NCT02033785

Brief Summary

Holmium laser prostatectomy will enhance voiding function. Holmium laser prostatectomy will enhance sleep quality. Holmium laser prostatectomy will enhance renal function. Holmium laser prostatectomy will enhance erectile function. Holmium laser prostatectomy will enhance the health-related quality of life.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 7, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 13, 2014

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

January 13, 2014

Status Verified

January 1, 2014

Enrollment Period

2 years

First QC Date

January 7, 2014

Last Update Submit

January 9, 2014

Conditions

Prostatic Hyperplasia

Keywords

Prostatic hyperplasia

Outcome Measures

Primary Outcomes (5)

  • Maximal flow rate

    This parameter can be obtained from urodynamic study.

    3 months

  • Maximal detrusor pressure

    This parameter can be obtained from urodynamic study.

    3 months

  • Bladder outlet obstruction index

    This parameter can be obtained from urodynamic study.

    3 months

  • schäfer grade

    This parameter can be obtained from urodynamic study.

    3 months

  • Compliance

    This parameter can be obtained from urodynamic study.

    3 months

Secondary Outcomes (5)

  • Maximal flow rate

    12 months

  • Maximal detrusor pressure

    12 months

  • Bladder outlet obstruction index

    12 months

  • schäfer grade

    12 months

  • Compliance

    12 months

Other Outcomes (15)

  • international index of erectile function

    3 months

  • international index of erectile function

    12 months

  • normalized rigidity activity unit in penile tip

    3 months

  • +12 more other outcomes

Eligibility Criteria

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

Primary Care Clinic

You may qualify if:

  • Prostate size over 30 cc by transrectal ultrasonography
  • prostate-specific antigen level less than 10 ng/ml
  • International prostate symptom score more than 7
  • At least one of followings: Bladder outlet obstruction index \> 40, maximal flow rate \< 10 cc/sec, postvoid residual urine \>100cc or schäfer grade II or more

You may not qualify if:

  • Patients who do not want surgery
  • Evidence of prostate cancer or bladder cancer during evaluation or treatment
  • All of followings: Bladder outlet obstruction index is less than 40, maximal flow rate is 10 or more cc/sec, postvoid residual urine is less than 100cc and schäfer grade II or less
  • Major depressive disorder, Dementia, Parkinson's disease, Neurological deficits
  • History of pelvic radiation therapy
  • Poorly controlled diabetes mellitus or hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Vincent's Hospital, The Catholic University of Korea

Suwon, Gyeonggi-do, 442-723, South Korea

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Seung-Ju Lee

    The Catholic University of Korea

    STUDY CHAIR

  • Dong Sup Lee

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung-Ju Lee, MD, PhD

CONTACT

82-31-249-8305lee.seungju@gmail.com

Dong Sup Lee, MD, PhD

CONTACT

82-31-249-8276lds@catholic.ac.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior researcher

Study Record Dates

First Submitted

January 7, 2014

First Posted

January 13, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

January 13, 2014

Record last verified: 2014-01

Locations

KR(1)