IncontinenceNCT03938844
BURCH Colposuspension or Transobturatuar Tape (TOT)
An observational study of Incontinence, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Stress urinary incontinence surgery combined with hysterectomy can often be applied to patients in the same session. The aim of this study was to determine which urinary incontinence surgery would be a better option for patients who would have hysterectomy. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Incontinence
- What is being tested?
- BURCH Colposuspension and TOT
- Type of treatment
- Surgery or procedure
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2014to 1 Jan 2017
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women between the ages of 40-65 who ; tlh operation with benign reasons and planned, and concurrent stress describing urinary incontinence.
Who may be able to join
- tlh operation with benign reasons and planned,
- concurrent stress describing urinary incontinence,
- Women between the ages of 40-65
Who cannot join
- planned operation with malignant causes,
- urinary tract infection,
- medication area for incontinence
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, 33404
About this study
Official title: Which Anti-İncontinence Surgery Option is Better in Patients With Total Laparoscopic Hysterectomy? BURCH Colposuspension or Transobturatuar Tape (TOT)
Stress urinary incontinence surgery combined with hysterectomy can often be applied to patients in the same session. The aim of this study was to determine which urinary incontinence surgery would be a better option for patients who would have hysterectomy.
The aim of this study was to retrospectively review the data of 69 patients between the ages of 2014 and 2017 who underwent total laparoscopic hysterectomy and anti-incontinence surgery (TOT and Burch) for benign indications (uterine pathology) and stress urinary incontinence (SUI). In addition to demographic data and preoperative examination findings, operative times, postoperative hemogram values, postvoiding residual amounts and complications were examined.
In addition, FSI test results of women with sexual activity were compared with ICIQ-UI and UDI-6 interrogations related to urinary incontinence.
- Conditions
- Incontinence
- Being tested
- BURCH Colposuspension, TOT
- Keywords
- hysterectomy, anti-incontinence surgery, Burch, Tot, stress 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.
BURCH ColposuspensionProcedure or surgery
stress urinary incontinence surgery ( burch or tot)
TOTProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| TLH with BURCH Colposuspension | the patients who underwent simultaneous burch copying with TLH was evaluated. In addition to demographic data and preoperative examination findings, operative times, postoperative hemogram values, postvoiding residual amounts and complications were examined. In addition, FSI test results of women with sexual activity were compared with ICIQ-UI and UDI-6 interrogations related to urinary incontinence. Receives: Procedure: BURCH Colposuspension | |
| TLH with Transobturatuar Tape (TOT) | In cases of simultaneous toting with TLH; In addition to demographic data and preoperative examination findings, operative times, postoperative hemogram values, postvoiding residual amounts and complications were examined. In addition, FSI test results of women with sexual activity were compared with ICIQ-UI and UDI-6 interrogations related to urinary incontinence. Receives: Procedure: TOT |
What is being measured
The primary outcome is the main question the study is designed to answer.
operation time
The duration of the procedure for stress urinary incontinence surgery was evaluated. recorded in minutes.
Measured: 2 years
postoperative hemogram values
postoperative hemogram values were evaluated. Recorded in g / dl.
Measured: 2 years
postvoiding residues
postvoiding residues were measured. Recorded in ml.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start1 Jan 2014
- Primary completion1 Jan 2017
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938844
- Sponsor's protocol ID
- 2018.01.07
- Status last verified
- May 2019
- First submitted
- 2 May 2019
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Anti-İncontinence Surgery Option is Better in Patients With Total Laparoscopic Hysterectomy? BURCH Colposuspension or Transobturatuar Tape (TOT)
- ClinicalTrials.gov ID
- NCT03938844
- Acronym / sponsor ID
- 2018.01.07
- Conditions
- Incontinence
- Keywords
- hysterectomy, anti-incontinence surgery, Burch, Tot, stress incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 6 May 2019 (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.
Stress urinary incontinence surgery combined with hysterectomy can often be applied to patients in the same session. The aim of this study was to determine which urinary incontinence surgery would be a better option for patients who would have hysterectomy.
The aim of this study was to retrospectively review the data of 69 patients between the ages of 2014 and 2017 who underwent total laparoscopic hysterectomy and anti-incontinence surgery (TOT and Burch) for benign indications (uterine pathology) and stress urinary incontinence (SUI). In addition to demographic data and preoperative examination findings, operative times, postoperative hemogram values, postvoiding residual amounts and complications were examined.
In addition, FSI test results of women with sexual activity were compared with ICIQ-UI and UDI-6 interrogations related to urinary incontinence.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TLH with BURCH Colposuspension | – | Procedure: BURCH Colposuspensionthe patients who underwent simultaneous burch copying with TLH was evaluated. In addition to demographic data and preoperative examination findings, operative times, postoperative hemogram values, postvoiding residual amounts and complications were examined. In addition, FSI test results of women with sexual activity were compared with ICIQ-UI and UDI-6 interrogations related to urinary incontinence. |
| TLH with Transobturatuar Tape (TOT) | – | Procedure: TOTIn cases of simultaneous toting with TLH; In addition to demographic data and preoperative examination findings, operative times, postoperative hemogram values, postvoiding residual amounts and complications were examined. In addition, FSI test results of women with sexual activity were compared with ICIQ-UI and UDI-6 interrogations related to urinary incontinence. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women between the ages of 40-65 who ; tlh operation with benign reasons and planned, and concurrent stress describing urinary incontinence.
Key inclusion criteria (3 listed)
- tlh operation with benign reasons and planned,
- concurrent stress describing urinary incontinence,
- Women between the ages of 40-65
Key exclusion criteria (3 listed)
- planned operation with malignant causes,
- urinary tract infection,
- medication area for incontinence
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 |
|---|---|---|
| BURCH Colposuspensionstress urinary incontinence surgery ( burch or tot) | Procedure or surgery | TLH with BURCH Colposuspension |
| TOT | Procedure or surgery | TLH with Transobturatuar Tape (TOT) |
Primary outcome
operation time
Time frame: 2 years
The duration of the procedure for stress urinary incontinence surgery was evaluated. recorded in minutes.
postoperative hemogram values
Time frame: 2 years
postoperative hemogram values were evaluated. Recorded in g / dl.
postvoiding residues
Time frame: 2 years
postvoiding residues were measured. Recorded in ml.
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 7 May 2019.
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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 Incontinence, 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 3 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 7 May 2019. 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?
operation time (time frame: 2 years). The study lists 3 primary outcomes in all. 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 7 May 2019; AzTrials last refreshed its copy on 6 Nov 2026.