NCT02243085

Brief Summary

The aim of this study was to investigate the incidence of de novo urge urinary incontinence after the photoselective vaporization of the prostate for benign prostatic hyperplasia using the validated overactive bladder symptom score, and to determine the predictors of de novo urge urinary incontinence following the photoselective vaporization of the prostate.

Trial Health

55
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Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 17, 2014

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Last Updated

September 17, 2014

Status Verified

September 1, 2014

Enrollment Period

2 months

First QC Date

September 13, 2014

Last Update Submit

September 15, 2014

Conditions

Prostatic HyperplasiaUrgencyUrinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • de novo urge urinary incontinence at 6 months after surgery

    de novo urge urinary incontinence: OABSS (overactive bladder symptom score) question 4 of ≥ 2

    6 months postoperatively

Study Arms (1)

photoselective vaporization

Eligibility Criteria

Age40 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

men who underwent photoselective vaporization of the prostate using 80 watt potassium-titanyl-phosphate (KTP) laser or 120 watt high-power-system (HPS) laser for benign prostatic hyperplasia refractory to medical treatment

You may qualify if:

  • men in whom 6-months follow-up data were available
  • men who did not complain of urge urinary incontinence based on the OABSS (overactive symptom score): OABSS question 4 score of ≤ 1

You may not qualify if:

  • previous prostate or bladder surgery
  • a previous diagnosis of urethral stricture or prostate carcinoma or bladder cancer or neurogenic bladder disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dongguk University ilsan Hospital

Goyang-si, Gyeonggi-do, 410-773, South Korea

RECRUITING

MeSH Terms

Conditions

Prostatic HyperplasiaUrinary Incontinence

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Min Chul Cho, M.D., Ph.D.

    DongGuk University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Chul Cho, M.D., Ph.D.

CONTACT

82-31-961-7456cmc1206@empal.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 13, 2014

First Posted

September 17, 2014

Study Start

August 1, 2014

Primary Completion

October 1, 2014

Last Updated

September 17, 2014

Record last verified: 2014-09

Locations

KR(1)