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The Influence of Benign Prostatic Hyperplasia on Bladder Function

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ClinicalTrials.gov Identifier: NCT03098147
Recruitment Status : Unknown
Verified March 2017 by Xiangfu Zhou, Third Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Recruiting
First Posted : March 31, 2017
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Xiangfu Zhou, Third Affiliated Hospital, Sun Yat-Sen University

Brief 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. 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.

Condition or disease
Prostatic Hyperplasia

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: The Influence of Benign Prostatic Hyperplasia on Bladder Function: A Multi-centre, Prospective and Case-control Study
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. IPSS [ Time Frame: 1 year ]
    International Prostate Symptom Score


Secondary Outcome Measures :
  1. Qmax [ Time Frame: 1 year ]
    Maximum flow rate

  2. RUV [ Time Frame: 1 year ]
    residual urine volume

  3. OABSS [ Time Frame: 1 year ]
    Overactive Bladder Symptom Score



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
BPH in-patients from more than ten hospitals in southern China
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098147


Contacts
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Contact: Xiangfu Zhou, Professor +8618922102997 xiangfuzhou1962@163.com

Locations
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China, Guangdong
The Third Affiliated Hospital, Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 0086510000
Contact: Xiangfu Zhou, Professor         
Sponsors and Collaborators
Xiangfu Zhou
Investigators
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Study Director: Xiangfu Zhou, Professor The Third Affiliated Hospital, SUN YAT-SEN University
Additional Information:

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Responsible Party: Xiangfu Zhou, Professor, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03098147    
Other Study ID Numbers: Xzhou
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases