Prostatic HyperplasiaNCT02243085
Predictors of de Novo Urge Urinary Incontinence After Photoselective Vaporization of the Prostate
An observational study of Prostatic Hyperplasia and Urgency, run by DongGuk University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 90 years, men only
- Conditions the study is for
- Prostatic Hyperplasia, Urgency, Urinary Incontinence
- How many people
- 126 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2014to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- previous prostate or bladder surgery
- a previous diagnosis of urethral stricture or prostate carcinoma or bladder cancer or neurogenic bladder disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Dongguk University ilsan Hospital
Goyang-si, Gyeonggi-do, 410-773
Min Chul Cho, M.D., Ph.D., 82-31-961-7456 ext. 7456, cmc1206@empal.com
About this study
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.
- Conditions
- Prostatic Hyperplasia, Urgency, Urinary Incontinence
- Medical subject headings
- Prostatic Hyperplasia, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| photoselective vaporization | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
de novo urge urinary incontinence at 6 months after surgery
de novo urge urinary incontinence: OABSS (overactive bladder symptom score) question 4 of ≥ 2
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DongGuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Chul Cho, DongGuk University
- Investigators
- Min Chul Cho, M.D., Ph.D., Principal investigator, DongGuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243085
- Sponsor's protocol ID
- MCho2
- Status last verified
- Sep 2014
- First submitted
- 13 Sep 2014
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of de Novo Urge Urinary Incontinence After Photoselective Vaporization of the Prostate
- ClinicalTrials.gov ID
- NCT02243085
- Acronym / sponsor ID
- MCho2
- Conditions
- Prostatic Hyperplasia, Urgency, Urinary Incontinence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- DongGuk UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (estimated)
- First posted
- 17 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| photoselective vaporization | – | – |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- previous prostate or bladder surgery
- a previous diagnosis of urethral stricture or prostate carcinoma or bladder cancer or neurogenic bladder disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
de novo urge urinary incontinence at 6 months after surgery
Time frame: 6 months postoperatively
de novo urge urinary incontinence: OABSS (overactive bladder symptom score) question 4 of ≥ 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Chul Cho, M.D., Ph.D. principal investigator
DongGuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Hyperplasia and Urgency, run by DongGuk University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Chul Cho, M.D., Ph.D. (82-31-961-7456 ext. 7456, cmc1206@empal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
de novo urge urinary incontinence at 6 months after surgery (time frame: 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2014.