IncontinenceNCT04071288
Burch Colposuspension and Mid-urethral Sling Operations
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 is common in women. the treatment of this condition is surgery. investigators add stress incontinence surgery to patients who undergo total laparoscopic hysterectomy for benign reasons. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Incontinence
- What is being tested?
- total laparoscopic hysterectomy and simultaneous incontinence surgery with benign causes
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2017to 1 Jan 2020
- How long will I take part?
- 2 Years
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: A total laparoscopic hysterectomy was planned for benign causes, Patients who underwent simultaneous operation for incontinence
Who may be able to join
- A total laparoscopic hysterectomy was planned for benign causes,
- Patients scheduled for simultaneous operation for incontinence
Who cannot join
- Patients previously operated for urinary incontinence
- Patients whose diagnosis of stress urinary incontinence is uncertain
- Patients with urinary tract infection
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: Comparison of Burch Colposuspension and Mid-urethral Sling Operations for Stress Urinary Incontinence
Stress urinary incontinence is common in women. the treatment of this condition is surgery. investigators add stress incontinence surgery to patients who undergo total laparoscopic hysterectomy for benign reasons.
Depending on the patient's general condition and indications, the operation can be performed by vaginal approach, as well as mid-urethral sling operations and laparoscopic burch colposuspension.
The researchers aimed to compare these two types of operations performed on patients. In this way, the superiority and disadvantage of each other in two procedures will be demonstrated.
- Conditions
- Incontinence
- Being tested
- total laparoscopic hysterectomy and simultaneous incontinence surgery with benign causes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total laparoscopic hysterectomy and simultaneous incontinence surgery with benign causesProcedure or surgery
total laparoscopic hysterectomy and simultaneous incontinence surgery with benign causes; Burch colposuspension and mid-urethral sling operations for stress urinary incontinence
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic burch colposuspension | who underwent total laparoscopic hysterectomy for benign causes and had simultaneous incontinence; patients undergoing laparoscopic burch colposuspension Receives: Procedure: total laparoscopic hysterectomy and simultaneous incontinence surgery with benign causes | |
| mid urethral sling operations | who underwent total laparoscopic hysterectomy for benign causes and had simultaneous incontinence; patients undergoing mid-urethral sling operations Receives: Procedure: total laparoscopic hysterectomy and simultaneous incontinence surgery with benign causes |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence
in patients who underwent total laparoscopic hysterectomy and simultaneous incontinence surgery for benign reasons; In the early postoperative period, relapse will be evaluated at 1 month, 6 months and 12 months.
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 posted28 Aug 2019
- Study start1 Jan 2017
- Primary completion1 Jan 2019
- Study completion1 Jan 2020
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 2 Years
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
- NCT04071288
- Sponsor's protocol ID
- 2018.02.02
- Status last verified
- Feb 2020
- First submitted
- 24 Aug 2019
- Last updated
- 11 Feb 2020
- 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 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Burch Colposuspension and Mid-urethral Sling Operations for Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT04071288
- Acronym / sponsor ID
- 2018.02.02
- Conditions
- Incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 28 Aug 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 is common in women. the treatment of this condition is surgery. investigators add stress incontinence surgery to patients who undergo total laparoscopic hysterectomy for benign reasons.
Depending on the patient's general condition and indications, the operation can be performed by vaginal approach, as well as mid-urethral sling operations and laparoscopic burch colposuspension.
The researchers aimed to compare these two types of operations performed on patients. In this way, the superiority and disadvantage of each other in two procedures will be demonstrated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic burch colposuspension | – | Procedure: total laparoscopic hysterectomy and simultaneous incontinence surgery with benign causeswho underwent total laparoscopic hysterectomy for benign causes and had simultaneous incontinence; patients undergoing laparoscopic burch colposuspension |
| mid urethral sling operations | – | Procedure: total laparoscopic hysterectomy and simultaneous incontinence surgery with benign causeswho underwent total laparoscopic hysterectomy for benign causes and had simultaneous incontinence; patients undergoing mid-urethral sling operations |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- A total laparoscopic hysterectomy was planned for benign causes, Patients who underwent simultaneous operation for incontinence
Key inclusion criteria (2 listed)
- A total laparoscopic hysterectomy was planned for benign causes,
- Patients scheduled for simultaneous operation for incontinence
Key exclusion criteria (3 listed)
- Patients previously operated for urinary incontinence
- Patients whose diagnosis of stress urinary incontinence is uncertain
- Patients with urinary tract infection
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 |
|---|---|---|
| total laparoscopic hysterectomy and simultaneous incontinence surgery with benign causestotal laparoscopic hysterectomy and simultaneous incontinence surgery with benign causes; Burch colposuspension and mid-urethral sling operations for stress urinary incontinence | Procedure or surgery | laparoscopic burch colposuspension, mid urethral sling operations |
Primary outcome
recurrence
Time frame: 2 years
in patients who underwent total laparoscopic hysterectomy and simultaneous incontinence surgery for benign reasons; In the early postoperative period, relapse will be evaluated at 1 month, 6 months and 12 months.
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 11 Feb 2020.
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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 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 11 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?
recurrence (time frame: 2 years). 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 11 Feb 2020; AzTrials last refreshed its copy on 1 Nov 2026.