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

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ClinicalTrials.gov Identifier: NCT01604148
Recruitment Status : Completed
First Posted : May 23, 2012
Last Update Posted : May 23, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia

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.

Study Design

Study Type : Observational
Actual Enrollment : 300 participants
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
Study Start Date : July 2011
Primary Completion Date : July 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

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

Groups and Cohorts

HoLEP group
Holmium Laser Enucleation of Prostate Group

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes 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

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

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): NCT01604148

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

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01604148     History of Changes
Other Study ID Numbers: 2011-06-082
First Posted: May 23, 2012    Key Record Dates
Last Update Posted: May 23, 2012
Last Verified: May 2012

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

Additional relevant MeSH terms:
Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urological Manifestations
Signs and Symptoms