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The Influence of Benign Prostatic Hyperplasia on Bladder Function

NCT ID: NCT03098147

Last Updated: 2017-03-31

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

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-01

Study Completion Date

2020-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prostatic Hyperplasia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Sign the informed consent.
2. 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

Exclusion Criteria

1. The lower urinary tract obstruction caused not by BPH
2. Had a history of prostate cancer, surgery for benign prostatic hyperplasia or neurogenic bladder.
3. using medications known to affect urination or had a severe concomitant disease
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Xiangfu Zhou

OTHER

Sponsor Role lead

Responsible Party

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Xiangfu Zhou

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xiangfu Zhou, Professor

Role: STUDY_DIRECTOR

Third Affiliated Hospital, Sun Yat-Sen University

Locations

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The Third Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiangfu Zhou, Professor

Role: CONTACT

Phone: +8618922102997

Email: [email protected]

Facility Contacts

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Xiangfu Zhou, Professor

Role: primary

Other Identifiers

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Xzhou

Identifier Type: -

Identifier Source: org_study_id