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Functional Changes of Urogenital System After Holmium Laser Prostatectomy

T

The Catholic University of Korea

Status

Unknown

Conditions

Prostatic Hyperplasia

Study type

Observational

Funder types

Other

Identifiers

NCT02033785
L201401N1
VC13OISI0222 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

86 estimated patients

Sex

Male

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Seung-Ju Lee, MD, PhD; Dong Sup Lee, MD, PhD

Data sourced from clinicaltrials.gov

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