The tension-free vaginal tape (TVT) procedure, first described by Ulmsten and Petros,1 is the most widely documented minimally invasive surgical procedure for treatment of female stress urinary incontinence. It has become the standard minimally invasive procedure in many centers. Good short- and long-term cure rates, varying between 84% and 95%, have been reported.2–4 The most common complications related to the TVT procedure are voiding difficulties (8–17%), bladder perforations (2.7–17%), and symptoms of urgency (5–15%), all of which are complications normally associated with incontinence surgery.4–12 Because of the blind passage of the tape retropubically, a potential risk of injury to organs within the pelvis exists. Bowel perforations, necrotizing fascitis, and injury to large blood vessels have indeed been reported.13–18
To avoid these more serious complications, Delorme19 developed a procedure by which the tape is passed from a lateral approach through the obturator foramen on each side to support the mid-urethra, thus sparing the retropubic space. More recently de Leval20 developed an inside-out transobutator tape technique (TVT-O). Both transobturator techniques are thought to minimize the risk of serious complications as well as postoperative voiding difficulties. Short-term cure rates with the transobturator technique are promising.19–23
The present multicenter randomized clinical trial was initiated to compare the TVT procedure with the TVT-O procedure (both using the same polypropylene tape) in terms of intraoperative and immediate postoperative complications, cure rates, and health economic aspects. We here report on the intraoperative and the first 2-month postoperative events.
MATERIALS AND METHODS
Seven centers in Finland (four university hospitals and three central hospitals) participated in the clinical trial. Eight specialists in gynecology with wide experience in urogynecology and TVT surgery were specially trained in performing the TVT-O procedure and accepted to participate in this study. After the training period, they had performed at least five of the new TVT-O procedures independently before including patients into the study.
From March 2004 to November 2005, 273 women were randomly assigned to either the TVT or the TVT-O procedure. Acceptance was obtained from the Helsinki University Central Hospital Ethics Committee, and each patient gave written informed consent. The investigator called the randomization center to enter the patient in the allocated group. Patients were randomized using computer-generated random allocations in a ratio of 1:1 in balanced blocks of four.
The sample size calculation was performed assuming a 95% success rate with the TVT procedure and that a 10% difference in either success rate or rates of complications would be clinically important. With 70% power to show 10% difference, the sample size should be 260 patients, 130 patients in each group.
Inclusion and exclusion criteria are shown in the box. Preoperative evaluation comprised patient history, urine analysis, and physical examination including a cough stress test performed with the patient in a semilitothomy position and having arrived for the visit with her bladder comfortably filled (200–300 mL).
A 24-hour pad weighing test was included to be performed preoperatively and at the 1-, 3-, and 5-year follow-up visits. The following validated questionnaires were to be used preoperatively, at the 2-month follow-up, and at the 1-, 3-, and 5-year follow-up visits for condition-specific assessment: the Urinary Incontinence Severity Score (UISS), the Detrusor Instability Score (DIS), a visual analog scale (VAS 0–100), the Incontinence Impact Questionnaire–Short Form (IIQ-7), and the Urogenital Distress Inventory–Short Form (UDI-6).24–26 Quality-of-life assessment was carried out with the EuroQoL-5D questionnaire, which includes questions that assess mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. A thermometer-like scale, on which the patient draws a line to indicate how good or bad the state of her health is at the moment, was also used.27,28
The TVT and the TVT-O procedures were performed as originally described by Ulmsten1 and de Leval,20 respectively. Correct position of the patient on the operating table was given careful attention. The angle of the thighs in the stirrups was to be 70° during the TVT procedure and between 90° and 110° during the TVT-O procedure. Both procedures were performed under local anesthesia, using 75–135 mL prilocaine plus adrenalin diluted to 0.25%. Light intravenous sedation was used, enabling the patient to cooperate in performing the intraoperative cough test. The cough test was performed with a bladder volume of 300 mL, with the goal of adjusting the tape to allow a drop of saline to escape from the outer meatus of the urethra on strong coughing. Cystoscopy, using a 70° optic lens, was performed twice during the TVT procedure, after each passing of the needle retropubically, and once during the TVT-O procedure at the end of the operation to assure an intact bladder. The vaginal incision was made in the same fashion in both procedures, ie, a 1–1.5 cm sagittal incision starting 0.5 cm from the outer meatus of the urethra. The polypropylene tape was identical in both procedures, and commercially available TVT and TVT-O kits were used (Gynecare, Ethicon, Johnson & Johnson, Somerville, NJ). The TVT-O procedure was an “inside-out” procedure. A specific introducer, a winged guide, was pushed into the dissected pathway from the vaginal incision toward the obturator membrane to protect the bladder when the helical TVT-O passer was brought from the vaginal incision through the obturator membrane to its exit point 2 cm above the urethral level and 2 cm lateral to the tight folds. All patients received intravenous prophylactic antibiotic therapy at the beginning of the operation: a single dose of cefuroxime 1,500 mg or metronidazole 500 mg. No urinary catheter was left in the bladder, and the patients were asked to void spontaneously in the 3 hours immediately after the operation. Postvoid residual urine volumes were measured by catheterization or by ultrasonography.
Postoperative evaluation at 2 months was performed by a study nurse and an independent physician or the operating surgeon. The evaluation consisted of a clinical examination, a cough stress test performed in the same manner as preoperatively, residual urine measurement, and urine analysis. Postoperative bleeding and infection and other complications, rehospitalization, and the true duration of the sick leave were recorded. The Urinary Incontinence Severity Score, Detrusor Instability Score, visual analog scale, EuroQoL-5D, Incontinence Impact Questionnaire–Short Form, and Urogenital Distress Inventory–Short Form questionnaires were completed. Objectively cured was defined as a negative stress test. Subjective cure rates were evaluated by the above mentioned quality-of-life questionnaires.
Statistical analysis was performed with SAS 8.2 for Windows (SAS Institute, Cary, NC). For analysis of continuous variables, the independent-sample t test and the paired-sample t test were used to calculate statistical differences between and within the study groups. The χ2 test was applied for categorical variables. P<.05 was considered to indicate statistical significance.
Two hundred sixty-seven patients of the originally randomized 273 patients underwent the allocated operation, 136 in the TVT group and 131 in the TVT-O group. After randomization six patients dropped out. Four patients refused the operation, and one patient underwent an eye operation at the time she was scheduled for her incontinence procedure. In one patient, who was randomized to the TVT-O operation, the procedure could not technically be performed and was therefore altered to a TVT procedure. This patient is excluded from the analysis. One operation in the TVT-O group was erroneously performed under spinal anesthesia. This patient is included in the analysis. Table 1 shows the demographics of both groups. Figure 1 shows the flow chart of the trial. There was no statistically significant difference in any parameters between groups except the duration of symptoms, which was significantly shorter in the TVT group: 7 years (range 1–30) compared with 10 years (range 1–30), P=.003.
Table 2 shows operation time, theater time, hospital stay, need for analgesics, length of sick leave, and intraoperative and postoperative complications for both groups. The mean hospital stay was significantly shorter in the TVT group 14 (range 4–54) hours compared with 17 (range 5–80) hours, P=.027. Significantly more patients in the TVT-O group required postoperative opiate analgesia than in the TVT group, 28 (21.4%) compared with 16 (11.8%), P=.034, respectively. The number of patients complaining of postoperative groin pain was significantly greater in the TVT-O group than in the TVT group, 21 (16.0%) compared with 2 (1.5%), P<.001, respectively. The groin pain of the TVT patients disappeared within 5–10 days, whereas the groin pain of the TVT-O patients persisted for 2 weeks in ten patients, for 4 weeks in three patients, and for 2 months in one patient, the rest having pain for a few days.
There were no major intraoperative complications. One patient in the TVT group needed two units of blood transfusion because of a retropubic hematoma, and one patient in the TVT group had a intraoperative bleeding of 800 mL, which was managed by drainage on the side of bleeding. One patient in the TVT group experienced a wound infection. Eight percent of patients in the TVT group and 13% in the TVT-O group, respectively, were postoperatively treated because of urinary tract infections.
Postoperative voiding parameters are presented in Table 3. Return to normal voiding, defined as a postvoid residual urine volume less than 100 mL, was significantly more rapid in the TVT group than in the TVT-O group: mean (range) of 6 (1–54) hours compared with 9 (1–168) hours, P=.033. One patient in the TVT group needed repeated catheterization on the second postoperative day, while two patients in the TVT-O group were managed by self-catheterization for 1 and 3 weeks, respectively.
The objective cure rate, defined as a negative cough stress test at the 2-month follow-up visit, was similar in both groups, with 134 of 136 patients (98.5%) in the TVT group and 125 of 131 patients (95.4%) in the TVT-O group having negative cough stress tests. Subjective cure, measured by the condition-specific quality-of-life questionnaires were equal in both groups, showing a highly significant improvement, P<.001, Table 4. The EuroQoL-5D index values used as instruments to assess general health for five dimensions also showed a highly significant improvement at the 2-month follow-up, P<.001, with no difference between the groups, Tables 5 and 6.
Fifty patients (27 in the TVT group and 23 in the TVT-O group) had urgency symptoms before intervention, which was defined as having both urgency and frequency of moderate or severe degree in their Urogenital Distress Inventory–Short Form questionnaire. At the 2month follow-up visit, only one patient in each group had urgency symptoms by the same definition. Thus, 96 % in both groups were relieved of their urgency by surgery. Three patients in both groups had new symptoms of urgency postoperatively, either frequency or urgency, moderate or severe in their Urogenital Distress Inventory, or a score greater than 7 in the Detrusor Instability Score, the rate of de novo urge symptoms thus being 2.3%
None of the surgical procedures for treatment of female urinary stress incontinence that are described in the literature are ideal in the sense of resulting in complete cure without risks of complications. The TVT procedure is proven to be as effective as open colposuspension29 and more effective than laparoscopic mesh colposuspension30 in randomized clinical trials. Clinical reports also suggest that the TVT is associated with fewer postoperative complications than colposuspension.29 Reports on intraoperative complications of more severe nature, resulting from the inability to see into the retropubic space when performing the TVT operation have, however, encouraged surgeons to find alternative routes for placing the suburethral tape. However, modifications of a successful procedure do not necessarily result in improvement of clinical outcome.
The present randomized trial was designed to detect possible differences in complication and success rates when using identical tapes placed suburethrally either by the retropubic or the obturator route. The data presented here are part of the results of one of the few randomized clinical trials within the field of incontinence surgery that has succeeded in recruiting the number of patients that power calculations required.
Statistically significant differences were found. The TVT procedure was associated with a shorter postoperative hospital stay, a smaller number of patients complaining of postoperative pain, and apparently therefore, a lesser need of postoperative opiate analgesia than the TVT-O procedure. Return to normal voiding was also more rapid in the TVT group. Although statistically significant, the differences between the groups were small and hardly clinically significant. The total numbers of registered intra- and immediate postoperative complications were 18 (13.2%) in the TVT group and 41 (31.3%) in the TVT-O group. This difference was also significant but mostly because of the greater number of complaints of groin pain in the TVT-O patients, a problem that was resolved already at the 2-month follow-up visit.
The success rate of incontinence operations is usually reported either as short- or long-term subjective and/or objective cure rates. A 2-month follow-up period is too short for objective outcome measures to reveal the benefits of surgery, whereas subjective outcome measures potentially reveal the impact of adverse events on patients degree of satisfaction already at 2 months. Of objective outcome measures, only the stress test was performed at the 2-month follow-up visit, showing no difference between the groups, but a more than 95% success rate in both groups. There was a highly significant improvement in scores on the condition-specific and general health questionnaires compared with preoperative figures, with no difference between the groups.
De novo urge symptoms have been a problem with the traditional incontinence operations.31,32 It is, therefore, remarkable that fewer than 3% of the patients in both groups of the present trial developed new symptoms of urge. Also noteworthy is the finding that, as many as 96% of that 19% of patients who suffered preoperatively from urge symptoms were relieved of this problem at 2 months after the intervention. There was no difference between the groups regarding the effect of surgery on urge symptoms. Corresponding findings on relief of urge symptoms after TVT surgery have been reported in the literature.3,33 The present results do not support the opinion presented in the literature describing the transobutrator route that it causes fewer urge symptoms than the retropubic one.34
The fear of simple complications, such as bladder perforation, as well as more severe intra-abdominal organ injury, has been the objective of modifying the TVT procedure. The obturator route of placing the suburethral tape has been claimed to be more safe.21 The first prospective observational studies on the performance of the TVT procedure reported low rates of minor complication and no major or severe complications.2–4,9,35 The only published systematic follow-up reports on nationwide registries of complications associated with the TVT procedure also indicated a low rate of minor complications and very rare cases of major complications.8,36 As the TVT procedure has gained worldwide popularity, case reports on major complications have appeared.13,15,17,18 The number of prospective observational studies on the performance of the different transobturator procedures is growing, revealing the same optimism about low risk of complications. No systematic registry of complications associated with the transobturator procedure has yet been published. Reports on both bladder perforations and other complications not thought to occur with the obturator procedure have begun to appear (Hamilton Boyles S, Gregory WT, Clark A, Edwards SR. Complications associated with trans-obturator sling procedures [abstract]. Neurourol Urodyn 2005;24:423–5).22,37
Introduction of new surgical procedures for treatment of stress incontinence requires comparison with established and widely accepted surgical operations within randomized clinical trials to be able to detect equality or superiority in effectiveness and in rates of complications. Even modifications of effective operations need the same thorough evaluation before superiority can be claimed. Many of the new minimally invasive mid-urethral tape procedures have been offered for routine clinical use with the clinical experience of only a small number of patients with inadequate follow-up. The present study is a randomized, multicenter clinical trial in which the TVT-O procedure is compared with the TVT procedure. Contrary to what had been expected, we did not find a lower rate of complications with the TVT-O procedure. The overall number of minor complications was actually higher in the TVT-O group. All the complications in both groups were, however, minor and caused no clinical problem to the patients when evaluated 2-months postoperatively. The overall rate of complications was low in both groups, indicating that, with proper training and standardization of procedures, even multicenter studies come out with good results.
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