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NCT01604148 Clinical Trial

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

Benign Prostatic Hyperplasia Clinical Trial

Official title:
Retrospective Review of a Comprehensive Case Database of HoLEP (Holmium Laser Enucleation of Prostate) Procedure Performed by a Single Surgeon

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01604148
Other study ID # 2011-06-082
Secondary ID
Status Completed
Phase N/A
First received May 21, 2012
Last updated May 22, 2012
Start date July 2011
Est. completion date July 2011

Study information
Verified date May 2012
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Male
Age group 50 Years to 80 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

See also
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