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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

May 21, 2012
May 22, 2012
July 2011
July 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01604148 on ClinicalTrials.gov Archive Site
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Retrospective Review a Comprehensive Case Database of HoLEP Procedure Performed by a Single Surgeon
Retrospective Review of a Comprehensive Case Database of HoLEP (Holmium Laser Enucleation of Prostate) Procedure Performed by a Single Surgeon

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Probability Sample

Patients underwent Holmium Laser Enucleation of the Prostate by a single surgeon
  • Lower Urinary Tract Symptoms
  • Benign Prostatic Hyperplasia
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HoLEP group
Holmium Laser Enucleation of Prostate Group
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Male
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01604148
2011-06-082
No
Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Kyu-Sung Lee, Ph.D, M.D. Samsung Medical Center
Samsung Medical Center
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP