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ORIGINAL RESEARCH |
From the Mount Auburn Hospital, Harvard Medical School, Cambridge, Mas-sachusetts; Northside Hospital, Alpharetta, Georgia; and Atlanta Center for Laparoscopic Urogynecology, Atlanta, Georgia.
Address reprint requests to: C. R. Rardin, MD, 725 Concord Avenue, Suite 3300, Cambridge, MA 02138; E-mail: crardin{at}earthlink.net.
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ABSTRACT |
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METHODS: A retrospective, multicenter study of 245 consecutive women who were treated with tension-free vaginal tape for genuine stress urinary incontinence (157 for primary and 88 for recurrent genuine stress urinary incontinence) over a 27-month period was performed. Concurrent surgical repairs were performed as required. Subjective and objective outcome data were assessed from routine postoperative visits. Office and hospital records were reviewed to determine patient characteristics, intraoperative findings, and surgical outcomes.
RESULTS: Women with recurrent genuine stress urinary incontinence were older (mean age 64.6 versus 59.4 years, P = .004) than those with primary incontinence; they were less likely to have an intact uterus (22.7% versus 66.9%, P < .001), and were more likely to have intrinsic sphincter deficiency (70.5% versus 47.1%, P < .001). The mean duration of follow-up was 38 (±16) weeks. Cure rates among patients with recurrent versus primary genuine stress urinary incontinence were similar (85% and 87%, respectively, P = .23). Complication rates were similarly low in both groups (4.5% versus 7.6% for recurrent and primary genuine stress urinary incontinence, respectively, P = .35). Postoperative voiding dysfunction occurred at low rates in both groups.
CONCLUSION: Tension-free vaginal tape is a highly effective treatment among patients with recurrent stress incontinence, with outcomes comparable with those among patients with primary incontinence.
Recurrence of genuine stress urinary incontinence after anti-incontinence surgery remains a challenging situation for patient and surgeon alike. Conventional wisdom suggests that success rates decline with repeat surgery, and that surgical revision may be associated with increased rates of complication, attributable to a previously altered surgical field.
Tension-free vaginal tape (TVT) has been demonstrated to be a safe and effective treatment for primary genuine stress urinary incontinence, offering the benefits of a minimally invasive technique, with good long-term results.1 Relatively lacking, however, is support for its use in the population with recurrent genuine stress urinary incontinence. We sought to estimate the safety and efficacy of TVT in the treatment of that population, compared with patients with primary incontinence.
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MATERIALS AND METHODS |
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The TVT procedure was performed according to published guidelines, and additional surgical procedures and vaginal repairs were performed as indicated. Patients underwent retrograde bladder filling with voiding assessment before discharge, and were discharged with bladder drainage in cases of impaired bladder emptying.
Patients were routinely followed at 2 and 6 weeks, 6 months, and 1 year postoperatively. Patients reporting any urine leakage at all after the procedure, or those unable to provide reliable histories, underwent clinical assessment, including sitting and standing cough stress tests performed at 300 mL (or at bladder capacity, if less than that amount).
Success was defined as an absence of urine leakage by patient report, where reliable histories could be obtained; improvement was defined as stress-related leakage that was subjectively improved over baseline. In addition, any case in which genuine stress urinary incontinence was corrected, but some degree of urge incontinence (whether persistent or de novo) was present, was considered improved as long as the patient reported overall improvement from baseline. Failure was defined as full recurrence of genuine stress urinary incontinence (as determined subjectively), or in any case where additional anti-incontinence procedures were considered.
Statistical tests on continuous variables were conducted using the Student t test assuming unequal variances for the two samples. The 
2 test for independence was used for discrete variables. All terminology conformed to the recommendations of the International Continence Society except where otherwise specified.
This study was not supported in any way by Gynecare, Inc., or by any other corporate entity.
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RESULTS |
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Preoperative patient demographics, comorbidities, and clinical findings (including cotton-swab angle and urodynamic parameters) are displayed in Tables 1
, 2, and 3, respectively. Patients with recurrent incontinence were significantly older, more likely to have undergone previous hysterectomy, and more likely to have a diagnosis of intrinsic sphincter deficiency (with or without concurrent urethral hypermobility). Nineteen (12%) and ten (11%) of the patients in the primary and recurrent incontinence groups, respectively, were diagnosed with intrinsic sphincter deficiency by means of borderline values in both parameters (20–30 cm H2O and 60–70 cm H2O for maximum urethral closure pressure and Valsalva leak point pressure, respectively), as well as a positive empty supine stress test. Mean cotton-swab angle with strain was higher among patients with primary incontinence (51.6 degrees from horizontal, ±19.9) than were patients with recurrent incontinence (45.4 degrees, ± 21.9; P = .03). Patients with recurrent incontinence had a significantly lower mean Valsalva leak point pressure; other mean urodynamic parameters were not significantly different between groups. Patients with primary incontinence were more likely to have been diagnosed with detrusor instability or overactive bladder syndrome before TVT placement (see Table 2).
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. There was a low incidence of readmission, usually for incision site or pelvic hematoma or abscess. One patient in the primary incontinence group, who underwent concurrent colpocleisis with perineorrhaphy, had a pelvic hematoma attributed to the colpocleisis, received blood transfusions, and had laboratory evidence of a minor myocardial infarction. There was one postoperative death in the primary group of an elderly patient with significant coexisting cardiac comorbidity who underwent TVT and pelvic repairs under local anesthetic after preoperative medical clearance. She was discharged on the first postoperative day in stable condition and died suddenly while asleep the following evening without antecedent symptoms or complications. No postmortem autopsy was done, and the death was presumed due to cardiac factors. One patient, also in the primary incontinence group, had a small vaginal erosion of mesh, which was successfully treated with simple excision of the exposed mesh.
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Patients in the primary incontinence group were more likely to experience impaired bladder emptying or urge incontinence (including de novo urge incontinence); the rates of overactive bladder syndrome were similar between the two groups. These data are displayed in Table 6.
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DISCUSSION |
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Tension-free vaginal tape offers an attractive alternative, in its minimally invasive nature and low morbidity.8,9 Extrapolation of outcomes data from other sling techniques in the treatment of recurrent incontinence to TVT, however, must be done with caution, as several features of TVT are distinctive, including its midurethral placement and its minimal dissection. Tension-free vaginal tape has recently been assessed in patients with recurrent incontinence, demonstrating efficacy with an 82% cure rate and 91% cured/improved rate, with a good safety profile.10 However, patients with intrinsic sphincter deficiency and those with symptoms of prolapse were excluded from that study.
This evaluation of TVT for the treatment of recurrent incontinence, in a population inclusive of intrinsic sphincter deficiency and prolapse, demonstrates that the efficacy and safety of TVT in this group of patients are not significantly different from that observed in the primary incontinence population. Rates of cure and complication compare favorably with those quoted for other techniques of anti-incontinence surgery.11
For the purposes of this study, patients who had no complaint of postoperative incontinence were not routinely subjected to objective measures. It has been previously demonstrated that subjective cure rates are often higher than objective cure rates.4,12 It is important to the scientific evaluation of surgery to confirm subjective data, as it is prone to bias on the part of both surgeon and patient. However, as suggested by Arnold et al, the subjective complaint of the patient is usually the stimulus to seek care, and therefore should be our primary endpoint in evaluation of a patient’s progress.13 We do not know the prevalence of objective evidence of incontinence in the general, healthy population (false-positive rate), and therefore should not use it as a gold standard in the incontinent population.
The finding that patients with recurrent incontinence were more likely to have heart disease may be a function of their older age. The fact that they were less likely to have baseline detrusor instability or overactive bladder syndrome, compared with their counterparts with primary incontinence, may reflect the surgeons’ reluctance to perform surgery on older, more complicated patients with mixed incontinence.
The low rates of failure in both groups do not permit formal analysis of time dependence; it may be presumed, however, that such a pattern is likely to arise, as they have with other anti-incontinence procedures. These data do not support the generally accepted hypothesis that risk of failure increases with number of previous procedures, in that all patients with two or more previous procedures were cured; however, the number of such patients is low (five), and no formal conclusions in this regard should be drawn. Similarly, the small numbers of failures did not permit analysis of the risk of failure as a function of the specific previous procedure. The incidence of mesh erosion, although uncommon in the extant TVT literature,14 is likely to be time dependent; in these and other respects, longer-term evaluation will be of much use.
The current data provide evidence that TVT is comparably safe and effective among patients with recurrent incontinence, with or without intrinsic sphincter deficiency or pelvic organ prolapse, as it has been shown to be among patients with primary incontinence.
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Footnotes |
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Received December 28, 2001. Received in revised form June 14, 2002. Accepted July 11, 2002.
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REFERENCES |
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2. Rardin CR, Rosenblatt PL, Kohli N, Miklos JR, Heit M, Lucente VR. Release of tension-free vaginal tape for the treatment of refractory postoperative voiding dysfunction. Obstet Gynecol 2002;100:898–902.
3. Holschneider CH, Solh S, Lebnerz TB, Montz FJ. The modified Pereyra procedure in recurrent stress urinary incontinence: A 15-year review. Obstet Gynecol 1994;83: 573–8.[Medline]
4. Amaye-Obu FA, Drutz HP. Surgical management of recurrent stress urinary incontinence: A 12-year experience. Am J Obstet Gynecol 1999;181:1296–309.[Medline]
5. Alcalay M, Monga A, Stanton SL. Burch colposuspension: A 10–20 year follow up. Br J Obstet Gynaecol 1996;103: 290.
6. Hodgkinson CP. Recurrent stress urinary incontinence. Am J Obstet Gynecol 1978;132:844–60.[Medline]
7. Benson JT. The effect of vaginal dissection on the pudendal nerve. Obstet Gynecol 1993;82:387–9.
8. Ulmsten U, Falconer C, Johnson P, Jomaa M, Lanner L, Nilsson CG, et al. A multicenter study of TVT (tension-free vaginal tape) for surgical management of stress urinary incontinence. Int Urogynecol J 1998;9:210–3.
9. Wang AC, Lo TS. Tension-free vaginal tape. A minimally invasive solution to stress urinary incontinence in women. J Reprod Med 1998;43:429–34.[Medline]
10. Rezapour M, Ulmsten U. Tension-free vaginal tape (TVT) in women with recurrent stress urinary incontinence—a long-term followup. Int Urogynecol J 2001;12: S9–11.
11. Kohli N, Karram M. Surgery for genuine stress incontinence. In: Walters M, Karram M, eds. Urogynecology and reconstructive pelvic surgery. 2nd ed. St. Louis: Mosby, 1999:171–96.
12. McLennan MT, Bent AE, Richardson DA. Evaluation of different surgical procedures. In: Ostergard DR, Bent AE, eds. Urogynecology and urodynamics, theory and practice. 4th ed. Baltimore: Williams and Wilkins, 1996: 517–26.
13. Arnold EP, Webster JR, Loose H, Brown AD, Warwick RT, Whiteside CG, et al. Urodynamics of female incontinence: Factors influencing the results of surgery. Am J Obstet Gynecol 1973;117:805–13.[Medline]
14. Kuuva N, Nilsson CG. A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure. Neurourol Urodyn 2000;19:394–5.
This article has been cited by other articles:
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  M. T. Margolis and C. R. Rardin Tension-Free Vaginal Tape: Outcomes Among Women With Primary Versus Recurrent Stress Urinary Incontinence Obstet. Gynecol., April 1, 2003; 101(4): 817 - 818. [Full Text] [PDF]
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