Stress Urinary IncontinenceNCT03225742
The Impact of Postoperative Catheterization Time After Stress Incontinence Surgery to Success of Surgery
An observational study of Stress Urinary Incontinence and Surgery, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
After incontinence surgery, the patients randomly will be divided two groups. In group A postoperative urinary catheterization time will be applied one day, In group B catheterization will be applied two days. After removal of urinary catheter, residual volume will be measured and voiding function will be controlled. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women only
- Conditions the study is for
- Stress Urinary Incontinence, Surgery
- What is being tested?
- to measure the residual volume after catheterization
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2017to 1 Feb 2018
- 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 35 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: the women who have stress incontinence at physical examination and urodynamics tests
Who may be able to join
- stress incontinence
- resistant to medical treatment
Who cannot join
- had no surgery before
- has no accompanying uterine descensus
- has no neurogenic disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Postoperative Catheterization Time After Stress Incontinence Surgery to Voiding Dysfunction, Urinary Retention and Success of Surgery
After incontinence surgery, the patients randomly will be divided two groups. In group A postoperative urinary catheterization time will be applied one day, In group B catheterization will be applied two days. After removal of urinary catheter, residual volume will be measured and voiding function will be controlled. In postoperative period; third, sixth month and one year after surgery stress test will be applied to control success of surgery
- Conditions
- Stress Urinary Incontinence, Surgery
- Being tested
- to measure the residual volume after catheterization
- 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.
to measure the residual volume after catheterizationDiagnostic test
after first micturition to measure the residual volume in bladder
| Study group | Role | What they receive |
|---|---|---|
| urinary catheterization time; one day | the patient urinary catheterization after surgery; one day Receives: Diagnostic Test: to measure the residual volume after catheterization | |
| urinary catheterization time; two day | the patient urinary catheterization after surgery; two day Receives: Diagnostic Test: to measure the residual volume after catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
early postoperative voiding dysfunction and urinary retention
after removal of urinary catheter, has residual volume much more than 150cc (to be measured with urinary catheterization)
Measured: two days
Secondary outcomes (1)
The success of stress urinary incontinence surgery
third, sixth month and one year after surgery, absence of stress urinary incontinence
Measured: third month, sixth month and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start1 Feb 2017
- Primary completion1 Aug 2017
- Study completion1 Feb 2018
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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerem Doga Seckin, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225742
- Sponsor's protocol ID
- 2016/01
- Status last verified
- Mar 2018
- First submitted
- 14 Jul 2017
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Postoperative Catheterization Time After Stress Incontinence Surgery to Voiding Dysfunction, Urinary Retention and Success of Surgery
- ClinicalTrials.gov ID
- NCT03225742
- Acronym / sponsor ID
- 2016/01
- Conditions
- Stress Urinary Incontinence, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 21 Jul 2017 (actual)
- 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.
After incontinence surgery, the patients randomly will be divided two groups. In group A postoperative urinary catheterization time will be applied one day, In group B catheterization will be applied two days. After removal of urinary catheter, residual volume will be measured and voiding function will be controlled. In postoperative period; third, sixth month and one year after surgery stress test will be applied to control success of surgery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| urinary catheterization time; one day | – | Diagnostic Test: to measure the residual volume after catheterizationthe patient urinary catheterization after surgery; one day |
| urinary catheterization time; two day | – | Diagnostic Test: to measure the residual volume after catheterizationthe patient urinary catheterization after surgery; two day |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- the women who have stress incontinence at physical examination and urodynamics tests
Key inclusion criteria (2 listed)
- stress incontinence
- resistant to medical treatment
Key exclusion criteria (3 listed)
- had no surgery before
- has no accompanying uterine descensus
- has no neurogenic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| to measure the residual volume after catheterizationafter first micturition to measure the residual volume in bladder | Diagnostic test | urinary catheterization time; one day, urinary catheterization time; two day |
Primary outcome
early postoperative voiding dysfunction and urinary retention
Time frame: two days
after removal of urinary catheter, has residual volume much more than 150cc (to be measured with urinary catheterization)
1 secondary outcome
The success of stress urinary incontinence surgery
Time frame: third month, sixth month and one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Surgery, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 20 Feb 2020. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early postoperative voiding dysfunction and urinary retention (time frame: two days). 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 20 Feb 2020.