Lower Urinary Tract SymptomsPOInTNCT03394651
Prostatic Obstruction Investigation Team Multicenter Study
An observational study of Lower Urinary Tract Symptoms, run by Changhai Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms
- What is being tested?
- Oral medications to treat lower urinary tract symptoms and Minimal invasive transurethral prostate procedures
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 11,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 1 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Chinese male, 45 year or elder, presenting lower urinary tract symptoms.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Qi-Xiang Song, MD, 8615021223013, rex_song918@qq.com
About this 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)
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.
Read the 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.
- Conditions
- Lower Urinary Tract Symptoms
- Being tested
- Oral medications to treat lower urinary tract symptoms, Minimal invasive transurethral prostate procedures
- Keywords
- male, lower urinary tract symptoms, comorbidities, chronic kidney diseases, urodynamics, medical therapy, surgical treatment
- Medical subject headings
- Lower Urinary Tract Symptoms, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral medications to treat lower urinary tract symptomsDrug
Patients in this group will receive oral medication(s) depending on doctors' prescriptions.
Minimal invasive transurethral prostate proceduresProcedure or surgery
Patients in this group will receive surgical treatment.
| Study group | Role | What they receive |
|---|---|---|
| Oral medication group | Patients in this group will receive oral medications to treat lower urinary tract symptoms Receives: Drug: Oral medications to treat lower urinary tract symptoms | |
| Surgical treatment group | Patients in this group receive minimal invasive transurethral prostate procedures. Receives: Procedure: Minimal invasive transurethral prostate procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of IPSS scores between baseline and follow-up
Measured using standard IPSS scoring system
Measured: 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: 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: 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: 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: 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: 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: 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: 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
systolic pressure/ diastolic pressure in mmHg.
Measured: 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
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: 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
The blood glucose level will be assessed using multiple serum parameters, namely, fast blood-glucose (mmol/L), glycosylated hemoglobin (%), glycated albumin (%)
Measured: 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
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), β2-MG (mg/L), NAG (U/L), Na (mmol/L), K (mmol/L), the degree of urine protein
Measured: 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
Serum PSA level will be measured to rule out prostate cancer
Measured: 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 RBC (/HP) between baseline and follow-up
Urine RBC will be measured to detect the incidence of urinary tract infection or tumor
Measured: 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 WBC (/HP) between baseline and follow-up
Urine WBC will be measured to detect the incidence of urinary tract infection
Measured: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start1 Apr 2018
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Hospital, Zhongda Hospital, RenJi Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The Second Hospital of Nanjing Medical University, Shanghai Changzheng Hospital, Third Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital of Suzhou Medical College, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Zhujiang Hospital, Zhejiang University, Shanghai Zhongshan Hospital, Xinqiao Hospital of Chongqing, Zhejiang Provincial People's Hospital, Huashan Hospital, Southwest Hospital, China, First Affiliated Hospital of Fujian Medical University, The First Affiliated Hospital of Beijing University, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Tianjin Medical University Second Hospital, The Third Affiliated Hospital of Beijing University, Jiangsu Provincial People's Hospital
- Responsible party
- Principal investigator, Yinghao Sun, Changhai Hospital
- Investigators
- Yinghao Sun, MD, PhD, Study chair, Changhai HospitalWei Xue, MD, PhD, Principal investigator, RenJi HospitalQi-Xiang Song, MD,PhD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394651
- Sponsor's protocol ID
- POINT-2017
- Acronym
- POInT
- Status last verified
- Nov 2018
- First submitted
- 14 Dec 2017
- Last updated
- 14 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31562145
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03394651
- Acronym / sponsor ID
- POInT / POINT-2017
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- male, lower urinary tract symptoms, comorbidities, chronic kidney diseases, urodynamics, medical therapy, surgical treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 11,500 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Beijing Hospital, Zhongda Hospital, RenJi Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The Second Hospital of Nanjing Medical University, Shanghai Changzheng Hospital, Third Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital of Suzhou Medical College, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Zhujiang Hospital, Zhejiang University, Shanghai Zhongshan Hospital, Xinqiao Hospital of Chongqing, Zhejiang Provincial People's Hospital, Huashan Hospital, Southwest Hospital, China, First Affiliated Hospital of Fujian Medical University, The First Affiliated Hospital of Beijing University, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Tianjin Medical University Second Hospital, The Third Affiliated Hospital of Beijing University, Jiangsu Provincial People's Hospital
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 9 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral medication group | – | Drug: Oral medications to treat lower urinary tract symptomsPatients in this group will receive oral medications to treat lower urinary tract symptoms |
| Surgical treatment group | – | Procedure: Minimal invasive transurethral prostate proceduresPatients in this group receive minimal invasive transurethral prostate procedures. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese male, 45 year or elder, presenting lower urinary tract symptoms.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral medications to treat lower urinary tract symptomsPatients in this group will receive oral medication(s) depending on doctors' prescriptions. | Drug | Oral medication group |
| Minimal invasive transurethral prostate proceduresPatients in this group will receive surgical treatment. | Procedure or surgery | Surgical treatment group |
Primary outcome
The changes of IPSS scores between baseline and follow-up
Time frame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided, or 1, 6, 18, 24 months after surgery.
Measured using standard IPSS scoring system
The changes of nocturia symptoms between baseline and follow-up
Time frame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided, or 1, 6, 18, 24 months after surgery
Measured using standard ICIQ-N-QoL score
The changes of erectile function between baseline and follow-up
Time frame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided, or 1, 6, 18, 24 months after surgery
Measured using standard IIEF score
The changes of maximum flow rate (ml/s) between baseline and follow-up
Time frame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery
Maximum flow rate will be measured using urinary flow study
The changes of post void residual volume (ml) between baseline and follow-up
Time frame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery
post void residual volume (ml) will be measured using urinary flow study
The changes of detrusor pressure at maximum flow rate (cmH2O) between baseline and follow-up
Time frame: Measured at baseline (if surgical treatment is required) and 1, 6, 18, 24 months after surgery
It will be measured using pressure-flow study
The changes of prostate volume (ml) between baseline and follow-up
Time frame: Measured at baseline and 6, 12, 18, 24, 36 months after oral medication treatment
Prostate volume (ml) will be measured using transrectal prostate ultrasound and calculated as: prostate volume (ml) = length (mm) * width (mm) * height (mm) * 0.52
The changes of intravesical prostate protrusion (mm) between baseline and follow-up
Time frame: Measured at baseline and 6, 12, 18, 24, 36 months after oral medication treatment
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
7 secondary outcomes
The changes of Blood pressure between baseline and follow-up
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 RBC (/HP) between baseline and follow-up
Time frame: 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 WBC (/HP) between baseline and follow-up
Time frame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Derived from this study: PubMed 31562145Song 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yinghao Sun, MD, PhD study chair
Changhai Hospital
Wei Xue, MD, PhD principal investigator
RenJi Hospital
Qi-Xiang Song, MD,PhD principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Urinary Tract Symptoms, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qi-Xiang Song, MD, PhD (086-15021223013, rex_song918@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of IPSS scores between baseline and follow-up (time frame: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided, or 1, 6, 18, 24 months after surgery.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03394651, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.