HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Nilsson, C. G. Articles by Rezapour, M. Search for Related Content PubMed PubMed Citation Articles by Nilsson, C. G. Articles by Rezapour, M. Related Collections Gynecologic surgery Urogynecology

Seven-Year Follow-up of the Tension-Free Vaginal Tape Procedure for Treatment of Urinary Incontinence

Carl Gustaf Nilsson, MD, PhD^*, Christian Falconer, MD, PhD and Masoumeh Rezapour, MD, PhD

From the *Department of Obstetrics and Gynecology, Helsinki University Central Hospital, Helsinki, Finland; Danderyd Hospital, Stockholm, Sweden; and Department of Obstetrics and Gynecology, Uppsala University Hospital, Uppsala, Sweden.

	ABSTRACT

TOP ABSTRACT MATERIALS AND METHODS RESULTS DISCUSSION REFERENCES

 
OBJECTIVE: To evaluate the long-term cure rates and late complication rates after treatment of female urinary stress incontinence with the minimally invasive tension-free vaginal tape operation.

METHODS: Prospective observational, 3-center cohort study originally of 90 women requiring surgical treatment for primary urinary stress incontinence. Assessment variables included a 24-hour pad weighing test, a stress test, visual analog scale for assessing the degree of bother, and a questionnaire assessing the subjective perception of the women on their continence status.

RESULTS: The follow-up time was a mean of 91 months (range 78–100 months). Both objective and subjective cure rates were 81.3% for the 80 women available for follow-up. Asymptomatic pelvic organ prolapse was found in 7.8%, de novo urge symptoms in 6.3%, and recurrent urinary tract infection in 7.5% of the women. No other long-term adverse effects of the procedure were detected.

CONCLUSION: The tension-free vaginal tape procedure for treatment of female urinary stress incontinence is effective over a period of 7 years.

LEVEL OF EVIDENCE: II-3

Low cure rates and high complication rates have been a concern among those studying many of the minimally invasive procedures. Endoscopic colposuspension, periurethral bulking agents, and needle suspension procedures have been associated with either unacceptable complications or rapidly declining cure rates^1–3

The tension-free vaginal tape (TVT) procedure for treatment of female stress incontinence has become a widely used new minimally invasive operation probably due to the fact that it has been systematically and prospectively evaluated. Numerous reports reveal high rates of cure in primary cases of stress incontinence,^4–6 in recurrent cases,^7,8 in cases of mixed incontinence,^6,9 and in cases with intrinsic sphincter deficiency.¹⁰ A nationwide survey of the incidence of intraoperative and postoperative complications in connection with the TVT procedure has been performed in Finland. The results of this survey indicate a low rate of complications, even though the learning curve of the performing surgeons was included in the material.¹¹

High long-term cure rates enhance the cost-effectiveness of a given treatment. Five-year follow-up results of the TVT procedure have been published.¹² The cure rate of 85% corresponds very well with those of our most effective traditional, but more invasive, surgical incontinence procedures. The aim of the present study was to evaluate the continence status 7 years postoperatively of the women included in one of the earliest prospective clinical trials.

	MATERIALS AND METHODS

TOP ABSTRACT MATERIALS AND METHODS RESULTS DISCUSSION REFERENCES

 
Ninety consecutive patients suffering from urodynamically proven stress incontinence had a tension-free vaginal tape procedure performed between January 1, 1995, and October 15, 1996. The trial was a prospective 3-center study in 2 Nordic countries. All women were primary cases of stress incontinence, with no prior incontinence surgery. Twenty-five women reported symptoms of urge. Symptoms of urge included frequency more than 8 per day, urgency and nocturia more than 2 per day. Women with detrusor instability on preoperative urodynamic studies were excluded, as were those with intrinsic sphincter deficiency, defined as maximal urethral closure pressure less than 20 cm H₂O. Women with grade I cystocele not requiring surgical intervention were included.

The study protocol included preoperative urodynamic studies (micro tip urethrocystometry and urethral profilometry) in a sitting position according to previously described techniques¹³), a stress test (cough provocation) in the sitting or standing position with a bladder volume of 300 ml, a 24-hour pad-weighing test,¹⁴ a 2-day voiding diary, and residual urine measurements.

At postoperative follow-up visits the stress test, the 24-hour pad-weighing test, and the 2-day voiding diary were repeated. Postoperative quality of life was assessed by using a visual analog scale (VAS) where 0 represents no urinary problems and 100 unbearable urinary complaints.

A questionnaire was used in which the women stated whether they felt that they were cured of their incontinence or that they were improved or that treatment had failed. The women were also asked whether their continence situation was unchanged, improved, or worse compared with the situation at their previous 5-year follow-up visit.¹² Changes in medical history since the 5-year visit were recorded, and a gynecologic examination was performed.

The TVT procedure was carried out as described in detail previously.¹⁵ All operations were performed under local infiltration anesthesia using 0.25% prilocaine with epinephrine. The standard TVT set with a polypropylene tape was used (Gynecare TVT, Ethicon Inc., Somerville, NJ). Cystoscopy was performed twice during the operation, after each retropubic pass of the TVT needle to detect bladder injuries. Adjustment of the tape—the tension test—was performed by using the cough test. The patients were asked to cough strongly at a bladder volume of 300 ml. A few drops of saline were allowed to escape the external meatus of the urethra to avoid postoperative voiding difficulties. Postoperatively the patients were regarded as objectively cured if they had a negative stress test and a negative 24-hour pad-weighing test (less than 8 g per 24 hours).

The ethics committees of the 3 centers, Helsinki University Hospital, Danderyd Hospital, Stockholm, and Uppsala University Hospital, approved the study. All women gave informed consent to participation in the trial.

	RESULTS

TOP ABSTRACT MATERIALS AND METHODS RESULTS DISCUSSION REFERENCES

 
Of the original 90 women enrolled in the trial, 3 had died at the time of the 7-year follow-up visit. Six women lived in nursing homes, being disabled to a degree that they could not be evaluated, and 1 woman was completely lost to follow-up. Eighty women could be reached, 16 of them only by telephone due to various reasons (living in nursing homes or moved away from the region). Only subjective assessment using the questionnaire was performed in these 16 women. Sixty-four women could visit the clinics and be fully evaluated. The patient characteristics are shown in Table 1.

The mean follow-up time was 91.1 (range 78–100) months, which is 7.6 years. Of the 64 women who visited the clinics, 54 (84.4%) had a negative pad test, 7 (10.9%) had a positive pad test (range 10–132g per 24 hours),and 3 women refused to perform the pad test, claiming they were completely dry.

The stress test was not possible to perform in the standardized way in 3 women, and the remaining 61 (95.3%) women had a negative stress test. The criteria for objective cure were met by 81.3% of the clinically evaluated women.

The results of the subjective evaluation of 80 women reached for follow-up are presented in Table 2. Both the objective and subjective cure rate was 81.3%.

Eighteen (22.5%) of the evaluated 80 women had symptoms of urge. Table 3 shows the medical status of these 18 women. Asymptomatic pelvic organ prolapse, grade I–II and not requiring surgical intervention, was seen in 5 (7.8%) of the 64 women seen at the clinics. Recurrent urinary tract infections were reported by 6 (7.5%) of 80 women interviewed. Five (6.3%) of 80 reported de novo urge symptoms. None of the women complained of voiding difficulties, and no sign of tape material rejection could be seen or was reported.

	DISCUSSION

TOP ABSTRACT MATERIALS AND METHODS RESULTS DISCUSSION REFERENCES

 
A commonly encountered problem with new promising surgical procedures for treatment of female stress incontinence is the difficulty of predicting the effectiveness of a given treatment over time. A systematic prospective follow-up allows one to take a closer look at this problem. Long-term follow-up, however, is associated with a growing proportion of the original subjects being lost to follow-up. Interestingly, in our study, of 90 women who were originally enrolled, 80 were amenable to follow-up after 7 years and 64 of 90 (71%) could be clinically evaluated according to the protocol. Only 1 patient was completely lost to follow-up. Another 9 patients could not be evaluated due to death unrelated to the treatment or were severely disabled by illness. Some of the patients were elderly, a few over 90 years of age. The lower the rate of those lost to follow-up, the more reliably cure rates reflect the true durability of effectiveness of treatment in a certain population. Therefore, a cure rate of more than 80% in a population such as the present one has to be regarded as reassuring. Long-term cure rates of around 70–80% have been reported for the open Burch colposuspension operation, regarded as the standard for traditional incontinence procedures.^16,17 Long-term cure rates for less invasive incontinence procedures such as needle suspensions and periurethral bulking agents have been rather disappointing, ranging between 5% and 48%.^18–20 In our current study, 97.5% of the women regarded the TVT operation as successful. When comparing their continence status at 7 years of follow-up to that at the prior 5-year visit, 88% felt that the situation was unchanged, but 5% felt that they had improved, and 8% felt that their situation had become worse. This perhaps reflects changes in health status and life style more than the actual mechanism of action of the tension-free tape.

Importantly, no signs of tape erosion or any tissue reactions indicating tape material rejection were found. In an aging population many illnesses occur that are known to affect bladder function, causing symptoms of overactivity, including incontinence. The patients’ subjective perception of their incontinence status is naturally affected by these conditions and consequently does not necessarily reflect the effectiveness with which an operation cures stress incontinence. Eighteen of the women in the present study presented with symptoms of an overactive bladder at their 7 years follow-up visit. Thirteen had diseases or conditions that commonly are associated with bladder problems. Only 5 women were thought to have de novo urge symptoms unrelated to any known illnesses. Whether the urge symptoms of these women are directly associated with the TVT operation, performed 7 years earlier, is a question of debate. In any case, the rate of urge problems with the TVT procedure seems to be low in comparison with traditional incontinence surgery.²

Quality of life can be assessed in many ways. Generic instruments for measurement of health-related quality of life have been relatively insensitive for use in assessing the impact of urinary incontinence on quality of life and treatment efficacy.²¹ The visual analog scale is a generally accepted tool in research concerning measurement of the impact of disease and effects of medical intervention on health-related quality of life and had also been successfully used in urinary incontinence studies^22–24. As Stach-Lempinen et al²⁵ have shown, the VAS is an easy, valid, reproducible measure, which is responsive to treatment for women suffering from urinary incontinence. We therefore chose this instrument for assessing quality of life and believe that the VAS nicely reflects how objectively assessed cure influences women's perception of changes in quality of life. The absence of long-term adverse events associated with the TVT operation and high subjective and objective 7-year postoperative cure rates make the TVT operation a recommendable surgical treatment for female stress urinary incontinence.

	Footnotes

 
The authors recognize Ulf Ulmstead, MD, PhD, deceased March 2004, for his contribution to this study.

Reprints are not available. Address correspondence to: Carl Gustaf Nilsson, Department of Obstetrics and Gynecology, Helsinki University Central Hospital, Haartmaninkatu 2, Helsinki, POB 140,00029 HUS, Finland; e-mail: carl.nilsson{at}hus.fi.

Received May 19, 2004. Received in revised form August 19, 2004. Accepted August 25, 2004.

doi:10.1097/01.AOG.0000146639.62563.e5

	REFERENCES

TOP ABSTRACT MATERIALS AND METHODS RESULTS DISCUSSION REFERENCES

 
1. Lose G. Laparoscopic Burch colposuspension. Acta Obstet Gynecol Scand 1998;77suppl:29–33.

2. Jarvis GJ. Surgery for genuine stress incontinence. BJOG 1994;101:371–4.

3. 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;173:66–71.[Medline]

4. Ulmsten U, Falconer C, Johnson P, Jomaa M, Lanner L, Nilsson CG, et al. A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence. Int J Urogynecol J Pelvic Floor Dysfunct 1998;9:210–3.

5. Olsson I, Kroon U. A three-year postoperative evaluation of tension-free vaginal tape. Gynecol Obstet Invest 1999;48:267–9.[Medline]

6. Nilsson CG, Kuuva N. The tension-free vaginal tape procedure is successful in the majority of women with indications for surgical treatment of urinary stress incontinence. BJOG 2001;108:414–9.[Medline]

7. Rezapour M, Ulmsten U. Tension-free vaginal tape (TVT) in women with recurrent stress urinary incontinence—a long-term follow-up. Int J Urogynecol J Pelvic Floor Dysfunct 2001;12suppl:9–11.

8. Kuuva N, Nilsson CG. Tension-free vaginal tape procedure: an effective minimally invasive operation for the treatment of recurrent stress urinary incontinence? Gynecol Obstet Invest 2003;56:93–8.[Medline]

9. Rezapour M, Ulmsten U. Tension-free vaginal tape (TVT) in women with mixed urinary incontinence—a long-term follow-up. Int J Urogynecol J Pelvic Floor Dysfunct 2001;12suppl:15–8.

10. Rezapour M, Ulmsten U. Tension-free vaginal tape (TVT) in stress incontinent women with intrinsic sphincter deficiency (ISD)—a long-term follow-up. Int J Urogynecol J Pelvic Floor Dysfunct 2001;12suppl:12–4.

11. Kuuva N, Nilsson CG. A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure. Acta Obstet Gynecol Scand 2002;81:72–7.[Medline]

12. Nilsson CG, Kuuva N, Falconer C, Rezapour M, Ulmsten U. Long-term results of the tension-free vaginal tape (TVT) procedure for surgical treatment of female stress urinary incontinence. Int J Urogynecol J Pelvic Floor Dysfunct 2001;12suppl:5–8.

13. Ulmsten U, Asmussen M, Lindström K. A new technique for simultaneous urethrocystometry and measurement of the urethral pressure profile. Urol Int 1977;32:88–92.[Medline]

14. Victor A, Larsson G, Åsbrink AS. A simple patient-administered test for objective quantification of the symptom of urinary incontinence. Scand J Urol Nephrol 1987;21:277–9.[Medline]

15. Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int J Urogynecol J Pelvic Floor Dysfunct 1996;7:81–6.

16. Feyereisl J, Dreher E, Haenggi W, Zikmund J, Schneider HA. Long-term results after Burch colposuspension. Am J Obstet Gynecol 1994;171:647–52.[Medline]

17. Alcalay M, Monga A, Stanton S. Burch colposuspension: a 10–20 year follow up [published erratum appears in Br J Obstet Gynaecol 1996;103:290]. BJOG 1995;102:740–5.

18. Trockman BA, Leach GE, Hamilton J. Modified Pereyra bladder neck suspension: 10-year mean followup outcome analysis of 125 patients. J Urol 1995;154:1841–7.[Medline]

19. Tebyani N, Patel H, Yamaguchi R, Aboseif SR. Percutaneous needle bladder neck suspension for treatment of stress urinary incontinence in women: long-term results. J Urol 2000;163:1510–2.[Medline]

20. Sheriff MS, Foley S, McFarlane J, Nauth-Misir R, Shah PJR. Endoscopic correction of intractable stress incontinence with silicone micro-implants. Eur Urol 1997;32:284–8.[Medline]

21. Kelleher CJ, Cardozo LD, Toozs-Hobson PM. Quality of life and urinary incontinence. Curr Opin Obstet Gynecol 1995;7:404–8.[Medline]

22. Parkin DE, Davis JA. Use of a visual analogue scale in the diagnosis of urinary incontinence. Br Med J (Clin Res Ed) 1986;293:365–6

23. Frazer MI, Haylen BT, Sutherst JR. The severity of urinary incontinence in women: comparison of subjective and objective tests. Br J Urol 1989;63:14–5.[Medline]

24. Vinsnes AG, Hunskaar S. Distress associated with urinary incontinence, as measured by a visual analogue scale. Scand J Caring Sci 1991;5:57–61.[Medline]

25. Stach-Lempinen B, Kujansuu E, Laippala P, Metsänoja R. Visual analogue scale, urinary incontinence severity score and 15 D–psychometric testing of three different health-related quality-of-life instruments for urinary incontinent women. Scand J Urol Nephrol 2001;35:476–83.[Medline]

This article has been cited by other articles:

				C. M. Zahn, S. Siddique, S. Hernandez, and E. G. Lockrow Anatomic Comparison of Two Transobturator Tape Procedures Obstet. Gynecol., March 1, 2007; 109(3): 701 - 706. [Abstract] [Full Text] [PDF]

				M. H. Parekh, V. A. Minassian, and D. Poplawsky Bilateral bladder erosion of a transobturator tape mesh. Obstet. Gynecol., September 1, 2006; 108(3 Pt 2): 713 - 715. [Abstract] [Full Text] [PDF]

This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Nilsson, C. G. Articles by Rezapour, M. Search for Related Content PubMed PubMed Citation Articles by Nilsson, C. G. Articles by Rezapour, M. Related Collections Gynecologic surgery Urogynecology