Insertion of tension-free vaginal tape (TVT) is a promising new surgical procedure for the treatment of genuine stress incontinence in women. This procedure, first described by Ulmsten and colleagues in 1995 [1,2] is now widely used in Scandinavia, and is being evaluated in the UK in comparison to the traditional Burch colposuspension. The procedure involves insertion of a prolene tape (Ethicon TVT, Ethicon, Edinburgh, UK) using two 9-mm needles, which are attached to either end of the tape. The needles are passed through either side of the mid-urethra and brought out behind the symphysis pubis through two small abdominal incisions. A cystoscopy is performed to confirm that there has been no bladder damage and the bladder is filled. The conscious patient is then asked to cough forcibly and the tape is adjusted until continence is achieved. This contrasts with traditional operations, performed under general or regional anaesthesia, which rely on a surgical estimate of the degree of suspension needed. If this estimate is incorrect then urinary retention or persistent incontinence occurs.
Adoption of tension-free vaginal tape in UK practice has been relatively slow and may have been hindered by concerns over the ability to provide adequate analgesia during the procedure without general or regional anaesthesia (personal communication). We have found no published description of recommended anaesthetic techniques, and therefore decided to investigate the quality of anaesthetic and surgical conditions obtained using a combined sedative and local anaesthetic regimen.
Following informed consent, 24 consecutive female patients scheduled for insertion of tension-free vaginal tape were studied. One surgeon (MP) carried out all the procedures and one anaesthetist (AN) performed all sedation and was responsible for data collection. Patients of ASA grades I–III were included. Exclusion criteria included a history of oesophageal reflux, orthopnoea and drug reaction to any of the planned medications. The procedure was explained and all patients were instructed in the use of visual analogue scores (VAS) and in completion of a digit symbol substitution test (DSST). A baseline DSST was then performed.
Premedication was not used unless requested specifically by the patient, in which case 20 mg of temazepam was prescribed. In the anaesthetic room, patients were asked to mark a 100-mm visual analogue scale for anxiety, anchored at ‘not anxious at all’ and ‘worst possible anxiety’. Patients were also shown the first of two pictures, which they knew they would be asked to recall at the end of the procedure.
Intravenous (i.v.) access was secured. Electrocardiography, noninvasive automatic arterial pressure monitoring and pulse oximetry were used throughout the procedure. Oxygen was administered via a Hudson mask at 3–4 L min–1. A 20-G plastic venous cannula, without needle, inserted through the Hudson mask, was used to monitor expired CO2 to permit measurement of respiratory rate. Midazolam 1–2 mg, followed by 25–50 μg increments of fentanyl were administered until a sedation score of 2 was achieved. Sedation was scored similarly to the Observer’s Assessment of Anaesthesia and Analgesia Scale (OAA/S) scale with: 1=awake/alert, 2=awake/eyes open but drowsy, 3=asleep eyes closed/rouses to voice, 4=asleep/difficult to rouse, 5=unresponsive .
Following transfer and positioning in lithotomy, further 25 μg increments of fentanyl were administered until the respiratory rate was about 12 breaths min–1, or a sedation score of 3 was achieved. The sedation score was then recorded and local anaesthetic infiltration of the planned entry, exit sites and track of the needle was performed. A maximum volume of 100 mL of 0.5% prilocaine with epinephrine 1 in 150 000 was used. A second picture was shown to the patient at this time and sedation score was again recorded before insertion of the first needle.
A nurse observer, the anaesthetist and the surgeon independently scored the quality of anaesthesia and analgesia as being ‘poor’, ‘adequate’, ‘good’ or ‘excellent’. The nursing and anaesthetic scores were based on facial expression, vocalization and movement during the procedure, and the surgical score based on vocalization, movement and co-operation and strength during incontinence testing. Heart rate, respiratory rate, arterial oxygen saturation and arterial pressure were automatically recorded at 5-min intervals throughout the procedure. Incremental doses of propofol 10 mg and fentanyl 25 μg were administered at the discretion of the anaesthetist if anything other than a mild reaction during insertion of the surgical needle was seen. Once the second needle was passed successfully, no further sedation or analgesia was given. All drugs and the dosages given were then recorded. A cystoscope was used to fill the bladder with 400 mL of 0.9% saline, which was then removed. The patient was roused and instructed to cough as explosively as possible. The final adjustment of the position of the tape was then made until minimal urinary leak was achieved. Sedation score and a verbal pain score (0=no pain, 10=worst pain imaginable) were recorded on arrival in the recovery unit. A second DSST was performed 30 min after arrival in the recovery room. All procedures were carried out in the afternoon and patients were admitted overnight to allow ultrasound imaging of the bladder to be performed before discharge. After the operation, but before discharge, an interview was conducted and patients were questioned regarding intraoperative recall up to the period of incontinence testing. They were specifically questioned regarding recall of pain during any part of the procedure, recall of the two pictures shown before and after sedation and whether they would have the procedure again. A paired t-test was performed on baseline and intraoperative measurement of heart rate and systolic arterial pressure and Pearson’s test was used for correlation between preoperative anxiety and intraoperative drug use;P < 0.05 was considered significant.
Twenty-four patients were recruited and all successfully completed the study. The VAS result and DSST scores for one patient were lost. Patients varied in age from 38 to 77 (mean 56, SD ± 11) years. Mean weight was 79 kg (SD ± 14.5). Several patients had undergone previous surgery for urinary stress incontinence. Four patients received 20 mg of temazepam as premedication.
The mean (± SD) scores for DSST before and after the operation were 22.4 (7.8) and 20.8 (6.9) correctly matched symbol digit pairs (Figure 1). The median dose of midazolam was 3.5 mg with a range of 2–6 mg and the median fentanyl dose was 400 μg (range 150–900 μg). There was a significant positive correlation between anxiety before the operation on visual analogue scoring and intraoperative fentanyl requirements [r =0.48; 95% CI: 0.05–0.75;P < 0.05 (Figure 2)]. All patients successfully recalled the preoperative picture and none recalled the one shown during operation. The quality of anaesthesia scores is shown in Table 1.
There was no significant change in heart rate or systolic arterial pressure compared with baseline across the group. One patient developed a supraventricular tachycardia, which was self-limiting, asymptomatic and not associated with hypotension. Sedation scores were in the range 2–3 (eyes closed spontaneously but rousable) during the procedure for 23 patients, one patient scored 4. Four patients complained of nausea after operation. One of these had chronic pancreatitis, and required i.v. opioids and antiemetics in recovery. All patients were discharged home less than 24 h postoperatively.
This was a prospective observational study. No attempt was made to blind either observers or patients to the drugs or dosages being used; the dosages used were at the discretion of the anaesthetist. Despite these limitations, we believe that we have demonstrated that satisfactory intraoperative conditions for the patient and the surgeon can be achieved for this procedure with a simple local anaesthetic and sedative regimen. Although we chose not to attempt to measure pain scores during the procedure because of sedation, indirect evidence of discomfort in the form of movement and vocalization suggested that adequate analgesia was achieved. In addition, none of our patients had any postoperative recall of pain during the procedure up to the period of incontinence testing. Despite the use of significant doses of fentanyl and midazolam, sedation scores and psychomotor performance assessed by the use of the DSST were comparable with those encountered in day surgery following general anaesthesia . We found a relationship between preoperative anxiety and the dose of fentanyl used, and strategies to reduce anxiety might result in lower analgesic requirements with improvement in the ability to co-operate with incontinence testing and a reduction in nausea and sedation postoperatively.
The use of tension-free vaginal tape has received little attention in the UK literature, but the procedure is likely to become increasingly common. Insertion of tension-free vaginal tape is envisaged as a day-case procedure, and our results suggest that it should be possible to meet normal discharge criteria using this or similar techniques. General anaesthesia can be used for this procedure, but there are several potential problems. If the entire procedure is performed under general anaesthesia, this negates one of the key benefits of the technique, the ability to assess incontinence during the procedure. Alternatively, general anaesthesia can be discontinued and the patient allowed to awaken prior to incontinence testing. Although rapid emergence can be achieved using modern agents, there may still be questions regarding the normality of sphincter control and muscle tone. It is also sometimes necessary in our experience to sedate patients again after the tape has been placed, in order to allow repositioning of the tape, surgical closure or an additional procedure, such as anterior repair to be performed. A second induction of general anaesthesia or the use of sedation in these circumstances would be undesirable.
Regional anaesthesia has been used for this procedure [5,6]. However, the resulting relaxation of pelvic floor and detrusor muscles  may make assessment of stress incontinence more difficult, while the resulting hypotonic bladder may delay postoperative spontaneous voiding, increasing the need for catheterization, and prolonging hospital stay . We elected to use an opioid-based technique because, even with local infiltration, the insertion of two 9-mm needles through the pelvic floor and abdominal muscles is painful. Sedative regimens offering equal or superior conditions, especially in terms of rapid emergence and a reduction in nausea could perhaps be devised using target-controlled infusions of propofol and or remifentanil.
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