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The Influence of Benign Prostatic Hyperplasia on Bladder Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Xiangfu Zhou, Third Affiliated Hospital, Sun Yat-Sen University

Tracking Information
First Submitted Date March 27, 2017
First Posted Date March 31, 2017
Last Update Posted Date March 31, 2017
Actual Study Start Date March 1, 2017
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 30, 2017)
IPSS [ Time Frame: 1 year ]
International Prostate Symptom Score
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 30, 2017)
  • Qmax [ Time Frame: 1 year ]
    Maximum flow rate
  • RUV [ Time Frame: 1 year ]
    residual urine volume
  • OABSS [ Time Frame: 1 year ]
    Overactive Bladder Symptom Score
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title The Influence of Benign Prostatic Hyperplasia on Bladder Function
Official Title The Influence of Benign Prostatic Hyperplasia on Bladder Function: A Multi-centre, Prospective and Case-control Study
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population BPH in-patients from more than ten hospitals in southern China
Condition Prostatic Hyperplasia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 30, 2017)
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2020
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sexes Eligible for Study: Male
Ages 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
Administrative Information
NCT Number NCT03098147
Other Study ID Numbers Xzhou
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Xiangfu Zhou, Third Affiliated Hospital, Sun Yat-Sen University
Study Sponsor Xiangfu Zhou
Collaborators Not Provided
Study Director: Xiangfu Zhou, Professor The Third Affiliated Hospital, SUN YAT-SEN University
PRS Account Third Affiliated Hospital, Sun Yat-Sen University
Verification Date March 2017