Stress Urinary IncontinenceNCT03949348
Transobturator Urethral Sling Placement With an Autologous Rectus Facia
A study testing Mid-urethral sling placement using autologous rectus fascia and Mid-urethral sling placement using synthetic mesh in people with Stress Urinary Incontinence and Surgery--Complications, run by Ankara Training and Research Hospital.
Trial summary
The investigators aimed to evaluate outcomes of transobturator urethral sling placement using autologous rectus fascia for female stress urinary incontinence at perioperatively and at 2-year follow-up. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Stress Urinary Incontinence, Surgery--Complications
- What is being tested?
- Mid-urethral sling placement using autologous rectus fascia and Mid-urethral sling placement using synthetic mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 1 Jan 2021
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patients that underwent mid-urethral sling placement
Who cannot join
- active urinary infection
- neurologic disorders
- malignancies
- history of radiotherapy
About this study
Official title: Transobturator Urethral Sling Placement With an Autologous Rectus Facia for Female Stress Urinary Incontinence.
The investigators aimed to evaluate outcomes of transobturator urethral sling placement using autologous rectus fascia for female stress urinary incontinence at perioperatively and at 2-year follow-up.
Read the detailed description
Stress urinary incontinence (SUI) is very common condition in middle-aged women, and can affect quality of life. Some clinical trials reported that the lifetime risk of a woman undergoing surgery for SUI is increase in up to 15%. The midurethral synthetic sling is the most common surgery performed for female SUI. This procedure has high efficacy and low perioperative morbidity.
Although many clinical trials have demonstrated that synthetic mid-urethral slings are safe, effective and recommended by several guidelines (e.g. Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction/American Urogynecologic Society and American Urologic Association), the safety and efficacy of surgery for SUI using mesh devices has been questioned by a community of patients and clinicians. After Food and Drug Administration notification on mesh use in pelvic surgery, many patients and providers begin to search of different surgery without synthetic mesh alternatives in SUI. Recently, female patients in England formed the campaign group "Sling the Mesh" to protest the synthetic mesh.
Several options such as the autologous pubovaginal sling, biologic grafts, or urethral bulking agent injection have some problems related to morbidity or efficacy. The autologous pubovaginal urethral sling is associated with a higher risk of postoperative voiding dysfunction.
The investigators aimed to demonstrate the feasibility of an autologous transobturator urethral sling to avoid the related problems of synthetic mesh placement and the increased rate of voiding dysfunction with pubovaginal sling placement.
- Being tested
- Mid-urethral sling placement using autologous rectus fascia, Mid-urethral sling placement using synthetic mesh
- Keywords
- midurethral sling placement, synthetic mesh, autologous rectus fascia, transobturator approach
- 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.
Mid-urethral sling placement using autologous rectus fasciaProcedure or surgery
Mid-urethral sling placement using autologous rectus fascia
Mid-urethral sling placement using synthetic meshProcedure or surgery
Mid-urethral sling placement using synthetic mesh
| Study group | Role | What they receive |
|---|---|---|
| autologous fascia | Active comparator | Patients who underwent a transobturator sling placement using autologous rectus fascia Receives: Procedure: Mid-urethral sling placement using autologous rectus fascia |
| synthetic mesh | Active comparator | Patients who underwent a transobturator sling placement using synthetic mesh Receives: Procedure: Mid-urethral sling placement using synthetic mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICIQ-SF
The ICIQ-UI Short Form is a brief and psychometrically robust patient-completed questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence in women in research and clinical practice across the world. It is scored on a scale from 0-21; higher values represent worse outcomes. The ICIQ-UI Short Form provides a brief and robust measure to assess the impact of symptoms of incontinence on outcome.
Measured: 2 years
Secondary outcomes (1)
Treatment Benefit Scale
TBS consists of four categories scored as 1 (greatly improved) or 2 (improved), considered as ''yes,'' or 3 (not changed) or 4 (worsened), which were considered as ''no''
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 posted14 May 2019
- Study start1 May 2016
- Primary completion1 Jan 2019
- Study completion1 Jan 2021
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients who undergo a transobturator sling placement using autologous rectus fascia
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammet Fatih Kilinc, Ankara Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949348
- Sponsor's protocol ID
- 0635
- Status last verified
- Aug 2021
- First submitted
- 13 May 2019
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Linder BJ, Elliott DS. Autologous Transobturator Urethral Sling Placement for Female Stress Urinary Incontinence: Short-term Outcomes. Urology. 2016 Jul;93:55-9. doi: 10.1016/j.urology.2016.03.025. Epub 2016 Mar 29.
PubMed 27036519Linder BJ, Elliott DS. Autologous transobturator urethral sling placement for female stress urinary incontinence. J Urol. 2015 Mar;193(3):991-6. doi: 10.1016/j.juro.2014.08.125. Epub 2014 Oct 19.
PubMed 25444955
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transobturator Urethral Sling Placement With an Autologous Rectus Facia for Female Stress Urinary Incontinence.
- ClinicalTrials.gov ID
- NCT03949348
- Acronym / sponsor ID
- 0635
- Keywords
- midurethral sling placement, synthetic mesh, autologous rectus fascia, transobturator approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 14 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.
The investigators aimed to evaluate outcomes of transobturator urethral sling placement using autologous rectus fascia for female stress urinary incontinence at perioperatively and at 2-year follow-up.
Detailed description
Stress urinary incontinence (SUI) is very common condition in middle-aged women, and can affect quality of life. Some clinical trials reported that the lifetime risk of a woman undergoing surgery for SUI is increase in up to 15%. The midurethral synthetic sling is the most common surgery performed for female SUI. This procedure has high efficacy and low perioperative morbidity.
Although many clinical trials have demonstrated that synthetic mid-urethral slings are safe, effective and recommended by several guidelines (e.g. Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction/American Urogynecologic Society and American Urologic Association), the safety and efficacy of surgery for SUI using mesh devices has been questioned by a community of patients and clinicians. After Food and Drug Administration notification on mesh use in pelvic surgery, many patients and providers begin to search of different surgery without synthetic mesh alternatives in SUI. Recently, female patients in England formed the campaign group "Sling the Mesh" to protest the synthetic mesh.
Several options such as the autologous pubovaginal sling, biologic grafts, or urethral bulking agent injection have some problems related to morbidity or efficacy. The autologous pubovaginal urethral sling is associated with a higher risk of postoperative voiding dysfunction.
The investigators aimed to demonstrate the feasibility of an autologous transobturator urethral sling to avoid the related problems of synthetic mesh placement and the increased rate of voiding dysfunction with pubovaginal sling placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients who undergo a transobturator sling placement using autologous rectus fascia
| Arm | Type | Receives |
|---|---|---|
| autologous fascia | Active comparator | Procedure: Mid-urethral sling placement using autologous rectus fasciaPatients who underwent a transobturator sling placement using autologous rectus fascia |
| synthetic mesh | Active comparator | Procedure: Mid-urethral sling placement using synthetic meshPatients who underwent a transobturator sling placement using synthetic mesh |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- female patients that underwent mid-urethral sling placement
Key exclusion criteria (4 listed)
- active urinary infection
- neurologic disorders
- malignancies
- history of radiotherapy
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 |
|---|---|---|
| Mid-urethral sling placement using autologous rectus fasciaMid-urethral sling placement using autologous rectus fascia | Procedure or surgery | autologous fascia |
| Mid-urethral sling placement using synthetic meshMid-urethral sling placement using synthetic mesh | Procedure or surgery | synthetic mesh |
Primary outcome
ICIQ-SF
Time frame: 2 years
The ICIQ-UI Short Form is a brief and psychometrically robust patient-completed questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence in women in research and clinical practice across the world. It is scored on a scale from 0-21; higher values represent worse outcomes. The ICIQ-UI Short Form provides a brief and robust measure to assess the impact of symptoms of incontinence on outcome.
1 secondary outcome
Treatment Benefit Scale
Time frame: 2 years
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 26 Aug 2021.
- Results publication: PubMed 27036519Linder BJ, Elliott DS. Autologous Transobturator Urethral Sling Placement for Female Stress Urinary Incontinence: Short-term Outcomes. Urology. 2016 Jul;93:55-9. doi: 10.1016/j.urology.2016.03.025. Epub 2016 Mar 29.
- Results publication: PubMed 25444955Linder BJ, Elliott DS. Autologous transobturator urethral sling placement for female stress urinary incontinence. J Urol. 2015 Mar;193(3):991-6. doi: 10.1016/j.juro.2014.08.125. Epub 2014 Oct 19.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Mid-urethral sling placement using autologous rectus fascia and Mid-urethral sling placement using synthetic mesh in people with Stress Urinary Incontinence and Surgery--Complications, run by Ankara Training and Research Hospital.
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 1 inclusion and 4 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 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
ICIQ-SF (time frame: 2 years). 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 NCT03949348, 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 26 Aug 2021.