Efficacy of Mini Sling Versus Transobturator Tape in Surgical Management of Women With Stress Urinary Incontinence

Stress Urinary Incontinence Clinical Trial

Official title:

Efficacy of Mini Sling Versus Transobturator Tape in Surgical Management of Women With Stress Urinary Incontinence

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06334848
• Other study ID #: TOT versus mini sling
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: September 2025

Study information

• Verified date: March 2024
• Source: Ain Shams University
• Contact: Tarek Salem
• Phone: 00201002519888
• Email: tareksalemrezk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the efficacy of mini sling against Transobturator tape for surgical management of women with stress urinary incontinence.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: September 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Procedure:
• transobturator tape
Women with stress urinary incontinence are treated by transobturator tape versus mini sling

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

References & Publications (14)

Chang 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. — View Citation

Cox 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. Erratum In: Nat Rev Urol. 2013 Apr;10(4):188. — View Citation

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. — View Citation

Emami 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. — View Citation

Falah-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. Erratum In: Int Urogynecol J. 2021 Jun;32(6):1607. — View Citation

Khandelwal C, Kistler C. Diagnosis of urinary incontinence. Am Fam Physician. 2013 Apr 15;87(8):543-50. — View Citation

Kim 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. — View Citation

Kokanali 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. — View Citation

Kowalik 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. — View Citation

Maturana 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. — View Citation

Nambiar 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. — View Citation

Novara 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. Erratum In: Eur Urol. 2007 Nov;52(5):1548. — View Citation

Rudnicki 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. — View Citation

Tran LN, Puckett Y. Urinary Incontinence. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK559095/ — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	one year
Primary	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)	one year
Secondary	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)	one year