Prostatic HyperplasiaNCT03098147
The Influence of Benign Prostatic Hyperplasia on Bladder Function
An observational study of Prostatic Hyperplasia, run by Xiangfu Zhou at 1 site in China.
Trial summary
Lower urinary tract symptoms(LUTS) are the main symptoms of benign prostatic hyperplasia(BPH), a benign but progressive disease which can advance to be with overactive bladder(OAB) symptoms. Moreover, LUTS and OAB symptoms can badly influence patients' especially the elderly's quality of life. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Prostatic Hyperplasia
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2017to Apr 2020
- How long will I take part?
- 1 Year
- 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 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: BPH in-patients from more than ten hospitals in southern China
Who may be able to join
- Sign the informed consent.
- The BPH in-patients who take 'dysuria' as the main self-reported symptom and meet the following conditions, 1) Maximal urinary flow rate less than 20 ml per second, 2) Volume of prostate more than 20ml measured by transrectal ultrasound 3) PSA ranges from 0 to 10ng/ml 4) IPSS>1
Who cannot join
- The lower urinary tract obstruction caused not by BPH
- Had a history of prostate cancer, surgery for benign prostatic hyperplasia or neurogenic bladder.
- using medications known to affect urination or had a severe concomitant disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 0086510000
Xiangfu Zhou, Professor
About this study
Official title: The Influence of Benign Prostatic Hyperplasia on Bladder Function: A Multi-centre, Prospective and Case-control Study
Lower urinary tract symptoms(LUTS) are the main symptoms of benign prostatic hyperplasia(BPH), a benign but progressive disease which can advance to be with overactive bladder(OAB) symptoms. Moreover, LUTS and OAB symptoms can badly influence patients' especially the elderly's quality of life. Therefore, it appears to be urge to carry out researches on the functional impairment of bladder along with the advance of BPH. Besides, the management aimed at improving the LUTS and OAB symptoms come to be the key one among the management of BPH. For a long period, medication and surgery sustain to be the two most common therapies for BPH patients. Both patients and urologists prefer pharmacotherapeutics to surgery，which contributes to the rising number of BPH patients companied with OAB symptoms and storing symptoms complaint post-surgery. In fact, investigators usually find bladder impairment macroscopically in the BPH surgery: mild may be the trabeculation, worse can be the cabin, and severe may be the diverticula. Furthermore, it's not uncommon that patients with a long BPH history continually suffer from dysuria after surgery due to the detrusor muscle weakness. Consequently, investigators need to catch a moment when investigators should operate on such a patient in order to harvest a satisfying outcome. And perhaps the moment should be ahead of the existing guideline suggests. Thus, for understanding the influence of BPH on bladder function, investigators plan to conduct a prospective, case-control study recruiting in-patients with different degree of obstruction. Our team wish that such a clinical trail could provide valuable evidence for us to find out relatively better operating timing and serial indications. For the purpose of improving the quality of life and prolong life-span, investigators design the study above to maximum the operating outcome and minimize the bladder dysfunction.
- Conditions
- Prostatic Hyperplasia
- Medical subject headings
- Prostatic Hyperplasia
What is being measured
The primary outcome is the main question the study is designed to answer.
IPSS
International Prostate Symptom Score
Measured: 1 year
Secondary outcomes (3)
Qmax
Maximum flow rate
Measured: 1 year
RUV
residual urine volume
Measured: 1 year
OABSS
Overactive Bladder Symptom Score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start1 Mar 2017
- Primary completionApr 2019 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HyperplasiaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Xiangfu Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiangfu Zhou, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Xiangfu Zhou, Professor, Study director, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098147
- Sponsor's protocol ID
- Xzhou
- Status last verified
- Mar 2017
- First submitted
- 27 Mar 2017
- Last updated
- 31 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Benign Prostatic Hyperplasia on Bladder Function: A Multi-centre, Prospective and Case-control Study
- ClinicalTrials.gov ID
- NCT03098147
- Acronym / sponsor ID
- Xzhou
- Conditions
- Prostatic Hyperplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Xiangfu ZhouUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 31 Mar 2017 (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.
Lower urinary tract symptoms(LUTS) are the main symptoms of benign prostatic hyperplasia(BPH), a benign but progressive disease which can advance to be with overactive bladder(OAB) symptoms. Moreover, LUTS and OAB symptoms can badly influence patients' especially the elderly's quality of life. Therefore, it appears to be urge to carry out researches on the functional impairment of bladder along with the advance of BPH. Besides, the management aimed at improving the LUTS and OAB symptoms come to be the key one among the management of BPH. For a long period, medication and surgery sustain to be the two most common therapies for BPH patients. Both patients and urologists prefer pharmacotherapeutics to surgery，which contributes to the rising number of BPH patients companied with OAB symptoms and storing symptoms complaint post-surgery. In fact, investigators usually find bladder impairment macroscopically in the BPH surgery: mild may be the trabeculation, worse can be the cabin, and severe may be the diverticula. Furthermore, it's not uncommon that patients with a long BPH history continually suffer from dysuria after surgery due to the detrusor muscle weakness. Consequently, investigators need to catch a moment when investigators should operate on such a patient in order to harvest a satisfying outcome. And perhaps the moment should be ahead of the existing guideline suggests. Thus, for understanding the influence of BPH on bladder function, investigators plan to conduct a prospective, case-control study recruiting in-patients with different degree of obstruction. Our team wish that such a clinical trail could provide valuable evidence for us to find out relatively better operating timing and serial indications. For the purpose of improving the quality of life and prolong life-span, investigators design the study above to maximum the operating outcome and minimize the bladder dysfunction.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- BPH in-patients from more than ten hospitals in southern China
Key inclusion criteria (2 listed)
- Sign the informed consent.
- The BPH in-patients who take 'dysuria' as the main self-reported symptom and meet the following conditions, 1) Maximal urinary flow rate less than 20 ml per second, 2) Volume of prostate more than 20ml measured by transrectal ultrasound 3) PSA ranges from 0 to 10ng/ml 4) IPSS>1
Key exclusion criteria (3 listed)
- The lower urinary tract obstruction caused not by BPH
- Had a history of prostate cancer, surgery for benign prostatic hyperplasia or neurogenic bladder.
- using medications known to affect urination or had a severe concomitant disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IPSS
Time frame: 1 year
International Prostate Symptom Score
3 secondary outcomes
Qmax
Time frame: 1 year
RUV
Time frame: 1 year
OABSS
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Individual participant dataSharing planned: No
Related trials for Prostatic Hyperplasia
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RT-310 Safety and Feasibility BPH Study
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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.
Xiangfu Zhou, Professor study director
Third Affiliated Hospital, Sun Yat-Sen University
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 Prostatic Hyperplasia, run by Xiangfu Zhou 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 2 inclusion and 3 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 31 Mar 2017. 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 Xiangfu Zhou, Professor (+8618922102997, xiangfuzhou1962@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IPSS (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2017.