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Retrospective Review a Comprehensive Case Database of HoLEP Procedure Performed by a Single Surgeon

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01604148
First received: May 21, 2012
Last updated: May 22, 2012
Last verified: May 2012
History of Changes
  Purpose

Persistent detrusor overactivity (DO) after transurethral prostatectomy results in symptomatic failure in more than one third of the patients. Storage symptoms are major complaints in the early postoperative period after Holmium Laser Enucleation of the Prostate (HoLEP). To investigate the effect of DO in the patients with Benign Prostatic Obstruction (BPO), the investigators evaluated the changes in the storage symptoms following HoLEP in conjunction with the prescription of the anticholinergic drugs.


Condition
Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Review of a Comprehensive Case Database of HoLEP (Holmium Laser Enucleation of Prostate) Procedure Performed by a Single Surgeon

Resource links provided by NLM:

Drug Information available for: Holmium
U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Enrollment: 300
Study Start Date: July 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
HoLEP group
Holmium Laser Enucleation of Prostate Group

Detailed Description:

Eighty men with urodynamically proven BPO underwent HoLEP at our hospital. All patients were evaluated preoperatively with International Prostate Symptom Score (IPSS), International Continence Society male questionnaire short form (ICS-SF), 3-day frequency - volume charts (FVC), transrectal ultrasonography, and uroflowmetry with postvoid residual urine volume. The patients were divided into two groups; BPO without DO (Non-DO group) and BPO with DO (DO group). We assessed the patients postoperatively at 2 weeks, 1, 3 and 6 months after surgery.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients underwent Holmium Laser Enucleation of the Prostate by a single surgeon

Criteria

Inclusion Criteria:

  • 50 yrs or greater
  • International prostatic symptom score >= 12
  • Bladder outlet obstruction confirmed by pressure-flow study (BOOI > 20)

Exclusion Criteria:

  • Patients with urologic malignancies such as prostate cancer and bladder cancer
  • Patients underwent urethral, prostate surgery
  • Patients with urethral stricture or bladder diverticulum or bladder neck contracture
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604148

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 130-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Kyu-Sung Lee, Ph.D, M.D. Samsung Medical Center
  More Information

No publications provided

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01604148     History of Changes
Other Study ID Numbers: 2011-06-082
Study First Received: May 21, 2012
Last Updated: May 22, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Holmium Laser Enucleation of Prostate

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013