Stress Urinary IncontinenceNCT05452811
Open Retropubic Versus Laparoscopic Colposuspension (Burch Operation) Techniques for Female Stress or Mixed Urinary Incontinence; A Ten-year Experience in a Tertiary Center
An observational study of Stress Urinary Incontinence, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
To evaluate postoperative course, efficacy, and complication rates of Open Burch Colposuspension and Laparoscopic Burch Colposuspension techniques in stress or mixed urinary incontinence at a single training and research hospital over the last 10 years in Istanbul, Turkey. Read more about this study
- Who is it for?
- Ages 30 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Burch colposuspension
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2022to 30 Oct 2022
- 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 30 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: A retrospective cohort study was performed on 150 patients with a diagnosis of SUI or mixed urinary incontinence who underwent anti-incontinence surgery between January 2011 to May 2022 in the department of Obstetrics and Gynecology of Kanuni Sultan Suleyman Training and Research Center in Istanbul.
Who may be able to join
- patients having SUI or mixed urinary incontinence whom conservative therapy (Kegel's pelvic floor exercises, bladder training, electrical stimulation, or medication) failed
- SUI had been proven by urodynamic assessments.
- patients who had urethral hypermobility supported by a Q-type test with a cotton swab angle greater than 300
- patients having a residual urinary volume of less than 100 mL were included.
Who cannot join
- history of anti-incontinence surgery
- pelvic inflammatory diseases
- urinary retention
- SUI with intrinsic sphincter deficiency
- neurogenic bladder
- suspected malignancy
Show all 13Show fewer
- urge incontinence
- chronic cystitis
- urinary tract infection
- prescription of anticoagulant or antipsychotic treatment
- coagulation disorders
- physically and medically unsuitable for colposuspension surgery
- pregnancy and loss to follow-up.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, 34307
About this study
To evaluate postoperative course, efficacy, and complication rates of Open Burch Colposuspension and Laparoscopic Burch Colposuspension techniques in stress or mixed urinary incontinence at a single training and research hospital over the last 10 years in Istanbul, Turkey.
Read the detailed description
A retrospective cohort study was conducted in all Burch Colposuspension cases performed between January 2001 and May 2022 at Kanuni Sultan Süleyman Training and Research Center. All patients' data were reviewed from the electronic medical records and analyzed who underwent Burch colposuspension surgery either with an open or laparoscopic approach. The primary outcome was surgical success, whereas secondary outcomes were perioperative and postoperative data including surgical type (open or laparoscopic), operating time, duration of hospital stay, estimated blood loss, complications during surgery, and additional interventional procedure types.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Burch colposuspension
- Keywords
- Burch colposuspension, laparoscopy, outcome, retropubic, 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.
Burch colposuspensionProcedure or surgery
Anti-incontinence surgery for stress urinary incontinence
| Study group | Role | What they receive |
|---|---|---|
| Open Burch Colposuspension | The retropubic space was entered through a laparotomy Pfannenstiel incision, and two permanent sutures were placed on each side lateral to the urethra, one set at the level of the mid urethra and the other set at the level of the bladder neck. Receives: Procedure: Burch colposuspension | |
| Laparoscopic Burch Colposuspension | After a pneumo peritoneum was established entrance to the retropubic space began with a transverse incision of the anterior peritoneum using sharp dissection and electrocautery. The space was developed using blunt and sharp dissection to identify clearly the retropubic anatomy, including the pubic symphysis, bladder neck, and Cooper's ligaments. The bladder neck was identified and the paraurethral tissue was exposed. A no. 0 permanent suture then was introduced through the 10-mm port and was grasped with a laparoscopic needle driver. With the surgeon's hand in the vagina to elevate the paraurethral tissue, two figure-of-eight sutures incorporating full-thickness vagina excluding epithelium were placed on each side, one set lateral to the mid urethra and the other set lateral to the bladder neck. Each of these sutures then was passed through the ipsilateral Cooper's ligament and was secured with a series of extracorporeal knots using an endoscopic knot pusher. Receives: Procedure: Burch colposuspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical success
Provided by the patient's feeling of the "Absence of a bulge in the vagina"
Measured: 12 months after intervention
Secondary outcomes (2)
estimated blood loss
Blood loss during surgery ( taking blood count-WBC)
Measured: intraoperative
complications
Complications occurring in between during surgery and 6.th week of surgery
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start15 May 2022
- Primary completion15 Jul 2022
- Study completion30 Oct 2022
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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozan Karadeniz, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452811
- Sponsor's protocol ID
- KanuniSSSEAH
- Status last verified
- Dec 2022
- First submitted
- 4 Jul 2022
- Last updated
- 6 Dec 2022
- 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 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Retropubic Versus Laparoscopic Colposuspension (Burch Operation) Techniques for Female Stress or Mixed Urinary Incontinence; A Ten-year Experience in a Tertiary Center
- ClinicalTrials.gov ID
- NCT05452811
- Acronym / sponsor ID
- KanuniSSSEAH
- Conditions
- Stress Urinary Incontinence
- Keywords
- Burch colposuspension, laparoscopy, outcome, retropubic, stress urinary incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 11 Jul 2022 (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.
To evaluate postoperative course, efficacy, and complication rates of Open Burch Colposuspension and Laparoscopic Burch Colposuspension techniques in stress or mixed urinary incontinence at a single training and research hospital over the last 10 years in Istanbul, Turkey.
Detailed description
A retrospective cohort study was conducted in all Burch Colposuspension cases performed between January 2001 and May 2022 at Kanuni Sultan Süleyman Training and Research Center. All patients' data were reviewed from the electronic medical records and analyzed who underwent Burch colposuspension surgery either with an open or laparoscopic approach. The primary outcome was surgical success, whereas secondary outcomes were perioperative and postoperative data including surgical type (open or laparoscopic), operating time, duration of hospital stay, estimated blood loss, complications during surgery, and additional interventional procedure types.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Burch Colposuspension | – | Procedure: Burch colposuspensionThe retropubic space was entered through a laparotomy Pfannenstiel incision, and two permanent sutures were placed on each side lateral to the urethra, one set at the level of the mid urethra and the other set at the level of the bladder neck. |
| Laparoscopic Burch Colposuspension | – | Procedure: Burch colposuspensionAfter a pneumo peritoneum was established entrance to the retropubic space began with a transverse incision of the anterior peritoneum using sharp dissection and electrocautery. The space was developed using blunt and sharp dissection to identify clearly the retropubic anatomy, including the pubic symphysis, bladder neck, and Cooper's ligaments. The bladder neck was identified and the paraurethral tissue was exposed. A no. 0 permanent suture then was introduced through the 10-mm port and was grasped with a laparoscopic needle driver. With the surgeon's hand in the vagina to elevate the paraurethral tissue, two figure-of-eight sutures incorporating full-thickness vagina excluding epithelium were placed on each side, one set lateral to the mid urethra and the other set lateral to the bladder neck. Each of these sutures then was passed through the ipsilateral Cooper's ligament and was secured with a series of extracorporeal knots using an endoscopic knot pusher. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A retrospective cohort study was performed on 150 patients with a diagnosis of SUI or mixed urinary incontinence who underwent anti-incontinence surgery between January 2011 to May 2022 in the department of Obstetrics and Gynecology of Kanuni Sultan Suleyman Training and Research Center in Istanbul.
Key inclusion criteria (4 listed)
- patients having SUI or mixed urinary incontinence whom conservative therapy (Kegel's pelvic floor exercises, bladder training, electrical stimulation, or medication) failed
- SUI had been proven by urodynamic assessments.
- patients who had urethral hypermobility supported by a Q-type test with a cotton swab angle greater than 300
- patients having a residual urinary volume of less than 100 mL were included.
Key exclusion criteria (13 listed)
- history of anti-incontinence surgery
- pelvic inflammatory diseases
- urinary retention
- SUI with intrinsic sphincter deficiency
- neurogenic bladder
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 colposuspensionAnti-incontinence surgery for stress urinary incontinence | Procedure or surgery | Laparoscopic Burch Colposuspension, Open Burch Colposuspension |
Primary outcome
Surgical success
Time frame: 12 months after intervention
Provided by the patient's feeling of the "Absence of a bulge in the vagina"
2 secondary outcomes
estimated blood loss
Time frame: intraoperative
complications
Time frame: up to 6 weeks
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 6 Dec 2022.
- 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, 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 4 inclusion and 13 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 6 Dec 2022. 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?
Surgical success (time frame: 12 months after intervention). 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 6 Dec 2022.