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Functional Changes of Urogenital System After Holmium Laser Prostatectomy

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ClinicalTrials.gov Identifier: NCT02033785
Recruitment Status : Unknown
Verified January 2014 by Seung-Ju Lee, The Catholic University of Korea.
Recruitment status was:  Not yet recruiting
First Posted : January 13, 2014
Last Update Posted : January 13, 2014
Sponsor:
Information provided by (Responsible Party):
Seung-Ju Lee, The Catholic University of Korea

Brief Summary:

Holmium laser prostatectomy will enhance voiding function.

Holmium laser prostatectomy will enhance sleep quality.

Holmium laser prostatectomy will enhance renal function.

Holmium laser prostatectomy will enhance erectile function.

Holmium laser prostatectomy will enhance the health-related quality of life.


Condition or disease
Prostatic Hyperplasia

Detailed Description:
Check urodynamic parameters for voiding function evaluation Check low urinary tract symptoms (IPSS: international prostate symptom score) for voiding function evaluation Check Pittsburgh Sleep Quality Index for sleep quality evaluation Check estimated glomerular filtration rate and urine protein/creatinine ratio for renal function evaluation Check International Index of Erectile Function score (IIEF-5) for erectile function evaluation Check nocturnal penile tumescence parameters for erectile function evaluation Check 36-Item Short- Form Health Survey (SF-36) for evaluation of the health-related quality of life.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 86 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Prospective Cohort Study of Holmium Laser Prostatectomy For Observing Functional Changes in Benign Prostate Hyperplasia Patients
Study Start Date : February 2014
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Maximal flow rate [ Time Frame: 3 months ]
    This parameter can be obtained from urodynamic study.

  2. Maximal detrusor pressure [ Time Frame: 3 months ]
    This parameter can be obtained from urodynamic study.

  3. Bladder outlet obstruction index [ Time Frame: 3 months ]
    This parameter can be obtained from urodynamic study.

  4. schäfer grade [ Time Frame: 3 months ]
    This parameter can be obtained from urodynamic study.

  5. Compliance [ Time Frame: 3 months ]
    This parameter can be obtained from urodynamic study.


Secondary Outcome Measures :
  1. Maximal flow rate [ Time Frame: 12 months ]
    This parameter can be obtained from urodynamic study.

  2. Maximal detrusor pressure [ Time Frame: 12 months ]
    This parameter can be obtained from urodynamic study.

  3. Bladder outlet obstruction index [ Time Frame: 12 months ]
    This parameter can be obtained from urodynamic study.

  4. schäfer grade [ Time Frame: 12 months ]
    This parameter can be obtained from urodynamic study.

  5. Compliance [ Time Frame: 12 months ]
    This parameter can be obtained from urodynamic study.


Other Outcome Measures:
  1. international index of erectile function [ Time Frame: 3 months ]
  2. international index of erectile function [ Time Frame: 12 months ]
  3. normalized rigidity activity unit in penile tip [ Time Frame: 3 months ]
    This parameter can be obtained from nocturnal penile tumescence test.

  4. normalized rigidity activity unit in penile tip [ Time Frame: 12 months ]
    This parameter can be obtained from nocturnal penile tumescence test.

  5. normalized rigidity activity unit in penile base [ Time Frame: 3 months ]
    This parameter can be obtained from nocturnal penile tumescence test.

  6. Estimated glomerular filtration rate [ Time Frame: 3 months ]
  7. Estimated glomerular filtration rate [ Time Frame: 12 months ]
  8. Urinary protein to creatinine ratio [ Time Frame: 3 months ]
  9. Urinary protein to creatinine ratio [ Time Frame: 12 months ]
  10. International prostate symptom score [ Time Frame: 3 months ]
  11. International prostate symptom score [ Time Frame: 12 months ]
  12. Pittsburgh Sleep Quality Index [ Time Frame: 3 months ]
  13. Pittsburgh Sleep Quality Index [ Time Frame: 12 months ]
  14. Health-related quality of life, short form 36 score [ Time Frame: 3 months ]
  15. Health-related quality of life, short form 36 score [ Time Frame: 12 months ]


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:   Probability Sample
Study Population
Primary Care Clinic
Criteria

Inclusion Criteria:

  • Prostate size over 30 cc by transrectal ultrasonography
  • prostate-specific antigen level less than 10 ng/ml
  • International prostate symptom score more than 7
  • At least one of followings: Bladder outlet obstruction index > 40, maximal flow rate < 10 cc/sec, postvoid residual urine >100cc or schäfer grade II or more

Exclusion Criteria:

  • Patients who do not want surgery
  • Evidence of prostate cancer or bladder cancer during evaluation or treatment
  • All of followings: Bladder outlet obstruction index is less than 40, maximal flow rate is 10 or more cc/sec, postvoid residual urine is less than 100cc and schäfer grade II or less
  • Major depressive disorder, Dementia, Parkinson's disease, Neurological deficits
  • History of pelvic radiation therapy
  • Poorly controlled diabetes mellitus or hypertension

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): NCT02033785


Contacts
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Contact: Seung-Ju Lee, MD, PhD 82-31-249-8305 lee.seungju@gmail.com
Contact: Dong Sup Lee, MD, PhD 82-31-249-8276 lds@catholic.ac.kr

Locations
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Korea, Republic of
St. Vincent's Hospital, The Catholic University of Korea Not yet recruiting
Suwon, Gyeonggi-do, Korea, Republic of, 442-723
Sponsors and Collaborators
The Catholic University of Korea
Investigators
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Study Chair: Seung-Ju Lee The Catholic University of Korea
Principal Investigator: Dong Sup Lee The Catholic University of Korea

Additional Information:

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Responsible Party: Seung-Ju Lee, Senior researcher, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT02033785     History of Changes
Other Study ID Numbers: L201401N1
VC13OISI0222 ( Other Identifier: IRB of St. Vincent's Hospital )
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: January 13, 2014
Last Verified: January 2014
Keywords provided by Seung-Ju Lee, The Catholic University of Korea:
Prostatic hyperplasia
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male