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ORIGINAL RESEARCH |
From the Central-Ostrobothnian Central Hospital, Kokkola; Oulu University Hospital, Oulu; Kuopio University Hospital, Kuopio; Tampere University Hospital, Tampere; Turku University Hospital, Turku; and Helsinki University Central Hospital, Helsinki, Finland.
Address reprint requests to: Antti Valpas, Department of Obstetrics and Gynecology, Central-Ostrobothnian Central Hospital, Mariankatu 16–20, FIN-67200 Kokkola, Finland; e-mail: antti.valpas{at}kolumbus.fi.
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ABSTRACT |
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 ABSTRACT MATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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METHODS: In 6 departments of gynecology in Finland, including 4 university teaching hospitals and 2 central hospitals, 128 women with urodynamic stress incontinence were randomly allocated to 2 treatment groups. Seventy were treated with TVT and 51 by means of laparoscopic mesh colposuspension. There were 7 dropouts. Inclusion criteria were history of stress incontinence, positive stress test, and urodynamic conformation of stress incontinence. Exclusion criteria were age older than 70 years, previous incontinence surgery, more than 3 episodes of urinary tract infection within the last 2 years, coincident other gynecological surgery, body mass index more than 32 kg/m2, urethral closure pressure less than 20 cm H2O, and residual volume more than 100 mL in preoperative urodynamic evaluation. Assessment took place before treatment and at 12 months postoperatively with the cough stress test, Urge Score, 48-hour pad test, King's College Health Questionnaire, Visual Analog Scale, and Urinary Incontinence Severity Score.
RESULTS: When negative stress test was used as criteria for cure, 85.7% of women in the TVT group and 56.9% in the laparoscopic mesh colposuspension group were objectively cured. Subject satisfaction was significantly better after the TVT procedure than after laparoscopic mesh colposuspension.
CONCLUSION: Treatment with TVT results in higher objective and subjective cure rates at 1 year than treatment by means of laparoscopic mesh colposuspension.
LEVEL OF EVIDENCE: I
Open colposuspension (Burch procedure) has been regarded as the gold standard for operative treatment of stress urinary incontinence in women.3 The trend within gynecological surgery in the 1990s was toward minimally invasive procedures, which have been claimed to offer quicker recovery and less postoperative pain. Laparoscopic approaches to various gynecological procedures were introduced at the beginning of the last decade. Vancaillie and Schuessler4 were the first to describe the laparoscopic technique of bladder neck suspension operations. Later, several modifications were published. Instead of sutures, mesh and surgical staples have been used5 and an extraperitoneal approach6 has been described to avoid the potential complications of pneumoperitoneum.
A new theory, the midurethra concept, concerning the mechanisms of incontinence was presented in 1990 by Petros and Ulmsten.7 Based on this new theory, a minimally invasive procedure, usually called the tension-free vaginal tape (TVT) procedure, was developed for surgical treatment of female stress urinary incontinence. The procedure is thought to work by providing pubourethral "neoligaments," which give support to the midurethra so that increased intra-abdominal pressure results in dynamic kinking of the urethra, thus preventing urine loss.
Many of the new techniques have been brought into clinical practice without controlled clinical trials, and there are limited data from randomized clinical trials in which different incontinence procedures have been compared.8,9 The existing studies have been criticized for insufficient numbers of patients and statistical power, as well as the lack of standardized criteria for entry to the study and outcome measures.9 The aim of the present prospective randomized clinical multicenter trial was to compare 2 modern surgical procedures for the treatment of female stress urinary incontinence: the TVT procedure and laparoscopic mesh colposuspension.
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MATERIALS AND METHODS |
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The trial was conducted in 4 University Hospital clinics and 2 Central Hospital clinics in Finland. The women were recruited between April 14, 1999, and April 19, 2001.
Sample size calculation showed that, if the cure rate for TVT is assumed to be 95% and for laparoscopic mesh colposuspension 80%, if for a type I error 5% is accepted, and if for the smallest noticeable difference 10% is assumed and for a type II error 20% is accepted, the sample size should be 176 subjects.
Randomization was conducted by means of a computer-generated randomization list separately for each center. The lists were kept at the randomization center, Helsinki University Central Hospital. After the subject had signed the written consent document, the investigator called the randomization center to enter her into the allocated group: either the TVT group (group 1) or the laparoscopic group (group 2). In some centers randomization took place at the time of the visit when preoperative evaluation was conducted. In other centers, randomization took place when the subject was admitted to hospital for surgery. This explains why 4 women refused surgery after randomization: while waiting for the operation they decided not to undergo surgery (Fig. 1). Randomization (40 patients per center) was used for each participating hospital. The baseline characteristics of the 2 groups are given in Table 1.
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Preoperative evaluation included clinical evaluation and urodynamic investigation: medium fill cystometry and urethral pressure profilometry at rest and under stress. At some centers uroflowmetry was also performed. The stress test was performed after urodynamic evaluation with a 300 mL-filled bladder. Forty-eight-hour pad tests were also conducted.10–12 The test result was regarded as negative if the weight gain of pads was less than 8 g in 48 hours.13
In the assessment of patients, we used validated objective and subjective outcome measures. The history of the subjects was quantified by using 2 symptom scores, the Urinary Incontinence Severity Score14 and the Urge Score.15 Quality of life was evaluated by means of the King's College Health Questionnaire.16 The women also quantified the severity of incontinence by means of the Visual Analog Scale (VAS). The Urinary Incontinence Severity Score is an incontinence-specific quality-of-life measurement to assess a subject's subjective degree of social, hygienic, and professional handicap as a result of incontinence. The questionnaire consists of 10 specific questions that are designed to assess impairment of quality of life arising from urinary incontinence. The reply to each question is scored 0, 1, or 2 (no, slight, or marked impairment of quality of life, respectively). The sum of these scores is termed the Urinary Incontinence Severity Score. A score of 0 means no inconvenience at all, whereas 20 represents maximal inconvenience.14 The score is obtained via a standardized questionnaire to quantify the symptoms associated with detrusor instability. The questionnaire consists of 10 specific questions scored from 0 to 2. The sum of the scores is the Urge Score. A score of more than 7 indicates increased risk of motor urge incontinence.15 The King's College Health Questionnaire is a condition-specific quality-of-life questionnaire for the assessment of women with urinary incontinence.16 The 21 questions are presented in 8 domains, with separate scales, to measure the severity of urinary symptoms. Scores in the domains range from 0 to 100, a higher score indicating greater quality-of-life impairment. We used a translated version of the questionnaire, which has not, however, been validated in Finnish.
The first postoperative visit took place 6 weeks after surgery. The data on postoperative recovery and immediate complications has been published previously.17 At the 1-year follow-up visit the above-mentioned investigations were repeated, and subject satisfaction was evaluated by means of 2 questions. Firstly, the women were asked whether the result of the operation corresponded with their expectations, and secondly, they were asked whether or not they would recommend the procedure to a friend. In 2 centers urodynamic investigation was conducted as part of the evaluation. Use of other incontinence treatments during the follow-up year was also inquired about.
Primary outcomes were negative stress test result and negative 48-hour pad test result (< 8 g/48 h). Secondary outcome measures included subjective cure of incontinence, the effect of surgery on Urinary Incontinence Severity Score, Urge Score, and the King's College Health Questionnaire score, and the results of other possible treatments for incontinence.
The surgical procedures have been described in detail elsewhere.17 Both groups received prophylactic antibiotics: A single intravenous dose of metronidazole (500 mg) or cefuroxime (1.5 g) was given during the operation. In brief, the TVT operation was conducted under local anesthesia and sedation as originally described by Ulmsten et al.18 A TVT device with special needle instruments was used. A polypropylene mesh tape (Prolene; Ethicon, Somerville, NJ) was placed under the midurethra by using a needle kit (TVT Device; Gynecare, Johnson & Johnson, Somerville, NJ). During the operation, a cough test was used in adjustment of the tightness of the tape: with 300–400 mL of saline in the bladder, the subject was asked to cough—a few drops were allowed to escape at this step of the procedure to confirm tension-free placement of the tape to prevent postoperative voiding problems. No catheter was left in place. Laparoscopic mesh colposuspension was performed under general anesthesia with the subject lying in a semilithotomy position. An extraperitoneal approach was used, as described by Hannah and Chin.6 The bladder neck was elevated by using a tacker-mesh technique (Origin Tacker System; Origin Medsystems Inc, Menlo Park, CA). The catheter was removed next morning.
Data were entered into a database from individual case report forms. Statistical analysis was conducted on an intention-to-treat basis. Analysis software used was SPSS 10.0 (SPSS Inc, Chicago, IL) for Windows. For continuous variables, the paired-samples t test was used, and for categorical variables, the 
2 test or Fisher exact test was performed, as appropriate. Wilson's method was used to calculate statistical differences (with 95% confidence intervals) in the main outcome measures because it was thought to have better statistical properties than the traditional method.19,20
Informed written consent was obtained from every subject. The study and the study protocol were accepted by ethical committee of each participating center.
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RESULTS |
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A negative stress test result was recorded in 60 (85.7%) subjects in the TVT group and 29 (56.9%) in the laparoscopic mesh group (Table 2 and Table 3). The post hoc power calculation gives power 0.917. A negative 48-hour pad test result was recorded in 51 (72.9%) subjects in the TVT group and 30 (58.8%) in the laparoscopic mesh group, which gives a post hoc power 0.300. In both groups, a significant reduction was found in the mean values of 48-hour pad test. In the TVT group, the reduction was from 82.5 g to 3 g, and in the laparoscopic mesh group, from 68.4 g to 12.4 g. The difference between the mean values was statistically significant in favor of TVT (3.0 g versus 12.4 g per 48 hours; 95% confidence interval [CI] 0.44–18.4). When calculating the success rates, taking into account attenders only, the stress test result was negative in 60/66 (90.9%) in the TVT group and 29/47 (61.7%) in the laparoscopic mesh group. The difference between these success rates was 0.292 (ie, 29.2%), with a 95% CI of 0.136–0.443 using Wilson's method (two-tailed P value of .001). The 48-hour pad test result was negative in 51 of 61 (83.6%) in the TVT group and 30 of 42 (71.4%) in the laparoscopic mesh group. The difference between success rates was 0.122 with a 95% CI of –0.038–0.288 using Wilson's method (two tailed P value of .138).
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We found significant difference between the 2 procedures in VAS scores and in the majority of the domains in King's Health Questionnaire scores (Table 4). In the subjects’ personal perception of the result of the procedures, we found a significant difference in favor of TVT. Six women (11.8%) in the laparoscopic mesh colposuspension group used pads after the procedure; in the TVT group, nobody used pads at the time of the 1-year follow-up.
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DISCUSSION |
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Recently, Ward and Hilton22 published the results of a prospective randomized trial where TVT was compared with open colposuspension. They found that cure rates at 6 months in the 2 procedures were almost equal: 66% in the TVT group was cured and 57% in the open Burch group. These cure rates are lower than usually reported. Ward and Hilton used 2 objective criteria for cure: 1-hour pad test (< 1-g change in weight) and a negative stress test on urodynamic testing. So the criteria for cure in their study might have been stricter than criteria used in other studies. They report that stress testing was negative at cystometry in 81% of the patients in the TVT group and 67% after colposuspension. These figures are comparable to our findings: 86% had negative stress test in the TVT group and 57% in the laparoscopic mesh group. Surgery with TVT was associated with more operative complications than colposuspension, but colposuspension was associated with more postoperative complications and longer recovery.22
Studies involving comparison of open and laparoscopic colposuspension have shown that the immediate outcome is the same, but recovery is faster after laparoscopic colposuspension, and the return to normal activities is quicker.23 Operation time is somewhat longer with laparoscopic colposuspension, and the complication rates after each procedure are acceptable.24 However, follow-up studies have shown that, in the medium term (1–3 years after surgery), laparoscopic colposuspension is associated with a slightly poorer outcome than open colposuspension.25 Several different techniques of laparoscopic mesh colposuspension have been described, but there are only a few (inconclusive) studies in which their long-term results have been compared. Selection of an extraperitoneal technique involving mesh and tackers for this study was based on the fact that this specific technique was prevailing in Finland when the study was planned.
We compared TVT and laparoscopic mesh colposuspension in a prospective randomized manner, on a multicenter basis. All the surgeons participating in the study were experienced senior gynecological laparoscopic surgeons. Each of them was trained in the specific technique, and at least 20 laparoscopic colposuspensions had been performed by each before starting the study. Thorough hands-on training for the TVT procedure was carried out according to national guidelines before the surgeons performing these procedures were allowed to start the operations.26 This kind of rigorous approach is not common in the introduction of a new surgical technique. Although all laparoscopists performing colposuspension operations on our subjects had had hands-on training, there may have been differences in the technique. It is, however, not probable that such variations could explain the results of the study.
We have previously published the immediate outcomes of these 2 procedures, as well as the complications.17 The immediate postoperative results of these procedures were similar; complications were few and there was no difference between the procedures in complication rates. From this point of view, they are both feasible as primary operations for stress incontinence. However, the TVT procedure seems to be less invasive and requires fewer hospital resources than laparoscopic colposuspension.
After 1 year of follow-up, the TVT procedure was associated with significantly better results, both objectively and subjectively. Subject satisfaction was better after the TVT procedure than after laparoscopic mesh colposuspension (Table 2). Black et al27 have shown that, when evaluating the results of incontinence surgery, surgeons tend to be more optimistic than the subjects. About two thirds of the subjects were satisfied with the result of surgery, and 85% of the surgeons were satisfied with the results of the procedure after 1 year of follow-up. In our series, TVT met the subjects’ expectations better than laparoscopic colposuspension. Furthermore, nobody in the TVT group used pads at the time of the 1-year follow-up.
When evaluating quality of life by means of the King's College Health Questionnaire, there was a significant difference in favor of TVT in all domains other than General Health Perception, Sleep/Energy, and Part III.
Persson et al28 compared TVT with laparoscopic colposuspension in their study, in which 2 single-bite nonabsorbable sutures were placed on each side of the urethra. At 1-year follow-up, they found no difference between the objective and subjective cure rates. They also calculated that the TVT procedure was significantly more costly than laparoscopic colposuspension. Sensitivity analyses showed that surgical time and anesthesia fees were major cost-deciding factors. They stated that, while performing the TVT procedure, the full attention of the anesthesiologist must be focused on sedation and the possible conversion of local anesthesia to general anesthesia. (In their study general anesthesia was used in 4 of 38 subjects in the TVT group.) In our study all TVT procedures were successfully conducted under local anesthesia with sedation and no general anesthesia was needed. The TVT procedures were performed under the supervision of an anesthesia nurse backed up by the presence of an anesthesiologist in the ward. The operation time also differs in our study compared with that conducted by Persson et al. The mean operation time for the TVT procedure in our hands was 29 minutes, compared with 45 minutes in their study. Thus, their conclusion that the TVT procedure is more costly may not hold true in a different operative set-up. These 2 factors might explain their finding that the TVT procedure is more costly than laparoscopic colposuspension.
To avoid observer bias, the person(s) conducting postoperative evaluation should be blind to the surgical technique. Blinding may be possible when performing surgical studies on stress incontinence, as shown in a trial of laparoscopic versus open colposuspension.23 However, in our trial, the 2 procedures differed so much that the subjects would easily have been aware of their allocated treatment (incision, anesthesia), and the staff taking care of postoperative assessment were not blind to the procedure for logistical reasons, so there was a possibility of observer bias. Measurement of our treatment results relied partly on self-evaluation and validated questionnaires. These results could not be influenced by surgeons. All the women were informed that they would be operated on using modern techniques. Thus, the nature of the evaluation measures was such that, in our opinion, they exclude observer bias.
The number of subjects recruited fell short of the target in every participating center, as determined by sample size calculation, owing to limitations of time and recruiting problems. For these 2 reasons, the study was stopped prematurely. The data has been analyzed after stopping the study. Block size in randomization was based on an assumption of rapid recruitment, which was realistic considering the annual number of incontinence operations performed at each hospital. Because the number of subjects participating in the study remained unequal between hospitals, the numbers of subjects in the study groups were unequal. However, the groups were still comparable, and the nature of the randomization problem did not introduce a systematic bias. We were able to show significant differences in all primary and most secondary outcomes between the 2 procedures even although recruitment fell short of our target.
In conclusion, in our hands the tension-free vaginal tape procedure gives better results than laparoscopic mesh colposuspension, both objectively and subjectively, at 1-year follow-up. Long-term follow-up is needed to assess the success of these 2 procedures, and the subjects will be evaluated at 5 years.
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Footnotes |
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10.1097/01.AOG.0000128904.40103.e8
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REFERENCES |
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