NCT01604148

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2012

Completed
Last Updated

May 23, 2012

Status Verified

May 1, 2012

Enrollment Period

Same day

First QC Date

May 21, 2012

Last Update Submit

May 22, 2012

Conditions

Lower Urinary Tract SymptomsBenign Prostatic Hyperplasia

Keywords

Holmium Laser Enucleation of Prostate

Study Arms (1)

HoLEP group

Holmium Laser Enucleation of Prostate Group

Eligibility Criteria

Age50 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 130-710, South Korea

Location

MeSH Terms

Conditions

Lower Urinary Tract SymptomsProstatic Hyperplasia

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsProstatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Kyu-Sung Lee, Ph.D, M.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2012

First Posted

May 23, 2012

Study Start

July 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

May 23, 2012

Record last verified: 2012-05

Locations

KR(1)