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Functional Changes of Urogenital System After Holmium Laser Prostatectomy

Prospective Cohort Study of Holmium Laser Prostatectomy For Observing Functional Changes in Benign Prostate Hyperplasia Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02033785
Enrollment
86
Registered
2014-01-13
Start date
2014-02-28
Completion date
2016-03-31
Last updated
2014-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Hyperplasia

Keywords

Prostatic hyperplasia

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.

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.

Interventions

None listed

Sponsors

The Catholic University of Korea
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
50 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Maximal flow rate3 monthsThis parameter can be obtained from urodynamic study.
Compliance3 monthsThis parameter can be obtained from urodynamic study.
schäfer grade3 monthsThis parameter can be obtained from urodynamic study.
Bladder outlet obstruction index3 monthsThis parameter can be obtained from urodynamic study.
Maximal detrusor pressure3 monthsThis parameter can be obtained from urodynamic study.

Secondary

MeasureTime frameDescription
Maximal detrusor pressure12 monthsThis parameter can be obtained from urodynamic study.
Maximal flow rate12 monthsThis parameter can be obtained from urodynamic study.
Bladder outlet obstruction index12 monthsThis parameter can be obtained from urodynamic study.
schäfer grade12 monthsThis parameter can be obtained from urodynamic study.
Compliance12 monthsThis parameter can be obtained from urodynamic study.

Other

MeasureTime frameDescription
Estimated glomerular filtration rate3 months
normalized rigidity activity unit in penile base3 monthsThis parameter can be obtained from nocturnal penile tumescence test.
normalized rigidity activity unit in penile tip3 monthsThis parameter can be obtained from nocturnal penile tumescence test.
International prostate symptom score3 months
Pittsburgh Sleep Quality Index3 months
Health-related quality of life, short form 36 score3 months
Urinary protein to creatinine ratio3 months
international index of erectile function3 months

Countries

South Korea

Contacts

Primary ContactSeung-Ju Lee, MD, PhD
lee.seungju@gmail.com82-31-249-8305
Backup ContactDong Sup Lee, MD, PhD
lds@catholic.ac.kr82-31-249-8276

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026