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ORIGINAL RESEARCH |
From the Department of Obstetrics and Gynecology, Falun Hospital; Centre for Clinical Research, Falun, Sweden; and Institute for Women’s and Children’s Health, Uppsala University, Uppsala, Sweden.
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ABSTRACT |
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Methods: A mailed questionnaire was answered by 760 of 970 women who had undergone TVT surgery 2–8 years ago (78% response rate). Seventeen women had unclassified incontinence, and 51 women who developed de novo urgency were excluded, giving 580 (83.8%) with stress incontinence and 112 (16.2%) women with mixed incontinence eligible for analysis. Demographic, reproductive factors, and medical history were obtained. The questionnaire included detailed questions about urinary symptoms. Analysis of outcome was done for cohorts by number of years since the operation.
Results: The women with stress incontinence had a persistent cure rate of 85% from 2 to 8 years after the TVT procedure. The women with mixed incontinence had a persistent cure rate of 60% up to 4 years postoperatively, but the cure rate then steadily declined to 30% from 4 to 8 years after surgery. The increased rate of incontinence was due to urgency symptoms.
Conclusion: The results of this study indicate that initial good cure rates of TVT for mixed incontinence do not persist after 4 years.
Level of Evidence: III
A combination of stress and urgency incontinence has been estimated in different studies to account for as much as one third of all cases of female incontinence.2,3 Traditionally, medical treatment has been used for urgency symptoms. This has led to reluctance to undergo surgical treatment of combined stress and urgency incontinence, ie, mixed incontinence, and the first reports of surgery did not appear until the 1980s.4 The absence of long-term follow-ups makes it difficult to evaluate studies on the surgical results of mixed incontinence, which at the follow-up, in general, show encouraging results. The present study seeks to address this problem.
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SUBJECTS AND METHODS |
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Preoperatively, all women underwent routine assessment including a gynecological history, physical examination, and stress test. Urine analysis was used for screening, and urine culture was made when there was a suspicion of, or clinical symptoms that could be attributed to, urinary tract infection.
A positive stress test was a necessary criterion to establish stress incontinence. Concomitant urge incontinence relied on the woman’s history as defined by the International Continence Society:1 "Urge urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency" and "Mixed urinary incontinence is the complaint of involuntary leakage associated with urgency and also with exertion, effort, sneezing or coughing."
The tension-free vaginal tape procedure was performed as previously described.5 Patients were operated on under local anesthesia. When necessary, small doses of sedatives were given intravenously. The TVT procedure was ambulatory in 221 (23.7%) patients, and the remaining, in general, stayed in hospital for 1 or 2 nights.
In early 2004, a questionnaire and a prepaid, addressed envelope was mailed to the women. Specific questions elicited responses about stress and urgency incontinence and general results of the operation. Five alternatives were given: 1 "worsened," 2 "unchanged," 3 "improved," 4 "almost cured," and 5 "cured." Questions were also asked for de novo urgency, nocturnal incontinence, and frequency. In addition, the questionnaire was designed to obtain demographic information and reproductive history, as well as history of chronic diseases, such as diabetes, neurological disorders, bronchitis, and constipation, and information about smoking habits, recurrent urinary tract infections, sexual activity, and dyspareunia. Nonrespondents received a reminder approximately 1 month after the initial request.
The questionnaire was answered by 760 (78.4%) of the women. Seventeen women had a nonclassified incontinence, and 51 women with preoperative stress incontinence developed de novo urgency incontinence. These women were excluded from the study, leaving 692 women eligible for analysis. Of those, 580 (83.8%) had preoperative stress incontinence, and 112 (16.2%) were diagnosed as mixed incontinence.
Nonrespondents differed from respondents by a higher mean age (67.3 versus 62.2 years, P < .001) and body mass index (27.7 versus 26.9, P = .01). There were no significant differences by parity, estrogen treatment, previous incontinence surgery, incontinence classification, preoperative complications, such as excessive bleeding, postoperative complications (urinary infection, hematoma, and adjustment of the tape), or residual urine.
The number of TVTs were similarly distributed throughout the years studied, with the exception of 1995–1997, where fewer TVT procedures were performed. The latter patients were analyzed as one cohort. The women were grouped into cohorts by the number of years since they had undergone TVT surgery. The cohorts of women with urinary stress incontinence were as follows: 2 years (n = 93), 3 years (n = 116), 4 years (n = 113), 5 years (n = 102), and 6–8 years (n = 156). The cohorts of women with urinary mixed incontinence were as follows: 2 years (n = 29), 3 years (n = 32), 4 years (n = 21), 5 years (n = 17), and 6–8 years (n = 13). Women who underwent TVT surgery during 1995–1997 were analyzed together as "6–8 years after surgery."
Continuous variables, such as age and parity, were compared with the t test. Odds ratios and 95% confidence intervals for nominal variables were estimated by logistic regression, which was also used in multivariable analyses, mainly adjustment for age. The study was approved by the Research Ethical Committee, Uppsala University.
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RESULTS |
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The women with urinary mixed incontinence more often suffered from chronic constipation than did the women with stress incontinence (Table 2). Medical history was obtained in the questionnaire and also reviewed in the patient records. Other conditions did not differ between the 2 groups of women. The frequency of cases with a history of radiation because of gynecological cancer was higher in the women with mixed incontinence, but the actual figures were small.
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The women with stress incontinence had more preoperative and postoperative complications than the women with mixed incontinence (Table 3). Both differences were significant when the total patient population was analyzed. Other procedures during and after TVT surgery did not differ significantly between the women with mixed incontinence and those with stress incontinence.
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The women were asked about changes of their incontinence symptoms after the TVT surgery and were grouped by into cohorts according to the amount of time that had passed since the operation (Fig. 1). The answers were analyzed by years since the operation. Because there was a gradually increased mean age for surgery, there were small age differences by years after the TVT operation. The women with stress incontinence answered "cured" or "almost completely cured" in 80–90% of cases, irrespectively of number of years since the TVT procedure. Sixty percent of the women with mixed incontinence were reportedly cured up to 3 years after surgery. Thereafter, however, the outcome steadily declined until 6–8 years postoperatively, when the cure rate was only 30%. The difference in subjective cure rates after 2–4 years, as compared with after 5–8 years, in the women with mixed incontinence was significant (P = .02). Forty-seven (8.2%) of the women with stress incontinence, as compared with 30 (27.3%) with mixed incontinence, reported nocturnal incontinence.
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Total success rate for urinary stress incontinence among the 8 surgeons (another 2 surgeons had only one TVT operation each) are shown in Table 4. All of those 8 surgeons had performed more than 10 TVT procedures, and there were no significant differences in cure rates between the surgeons.
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The overall frequency of stress incontinence in women with mixed incontinence was similar, irrespective of the number of years since TVT surgery, and comparable with the women with genuine stress incontinence (Fig. 2). However, both urgency symptoms and actual episodes of urgency incontinence increased with time after the TVT procedure. The cure rate after 6–8 years had declined to 30%. Twenty-three (40.4%) of the women with persistent or recurrent mixed urgency incontinence were on anticholinergic drugs, as compared with 2 (5.6%) of the women who reported cure.
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DISCUSSION |
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Previously, increased frequency of urge incontinence was found in women who had undergone hysterectomy, as compared with the women with stress incontinence.14 Interestingly, we also found a strong correlation between history of cesarean delivery in the total study population of women with urge incontinence, compared with those with stress incontinence. One could speculate whether dissection of the bladder during the operation might damage the bladder, either neurologically, muscularly, or mechanically. A similar correlation was found in women who had undergone radiation therapy for gynecological cancer, although the number of patients was small and the difference thus not significant. Our finding of a correlation between chronic constipation and urgency incontinence suggests a mechanical causation.
We also found that women with mixed incontinence were significantly older than the women with stress incontinence. This might be due to atrophy of the bladder epithelium, which could be associated with the increased use of local estrogens or with neurological disorders. The women with mixed incontinence also had higher body mass index, which might increase the intrapelvic pressure. A correlation between urgency and obesity is not a novel finding,15 but the mechanisms behind this correlation are less evident. The increased frequency of postoperative surgical correction of the tape in women with stress incontinence, compared with those with mixed incontinence, is not easily explained. It is, however, our subjective experience that the urethral hypermobility and anterior rotation is more pronounced in the former group of women. This mobility might have a tendency to stretch the tape tighter in these women.
Our finding of good initial surgical results of mixed incontinence confirms that of other studies, as mentioned previously. However, our cure rates for mixed incontinence were 20–25% lower than with stress incontinence. Some previous studies reported similar cure rates in the 2 types of incontinence. Jeffry et al6 reported 89% cure rates in both groups of patients, Rezapour and Ulmsten7 reported cure rates of 85% in mixed incontinence patients, and Nilsson and Kuuva9 had 81% and 88% cure rates, respectively. In addition, Debodinance et al10 found a 90% cure rate after TVT surgery in women with mixed incontinence, and Kulseng-Hansen11 reported an 81% cure rate of stress incontinent women, while also 81% of those with severe urgency reported a significant improvement postoperatively.
However, Laurikainen and Kiilholma12 reported a 97% cure rate among patients with stress, compared with 69% among those with urgency. Meschia et al8 found a difference between cure rates of women with genuine stress incontinence (90%) and women with concomitant urgency (about 50% "significant improvement" of urgency symptoms). Finally, Paick et al13 had a 96% cure rate in women with urinary stress incontinence, compared with 78% in those with mixed incontinence.
The results of these 3 latter studies are similar to the short-term results in our study. The difference of the results in these, compared with other studies, is not readily explained. The definition of urgency symptoms and urgency incontinence is difficult, in particular when there is mixed incontinence, and it is thus difficult to compare different studies. Moreover, "cure" rate or "improvement" are not well-defined goals and may vary between clinics.
There are 2 main reasons that a study like the present one has not been done previously. First, a long-term follow-up is necessary. According to our results, the recurrence of urgency symptoms started to appear in the cohorts of women who had their operation 4 or more years ago. In longitudinal studies, mean follow-ups were 8 months,11 10 months,13 16 months,9 17 months,12 21 months,8 and 30 months.6 None of these studies would have detected a long-term decline of the initial positive results with TVT surgery.
Second, even a longitudinal study would require a large study population, depending on the rate of mixed incontinence among women who had TVT surgery. This is even more necessary in cross-sectional studies like ours. We studied 743 patients, which was a minimum to be able to group the patients by years since surgery. Two previous studies have included more than 200 women,8,11 but both were multicenter studies. A cross-sectional study might introduce biases when different time periods are compared. These should be small in the present study because a limited number of surgeons has been involved, all have initially been taught by one of the authors (L.L.), and the same technique was used during the study. In addition, all TVT procedures have been performed at the same clinic, and the majority of the surgeons have performed many TVT operations. A comparison or results of TVT surgeries by these surgeons has shown similar outcomes among all the surgeons.
Long-term longitudinal studies would require fewer patients but have been disappointing because of losses to follow-up. In the study of Debodinance et al,10 of "three years’ experience involving 256 TVT operations," only 15 patients were checked after 3 years. In the study of Nilsson and Kuuva,9 39% of the patients were followed-up for 25 months. Others have only given a mean number of follow-up months,8,11,13 which would of course seemingly give losses for follow-up close to zero, in particular in those studies where only patients who were followed for at least 6 months7,13 were included in the study.
Our study has shown that the good results of TVT surgery for stress incontinence persist over a long time. But initial gratifying results on urinary urgency incontinence declined in this study in women who had TVT 3 or more years ago. If these findings could be confirmed, it would provide new evidence about the natural history of mixed incontinence and would be valuable for counseling the individual patient so that she can have reasonable expectations.
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Footnotes |
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doi:10.1097/01.AOG.0000167393.95817.dc
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REFERENCES |
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2. Milsom I, Abrams P, Cardozo L, Roberts RG, Thuroffs J, Wein AJ. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int 2001;87:760–6.[Medline]
3. Chaliha C, Khullar V. Mixed incontinence. Urology 2004;63 suppl:51–7.
4. McGuire EJ, Lytton B, Kohorn EI, Pepe V. The value of urodynamic testing in stress urinary incontinence. J Urol 1980;124:256–8.[Medline]
5. Ulmsten U, Petros P. Intravaginal slingplasy (IVS): an ambulatory surgical procedure for treatment of female urinary incontinence. Scand J Urol Nephrol 1995;29:75–82.[Medline]
6. Jeffry L, Deval B, Birsan A, Soriano D, Darai E. Objective and subjective cure rates after tension-free vaginal tape for treatment of urinary incontinence. Urology 2001;58:702–6.[Medline]
7. Rezapour M, Ulmsten U. Tension-free vaginal tape (TVT) in women with mixed urinary incontinence: a long-term follow-up. Int Urogynecol J Pelvic Floor Dysfunct 2001;12 suppl 2:S15–18.
8. Meschia M, Pifarotti P, Bernasconi F, Guercio E, Maffaiolini M, Magatti F, et al. Tension-free vaginal tape: analysis of outcomes and complications in 404 stress incontinent women. Int Urogynecol J Pelvic Floor Dysfunct 2001;12 suppl 2:S24–27.
9. 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]
10. Debodinance P, Deplore P, England JOB, Bologna M. Tension-free vaginal tape (TVT) in the treatment of urinary stress incontinence: 3 years experience involving 256 operations. Eur J Obstet Gynecol Reprod Biol 2002;105:49–58.[Medline]
11. Kulseng-Hanssen S. The development of a national database of the results of surgery for urinary incontinence in women. BJOG 2003;110:975–82.[Medline]
12. Laurikainen E, Kiilholma P. The tension-free vaginal tape procedure for female urinary incontinence without preoperative urodynamic evaluation. J Am Coll Surg 2003;196:579–83.[Medline]
13. Paick JS, Ku JH, Kim SW, Oh SJ, Son H, Shin JW. Tension-free vaginal tape procedure for the treatment of mixed urinary incontinence: significance of maximal urethral closure pressure. J Urol 2004;172:1001–5.[Medline]
14. van der Vaart CH, van der Bom JG, de Leeuw JRJ, Roovers JPWR, Heintz APM. The contribution of hysterectomy to the occurrence of urge and stress urinary incontinence symptoms. BJOG 2002;109:149–54.[Medline]
15. Moller LA, Lose G, Jorgensen T. Risk factors for lower urinary tract symptoms in women 40 to 60 years of age. Obstet Gynecol 2000;96:446–51.
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