Stress Urinary IncontinenceNCT06334848
Efficacy of Mini Sling Versus Transobturator Tape in Surgical Management of Women With Stress Urinary Incontinence
A study testing transobturator tape in people with Stress Urinary Incontinence, run by Ain Shams University.
Trial summary
To compare the efficacy of mini sling against Transobturator tape for surgical management of women with stress urinary incontinence. Read more about this study
- Who is it for?
- Ages Up to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- transobturator tape
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Sep 2025
- 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 Up to 60 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Women with a medical history of SUI
- mixed urinary incontinence (MUI) in which SUI had to be the dominating symptom
- confirmed by a positive standardized cough test with 300 cm3 water in the bladder
Who cannot join
- Women will be excluded if they are aged >60 years
- had previous incontinence or pelvic organ prolapse surgery
- planned or present pregnancy
- residual urine volume>100 ml
- previous pelvic irradiation
- neurological conditions such as multiple sclerosis
- current treatment with corticoids
- history of genital or abdominal cancer or a pelvic mass.
Trial locations and contacts
No sites are listed yet.
About this study
To compare the efficacy of mini sling against Transobturator tape for surgical management of women with stress urinary incontinence.
Read the detailed description
Urinary incontinence is defined as involuntary loss of urine and is divided into subtypes according to symptoms. These subtypes include SUI, in which urine loss occurs during exertion, physical exercise, coughing or sneezing; urgency urinary incontinence (UUI), in which urine loss is associated with urinary urgency; and mixed urinary incontinence (MUI), which is characterized by the association of stress loss with urgency.
There are non-surgical treatments (e.g., lifestyle modifications, pharmacotherapy, physiotherapy and vaginal pessary) and surgical treatments.
As regards sling use, it was found that mid urethral slings techniques achieved high cure rates in women with SUI and have become the mainstay for surgical treatment of SUI in women over the last 2 decades.
One of the modalities of such procedures is the transobturator mid urethral tape (TOT). It was introduced to minimize the complications of the previous retropubic tapes, which include injury to the bladder, major vessels, and bowel.
In an effort to maintain efficacy while eliminating some of the side effects, a new generation of tapes has been developed, called single incision tapes or mini-slings. They are designed to be shorter in length than standard mid-urethral slings and do not penetrate the tissues as deeply as standard slings.
- Conditions
- Stress Urinary Incontinence
- Being tested
- transobturator tape
- 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.
transobturator tapeProcedure or surgery
Also called mini sling
Women with stress urinary incontinence are treated by transobturator tape versus mini sling
| Study group | Role | What they receive |
|---|---|---|
| treatment of stress urinary incontinence by transobturator tape | Other | patients with stress urinary incontinence are treated by transobturator tape Receives: Procedure: transobturator tape |
| treatment of stress urinary incontinence by mini sling | Other | patients with stress urinary incontinence are treated by mini sling Receives: Procedure: transobturator tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding incidence of complications
comparing between mini sling and transobturator tape in surgical management of women with stress urinary incontinence regarding:
- Urinary continence measured by ICIQ(international continence index questionnaire)
Measured: one year
Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding postoperative pain
comparing between mini sling and transobturator tape in surgical management of women with stress urinary incontinence regarding:
- Post operative pain measured by NRS(numerical rating pain score)
Measured: one year
Secondary outcomes (1)
Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding sexual function
comparing between mini sling and transobturator tape in surgical management of women with stress urinary incontinence regarding:
- Sexual function measured by FSFI(female sexual function index)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study startApr 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Salem Rezk, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334848
- Sponsor's protocol ID
- TOT versus mini sling
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
D'Ancona C, Haylen B, Oelke M, Abranches-Monteiro L, Arnold E, Goldman H, Hamid R, Homma Y, Marcelissen T, Rademakers K, Schizas A, Singla A, Soto I, Tse V, de Wachter S, Herschorn S; Standardisation Steering Committee ICS and the ICS Working Group on Terminology for Male Lower Urinary Tract & Pelvic Floor Symptoms and Dysfunction. The International Continence Society (ICS) report on the terminology for adult male lower urinary tract and pelvic floor symptoms and dysfunction. Neurourol Urodyn. 2019 Feb;38(2):433-477. doi: 10.1002/nau.23897. Epub 2019 Jan 25.
PubMed 30681183Khandelwal C, Kistler C. Diagnosis of urinary incontinence. Am Fam Physician. 2013 Apr 15;87(8):543-50.
PubMed 23668444Leslie SW, Tran LN, Puckett Y. Urinary Incontinence. 2024 Aug 11. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK559095/
PubMed 32644521Falah-Hassani K, Reeves J, Shiri R, Hickling D, McLean L. The pathophysiology of stress urinary incontinence: a systematic review and meta-analysis. Int Urogynecol J. 2021 Mar;32(3):501-552. doi: 10.1007/s00192-020-04622-9. Epub 2021 Jan 8.
PubMed 33416968Kowalik CG, Dmochowski RR, De EJB. Surgery for female SUI: The ICI algorithm. Neurourol Urodyn. 2019 Aug;38 Suppl 4:S21-S27. doi: 10.1002/nau.23879. Epub 2019 May 2.
PubMed 31050030Novara G, Ficarra V, Boscolo-Berto R, Secco S, Cavalleri S, Artibani W. Tension-free midurethral slings in the treatment of female stress urinary incontinence: a systematic review and meta-analysis of randomized controlled trials of effectiveness. Eur Urol. 2007 Sep;52(3):663-78. doi: 10.1016/j.eururo.2007.06.018. Epub 2007 Jun 21.
PubMed 17601652Kim A, Kim S, Kim HG. Current Overview of Surgical Options for Female Stress Urinary Incontinence. Int Neurourol J. 2020 Sep;24(3):222-230. doi: 10.5213/inj.2040052.026. Epub 2020 Sep 30.
PubMed 33017893Nambiar A, Cody JD, Jeffery ST, Aluko P. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2017 Jul 26;7(7):CD008709. doi: 10.1002/14651858.CD008709.pub3.
PubMed 28746980Cox A, Herschorn S, Lee L. Surgical management of female SUI: is there a gold standard? Nat Rev Urol. 2013 Feb;10(2):78-89. doi: 10.1038/nrurol.2012.243. Epub 2013 Jan 15.
PubMed 23318365Rudnicki M, von Bothmer-Ostling K, Holstad A, Magnusson C, Majida M, Merkel C, Prien J, Jakobsson U, Teleman P. Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence. A randomized controlled trial. Acta Obstet Gynecol Scand. 2017 Nov;96(11):1347-1356. doi: 10.1111/aogs.13205. Epub 2017 Sep 15.
PubMed 28815547Emami M, Momtazan A, Maghsoudi R, Ameli M, Kashi A, Amirpoor M, Karimi S. Transobturator tape and mini-sling methods in stress urinary incontinence: Results of a randomized clinical trial. Urologia. 2019 Aug;86(3):152-155. doi: 10.1177/0391560319845255. Epub 2019 May 10.
PubMed 31072274Chang CP, Chang WH, Hsu YM, Chen YJ, Wen KC, Chao KC, Yen MS, Horng HC, Wang PH; Task Force on Gyn-Urodynamic Research Group. Comparison of single-incision mini-slings (Ajust) and standard transobturator midurethral slings (Align) in the management of female stress urinary incontinence: A 1-year follow-up. Taiwan J Obstet Gynecol. 2015 Dec;54(6):726-30. doi: 10.1016/j.tjog.2015.10.007.
PubMed 26700993Kokanali MK, Doganay M, Aksakal O, Cavkaytar S, Topcu HO, Ozer I. Risk factors for mesh erosion after vaginal sling procedures for urinary incontinence. Eur J Obstet Gynecol Reprod Biol. 2014 Jun;177:146-50. doi: 10.1016/j.ejogrb.2014.03.039. Epub 2014 Apr 13.
PubMed 24793930Maturana AP, Palos CC, Ghersel FR, Fernandes CE, Oliveira E. Randomized controlled trial comparing mini-sling with transobturator sling for the treatment of stress urinary incontinence. Int Urogynecol J. 2020 Sep;31(9):1925-1931. doi: 10.1007/s00192-019-04145-y. Epub 2019 Nov 29.
PubMed 31784809
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mini Sling Versus Transobturator Tape in Surgical Management of Women With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT06334848
- Acronym / sponsor ID
- TOT versus mini sling
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 28 Mar 2024 (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 compare the efficacy of mini sling against Transobturator tape for surgical management of women with stress urinary incontinence.
Detailed description
Urinary incontinence is defined as involuntary loss of urine and is divided into subtypes according to symptoms. These subtypes include SUI, in which urine loss occurs during exertion, physical exercise, coughing or sneezing; urgency urinary incontinence (UUI), in which urine loss is associated with urinary urgency; and mixed urinary incontinence (MUI), which is characterized by the association of stress loss with urgency.
There are non-surgical treatments (e.g., lifestyle modifications, pharmacotherapy, physiotherapy and vaginal pessary) and surgical treatments.
As regards sling use, it was found that mid urethral slings techniques achieved high cure rates in women with SUI and have become the mainstay for surgical treatment of SUI in women over the last 2 decades.
One of the modalities of such procedures is the transobturator mid urethral tape (TOT). It was introduced to minimize the complications of the previous retropubic tapes, which include injury to the bladder, major vessels, and bowel.
In an effort to maintain efficacy while eliminating some of the side effects, a new generation of tapes has been developed, called single incision tapes or mini-slings. They are designed to be shorter in length than standard mid-urethral slings and do not penetrate the tissues as deeply as standard slings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment of stress urinary incontinence by transobturator tape | Other | Procedure: transobturator tapepatients with stress urinary incontinence are treated by transobturator tape |
| treatment of stress urinary incontinence by mini sling | Other | Procedure: transobturator tapepatients with stress urinary incontinence are treated by mini sling |
Who may qualify
- Ages
- Up to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Women with a medical history of SUI
- mixed urinary incontinence (MUI) in which SUI had to be the dominating symptom
- confirmed by a positive standardized cough test with 300 cm3 water in the bladder
Key exclusion criteria (8 listed)
- Women will be excluded if they are aged >60 years
- had previous incontinence or pelvic organ prolapse surgery
- planned or present pregnancy
- residual urine volume>100 ml
- previous pelvic irradiation
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 |
|---|---|---|
| transobturator tapeAlso: mini slingWomen with stress urinary incontinence are treated by transobturator tape versus mini sling | Procedure or surgery | treatment of stress urinary incontinence by mini sling, treatment of stress urinary incontinence by transobturator tape |
Primary outcome
Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding incidence of complications
Time frame: one year
comparing between mini sling and transobturator tape in surgical management of women with stress urinary incontinence regarding: • Urinary continence measured by ICIQ(international continence index questionnaire)
Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding postoperative pain
Time frame: one year
comparing between mini sling and transobturator tape in surgical management of women with stress urinary incontinence regarding: • Post operative pain measured by NRS(numerical rating pain score)
1 secondary outcome
Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding sexual function
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Background: PubMed 30681183D'Ancona C, Haylen B, Oelke M, Abranches-Monteiro L, Arnold E, Goldman H, Hamid R, Homma Y, Marcelissen T, Rademakers K, Schizas A, Singla A, Soto I, Tse V, de Wachter S, Herschorn S; Standardisation Steering Committee ICS and the ICS Working Group on Terminology for Male Lower Urinary Tract & Pelvic Floor Symptoms and Dysfunction. The International Continence Society (ICS) report on the terminology for adult male lower urinary tract and pelvic floor symptoms and dysfunction. Neurourol Urodyn. 2019 Feb;38(2):433-477. doi: 10.1002/nau.23897. Epub 2019 Jan 25.
- Background: PubMed 23668444Khandelwal C, Kistler C. Diagnosis of urinary incontinence. Am Fam Physician. 2013 Apr 15;87(8):543-50.
- Background: PubMed 32644521Leslie SW, Tran LN, Puckett Y. Urinary Incontinence. 2024 Aug 11. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK559095/
- Background: PubMed 33416968Falah-Hassani K, Reeves J, Shiri R, Hickling D, McLean L. The pathophysiology of stress urinary incontinence: a systematic review and meta-analysis. Int Urogynecol J. 2021 Mar;32(3):501-552. doi: 10.1007/s00192-020-04622-9. Epub 2021 Jan 8.
- Background: PubMed 31050030Kowalik CG, Dmochowski RR, De EJB. Surgery for female SUI: The ICI algorithm. Neurourol Urodyn. 2019 Aug;38 Suppl 4:S21-S27. doi: 10.1002/nau.23879. Epub 2019 May 2.
- Background: PubMed 17601652Novara G, Ficarra V, Boscolo-Berto R, Secco S, Cavalleri S, Artibani W. Tension-free midurethral slings in the treatment of female stress urinary incontinence: a systematic review and meta-analysis of randomized controlled trials of effectiveness. Eur Urol. 2007 Sep;52(3):663-78. doi: 10.1016/j.eururo.2007.06.018. Epub 2007 Jun 21.
- Background: PubMed 33017893Kim A, Kim S, Kim HG. Current Overview of Surgical Options for Female Stress Urinary Incontinence. Int Neurourol J. 2020 Sep;24(3):222-230. doi: 10.5213/inj.2040052.026. Epub 2020 Sep 30.
- Background: PubMed 28746980Nambiar A, Cody JD, Jeffery ST, Aluko P. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2017 Jul 26;7(7):CD008709. doi: 10.1002/14651858.CD008709.pub3.
- Background: PubMed 23318365Cox A, Herschorn S, Lee L. Surgical management of female SUI: is there a gold standard? Nat Rev Urol. 2013 Feb;10(2):78-89. doi: 10.1038/nrurol.2012.243. Epub 2013 Jan 15.
- Background: PubMed 28815547Rudnicki M, von Bothmer-Ostling K, Holstad A, Magnusson C, Majida M, Merkel C, Prien J, Jakobsson U, Teleman P. Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence. A randomized controlled trial. Acta Obstet Gynecol Scand. 2017 Nov;96(11):1347-1356. doi: 10.1111/aogs.13205. Epub 2017 Sep 15.
- Background: PubMed 31072274Emami M, Momtazan A, Maghsoudi R, Ameli M, Kashi A, Amirpoor M, Karimi S. Transobturator tape and mini-sling methods in stress urinary incontinence: Results of a randomized clinical trial. Urologia. 2019 Aug;86(3):152-155. doi: 10.1177/0391560319845255. Epub 2019 May 10.
- Background: PubMed 26700993Chang CP, Chang WH, Hsu YM, Chen YJ, Wen KC, Chao KC, Yen MS, Horng HC, Wang PH; Task Force on Gyn-Urodynamic Research Group. Comparison of single-incision mini-slings (Ajust) and standard transobturator midurethral slings (Align) in the management of female stress urinary incontinence: A 1-year follow-up. Taiwan J Obstet Gynecol. 2015 Dec;54(6):726-30. doi: 10.1016/j.tjog.2015.10.007.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing transobturator tape in people with Stress Urinary Incontinence, run by Ain Shams University.
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 8 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: status not confirmed, as of the sponsor's last update on 28 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tarek Salem (00201002519888, tareksalemrezk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding incidence of complications (time frame: one year). The study lists 2 primary outcomes in all. 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 NCT06334848, which also lists 14 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 28 Mar 2024.