Tension-free vaginal tape for SUI: optimizing outcomes

Tension-free vaginal tape, a new type of sling procedure, offers a minimally invasive option to women with stress urinary incontinence. Here, the author describes the technique and reviews the data on its risks and complications and its long-term effect
on SUI.

The optimal surgical approach to treatment of stress urinary incontinence (SUI) in women continues to be a topic of controversy. This debate is fueled, in part, by the difficulty in comparing data on the different surgical procedures due to variations in patient selection, diagnostic methods, techniques, outcome criteria, and length of follow-up. In a systematic review of 11 randomized controlled trials, 20 nonrandomized trials/prospective cohort studies, and 45 retrospective cohort studies, Black and Downs concluded that the best clinical to reoperation.

Patients with postoperative voiding difficulty can be taught intermittent self-catheterization, or an indwelling Foley catheter can be inserted. If a Foley is used, give the patient a prophylactic antibiotic, such as nitrofurantoin macrocrystals 50 mg b.i.d. The catheter should be removed every 3 to 4 days for a voiding trial to see if the problem has resolved.

For those patients with persistent voiding difficulties at 2 weeks, I recommend an attempt at stretching the tape. This is done in the following manner: Place the patient in dorsal lithotomy position on an examining table. Inject xylocaine 2% gel into the urethra. After
5 minutes, insert a #16 Hanks cervical dilator into the urethra. Pull straight down on the dilator firmly but gently, keeping the instrument parallel to the floor. In some cases, this relieves the voiding problem.

For the rare patient who has persistent retention or a significant voiding problem at 2 months postoperatively, I recommend cutting the tape. Inject xylocaine 1% with epinephrine under the midurethra and laterally. Make a 2-cm incision in the vaginal mucosa parallel and lateral to the midurethra at the 4 o'clock position relative to the urethral meatus. Cut the tape, which is felt as a firm structure lateral to the midurethra. Then close the vaginal mucosa with 3-0 delayed absorbable suture. This procedure usually will relieve excess tension but still leave enough support to maintain continence due to scar formation around the tape.

How well does it work?

In a multicenter prospective study of TVT performed in 131 patients who were followed for at least 1 year, 91% were cured, 7% improved, and 2% failed. The mean operative time was 28 minutes. All patients had local anesthesia with sedation. Ninety percent were discharged within 24 hours without a catheter, but 3 required a catheter for 3 days and 1 was catheterized for more than 10 days.27

In another study of 51 patients, follow-up at 3 years demonstrated a 90% cure rate, a 6% improvement rate, and a 4% failure rate.28 Other researchers studying 50 women at 3 years after TVT found that 86% were cured and that 11% had significant improvement of symptoms. No deterioration of results occurred over the 3-year period.29

Additionally, a 1- to 2-year follow-up study in which the researchers used postoperative urodynamics and pad testing on 39 women who had undergone TVT revealed a success rate (cured plus improved) of 90%.30

A multicenter prospective randomized trial comparing TVT with Burch colposuspension is ongoing in the United Kingdom and Ireland. An initial report presented to the American Continence Society in August 2000 includes 170 TVT procedures and 146 colposuspensions. At 6 months, 68% of the TVT group and 66% of the colposuspension group were objectively cured of stress incontinence, based on a negative 1-hour pad test and no leakage during cystometrogram (CMG). On CMG alone, the cure rate was 89% for TVT and 85% for colposuspension. The authors note that postoperative opiate analgesia usage was significantly lower following TVT (21%) versus colposuspension (91%). The median time to return to work and to full activity was significantly shorter for TVT patients than for colposuspension patients.31

Lastly, 36 patients with urodynamically verified intrinsic sphincter deficiency (maximum urethral pressure less than 20 cm H2O) were treated with TVT. Among the women in this cohort, 27 were completely cured, 4 experienced a cure of SUI but had persistent urge
incontinence, and 2 reported improved symptoms. There also were 2 failures and 1 de novo detrusor instability.32

What will the future reveal?

Two centuries ago, a wise physician said, "New medicines and new methods of cure always work miracles-for a while."33 Indeed, using TVT to treat SUI is a relatively new technique. However, there are a few factors that contribute to its promise of a long-term
cure. Beyond the fact that other sling procedures have an excellent record of long-term cure, polypropylene is a stable material that is unlikely to deteriorate with time. In addition, there is increased collagen metabolism around the tape postoperatively, which
promotes ingrowth of tissue through the mesh. This reaction was demonstrated in a 2-year follow-up study, which showed an increase in extractable collagen in the paraurethral connective tissue following TVT.34

Nonetheless, the evidence remains sparse. The few studies that have been published indicate that the short-term efficacy of TVT is comparable to other accepted procedures for SUI; however, long-term results (5 years or longer) are not yet available. Despite a low complication rate in the hands of surgeons with expertise in managing female urinary incontinence and a rapid patient recovery, widespread acceptance of TVT will depend on additional long-term data and more prospective randomized trials that compare this technique with other surgical treatments for incontinence.

Key points

It is critical to avoid deviating too far laterally or superiorly with the insertion needle.  Perform cystoscopy using a 70-degree lens after placing each insertion needle to rule out bladder perforation.  To position the TVT, insert a clamp between the tape and the urethra and then gently pull the tape toward the urethra. The clamp creates a 0.5-cm gap, ensuring tension-free placement. Increased collagen metabolism postoperatively promotes ingrowth of tissue through the mesh over time, eliminating the need to anchor the sling to bone or tissue.  Researchers have demonstrated a short-term (1 to 3 years) cure rate of about 90% when treating stress urinary incontinence with TVT.

References:

References

1. Black NA, Downs SH. The effectiveness of surgery for stress incontinence in women: a systematic review. Br J Urol. 1996;78:497.

2. Leach GE, Dmochowski RR, Appell RA, et al. Female Stress Urinary Incontinence Clinical Guidelines Panel summary report on surgical management of female stress urinary incontinence. The American Urological Association. J Urol. 1997;158:875.

3. Alcalay M, et al. Burch colposuspension: a 10-20 year follow-up. Br J Obstet Gynaecol. 1995;102:740.

4. Eriksen BC, et al. Long-term effectiveness of the Burch colposuspension in female urinary stress incontinence. Acta Obstet Gynecol Scand. 1990;69:45.

5. Bergman A, Elia G. Three surgical procedures for genuine stress incontinence: five year follow-up of a prospective randomized study. Am J Obstet Gynecol. 1995;173:66.

6. Dainer M, et al. The Burch procedure: a comprehensive review. Obstet Gynecol Surv. 1998;54:49.

7. Ross JW. Multichannel urodynamic evaluation of laparoscopic Burch colposuspension for genuine stress incontinence. Obstet Gynecol. 1998;91(1):55.

8. Liu CY. Laparoscopic retropubic suspension (Burch procedure): a review of 58 cases. J Reprod Med. 1993;38:526.

9. Lobel RW, David GD. Long-term results of laparoscopic Burch urethropexy. J Am Assoc Gynecol Laparos. 1997:4:341.

10. Su TH, Wang KG, Hsu CY, et al. Prospective comparison of laparoscopic and traditional colposuspensions in the treatment of genuine stress incontinence. Acta Obstet Gynecol Scand. 1997;76(6):576.

11. Langer R, et al. A new colpo-needle suspension for the surgical treatment of stress incontinence: a 2-year follow-up. Eur Urol. 1994;26:258.

12. Liapis A, Pyrgiotis E, Kontoravdis A, et al. Genuine stress incontinence: prospective randomized comparison of two operative methods. Eur J Obstet Gynecol Reprod Biol. 1996;64:69.

13. Jarvis GJ. Surgery for genuine stress incontinence. Br J Obstet Gynaecol. 1994;101:371.

14. Ostergard DR. Primary slings for everyone with genuine stress incontinence? The argument against. Int Urogynecol J. 1997;8:321.

15. Chan PT, Fournier C, Corcos J. Short-term complications of pubovaginal sling procedure for genuine stress incontinence in women. Urology. 2000;55:207.

16. Chaikin DC, Rosenthal J, Blaivas JG. Pubovaginal fascial sling for all types of stress urinary incontinence: long-term analysis. J Urol. 1998;160:1312.

17. Marinkovic S, et al. Analysis of early outcome: Burch procedure versus pubovaginal sling. Int Urogynecol J Pelvic Floor Dysfunct. 1998;9:94.

18. Cross CA, Cespedes, RD, McGuire EJ. Treatment results using pubovaginal slings in patients with large cystoceles and stress incontinence. J Urol. 1997;158:431.

19. Young SB, et al. The Mersilene mesh suburethral sling: a clinical and urodynamic evaluation. Am J Obstet Gynecol. 1995;173:1719.

20. Pandit M, DeLancey JOL, Ashton-Miller JA, et al. Quantification of intramuscular nerves within the female striated urogenital sphincter muscle. Obstet Gynecol. 2000;95:797.

21. Horbach NS, Ostergard DR. Predicting intrinsic urethral sphincter dysfunction in women with stress urinary incontinence. Obstet Gynecol. 1994;84:188.

22. Sarver R, Govier FE. Pubovaginal slings: past, present and future. Int Urogynecol J Pelvic Floor Dysfunct. 1997;8:358.

23. Ulmsten U, Petros P. Intravaginal slingplasty (IVS): an ambulatory surgical procedure for treatment of female urinary incontinence. Scand J Urol Nephrol. 1995;29:75.

24. Versi E, Cardozo LD, Studd JW, et al. Internal urinary sphincter in maintenance of female continence. BMJ. 1986;292:166.

25. Kuuva N, Nilsson C-G. A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure. Neurourol Urodyn. 2000;19:394.

26. MAUDE. Food and Drug Administration Manufacturer and User Facility Device Experience Database. Available at: http://www.fda.gov/cdrh/maude.html. Accessed November 3, 2000.

27. Ulmsten U, Falconer C, Johnson P, et al. A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1998;9:210.

28. Olsson I, Kroon U. A three-year postoperative evaluation of tension-free vaginal tape. Gynecol Obstet Invest. 1999;48:267.

29. Ulmsten U, Johnson P, Rezapour M. A three-year follow up of tension free vaginal tape for surgical treatment of female stress urinary incontinence. Br J Obstet Gynaecol. 1999;106:345.

30. Wang AC. An assessment of the early surgical outcome and urodynamic effects of the tension-free vaginal tape (TVT). Int Urogynecol J. 2000;11:282.

31. Ward KL, Hilton P, Browning J. A randomised trial of colposuspension and tension-free vaginal tape (TVT) for primary genuine stress incontinence. Neurourol Urodyn. 2000;19:386.

32. Jacquetin B, Fatton B. Efficacy of TVT procedure in management of female stress urinary incontinence due to intrinsic sphincteric deficiency. Int Urogynecol J. 1999;10:S12.

33. Heberden W. Commentaries on the History and Cure of Diseases. London: T. Payne; 1803.

34. Falconer C, Edman-Ordeberg G, Malmstrom A, Ulmsten U. Clinical outcome and changes in connective tissue metabolism after intravaginal slingplasty in stress incontinent women. Int Urogynecol J. 1996;7:133.

Dr. Flesh is a clinical instructor of obstetrics, gynecology, and reproductive biology at Harvard Medical School and director of urogynecology and pelvic reconstructive surgery at Harvard Vanguard Medical Associates, both in Boston, Mass.

The author reports no financial relationships with any companies whose products are mentioned in this article.