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

NCT06334848 | Not Yet Recruiting

• 1 other identifier: TOT versus mini sling
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding sexual function

  one year

Study Arms (2)

treatment of stress urinary incontinence by transobturator tape

OTHER

patients with stress urinary incontinence are treated by transobturator tape

Procedure: transobturator tape

treatment of stress urinary incontinence by mini sling

OTHER

patients with stress urinary incontinence are treated by mini sling

Procedure: transobturator tape

Interventions

transobturator tape PROCEDURE

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

Also known as: mini sling

treatment of stress urinary incontinence by mini sling; treatment of stress urinary incontinence by transobturator tape

Eligibility Criteria

• Age: Up to 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (14)

• 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.

  PMID: 30681183 BACKGROUND

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

  PMID: 23668444 BACKGROUND

• Leslie SW, Tran LN, Puckett Y. Urinary Incontinence. 2024 Aug 11. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK559095/

  PMID: 32644521 BACKGROUND

• 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.

  PMID: 33416968 BACKGROUND

• 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.

  PMID: 31050030 BACKGROUND

• 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.

  PMID: 17601652 BACKGROUND

• 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.

  PMID: 33017893 BACKGROUND

• 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.

  PMID: 28746980 BACKGROUND

• 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.

  PMID: 23318365 BACKGROUND

• 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.

  PMID: 28815547 BACKGROUND

• 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.

  PMID: 31072274 BACKGROUND

• 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.

  PMID: 26700993 BACKGROUND

• 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.

  PMID: 24793930 BACKGROUND

• 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.

  PMID: 31784809 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Suburethral Slings

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Central Study Contacts

Tarek Salem

CONTACT

00201002519888; tareksalemrezk@gmail.com

Ahmed Emam

CONTACT

00201228770965; emam606@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 28, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 28, 2024

Record last verified: 2024-03