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A comparison of the objective and subjective outcomes of colposuspension for stress incontinence in women
British Journal of Obstetrics and Gynaecology April 2001, Vol. 108, pp. 408±413
A comparison of the objective and subjective outcomes of colposuspension for stress incontinence in women John Bidmead a, Linda Cardozo a,*, Anne McLellan a, Vik Khullar b, Cornelius Kelleher c Objectives To investigate the impact of colposuspension for stress incontinence on the symptoms and quality of life of women undergoing both primary and repeat surgery for genuine stress incontinence and in addition to assess the use of a condition speci®c quality of life questionnaire as an outcome measure following surgery. Design Prospective case series: videocystourethrography performed before and between six and twelve months after surgery. Validated condition speci®c quality of life (QoL) questionnaires completed by women before and six to twelve months after surgery. Setting A tertiary referral Urogynaecology Unit in a teaching hospital. Participants A consecutive series of 83 women undergoing colposuspension between March 1995 and December 1997. Pre-operative assessment and surgery was performed by, or was under the direct supervision of, the unit director. Intervention Modi®ed Burch colposuspension. Main outcome measures Objective results of surgery assessed with videocystourethrography. Subjective results evaluated using a condition speci®c QoL tool, the Kings Health Questionnaire (KHQ). Symptom severity was evaluated as a component of the condition speci®c QoL questionnaire. Results Objective cure was demonstrated in 92% of women undergoing primary surgery with an 8% incidence of de-novo detrusor instability and a 10% incidence of voiding dif®culties. In the group of women having repeat surgery the objective cure rate was 81% with no de-novo detrusor instability and a 6% incidence of post-operative voiding dif®culties. QoL scores improved in 95% of women. Improvements of over 25% were seen in 70% of women and of over 50% in 28%. However, 2.4% of women recorded a deterioration in QoL scores. Conclusions Colposuspension performed in this setting, assessed using both objective and standardised subjective measures, completed by women themselves, appears to produce good objective and subjective results and leads to enhanced quality of life in the great majority of women.
INTRODUCTION Outcome measures used in assessing the results of surgery have consisted of objective tests of urinary leakage such as pad testing and cystometry. Subjective measures have often been reported as the opinion of the surgeon and not of the woman herself. Other methods of obtaining subjective results have often involved unstructured face to face, or even telephone interviews. Symptomatic cure may be claimed in response to often quite vague questioning such as ªare you better?º A recent
a
Department of Urogynaecology, Kings College Hospital, London, UK b Department of Obstetrics and Gynaecology St. Mary's Hospital London, UK c Department of Obstetrics and Gynaecology St. Thomas Hospital, London, UK * Correspondence: Professor L.D. Cardozo, The Sloes, Potter Street Hill, Pinner, Middlesex HA5 3YH, UK. q RCOG 2001 British Journal of Obstetrics and Gynaecology PII: S03 06-5456(00)0009 3-0
multicentre study which assessed the subjective results of surgery reported by both the surgeon and the woman herself, has highlighted the dif®culty of using the subjective assessment of the clinician as an outcome measure 1. Objective measurements of outcome are clearly important, particularly in the context of clinical studies and research. However the fundamental aim of treatment of stress incontinence is to bring about an improvement in a woman's quality of life. Urinary incontinence has been de®ned by the International Continence Society (ICS) as `a condition of involuntary urine loss that is a social or hygienic problem and which is objectively demonstrable' 2. This is a distressing problem and profoundly affects the social, psychological, occupational, domestic, and sexual lives of 15%±30% of women of all ages 3. Genuine stress incontinence is de®ned by the ICS as the involuntary loss of urine when the intravesical pressure exceeds the intraurethral pressure in the absence of detrusor activity. genuine stress incontinence often leads women to give up many aspects of their usual life and impairs social, interpersonal and sexual relationships. genuine stress incontinence www.bjog-elsevier.com
IMPACT OF COLPOSUSPENSION FOR STRESS INCONTINENCE 409
also has an adverse effect on a woman's professional and career performance or ability to ful®l domestic commitments. Treatment of genuine stress incontinence is therefore not only important on an individual level. There are also economic considerations and the wider effect on society as a whole to be taken into account. The impact of genuine stress incontinence is affected by a complex interaction of many factors, all of which contribute to overall morbidity and measurement of objective parameters alone may not give complete insight into the effect of genuine stress incontinence, and the result of treatment, on the life of an individual woman 4. In order to assess the effect of urinary incontinence on daily life some form of standardised subjective measure is needed. Quality of life measurements are appropriate for this purpose. There are two types of quality of life questionnaires available, generic and disease speci®c. Generic questionnaires are designed to measure a broad range of health indices and have been shown to be useful in conducting larger population based studies. Examples of commonly used generic quality of life tools include the Nottingham Health Pro®le and the Short Form 36 5,6. These generic questionnaires have shown an overall reduction in quality of life parameters of incontinent women 7. However generic questionnaires appear to be relatively insensitive to the effect of urinary symptoms on quality of life, and unresponsive to changes with treatment 8. This is to be expected as they are designed to measure a broad range of health indicators rather than subtle changes in symptoms in any one system. Disease speci®c questionnaires assess the same multidimensional areas of quality of life but are designed to be more applicable and sensitive to issues that affect patients with a particular medical condition. An understanding of the effect of any condition is essential in the planning of appropriate investigation and treatment. It is also increasingly important to assess the effect of any new intervention not only in terms of objective measures but also its effect on quality of life and health care economics. For this reason a condition-speci®c questionnaire, the ªKings Health Questionnaireº was developed for use in women with urinary symptoms in the Urogynaecology unit at Kings College Hospital 9. We describe the outcome of colposuspension in terms of an objective measure; videocystourethrography and a subjective measure, a quality of life questionnaire speci®cally designed to measure symptoms of urinary tract disorders and the impact of those symptoms on everyday life. SUBJECTS AND METHODS Women in this study were those referred to a tertiary referral unit, a teaching hospital department of urogynaecology, either from general practitioners or from gynaeq RCOG 2001 Br J Obstet Gynaecol 108, pp. 408±413
cologists or urologists in the south of England. All women referred to the unit are assessed clinically and undergo videocystourethrography. Women diagnosed as having genuine stress incontinence are referred for pelvic ¯oor physiotherapy in the ®rst instance. Women with mixed incontinence; abnormal detrusor activity and urethral sphincter incompetence, are treated with bladder retraining, pelvic ¯oor physiotherapy and anticholinergic medication. Surgery is offered if conservative management has failed and when abnormal detrusor activity, if present, is controlled by medication, as assessed by reported symptoms and repeat videocystourethrography or ambulatory urodynamics. A quality of life questionnaire, a-condition speci®c tool the ªKings Health Questionnaireº was completed prior to surgery. Open modi®ed Burch colposuspension was performed using absorbable polydianoxone sutures (Ethicon Edinburgh UK). Four sutures were placed into the paravaginal tissue and ileopectineal ligament on each side. A retropubic drain and suprapubic catheter were inserted at the time of surgery. The suprapubic catheter was clamped 48 hour after surgery and removed when post-micturition residuals were consistently below 50 mL. Following surgery videocystourethrography was repeated at between six and 12 months post-operatively and the questionnaire completed again at this time. The Kings Health Questionnaire consists of four sections. The ®rst section contains two domains that measure women's perception of their general health and the impact of urinary symptoms on their life. The second contains 14 questions that allow women to rate the impact of their urinary symptoms on ®ve other quality of life domains: role limitation, physical/social limitation, personal relationships, emotions and sleep and energy. The third section assesses the severity of measures associated with urinary incontinence such as the need to wear pads or the need to change clothing. The fourth consists of a separate scale for rating different urinary symptoms. The questionnaire was developed after assessment of existing quality of life tools and discussion with women suffering from urinary problems. Seven successive versions of the Kings Health Questionnaire were tested during its development, each question was analysed for ambiguity, redundancy and ease of comprehension. The reliability, consistency and test-retest reliability were assessed at each stage and the ®nal version consists of twenty-one questions divided into the eight domains together with a section of severity measures and the symptom severity scale. The questionnaire is printed in large type so that it can be quickly and easily completed. The Kings Health Questionnaire has been used in surgical and pharmacological studies and has been shown to be extremely sensitive to changes in urinary symptoms 10. It has also been translated into twenty-six languages. The elements of the Kings Health
410 J. BIDMEAD ET AL. Table 1. Previous gynaecological surgery. PFR pelvic ¯oor repair; TAH transabdominal hysterectomy; MMK Marshalkl-Marchetti, Krantz; BSO Bilateral Salpingo-oophorectomy. Type of prior gynaecological surgery None Abdominal hysterectomy 1/- BSO Vaginal hysterectomy and PFR Colposuspension 1/- TAH Anterior colporrhaphy Abdominal hysterectomy and PFR Vaginal hysterectomy and PFR and anterior colporrhaphy Anterior vaginal repair twice Manchester repair, PFR and TAH colposuspension MMK procedure Radical hysterectomy and Colposuspension TAH BSO, anterior repair and Raz needle suspension MMK (twice) PFR, TAH and colposuspension TAH and sling
n (%) 25 21 8 8 5 4 3
(30.2) (25.4) (9.6) (9.6) (6) (4.8) (3.6)
2 1 1 1 1 1 1 1
(2.4) (1.2) (1.2) (1.2) (1.2) (1.2) (1.2) (1.2)
Questionnaire are summarised as follows: ² ² ² ² ² ² ² ² ²
General Health Perception Incontinence Impact Role limitation Physical/social limitation Personal relationships Emotions Sleep/energy Severity measures Symptom scores
of both the quality of life tool and the videocystourethrography were then compared. Results were analysed using Wilcoxon matched pairs test. Statistics software used was SPSS for Windows v8. RESULTS Objective testing: videocystourethrography Post-operative videocystourethrography results were examined for women undergoing primary surgery. No leakage of contrast beyond the bladder neck was seen on stress testing at maximum cystometric capacity in 47 (92%). Detrusor instability was demonstrated in 4(8%). Voiding dif®culty, de®ned as a peak ¯ow of less than 15 mls per second with a detrusor pressure of . 50 cm H2O or a persistent urinary residual volume of greater than 100 ml, was found in 5(10%). In the group of women having repeat surgery no leakage of contrast past the bladder neck on stress testing at maximum cystometric capacity was seen in 26(81%). None of this group had abnormal detrusor activity postoperatively and 2(6%) had voiding dif®culty as de®ned above. Results of videocystourethrography post-operatively for primary and secondary procedures are shown in Table 2. Condition speci®c quality of life results (Kings Health Questionnaire)
A total of 83 women completed the study, 51 had colposuspension as a primary procedure for stress incontinence, and 32 had undergone prior, failed, incontinence operations. The women had also undergone a variety of previous gynaecological procedures for differing indications as shown in Table 1. All women having primary incontinence surgery had urodynamically diagnosed genuine stress incontinence, of the women undergoing secondary surgery 10(12%) had detrusor instability treated with anticholinergic medication. The mean age of the women was 57 years (SD 10.5) with a range of 37 to 88 years. Videocystourethrography was performed pre-operatively and six to twelve months after surgery. Quality of life scores were recorded pre-operatively and at the same time as videocystourethrography post-operatively. The simple design of the questionnaire allowed completion by the women themselves without assistance from medical staff. The results
Results from 83 women were analysed. Analysis of the total scores for all domains revealed an improvement in 95% of women. The total scores of 70% of women improved by over 25% and in 28% of women by over 50% when compared with their pre-operative scores. Deterioration in quality of life scores was recorded by 2.4% of women. Changes in the scores for the eight quality of life domains were also analysed. Improvements were seen in all domains other than general health perception. Statistical analysis using Wilcoxon ranked pairs test showed highly signi®cant improvements in all of these domains. The results are summarised in Table 3. Symptom scores A number of urinary tract symptoms are assessed as an integral part of the Kings Health Questionnaire. Symptom scores were analysed pre and post-operatively. Eighty-nine percent of women complained of stress
Table 2. Postoperative urodynamic results. Values are shown as n (%). VCU rsults Primary colposuspension (n 51) Secondary colposuspension (n 32)
Objective cure
Detrusor instability
Voiding dif®culties
47 (92%) 26 (81%)
4 (8) 0
5 (10) 2 (6)
q RCOG 2001 Br J Obstet Gynaecol 108, pp. 408±413
IMPACT OF COLPOSUSPENSION FOR STRESS INCONTINENCE 411 Table 3. Pre and postoperative QoL scores. Signi®cance by wilcoxon ranked pairs, all P , 0.0001, except general health perception. QoL domain
Pre-operative median score
Range (25±75th centiles)
Post-operative median score
Range (25±75th centile)
25 100 66 66 33 33 66 50 75
(25±50) (66±100) (33±83) (33±83) (0±66) (0±58) (33±88) (33±66) (41±83)
25 33 0 0 0 11 0 33 16
(0±25) (0±33) (0±16) (0±16) (0±0) (0±0) (0±22) (16±50) (0±33)
General health perception a Incontinence impact Role limitation Physical limitation Social limitation Personal relationships Emotions Sleep/energy Severity measures a
Signi®cance NS.
Pad usage forms part of the Kings Health Questionnaire. Women are asked to report their need to use incontinence pads to remain dry. Pre-operatively 63% of women reported the need to wear a pad, always or often. This changed to only 8% post-operatively and 71% of women recorded never needing to use pads post-operatively. Similar results were recorded for the need to change underwear. These results are summarised in Table 4.
®t from surgery. One of those who did not bene®t had suffered from lifelong irritative urinary symptoms and had previously undergone a vaginal hysterectomy and pelvic ¯oor repair and an anterior vaginal repair. Preoperative urodynamics showed a stable bladder with moderate genuine stress incontinence and post-operative tests showed normal urodynamics. Her irritative symptoms, however, persisted. The second woman underwent a repeat colposuspension for moderate genuine stress incontinence which resulted in normal post-operative urodynamics. However she developed intractable right iliac fossa pain, thought to be due possibly to the presence of the suspensory sutures. This resulted in her reported deterioration in quality of life. Both of these cases highlight the importance of subjective post-operative assessment. On objective urodynamic testing both were cured of their genuine stress incontinence. The persistence of irritative urinary symptoms and post-operative pain led to an overall adverse outcome identi®ed by quality of life assessment but not using conventional objective tests of cure.
Deterioration in quality of life scores
Objective and subjective cure
Two women reported a deterioration in quality of life scores following colposuspension. This is of particular concern as the purpose of surgery is to improve patients symptoms. The aim of pre-operative investigation and patient selection is to choose those women likely to bene-
A total of 11 women had persistent stress incontinence on post colposuspension urodynamic testing. Conventionally these women would be regarded as having had failed surgery. Closer examination of the results of quality of life assessment for these women shows signi®cant improvement in quality of life scores in this group. This compares favourably with the improvement in scores in the group with cure of stress incontinence on urodynamic testing (Table 5). These results highlight the fact that while objective testing may be important in de®ning the outcome of
incontinence pre-operatively (the remaining 11% had covert stress incontinence revealed when vaginal prolapse was corrected during pre-operative videocystourethrography). Post-operatively 71% reported no stress incontinence and 21% only occasional leakage. Symptoms of urgency and urge incontinence fell from 55.4% and 54.2% respectively pre-operatively to 28% and14.7% post-operatively. These results are summarised in Table 4. Pad usage
Table 4. Pre and postoperative symptom scores. Values are given as (%) or n (%). Signi®cance by Wilcoxon ranked pairs, all P 0.0001. Pre-operative Symptom scores Stress Incontinence Urge Incontinence Urgency Frequency (.7 day) Pad Usage Never Sometimes Often All the time
Post-operative
89 54.2 55.4 77
8.6 14.7 28 33
11 (13) 19 (24) 11 (13) 42 (50)
59 (71) 18 (21) 3 (4) 3 (4)
q RCOG 2001 Br J Obstet Gynaecol 108, pp. 408±413
Table 5. Comparison of changes in pre and postoperative QoL scores according to urodynamic results. SI stress incontinence. Objective results No SI (n 11) Persistent SI (n 72)
Pre-op QoL score median (95%CI)
Post-op QoL score median (95%CI)
P
50 (46-57) 61 (8-69)
13 (13-20) 27 (8-36)
0.001 0.003
412 J. BIDMEAD ET AL.
surgery it can give a false impression of the symptomatic results. During cystometry the bladder is ®lled to maximum capacity and the woman encouraged to cough repeatedly, a situation which may rarely occur in normal life. It follows that women who have persistent stress incontinence during cystometry may not, in fact, be symptomatic during daily life. DISCUSSION Surgical treatment has been used for over one hundred years to improve the quality of life of women suffering from genuine stress incontinence and is recommended for women with stress incontinence which has not responded to conservative measures and which is causing social distress 11. There is no doubt that conservative therapy in the form of pelvic ¯oor physiotherapy, electrical stimulation and the use of prosthetic devices may cure or improve symptoms in a signi®cant number of women 12,13. We believe that conservative measures should always be used as ®rst line treatment before surgery is resorted to. However surgical treatment remains the only option for many women with genuine stress incontinence, which has not responded to conservative measures, and who wish to return to a normal level of activity. Assessment of the result of surgery for genuine stress incontinence is more complicated than it would initially appear. Simple cure of stress leakage is not suf®cient as the occurrence of post-operative voiding problems and urinary urgency and frequency may have a profound in¯uence on the outcome of surgery. Objective testing in the form of videocystourethrography, which is the current ªgold standardº objective measure or by using standardised pad tests can provide objective evidence of cure. However videocystourethrography is a somewhat blunt instrument and it is acknowledged that the results of videocystourethrography and the symptoms may not always correlate 14. Subjective results, in the form of a woman's symptoms recorded by the surgeon have always provided an important additional source of information regarding the outcome of surgery. There are a number of obvious ¯aws in this method of assessing subjective results. Women may feel inhibited discussing the outcome of recent surgery with the surgeon who undertook the operation and may report the absence of symptoms when this is not the case. Surgeons on the other hand may tend to interpret results over optimistically. In the recent study undertaken by Black et al. 15±17, 442 women having surgery for stress incontinence were recruited over an 18-month period. Pre-operative and post-operative data were obtained both from surgeons and women themselves. The results of this survey showed a marked discrepancy between previously published results and the
reports of women in the study, only 28% of whom described subjective cure. It was also apparent that surgeons' perception of results differed from those of their patients as surgeons considered the outcome successful in 85% of cases. The Kings Health Questionnaire was developed as a disease speci®c quality of life tool to circumvent some of these dif®culties in obtaining a standardised subjective and symptomatic measure of the effect of treatments, conservative, medical and surgical, on urinary tract disorders 9. The questionnaire is simple to complete and analyse and can be ®lled in by women themselves. This allows the reporting of symptoms without bias, which may be introduced during a consultation. Another advantage of assessment of quality of life in this manner is that more subtle undesirable sequelae of surgery, such as minor voiding dif®culties, urgency of micturition or wound discomfort, all of which contribute to the overall result, can be assessed. Reliance on standard objective outcome measures may not allow full appreciation of these effects. This makes quality of life assessment particularly useful when comparing the results of different surgical procedures. For these reasons quality of life data have been recommended by the International Continence Society as a standard outcome measure and this study demonstrates that such information adds signi®cantly to the assessment of surgical treatment 18. The objective cure rates demonstrated in this study concur with those of other published series most of which have been from similar units with a special interest in urogynaecology. In addition the improvement in quality of life scores together with signi®cant improvement in symptom scores and pad usage agree closely with the objective measures. These results suggest that after careful pre-operative assessment surgical treatment of stress incontinence can produce excellent results. In addition the improvement in quality of life scores seen amongst those women with persistent stress incontinence suggests that objective failure need not necessarily equate with symptomatic failure. It is important that any unit performing surgery for urinary incontinence should closely audit the results of surgical intervention but many hospitals will not have the resources to perform routine post-operative cystometry. Urodynamics is an invasive procedure and many women will understandably be reluctant to undergo post-operative urodynamics outside a research protocol. Ideally, an independent third party would record subjective data, reducing the bias inherent when patients are asked to report results to the unit carrying out the treatment. Outside the context of a clinical trial this is impracticable and the use of a self-completed patient questionnaire provides a pragmatic solution. The Department of Health NCHOD working group on outcome indicators in urinary incontinence has also recommended the collection of q RCOG 2001 Br J Obstet Gynaecol 108, pp. 408±413
IMPACT OF COLPOSUSPENSION FOR STRESS INCONTINENCE 413
symptom and quality of life data before and six months after treatment 19. The Kings Health Questionnaire appears to be an appropriate tool for such assessment, providing an easily used, standardised measure of subjective and symptomatic outcome.
10. 11.
References 1. Black N, Grif®ths J, Pope C, Bowling A, Abel P. Impact of surgery for stress incontinence on morbidity: cohort study. BMJ 1997;315:1493± 1498. 2. Abrams P, Blaivas JG, Stanton SL, Anderson JT. The standardisation of terminology of lower urinary tract function. Scand J Urol Nephrol. 1989;114(Suppl):5±19. 3. Thomas TM, Plymat KR, Blannin J, Meade TW. Prevalence of urinary incontinence. BMJ 1980;281:1243±1245. 4. Wyman J, Harkins S, Choi S, Taylor J, Fantl A. Psychosocial impact of urinary incontinence in women. Obstet Gynecol 1987;70:378±380. 5. Hunt SM, McEwen J, McKenna SP. Measuring health status. A new tool for clinicians and epidemiologists. J R Coll Gen Pract 1985;35:185±188. 6. Jenckinson C, Wright L, Coulter A. Quality of Life Measurement in Healthcare. A Review of Measures and Population Norms for the UKSF 36. Health Services Research unit, Department of Public Health and Primary Care. Oxford: University of Oxford, 1993. 7. Kelleher C, Cardozo L, Khullar V. The impact of urinary incontinence on quality of life. Neurourol Urodyn 1993;12:388±389. 8. Sand PK, Richardson DA, Staskin DR, Swift SE, Appell RA, et al. Pelvic ¯oor stimulation in the treatment of genuine stress incontinence: a multicentre placebo controlled trial. Neurourol Urodyn 1994;13:356± 357. 9. Kheller CJ, Cardozo LD, Khullar V, Salvatore S. A new questionnaire
q RCOG 2001 Br J Obstet Gynaecol 108, pp. 408±413
12. 13. 14. 15. 16. 17. 18.
19.
to assess the quality of life of urinary incontinent women. B J Obstet Gynaecol 1997;104:1374±1379. Kobelt G, Kichberger I, Malone-lee J. Quality of life aspects of the overactive bladder and the effects of treament with tolterodine. Br J Urol Int 1999;83:583±590. Fantl JA, Newman DK, Colling J, DeLancey JOL et al. Urinary Incontinence in Adults: Acute and Chronic Management. Clinical practise guideline no. 2. Rockville MD: US department of health and human services, Public Health Service, Agency for healthcare policy and research, 1996. (AHCPR Pud no. 96-068 2.) Tapp AJS, Hills B, Cardozo L. Who bene®ts from physiotherapy? Neurourol Urodyn 1988;7:259±265. Laycock J, Jerwood D. Does pre-modulated interferential therapy cure genuine stress incontinence? Physiotherapy 1993;79:553±560. Jarvis GJ, Hall S, Stamp S, Millar DR, Johnson A. An assessment of urodynamic examination in incontinent women. Br J Obstet Gynaecol 1980;87:893±896. Hutchings A, Grif®ths J, Black N. Surgery for Stress incontinence: factors associated with a successful outcome. Br J Urol 1998;82:634±641. Black NA, Bowling A, Grif®ths JM, et al. Impact of surgery for stress incontinence on the social lives of women. Br J Obstet Gynaecol 1998;105:605±612. Grif®ths JM, Black NA, Pope C, Stanley J, Bowling A, Abel PD. What determines the choice of procedure in stress incontinece surgery. Int J Technol Ass Healthcare 1998;14:431±455. Mattiason A, Djurhuus JC, Fantl A, Fonda D. Nordling J, Storer M. Standardisation of Outcome Studies in Patients with Lower Urinary Tract Dysfunction. Standardisation committee of the International Continence Society. ICS Annual meeting. Jerusalem, Israel. 1998. Brocklehurst J, Amess M, Goldacre M, Mason A, Wilkinson E, et al. Health Outcome Indicators, Urinary Incontinence. Report of a working group to the department of Health. Oxford: NCHOD, 1999.
Accepted 19 December 2000
A comparison of the objective and subjective outcomes of colposuspension for stress incontinence in women John Bidmead a, Linda Cardozo a,*, Anne McLellan a, Vik Khullar b, Cornelius Kelleher c Objectives To investigate the impact of colposuspension for stress incontinence on the symptoms and quality of life of women undergoing both primary and repeat surgery for genuine stress incontinence and in addition to assess the use of a condition speci®c quality of life questionnaire as an outcome measure following surgery. Design Prospective case series: videocystourethrography performed before and between six and twelve months after surgery. Validated condition speci®c quality of life (QoL) questionnaires completed by women before and six to twelve months after surgery. Setting A tertiary referral Urogynaecology Unit in a teaching hospital. Participants A consecutive series of 83 women undergoing colposuspension between March 1995 and December 1997. Pre-operative assessment and surgery was performed by, or was under the direct supervision of, the unit director. Intervention Modi®ed Burch colposuspension. Main outcome measures Objective results of surgery assessed with videocystourethrography. Subjective results evaluated using a condition speci®c QoL tool, the Kings Health Questionnaire (KHQ). Symptom severity was evaluated as a component of the condition speci®c QoL questionnaire. Results Objective cure was demonstrated in 92% of women undergoing primary surgery with an 8% incidence of de-novo detrusor instability and a 10% incidence of voiding dif®culties. In the group of women having repeat surgery the objective cure rate was 81% with no de-novo detrusor instability and a 6% incidence of post-operative voiding dif®culties. QoL scores improved in 95% of women. Improvements of over 25% were seen in 70% of women and of over 50% in 28%. However, 2.4% of women recorded a deterioration in QoL scores. Conclusions Colposuspension performed in this setting, assessed using both objective and standardised subjective measures, completed by women themselves, appears to produce good objective and subjective results and leads to enhanced quality of life in the great majority of women.
INTRODUCTION Outcome measures used in assessing the results of surgery have consisted of objective tests of urinary leakage such as pad testing and cystometry. Subjective measures have often been reported as the opinion of the surgeon and not of the woman herself. Other methods of obtaining subjective results have often involved unstructured face to face, or even telephone interviews. Symptomatic cure may be claimed in response to often quite vague questioning such as ªare you better?º A recent
a
Department of Urogynaecology, Kings College Hospital, London, UK b Department of Obstetrics and Gynaecology St. Mary's Hospital London, UK c Department of Obstetrics and Gynaecology St. Thomas Hospital, London, UK * Correspondence: Professor L.D. Cardozo, The Sloes, Potter Street Hill, Pinner, Middlesex HA5 3YH, UK. q RCOG 2001 British Journal of Obstetrics and Gynaecology PII: S03 06-5456(00)0009 3-0
multicentre study which assessed the subjective results of surgery reported by both the surgeon and the woman herself, has highlighted the dif®culty of using the subjective assessment of the clinician as an outcome measure 1. Objective measurements of outcome are clearly important, particularly in the context of clinical studies and research. However the fundamental aim of treatment of stress incontinence is to bring about an improvement in a woman's quality of life. Urinary incontinence has been de®ned by the International Continence Society (ICS) as `a condition of involuntary urine loss that is a social or hygienic problem and which is objectively demonstrable' 2. This is a distressing problem and profoundly affects the social, psychological, occupational, domestic, and sexual lives of 15%±30% of women of all ages 3. Genuine stress incontinence is de®ned by the ICS as the involuntary loss of urine when the intravesical pressure exceeds the intraurethral pressure in the absence of detrusor activity. genuine stress incontinence often leads women to give up many aspects of their usual life and impairs social, interpersonal and sexual relationships. genuine stress incontinence www.bjog-elsevier.com
IMPACT OF COLPOSUSPENSION FOR STRESS INCONTINENCE 409
also has an adverse effect on a woman's professional and career performance or ability to ful®l domestic commitments. Treatment of genuine stress incontinence is therefore not only important on an individual level. There are also economic considerations and the wider effect on society as a whole to be taken into account. The impact of genuine stress incontinence is affected by a complex interaction of many factors, all of which contribute to overall morbidity and measurement of objective parameters alone may not give complete insight into the effect of genuine stress incontinence, and the result of treatment, on the life of an individual woman 4. In order to assess the effect of urinary incontinence on daily life some form of standardised subjective measure is needed. Quality of life measurements are appropriate for this purpose. There are two types of quality of life questionnaires available, generic and disease speci®c. Generic questionnaires are designed to measure a broad range of health indices and have been shown to be useful in conducting larger population based studies. Examples of commonly used generic quality of life tools include the Nottingham Health Pro®le and the Short Form 36 5,6. These generic questionnaires have shown an overall reduction in quality of life parameters of incontinent women 7. However generic questionnaires appear to be relatively insensitive to the effect of urinary symptoms on quality of life, and unresponsive to changes with treatment 8. This is to be expected as they are designed to measure a broad range of health indicators rather than subtle changes in symptoms in any one system. Disease speci®c questionnaires assess the same multidimensional areas of quality of life but are designed to be more applicable and sensitive to issues that affect patients with a particular medical condition. An understanding of the effect of any condition is essential in the planning of appropriate investigation and treatment. It is also increasingly important to assess the effect of any new intervention not only in terms of objective measures but also its effect on quality of life and health care economics. For this reason a condition-speci®c questionnaire, the ªKings Health Questionnaireº was developed for use in women with urinary symptoms in the Urogynaecology unit at Kings College Hospital 9. We describe the outcome of colposuspension in terms of an objective measure; videocystourethrography and a subjective measure, a quality of life questionnaire speci®cally designed to measure symptoms of urinary tract disorders and the impact of those symptoms on everyday life. SUBJECTS AND METHODS Women in this study were those referred to a tertiary referral unit, a teaching hospital department of urogynaecology, either from general practitioners or from gynaeq RCOG 2001 Br J Obstet Gynaecol 108, pp. 408±413
cologists or urologists in the south of England. All women referred to the unit are assessed clinically and undergo videocystourethrography. Women diagnosed as having genuine stress incontinence are referred for pelvic ¯oor physiotherapy in the ®rst instance. Women with mixed incontinence; abnormal detrusor activity and urethral sphincter incompetence, are treated with bladder retraining, pelvic ¯oor physiotherapy and anticholinergic medication. Surgery is offered if conservative management has failed and when abnormal detrusor activity, if present, is controlled by medication, as assessed by reported symptoms and repeat videocystourethrography or ambulatory urodynamics. A quality of life questionnaire, a-condition speci®c tool the ªKings Health Questionnaireº was completed prior to surgery. Open modi®ed Burch colposuspension was performed using absorbable polydianoxone sutures (Ethicon Edinburgh UK). Four sutures were placed into the paravaginal tissue and ileopectineal ligament on each side. A retropubic drain and suprapubic catheter were inserted at the time of surgery. The suprapubic catheter was clamped 48 hour after surgery and removed when post-micturition residuals were consistently below 50 mL. Following surgery videocystourethrography was repeated at between six and 12 months post-operatively and the questionnaire completed again at this time. The Kings Health Questionnaire consists of four sections. The ®rst section contains two domains that measure women's perception of their general health and the impact of urinary symptoms on their life. The second contains 14 questions that allow women to rate the impact of their urinary symptoms on ®ve other quality of life domains: role limitation, physical/social limitation, personal relationships, emotions and sleep and energy. The third section assesses the severity of measures associated with urinary incontinence such as the need to wear pads or the need to change clothing. The fourth consists of a separate scale for rating different urinary symptoms. The questionnaire was developed after assessment of existing quality of life tools and discussion with women suffering from urinary problems. Seven successive versions of the Kings Health Questionnaire were tested during its development, each question was analysed for ambiguity, redundancy and ease of comprehension. The reliability, consistency and test-retest reliability were assessed at each stage and the ®nal version consists of twenty-one questions divided into the eight domains together with a section of severity measures and the symptom severity scale. The questionnaire is printed in large type so that it can be quickly and easily completed. The Kings Health Questionnaire has been used in surgical and pharmacological studies and has been shown to be extremely sensitive to changes in urinary symptoms 10. It has also been translated into twenty-six languages. The elements of the Kings Health
410 J. BIDMEAD ET AL. Table 1. Previous gynaecological surgery. PFR pelvic ¯oor repair; TAH transabdominal hysterectomy; MMK Marshalkl-Marchetti, Krantz; BSO Bilateral Salpingo-oophorectomy. Type of prior gynaecological surgery None Abdominal hysterectomy 1/- BSO Vaginal hysterectomy and PFR Colposuspension 1/- TAH Anterior colporrhaphy Abdominal hysterectomy and PFR Vaginal hysterectomy and PFR and anterior colporrhaphy Anterior vaginal repair twice Manchester repair, PFR and TAH colposuspension MMK procedure Radical hysterectomy and Colposuspension TAH BSO, anterior repair and Raz needle suspension MMK (twice) PFR, TAH and colposuspension TAH and sling
n (%) 25 21 8 8 5 4 3
(30.2) (25.4) (9.6) (9.6) (6) (4.8) (3.6)
2 1 1 1 1 1 1 1
(2.4) (1.2) (1.2) (1.2) (1.2) (1.2) (1.2) (1.2)
Questionnaire are summarised as follows: ² ² ² ² ² ² ² ² ²
General Health Perception Incontinence Impact Role limitation Physical/social limitation Personal relationships Emotions Sleep/energy Severity measures Symptom scores
of both the quality of life tool and the videocystourethrography were then compared. Results were analysed using Wilcoxon matched pairs test. Statistics software used was SPSS for Windows v8. RESULTS Objective testing: videocystourethrography Post-operative videocystourethrography results were examined for women undergoing primary surgery. No leakage of contrast beyond the bladder neck was seen on stress testing at maximum cystometric capacity in 47 (92%). Detrusor instability was demonstrated in 4(8%). Voiding dif®culty, de®ned as a peak ¯ow of less than 15 mls per second with a detrusor pressure of . 50 cm H2O or a persistent urinary residual volume of greater than 100 ml, was found in 5(10%). In the group of women having repeat surgery no leakage of contrast past the bladder neck on stress testing at maximum cystometric capacity was seen in 26(81%). None of this group had abnormal detrusor activity postoperatively and 2(6%) had voiding dif®culty as de®ned above. Results of videocystourethrography post-operatively for primary and secondary procedures are shown in Table 2. Condition speci®c quality of life results (Kings Health Questionnaire)
A total of 83 women completed the study, 51 had colposuspension as a primary procedure for stress incontinence, and 32 had undergone prior, failed, incontinence operations. The women had also undergone a variety of previous gynaecological procedures for differing indications as shown in Table 1. All women having primary incontinence surgery had urodynamically diagnosed genuine stress incontinence, of the women undergoing secondary surgery 10(12%) had detrusor instability treated with anticholinergic medication. The mean age of the women was 57 years (SD 10.5) with a range of 37 to 88 years. Videocystourethrography was performed pre-operatively and six to twelve months after surgery. Quality of life scores were recorded pre-operatively and at the same time as videocystourethrography post-operatively. The simple design of the questionnaire allowed completion by the women themselves without assistance from medical staff. The results
Results from 83 women were analysed. Analysis of the total scores for all domains revealed an improvement in 95% of women. The total scores of 70% of women improved by over 25% and in 28% of women by over 50% when compared with their pre-operative scores. Deterioration in quality of life scores was recorded by 2.4% of women. Changes in the scores for the eight quality of life domains were also analysed. Improvements were seen in all domains other than general health perception. Statistical analysis using Wilcoxon ranked pairs test showed highly signi®cant improvements in all of these domains. The results are summarised in Table 3. Symptom scores A number of urinary tract symptoms are assessed as an integral part of the Kings Health Questionnaire. Symptom scores were analysed pre and post-operatively. Eighty-nine percent of women complained of stress
Table 2. Postoperative urodynamic results. Values are shown as n (%). VCU rsults Primary colposuspension (n 51) Secondary colposuspension (n 32)
Objective cure
Detrusor instability
Voiding dif®culties
47 (92%) 26 (81%)
4 (8) 0
5 (10) 2 (6)
q RCOG 2001 Br J Obstet Gynaecol 108, pp. 408±413
IMPACT OF COLPOSUSPENSION FOR STRESS INCONTINENCE 411 Table 3. Pre and postoperative QoL scores. Signi®cance by wilcoxon ranked pairs, all P , 0.0001, except general health perception. QoL domain
Pre-operative median score
Range (25±75th centiles)
Post-operative median score
Range (25±75th centile)
25 100 66 66 33 33 66 50 75
(25±50) (66±100) (33±83) (33±83) (0±66) (0±58) (33±88) (33±66) (41±83)
25 33 0 0 0 11 0 33 16
(0±25) (0±33) (0±16) (0±16) (0±0) (0±0) (0±22) (16±50) (0±33)
General health perception a Incontinence impact Role limitation Physical limitation Social limitation Personal relationships Emotions Sleep/energy Severity measures a
Signi®cance NS.
Pad usage forms part of the Kings Health Questionnaire. Women are asked to report their need to use incontinence pads to remain dry. Pre-operatively 63% of women reported the need to wear a pad, always or often. This changed to only 8% post-operatively and 71% of women recorded never needing to use pads post-operatively. Similar results were recorded for the need to change underwear. These results are summarised in Table 4.
®t from surgery. One of those who did not bene®t had suffered from lifelong irritative urinary symptoms and had previously undergone a vaginal hysterectomy and pelvic ¯oor repair and an anterior vaginal repair. Preoperative urodynamics showed a stable bladder with moderate genuine stress incontinence and post-operative tests showed normal urodynamics. Her irritative symptoms, however, persisted. The second woman underwent a repeat colposuspension for moderate genuine stress incontinence which resulted in normal post-operative urodynamics. However she developed intractable right iliac fossa pain, thought to be due possibly to the presence of the suspensory sutures. This resulted in her reported deterioration in quality of life. Both of these cases highlight the importance of subjective post-operative assessment. On objective urodynamic testing both were cured of their genuine stress incontinence. The persistence of irritative urinary symptoms and post-operative pain led to an overall adverse outcome identi®ed by quality of life assessment but not using conventional objective tests of cure.
Deterioration in quality of life scores
Objective and subjective cure
Two women reported a deterioration in quality of life scores following colposuspension. This is of particular concern as the purpose of surgery is to improve patients symptoms. The aim of pre-operative investigation and patient selection is to choose those women likely to bene-
A total of 11 women had persistent stress incontinence on post colposuspension urodynamic testing. Conventionally these women would be regarded as having had failed surgery. Closer examination of the results of quality of life assessment for these women shows signi®cant improvement in quality of life scores in this group. This compares favourably with the improvement in scores in the group with cure of stress incontinence on urodynamic testing (Table 5). These results highlight the fact that while objective testing may be important in de®ning the outcome of
incontinence pre-operatively (the remaining 11% had covert stress incontinence revealed when vaginal prolapse was corrected during pre-operative videocystourethrography). Post-operatively 71% reported no stress incontinence and 21% only occasional leakage. Symptoms of urgency and urge incontinence fell from 55.4% and 54.2% respectively pre-operatively to 28% and14.7% post-operatively. These results are summarised in Table 4. Pad usage
Table 4. Pre and postoperative symptom scores. Values are given as (%) or n (%). Signi®cance by Wilcoxon ranked pairs, all P 0.0001. Pre-operative Symptom scores Stress Incontinence Urge Incontinence Urgency Frequency (.7 day) Pad Usage Never Sometimes Often All the time
Post-operative
89 54.2 55.4 77
8.6 14.7 28 33
11 (13) 19 (24) 11 (13) 42 (50)
59 (71) 18 (21) 3 (4) 3 (4)
q RCOG 2001 Br J Obstet Gynaecol 108, pp. 408±413
Table 5. Comparison of changes in pre and postoperative QoL scores according to urodynamic results. SI stress incontinence. Objective results No SI (n 11) Persistent SI (n 72)
Pre-op QoL score median (95%CI)
Post-op QoL score median (95%CI)
P
50 (46-57) 61 (8-69)
13 (13-20) 27 (8-36)
0.001 0.003
412 J. BIDMEAD ET AL.
surgery it can give a false impression of the symptomatic results. During cystometry the bladder is ®lled to maximum capacity and the woman encouraged to cough repeatedly, a situation which may rarely occur in normal life. It follows that women who have persistent stress incontinence during cystometry may not, in fact, be symptomatic during daily life. DISCUSSION Surgical treatment has been used for over one hundred years to improve the quality of life of women suffering from genuine stress incontinence and is recommended for women with stress incontinence which has not responded to conservative measures and which is causing social distress 11. There is no doubt that conservative therapy in the form of pelvic ¯oor physiotherapy, electrical stimulation and the use of prosthetic devices may cure or improve symptoms in a signi®cant number of women 12,13. We believe that conservative measures should always be used as ®rst line treatment before surgery is resorted to. However surgical treatment remains the only option for many women with genuine stress incontinence, which has not responded to conservative measures, and who wish to return to a normal level of activity. Assessment of the result of surgery for genuine stress incontinence is more complicated than it would initially appear. Simple cure of stress leakage is not suf®cient as the occurrence of post-operative voiding problems and urinary urgency and frequency may have a profound in¯uence on the outcome of surgery. Objective testing in the form of videocystourethrography, which is the current ªgold standardº objective measure or by using standardised pad tests can provide objective evidence of cure. However videocystourethrography is a somewhat blunt instrument and it is acknowledged that the results of videocystourethrography and the symptoms may not always correlate 14. Subjective results, in the form of a woman's symptoms recorded by the surgeon have always provided an important additional source of information regarding the outcome of surgery. There are a number of obvious ¯aws in this method of assessing subjective results. Women may feel inhibited discussing the outcome of recent surgery with the surgeon who undertook the operation and may report the absence of symptoms when this is not the case. Surgeons on the other hand may tend to interpret results over optimistically. In the recent study undertaken by Black et al. 15±17, 442 women having surgery for stress incontinence were recruited over an 18-month period. Pre-operative and post-operative data were obtained both from surgeons and women themselves. The results of this survey showed a marked discrepancy between previously published results and the
reports of women in the study, only 28% of whom described subjective cure. It was also apparent that surgeons' perception of results differed from those of their patients as surgeons considered the outcome successful in 85% of cases. The Kings Health Questionnaire was developed as a disease speci®c quality of life tool to circumvent some of these dif®culties in obtaining a standardised subjective and symptomatic measure of the effect of treatments, conservative, medical and surgical, on urinary tract disorders 9. The questionnaire is simple to complete and analyse and can be ®lled in by women themselves. This allows the reporting of symptoms without bias, which may be introduced during a consultation. Another advantage of assessment of quality of life in this manner is that more subtle undesirable sequelae of surgery, such as minor voiding dif®culties, urgency of micturition or wound discomfort, all of which contribute to the overall result, can be assessed. Reliance on standard objective outcome measures may not allow full appreciation of these effects. This makes quality of life assessment particularly useful when comparing the results of different surgical procedures. For these reasons quality of life data have been recommended by the International Continence Society as a standard outcome measure and this study demonstrates that such information adds signi®cantly to the assessment of surgical treatment 18. The objective cure rates demonstrated in this study concur with those of other published series most of which have been from similar units with a special interest in urogynaecology. In addition the improvement in quality of life scores together with signi®cant improvement in symptom scores and pad usage agree closely with the objective measures. These results suggest that after careful pre-operative assessment surgical treatment of stress incontinence can produce excellent results. In addition the improvement in quality of life scores seen amongst those women with persistent stress incontinence suggests that objective failure need not necessarily equate with symptomatic failure. It is important that any unit performing surgery for urinary incontinence should closely audit the results of surgical intervention but many hospitals will not have the resources to perform routine post-operative cystometry. Urodynamics is an invasive procedure and many women will understandably be reluctant to undergo post-operative urodynamics outside a research protocol. Ideally, an independent third party would record subjective data, reducing the bias inherent when patients are asked to report results to the unit carrying out the treatment. Outside the context of a clinical trial this is impracticable and the use of a self-completed patient questionnaire provides a pragmatic solution. The Department of Health NCHOD working group on outcome indicators in urinary incontinence has also recommended the collection of q RCOG 2001 Br J Obstet Gynaecol 108, pp. 408±413
IMPACT OF COLPOSUSPENSION FOR STRESS INCONTINENCE 413
symptom and quality of life data before and six months after treatment 19. The Kings Health Questionnaire appears to be an appropriate tool for such assessment, providing an easily used, standardised measure of subjective and symptomatic outcome.
10. 11.
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19.
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Accepted 19 December 2000