Could the Vaginal Wall Sling Still Have a Role After FDA's Warning? the Functional Outcomes at 20 Years

Overview

Journal Ther Adv Urol

Publisher Sage Publications

Date 2022 Mar 14

PMID 35281320

Authors

Ester Illiano

Francesco Trama

Alessandro Marchesi

Consuelo Fabi

Stefano Brancorsini

Elisabetta Costantini

Affiliations

Soon will be listed here.

Abstract

Introduction: Aims of this study were to evaluate the functional outcomes of a vaginal wall sling technique in patients with stress urinary incontinence at 20 years after surgery and to evaluate the patient's satisfaction after the surgical procedure.

Material And Methods: This was a prospective single-center study on patients with stress urinary incontinence who underwent vaginal sling surgery. Presurgery evaluation included history, pelvic examination, and urodynamic test. All patients completed Urogenital Distress Inventory-6 (UDI-6) questionnaire. They underwent checkups at 1, 3, 6, and 12 months postoperatively and then annually. The sling was created by making a rectangle (15-20 × 25 mm) on the anterior vaginal wall and it was reinforced by one roll of Marlex mesh on each side of the sling. The sutures were passed through the vagina at the suprapubic level after suprapubic incision, above the rectus fascia and tied without excessive tension.

Results: From May 1996 to May 2002, 40 women underwent vaginal wall sling surgery for stress urinary incontinence. Last visit was performed on 20 women between March 2020 and April 2020. Median follow-up was 251.3 months (20.9 years) (range = 204.3-285.4 months). The success rate after 5 years of surgical procedure was 80%; over 5 years, the objective cure rate was 45%. Considering only the group of 13 patients with pure stress urinary incontinence, the objective cure rate decreased to 38%, in particular 7 years after surgery. Women who did not resolve their urinary incontinence needed to undergo a new treatment. At over 5 years after surgery, there was an increase in urgency ( = 0.001) and voiding symptoms ( = 0.008) and urgency urinary incontinence (UUI) ( = 0.04). Ninety-five percent were very much worse or much worse according to the Patient Global Impression of Improvement (PGI-I) scale.

Conclusion: The vaginal wall sling does not guarantee good long-term functional outcomes in women with stress urinary incontinence.

Citing Articles

Surgical Treatments for Women with Stress Urinary Incontinence: A Systematic Review.

Calinescu B, Neacsu A, Martiniuc A, Dumitrescu D, Stanica C, Rosu G Life (Basel). 2023; 13(7).

PMID: 37511855 PMC: 10381666. DOI: 10.3390/life13071480.

Tension-free vaginal mesh for patients with pelvic organ prolapse: mid-term functional outcomes.

Obinata D, Yamaguchi K, Hashimoto S, Yoshizawa T, Mochida J, Takahashi S J Int Med Res. 2022; 50(6):3000605221106434.

PMID: 35734995 PMC: 9235303. DOI: 10.1177/03000605221106434.

References

Wu J, Gandhi M, Shah A, Shah J, Fulton R, Weidner A . Trends in inpatient urinary incontinence surgery in the USA, 1998-2007. Int Urogynecol J. 2011; 22(11):1437-43. DOI: 10.1007/s00192-011-1509-x. View

Choe J, Ogan K, Battino B . Antimicrobial mesh versus vaginal wall sling: a comparative outcomes analysis. J Urol. 2000; 163(6):1829-34. View

Costantini E, Mearini L, Mearini E, Pajoncini C, Guercini F, Bini V . Assessing outcome after a modified vaginal wall sling for stress incontinence with intrinsic sphincter deficiency. Int Urogynecol J Pelvic Floor Dysfunct. 2005; 16(2):138-46. DOI: 10.1007/s00192-004-1173-5. View

Metin A, Kayigil O, Ahmed S, Atmaca A . Is the efficacy of in situ vaginal wall slings decreasing in the late follow-up?. Int Urol Nephrol. 2007; 40(1):51-5. DOI: 10.1007/s11255-007-9217-7. View

Goldman H, Rackley R, Appell R . The in situ anterior vaginal wall sling: predictors of success. J Urol. 2001; 166(6):2259-62. View

Kaplan S, Santarosa R, Te A . Comparison of fascial and vaginal wall slings in the management of intrinsic sphincter deficiency. Urology. 1996; 47(6):885-9. DOI: 10.1016/S0090-4295(96)00062-3. View

Artibani W, Pesce F, Prezioso D, Scarpa R, Zattoni F, Tubaro A . Italian validation of the urogenital distress inventory and its application in LUTS patients. Eur Urol. 2006; 50(6):1323-9. DOI: 10.1016/j.eururo.2006.04.008. View

Novara G, Artibani W, Barber M, Chapple C, Costantini E, Ficarra V . Updated systematic review and meta-analysis of the comparative data on colposuspensions, pubovaginal slings, and midurethral tapes in the surgical treatment of female stress urinary incontinence. Eur Urol. 2010; 58(2):218-38. DOI: 10.1016/j.eururo.2010.04.022. View

Appell R . The use of bone anchoring in the surgical management of female stress urinary incontinence. World J Urol. 1997; 15(5):300-5. DOI: 10.1007/BF02202015. View

10.

Natale F, Illiano E, Marchesi A, La Penna C, Costantini E . Transobturator Tape: Over 10 Years Follow-up. Urology. 2019; 129:48-53. DOI: 10.1016/j.urology.2019.03.003. View

11.

Daneshgari F . Words of wisdom. Re: FDA public health notification: serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence. Eur Urol. 2009; 55(5):1235-6. DOI: 10.1016/j.eururo.2009.01.055. View

12.

Kilicarslan H, Gokce G, Ayan S, Guvenal T, Kaya K, Gultekin E . Predictors of outcome after in situ anterior vaginal wall sling surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2003; 14(5):339-41. DOI: 10.1007/s00192-003-1085-9. View

13.

Siegal A, Huang Z, Gross M, Mehraban-Far S, Weissbart S, Kim J . Trends of Mesh Utilization for Stress Urinary Incontinence Before and After the 2011 Food and Drug Administration Notification Between FPMRS-Certified and Non-FPMRS-Certified Physicians: A Statewide All-Payer Database Analysis. Urology. 2020; 150:151-157. DOI: 10.1016/j.urology.2020.06.053. View

14.

McGuire E, LYTTON B . Pubovaginal sling procedure for stress incontinence. J Urol. 1978; 119(1):82-4. DOI: 10.1016/s0022-5347(17)57390-5. View

15.

Rodrigues P, Hering F, Meler A, Campagnari J, DImperio M . Pubo-fascial versus vaginal sling operation for the treatment of stress urinary incontinence: a prospective study. Neurourol Urodyn. 2004; 23(7):627-31. DOI: 10.1002/nau.20063. View

16.

. Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair; Final order. Fed Regist. 2016; 81(2):353-61. View

17.

Chapple C, Cruz F, Deffieux X, Milani A, Arlandis S, Artibani W . Consensus Statement of the European Urology Association and the European Urogynaecological Association on the Use of Implanted Materials for Treating Pelvic Organ Prolapse and Stress Urinary Incontinence. Eur Urol. 2017; 72(3):424-431. DOI: 10.1016/j.eururo.2017.03.048. View

18.

Swift S . Intrinsic sphincter deficiency: what is it and does it matter anymore?. Int Urogynecol J. 2012; 24(2):183-4. DOI: 10.1007/s00192-012-1933-6. View

19.

Abdel-Fattah M, Ramsay I, Pringle S, Hardwick C, Ali H, Young D . Evaluation of transobturator tension-free vaginal tapes in management of women with recurrent stress urinary incontinence. Urology. 2011; 77(5):1070-5. DOI: 10.1016/j.urology.2011.01.016. View

20.

Raz S, Stothers L, Young G, Short J, Marks B, Chopra A . Vaginal wall sling for anatomical incontinence and intrinsic sphincter dysfunction: efficacy and outcome analysis. J Urol. 1996; 156(1):166-70. View