, chronic prostatitis, space-occupying lesions etc.
• Diagnosis or suspicion of renal, ureteral, bladder, prostate, urethral or pelvic tumor.
• Known neurogenic or congenital lower urinary tract dysfunction.
• Known urinary tract, prostate or pelvic surgical history.
• Existence of anatomical abnormalities of the urinary tract (e.g. diverticulum of the bladder or urethra, ectopic ureteral orifice etc.).
• The presence of acute conditions, such as, urinary tract infection, fever, heart failure etc.
• Patients with poor compliance or cognitive competence.

Sponsors & Collaborators

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

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 31562145 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood and urine

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Yinghao Sun, MD, PhD

  Changhai Hospital

  STUDY CHAIR

• Wei Xue, MD, PhD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

• Qi-Xiang Song, MD,PhD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qi-Xiang Song, MD, PhD

CONTACT

086-15021223013; rex_song918@qq.com

Wei Xue, MD, PhD

CONTACT

086-13801931604; uroxuewei@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: January 9, 2018
• Study Start: April 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2022
• Last Updated: November 14, 2018

Record last verified: 2018-11

Locations

CN (1)