Dr E. Karantanis, Pelvic Reconstruction and Urogynaecology Unit, Department of Obstetrics and Gynaecology, St George's Hospital, Blackshaw Road, Tooting, London SW17 0QT, UK.
Objective To evaluate peri-operative morbidity, continence outcome and patient satisfaction in older women (≥65 years) compared with younger women undergoing tension-free vaginal tape.
Design Case controlled study.
Setting Tertiary Urogynaecology Unit.
Sample Women undergoing tension-free vaginal tape for urodynamic stress incontinence between July 1999 and July 2002 were included. Those with detrusor overactivity, voiding difficulty at urodynamics or requiring concomitant prolapse surgery were excluded.
Methods Older women were case matched to a younger cohort for BMI, parity, mode of anaesthesia and whether it was a primary or secondary continence procedure.
Main outcome measures Operative morbidity and continence outcome were assessed at six weeks. After a minimum six months follow up, patient satisfaction and continence outcome were assessed using the Genitourinary Treatment Satisfaction Score (GUTSS).
Results The median hospital stay was one day and overall urinary tract infection rate was similar in both groups. Post-operative voiding difficulty rates were 3% in older versus 15% in younger women (P= 0.09). At six weeks, 65% of older versus 79% of younger women were dry (P= 0.2). At a median of 12 months, 15 (45%) of older versus 24 (73%) of younger women had no urinary symptoms (P= 0.05). Median GUTSS scores for satisfaction with continence outcome were lower for older 90% compared with 100% in younger women (P= 0.003).
Conclusions Tension-free vaginal tape is an effective continence intervention in older women but has a lower continence satisfaction rate compared with younger women.
Sixty-four percent of older incontinent women have the symptom of stress incontinence.1 Their surgical management poses a challenge as they are likely to suffer significant pre- and intra-operative morbidity and have a slower recovery. The tension-free vaginal tape is a surgical procedure with similar success rates but less operative morbidity and complications than the Burch colposuspension.2 Little is known, however, about the impact of tension-free vaginal tape on continence outcome and morbidity in older women as most tension-free vaginal tape studies analyse outcome parameters across the entire age range. The three-year open study by Ulmsten et al. in 19993 evaluated outcome following tension-free vaginal tape in women with a mean age of 57 years (SD 11). Subsequent studies assessed women with mean ages of 52 (range 33–88 years) without separately addressing the outcomes and complications in older cohorts.4,5
Recently, interest in tension-free vaginal tape outcomes in older women has developed with the emergence of two case series. Lo et al.6 in an observational study reported follow up data at 12 months in 45 older women with a 90% cure rate and minimal morbidity. However, the findings of Sevestre et al.7 noted a more modest 70% cure in a consecutive group of 76 older women after a mean two-year follow up. To adequately assess continence outcome and morbidity in older women, it is preferable to compare these outcome measures with a matched cohort of younger women. Review of abstracts published in congresses of the International Continence Society and International Urogynaecology Association between 1999 and 2002 revealed two studies comparing older and younger women, including a precursor abstract to this study.8
At our institution, the tension-free vaginal tape procedure is offered to women with urodynamic stress incontinence. Exclusions include significant medical contraindications and bleeding diatheses. Age is not a limiting factor. In this study, we evaluated continence outcome, peri-operative morbidity and patient satisfaction following tension-free vaginal tape in older women and compared these outcome measures to a case-matched cohort of younger women undergoing the same procedure.
All women attending the urogynaecology unit at St George's Hospital, London, who underwent tension-free vaginal tape between July 1999 and July 2002 were evaluated. Only women with a diagnosis of urodynamic stress incontinence were eligible. Exclusion criteria included women with (1) urodynamically proven mixed incontinence; (2) flow rates less than 15 mL/second and/or post-void residuals greater than 100 mL; (3) recurrent urinary tract infection; and (4) concomitant prolapse surgery. In each case, a standardised continence questionnaire and subtracted cystometry using a fixed protocol had been undertaken before surgery. Urodynamic diagnoses were made according to the criteria of the International Continence Society.9
We defined ‘older’ as aged equal to or greater than 65 years. The remainder were defined as younger women. Two databases representing 43 older and 69 younger women were established. Case matching was then undertaken using three criteria: (1) primary or repeat continence surgery, (2) body mass index (BMI) and (3) mode of anaesthesia.
Treatment outcomes for case-matched women were assessed by chart review. Peri-operative details included mode of anaesthesia, estimated blood loss, post-operative urinary tract infection, voiding difficulty, the rate of short term and long term self-catheterisation and duration of hospital stay. Continence outcome and complications were reassessed at six weeks. A GUTSS Questionnaire was completed at a minimum of six months following surgery.10 This is a validated instrument, which consists of a 10-part short questionnaire assessing both satisfaction with continence outcome and satisfaction with care received (Fig. 1). The scores beside each question are converted using an algorithm to an outcome satisfaction score (OS) (R0–16) and a care satisfaction score (CS) (R0–16). For each of these scores, a higher numerical rating indicates better satisfaction. These scores were then converted to percentages of the maximum score. Thus, the higher percentages reflect a greater degree of satisfaction.
Statistical analysis was undertaken using an SPSS for Windows statistical software package (SPSS, Chicago, Illinois, USA). As these data were non-parametric, statistical comparisons of groups were performed using the Mann–Whitney U test.
Of 43 women in the older cohort, 34 were suitable for case matching. The limitations to case matching were primarily due to higher BMI and/or the use of spinal anaesthesia. Table 1 shows the comparative baseline demographics for both matched groups and previous continence intervention. All women had symptoms of stress incontinence confirmed at urodynamics. In addition, nine (26%) in the older and nine (26%) in the younger reported pre-operative urge symptoms. Peri-operative details, continence outcomes and satisfaction are listed in Tables 2 and 3. Of note, one of the older women with post-operative recurrent urinary tract infection required diagnostic cystoscopy and removal of tension-free vaginal tape mesh from the bladder.
Table 1. Patient demographics. Values in parentheses are standard deviation while values in brackets are interquartile range.
Younger women (n= 34)
Older women (n= 34)
Qmax= maximum flow rate, PVR = post-void residual.
Incontinence increases with age, urodynamic stress incontinence being the most prevalent type of incontinence in older populations.1 First-line treatment is usually conservative with continence surgery deemed less desirable because of potential anaesthetic and surgical morbidity. Where conservative treatment fails, surgical intervention may be considered. Prior to the advent of the tension-free vaginal tape, Burch colposuspension was considered the ‘gold standard’ for continence surgery. This procedure carried greater risks in older women because of its abdominal approach, longer hospital stay and increased peri-operative morbidity.11 The main alternative, a urethral bulking procedure, was less invasive and was associated with lower morbidity but had disappointing long term outcomes.12 The tension-free vaginal tape offers a minimally invasive approach to continence surgery in older women with high short term success rates.3 There have been few subsequent studies however, specifically addressing the impact of age on tension-free vaginal tape outcome. Such data are important as a reduced continence outcome or increased complications may affect an older woman's decision to undergo this procedure. We therefore sought to analyse treatment outcome and morbidity in a case-matched series comparing older and younger women undergoing tension-free vaginal tape.
One of the advantages of a tension-free vaginal tape is the low rate of post-operative voiding difficulties. This is believed to be related to the flexibility of the sling and placement around the mid-urethra rather than bladder neck. Previously, adjustment of the tension-free vaginal tape with ‘coughing’ under local or regional anaesthesia was thought to be an important factor to prevent excessive tension and urethral obstruction. Subsequent studies have demonstrated that the ‘cough test’ is unnecessary and that continence outcome is independent of the mode of anaesthesia.13,14 The rates of voiding difficulty will also be influenced by definition and there is no current consensus on what constitutes significant voiding dysfunction. In our unit, we define significant voiding difficulty as an inability to void spontaneously following two trials, in the absence of a urinary tract infection and requiring CISC. By this definition, none of the older women in this study experienced significant voiding difficulty compared with 7% or two women in the younger cohort. Although we would normally expect older women to suffer greater voiding difficulty than younger women, in this study we identified a reverse trend but this did not reach statistical significance. In both patients, the problem resolved at six weeks and no further intervention was required.
In this study, the incidence of irritative urinary symptoms requiring antibiotic therapy for suspected infection following discharge home was 12% in younger women, and 18% in older women. However, only 50% of patients had urine cultures performed of which 30% demonstrated objective evidence of urinary tract infection. This incomplete data was due to treatment by the General Practitioner sometimes without a prior MSU. Rates of urinary tract infection after tension-free vaginal tape were not described by Ulmsten et al.3 but the randomised controlled study by Ward and Hilton2 demonstrated a similar 22% urinary tract infection rate six weeks after surgery.
The subjective outcome of urodynamic stress incontinence treatment is commonly measured using validated Quality of Life (QOL) scores. Most QOL questionnaires require pre- and post-operative assessment. A more pragmatic alternative is the assessment of patient satisfaction with continence outcome and the delivery of care, which are both cornerstones of clinical governance. The GUTSS questionnaire has the added advantage of being brief and of requiring only post-operative completion. GUTSS satisfaction scores have not been previously used to assess tension-free vaginal tape outcomes but were used in a recent randomised controlled trial comparing laparoscopic to open colposuspension.10
Using the GUTSS questionnaire, our case matching study between older and younger women undergoing tension-free vaginal tape demonstrated a significant difference in outcome satisfaction but not care satisfaction, with older women being less satisfied with the continence outcome. The cure rate at a median follow up 12 months was 72% in younger women and 45% in older women, which is comparable to the findings of Ward and Hilton2 and Lo et al.6
The reasons for such a divergence in cure rates between older and younger women are unclear but a number of mechanisms may be involved. Persistent stress incontinence is more common in older women from other studies evaluating surgical intervention. Perhaps ageing limits collagen deposition onto the tension-free vaginal tape with compromises suburethral support in such women.15 Additionally, older women may have had a longer history of incontinence, lesser degrees of urethral mobility or greater degrees of urethral rigidity, reducing tension-free vaginal tape effectiveness. The severity of urinary loss may also be an important prognostic factor. It is difficult to determine the precise nature of persistent bladder symptoms at 14 months in this study as those patients did not feel their symptoms were severe enough to warrant further urodynamic evaluation. While mixed incontinence is more common in older women, and is known to be associated with a lower continence outcome, it is unlikely to be a cause of diverging results in this study as pre-operative symptoms of mixed incontinence in the younger and older groups were balanced (nine in each group). Furthermore, only three of the older and two of the younger women with pre-operative mixed symptoms had persistent post-operative urge symptoms. Similarly, while older women are considered to be more likely to develop de novo post-operative irritative bladder symptoms, this was not evident in this study, as there was a similarly low incidence of such symptoms in both younger and older groups post-operatively.
This study demonstrates that tension-free vaginal tape is a safe and effective procedure for the correction of stress incontinence in older women. Although the continence satisfaction outcome was lower compared with younger women, those with persistent urinary symptoms did not feel they were severe enough to warrant further intervention.