Genuine Stress IncontinenceNCT05225168
Comparison of Minisling Suburethral Sling and Laparoscopic Buch Colposuspension
A study testing laparoscopic burch colposuspension operation and minisling suburethral sling in people with Genuine Stress Incontinence, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
When the studies in the literature including the mini-sling procedure and the laparoscopic buch colposuspension procedure are examined, it is seen that both methods are successful in the surgical treatment of stress urinary incontinence (SUI), but there is no study in which both procedures have been found to be… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Genuine Stress Incontinence
- What is being tested?
- laparoscopic burch colposuspension operation and minisling suburethral sling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jul 2021to 23 Mar 2023
- Phase
- Interventional
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be between the ages of 18-80
- Isolated genuine stress incontinence or accompanying pelvic organ prolapse
- Having accepted surgery for stress urinary incontinence -
Who cannot join
- 1. Previously undergo pelvic organ prolapse surgery 2. Having a chronic lung disease such as asthma or Chronic obstructive pulmonary disease (COPD) 3. Having juvenile diabetes mellitus 4. History of gynecological cancer 5. Mesh allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Minisling Suburethral Sling Use and Laparoscopic Buch Colposuspension Application in Terms of Surgical Efficacy and Side Effects in True Stress Urinary Incontinence Surgery
When the studies in the literature including the mini-sling procedure and the laparoscopic buch colposuspension procedure are examined, it is seen that both methods are successful in the surgical treatment of stress urinary incontinence (SUI), but there is no study in which both procedures have been found to be superior to each other in terms of efficacy and safety. The aim of this study is to compare the minisling suburethral sling and laparoscopic buch colposuspension application in terms of efficacy and side effects in patients who will undergo surgical treatment due to genuine SUI.
Read the detailed description
When the studies in the literature including the mini-sling procedure and the laparoscopic buch colposuspension procedure are examined, it is seen that both methods are successful in the surgical treatment of stress urinery incontinence (SUI), but there is no study in which both procedures have been found to be superior to each other in terms of efficacy and safety. The aim of this study is to compare the minisling suburethral sling and laparoscopic buch colposuspension application in terms of efficacy and side effects in patients who will undergo surgical treatment due to genuine SUI. Investigators planned to measure patients' Kings Health Questionary and Prolapse Quality of Life test at first and 6 months after the surgery and to determine how the operation affects the quality of life.
- Conditions
- Genuine Stress Incontinence
- Being tested
- laparoscopic burch colposuspension operation, minisling suburethral sling
- Keywords
- Genuine Stress Incontinence, minisling, laparoscopic burch
- 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.
laparoscopic burch colposuspension operationProcedure or surgery
Also called minisling suburethral sling
By pushing the urethra medially, two sutures are placed on the bladder at trigon level and midurethral and suspended on the bilateral iliopectineal ligament and colposuspension is supplied.
minisling suburethral slingProcedure or surgery
A vertical vaginal incision is made 1 cm below the external urethral meatus. It is followed by minimal vaginal dissection from the inferior portion of the ascending ramus of the ischiopubic bone to the obturator muscle. The arms of the mesh are fixed on both sides of the obturator internus muscle with the help of a trocar. After leaving a 1-2 mm gap between the mesh and the urethra, the vaginal wall is closed by suturing.
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic burch colposuspension group | Active comparator | this group will only have laparoscopic burch colposuspension Receives: Procedure: laparoscopic burch colposuspension operation |
| Minisling Suburethral Sling group | Active comparator | this group will only have Minisling Suburethral Sling Receives: Procedure: minisling suburethral sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary stress test for evaluating objective cure
In the postoperative period, urodynamics test will be determined at the 6th month and the absence of incontinence will be considered a cure.
Measured: changes in urodynamics test at postoperative first and the 6th month
Secondary outcomes (4)
subjective continence
Patient satisfaction will be investigated by keeping a urinary diary and questioning the quality of life.
Measured: changes at postoperative first and the 6th month
Prolapse quality of life (P-QoL) scale
Patients will be evaluated with the prolapse quality of life (P-QoL) scale. In this scale, the questions are rated 1 to 4, and as the total score increases, the quality of life decreases.
Measured: changes at postoperative first and the 6th month
King's Health Questionnaire
Patients will be evaluated with the King's Health Questionnaire
Measured: changes at postoperative first and the 6th month
Female sexual function scale (FSFI)
Patients will be evaluated with the Female sexual function scale (FSFI). In this scale, the questions are rated 0 to 5, and if the total score increases, it means the sexual life is better. A minimum of 2 and a maximum of 36 points can be obtained from this test.
Measured: changes at postoperative first and the 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start6 Jul 2021
- Primary completion6 Aug 2022
- Study completion23 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Genuine Stress IncontinenceStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Nur Cimilli Şenocak, Ataturk University
- Investigators
- Yakup Kumtepe, Study director, Ataturk UniversityYakup Kumtepe, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225168
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/284
- Status last verified
- Apr 2023
- First submitted
- 26 Jan 2022
- Last updated
- 24 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yilmaz TS, Kumtepe Y, Senocak GNC, Yilmaz EPT, Yapar A. Randomized Trial of Single-Incision Midurethral Sling and Laparoscopic Burch Colposuspension: Postoperative Surgical Outcomes and Complications. J Minim Invasive Gynecol. 2024 Sep;31(9):738-746. doi: 10.1016/j.jmig.2024.05.009. Epub 2024 May 23.
PubMed 38795840Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.
PubMed 37888839
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Minisling Suburethral Sling Use and Laparoscopic Buch Colposuspension Application in Terms of Surgical Efficacy and Side Effects in True Stress Urinary Incontinence Surgery
- ClinicalTrials.gov ID
- NCT05225168
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/284
- Conditions
- Genuine Stress Incontinence
- Keywords
- Genuine Stress Incontinence, minisling, laparoscopic burch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 6 Aug 2022 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 4 Feb 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.
When the studies in the literature including the mini-sling procedure and the laparoscopic buch colposuspension procedure are examined, it is seen that both methods are successful in the surgical treatment of stress urinary incontinence (SUI), but there is no study in which both procedures have been found to be superior to each other in terms of efficacy and safety. The aim of this study is to compare the minisling suburethral sling and laparoscopic buch colposuspension application in terms of efficacy and side effects in patients who will undergo surgical treatment due to genuine SUI.
Detailed description
When the studies in the literature including the mini-sling procedure and the laparoscopic buch colposuspension procedure are examined, it is seen that both methods are successful in the surgical treatment of stress urinery incontinence (SUI), but there is no study in which both procedures have been found to be superior to each other in terms of efficacy and safety. The aim of this study is to compare the minisling suburethral sling and laparoscopic buch colposuspension application in terms of efficacy and side effects in patients who will undergo surgical treatment due to genuine SUI. Investigators planned to measure patients' Kings Health Questionary and Prolapse Quality of Life test at first and 6 months after the surgery and to determine how the operation affects the quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic burch colposuspension group | Active comparator | Procedure: laparoscopic burch colposuspension operationthis group will only have laparoscopic burch colposuspension |
| Minisling Suburethral Sling group | Active comparator | Procedure: minisling suburethral slingthis group will only have Minisling Suburethral Sling |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- To be between the ages of 18-80
- Isolated genuine stress incontinence or accompanying pelvic organ prolapse
- Having accepted surgery for stress urinary incontinence -
Key exclusion criteria (1 listed)
- 1. Previously undergo pelvic organ prolapse surgery 2. Having a chronic lung disease such as asthma or Chronic obstructive pulmonary disease (COPD) 3. Having juvenile diabetes mellitus 4. History of gynecological cancer 5. Mesh allergy
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 |
|---|---|---|
| laparoscopic burch colposuspension operationAlso: minisling suburethral slingBy pushing the urethra medially, two sutures are placed on the bladder at trigon level and midurethral and suspended on the bilateral iliopectineal ligament and colposuspension is supplied. | Procedure or surgery | laparoscopic burch colposuspension group |
| minisling suburethral slingA vertical vaginal incision is made 1 cm below the external urethral meatus. It is followed by minimal vaginal dissection from the inferior portion of the ascending ramus of the ischiopubic bone to the obturator muscle. The arms of the mesh are fixed on both sides of the obturator internus muscle with the help of a trocar. After leaving a 1-2 mm gap between the mesh and the urethra, the vaginal wall is closed by suturing. | Procedure or surgery | Minisling Suburethral Sling group |
Primary outcome
urinary stress test for evaluating objective cure
Time frame: changes in urodynamics test at postoperative first and the 6th month
In the postoperative period, urodynamics test will be determined at the 6th month and the absence of incontinence will be considered a cure.
4 secondary outcomes
subjective continence
Time frame: changes at postoperative first and the 6th month
Prolapse quality of life (P-QoL) scale
Time frame: changes at postoperative first and the 6th month
King's Health Questionnaire
Time frame: changes at postoperative first and the 6th month
Female sexual function scale (FSFI)
Time frame: changes at postoperative first and the 6th month
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 24 Apr 2023.
- Derived from this study: PubMed 38795840Yilmaz TS, Kumtepe Y, Senocak GNC, Yilmaz EPT, Yapar A. Randomized Trial of Single-Incision Midurethral Sling and Laparoscopic Burch Colposuspension: Postoperative Surgical Outcomes and Complications. J Minim Invasive Gynecol. 2024 Sep;31(9):738-746. doi: 10.1016/j.jmig.2024.05.009. Epub 2024 May 23.
- Derived from this study: PubMed 37888839Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.
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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.
Yakup Kumtepe study director
Ataturk University
Yakup Kumtepe principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic burch colposuspension operation and minisling suburethral sling in people with Genuine Stress Incontinence, run by Ataturk University 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 1 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 24 Apr 2023. 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?
urinary stress test for evaluating objective cure (time frame: changes in urodynamics test at postoperative first and the 6th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05225168, which also lists 2 linked publications.
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 24 Apr 2023.