Stress Urinary IncontinenceNCT02242422
Serial Changes in Micturition Symptoms, Urine Flow and Bladder Voiding Efficiency Following Transobturator Tape Surgery
An observational study of Stress Urinary Incontinence, run by DongGuk University at 1 site in South Korea.
Trial summary
The aim of this study was to identify the serial changes in lower urinary tract symptoms (LUTS), urine flow and bladder voiding efficiency after transobturator tape (TOT) surgery for treatment of female stress urinary incontinence. Read more about this study
- Who is it for?
- Ages 20 to 90 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2014to Nov 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 20 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women who underwent transobturator tape surgery for treatment of female stress urinary incontinence
Who may be able to join
- women who underwent transobturator tape surgery for treatment of female stress urinary incontinence
Who cannot join
- any urinary tract infection
- pregnancy
- bladder malignancy
- postoperative follow-up of less than 12 months
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
Official title: Serial Changes in Lower Urinary Tract Symptoms, Urine Flow and Bladder Voiding Efficiency Following Transobturator Tape Surgery for Treatment of Female Stress Urinary Incontinence
The aim of this study was to identify the serial changes in lower urinary tract symptoms (LUTS), urine flow and bladder voiding efficiency after transobturator tape (TOT) surgery for treatment of female stress urinary incontinence.
- Conditions
- Stress Urinary Incontinence
- Medical subject headings
- Urinary Incontinence, Stress
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 |
|---|---|---|
| transobturator tape | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total overactive bladder symptom score (OABSS) after surgery
Measured: 1-week, and 1-, 3-, 6- and 12-months after surgery
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 completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies 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
- 200 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
- NCT02242422
- Sponsor's protocol ID
- MCho3
- Status last verified
- Sep 2014
- First submitted
- 14 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
- Serial Changes in Lower Urinary Tract Symptoms, Urine Flow and Bladder Voiding Efficiency Following Transobturator Tape Surgery for Treatment of Female Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT02242422
- Acronym / sponsor ID
- MCho3
- Conditions
- Stress Urinary Incontinence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- DongGuk UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Nov 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 identify the serial changes in lower urinary tract symptoms (LUTS), urine flow and bladder voiding efficiency after transobturator tape (TOT) surgery for treatment of female stress urinary incontinence.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transobturator tape | – | – |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women who underwent transobturator tape surgery for treatment of female stress urinary incontinence
Key inclusion criteria (1 listed)
- women who underwent transobturator tape surgery for treatment of female stress urinary incontinence
Key exclusion criteria (4 listed)
- any urinary tract infection
- pregnancy
- bladder malignancy
- postoperative follow-up of less than 12 months
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
Change in total overactive bladder symptom score (OABSS) after surgery
Time frame: 1-week, and 1-, 3-, 6- and 12-months after surgery
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 Stress Urinary Incontinence, 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 1 inclusion and 4 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?
Change in total overactive bladder symptom score (OABSS) after surgery (time frame: 1-week, and 1-, 3-, 6- and 12-months after surgery). 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.