Long term follow up of the cruciate fascial sling for women with genuine stress incontinence

Transcription

1 BJOG: an International Journal of Obstetrics and Gynaecology March 2002, Vol. 109, pp Long term follow up of the cruciate fascial sling for women with genuine stress incontinence Emma Hawkins a, *, Debbie Taylor b, Jennifer Hughes-Nurse c Objective To determine the long term success of the cruciate fascial sling procedure for the treatment of genuine stress incontinence in women. Design In 1998, a pre-validated questionnaire was sent to all women who had a cruciate fascial sling between 1979 and 1996 under the care of the senior author at a District General Hospital and in private practice. Participants Questionnaires were sent to 246 women; 198 (80%) were returned. Results Overall, 142 women felt that they were much improved or cured. The success rate was 74% (95% CI 70% 81%) in women having the sling as a primary procedure and 67% (95% CI 54% 81%) in women having the sling as a secondary procedure. There was no relationship between symptom severity score and age at time surgery, duration of follow up, current weight or body mass index, previous surgery for stress incontinence or concomitant surgery. Of the 103 women with six or more years of follow up, 29 felt that their operation had failed, 16 of whom thought that it lasted between five and 10 years. Urgency was experienced by 29% of women, three needed to perform intermittent self-catheterisation, and 9% found it difficult to empty their bladder. Thirty-seven women (19%) experienced problems that they attributed to the abdominal wound. Conclusion Although inevitably there are some failures over time, the cruciate fascial sling has good long term success rates. Direct comparison with the literature is impossible, as few studies have relied on properly validated questionnaires. INTRODUCTION a Harold Wood Hospital, Harold Wood, UK b Norfolk and Norwich Hospital, Norwich, UK c Fitzwilliam Hospital, Peterborough, UK * Correspondence: Mrs E. Hawkins, Harold Wood Hospital, Gubbins Lane, Harold Wood, UK. D RCOG 2002 BJOG: an International Journal of Obstetrics and Gynaecology PII: S (0 2) Surgery is usually recommended for women with stress incontinence in whom conservative treatment has failed 1. Although there are a wide variety of surgical techniques, in the United Kingdom colposuspension, needle suspension and anterior repair are the most frequently performed procedures 1. In a review of stress incontinence surgery, Jarvis noted that sling procedures tended to be the most successful, although with more complications 2. There have been few long term studies of sling procedures 3. We performed a Medline search using the MESH term urinary incontinence and free text sling and retrieved 395 references. Limiting the search to articles dealing with women and published in English reduced the search to 281 and from this 119 references were identified as follow up studies of the success of sling procedures in adult women with stress incontinence. Papers referring to the recently introduced TVT procedure were not included. Of these references we identified 26 that included women followed up for more than 60 months These articles are summarised in Table 1, and it is apparent that variable definitions of success are used and the timing of failure of surgery is often not stated. Thus, there is little information on which to confirm or refute the suggestion that women who have been cured at six months are likely to remain so 3,19,30. Since 1979 the senior author has used a modification of the Aldridge fascial sling (the cruciate sling) for the treatment of all women with stress incontinence both in the NHS and the private sector. The procedure was originally developed by Mr David Lees, at the Jessop Hospital in Sheffield, during the 1970s. An audit in 1992 had indicated a high level of patient satisfaction with the procedure and subjective success rates similar to those in the published literature. However, in view of the dearth of long term data, and the recent suggestion that surgery for stress incontinence was less successful than had been previously reported 1, a long term follow up study was undertaken. METHODS The technique of the Aldridge sling procedure has been described previously 31. Vertical straps of the rectus sheath are taken through a Pfannensteil incision as shown in Fig. 1. The strips taken are approximately 1cm wide and 10cm long and are separated from the underlying rectus muscles, but left attached to the rectus sheath inferiorly.

2 328 Table 1. Summary of published literature of all studies with long term data of success of sling procedures. References Primary or Years of follow No. of women Method to assess success Success rate Timing of failure secondary up mean surgery (range) Total Long term follow up E. HAWKINS ET AL. Autologous fascia (rectus or fascia lata) McLaren % secondary 6.7 (to 16) for 5 or more years Not clear how success assessed 71% cured 3 of 13 failures more than 5 years after surgery Low % secondary Not stated for more Demonstration of 86% cured All failures in first six months (0.5 7) than 2 years incontinence with a full bladder McGuire & Lytton % secondary 2.3 (0.8 6) 52 Not stated Urodynamics Satisfactory result in 96% No information Zacharin All secondary Up to for more than 5 years Personal interview, telephone or letter 78% cured, 6% improved With more than 5 years follow up 66% cured McIndoe et al % secondary 6.3 (1 18) 51 Not stated No information 39 (76%) cured No information Beck et al All secondary Not stated (0.5 10) for more than 2 years Cough stress test 92% cured No failures in women after 2 years Blaivas & Jacobs Mostly secondary 3.5 (1 8) 65 Not stated Chart review and telephone or mail standardised questionnaire 82% dry, 9% occasional incontinence No information Chaikin et al % secondary 3.1 (1 15) for more than 5 years Hassouna & Ghoniem ISD* 3.4 (0.5 8) for at least 3 years Morgan et al % ISD* 4.3 (2 5.8) followed for 5 years No urinary leakage on validated questionnaire, pad test and voiding diary Validated questionnaire Mailed urogenital distress inventory short form 73% cured, 19% improved Survival curve shows decline in success to 5 years 78% cured or improved 49% dry all the time 217 (88%) cured (includes women having further surgery) 82% improved with less than 3 years follow up 75% with more than 3 years Survival curve shows decline in success. 85% cure at 5 years Vaginal wall Viljoen % secondary Not stated for 5 years No information 95% cure No information (1.2 13) Litwiller et al % secondary 2.6 ( ) 42 Not stated Chart review and independent telephone interview 62% satisfied with their incontinence status No information Kaplan et al % ISD* 3.3 (1 6.4) followed more than 5 years Lyodura Iosif Primary Not stated (3 11) 61 Not stated Patient asserts no urine leakage and no leakage on cough test Interviewed by a third party 93% dry at 12 months Survival curve shows decline in success 92% cured Most recurrences within first 6 months

3 Polypropylene (Marlex) Bryans All secondary Not stated for more Unvalidated questionnaire 79% cured or improved 3 failures after 2 years (0.5 8) than 4 years Morgan et al % secondary Not stated 189 All over 5 yrs Interviewed, personally or 85% success No information (5 17) by telephone or letter Drutz et al Mostly secondary 2 ( ) 64 Not stated Urodynamics 95% cured stress incontinence, No information but 25% had urge incontinence Morgan et al Mostly secondary 4.1 (0.1 7) for 6.6 years Telephone questionnaire 85% cured, 9% improved 3 failures after 2 years Amaye-Obu & Drutz All secondary 2.5 (1 12) 92 Not stated Chart review, urodynamics & pad tests 67% subjective and objective cured Survival curve shows decline in success to 6 years Polytetrafluoroethylene (Gore-tex and Teflon) Goldman Mostly secondary Not stated 98 Not stated No information 82% cured No information (0.2 7) Weinberger & Ostergard % secondary 3.2 (1 6.25) for over Telephone interview 73% reported cure No information 5 years and urodynamics 61% cured on urodynamics Yamada et al Not stated Not stated (2 8.3) for over 5 years Questionnaires, validation unclear 84% cured, 10% improved No recurrence after 40 months Choe & Staskin % secondary 4.3 (2.3 7) 90 Not stated Questionnaires, no information on validation 89% cured stress incontinence, 17% had urge incontinence No information Silastic Brieger & Korda Not stated Not stated (1 8) Chin & Stanton % secondary Not stated (0.3 5) 47 Not stated Interviewed 70% success No information for 5 years Clinical assessment and pad test Urodynamics at 3 months 81% subjective cure, 69% objective cure (3 months) Survival curve shows decline in success to 3 years Polyethylene (Mersilene) Kersey % secondary Not stated (0.5 10) Iosif Primary Not stated (3 11) * Intrinsic sphincter deficiency for over 3 years 93 independently reviewed, 10 case note review 44 Not stated Patient asserts no urine leakage and no leakage on cough test 60% no longer incontinent No information 73% cured Most recurrences within first 6 months FOLLOW UP OF FASCIAL CRUCIATE SLING FOR GSI 329

4 330 E. HAWKINS ET AL. Fig. 1. Taking the strips of rectus fascia. Through a vaginal incision the bladder neck (identified by the presence of a urethral catheter with a 10ml balloon) is dissected out. In contrast to Aldridge, an anterior repair was only performed where there was significant anterior wall prolapse. The area lateral to the urethra is dissected out, and a finger passed into the cave of Retzius. Roberts forceps are passed into this space and used to penetrate the endopelvic fascia to pick up the fascial straps which are then passed either side of the bladder (Fig. 2). In the original Aldridge technique the straps are united in the midline, however, in this modification the straps are attached laterally and sutured together beneath the urethra as shown in Fig. 3 (hence it is termed the cruciate sling). The vaginal and abdominal incisions are closed and a suprapubic catheter is left in situ. All women had genuine stress incontinence proven by pre-operative urodynamic studies. A betidine vaginal suppository and metronidazole (1gPR) was given on the evening before surgery and 1.5g cefuroxime was given at induction and two doses of 750mg at eight and 16 hours post-operatively. On the fifth post-operative day the catheter was clamped and the woman encouraged to void spontaneously. When she was able to empty her bladder with residual urine of less than 100ml on two consecutive days the catheter was removed and she was allowed home. Women who were slow to void were discharged home with the catheter in situ, and taught to manage the catheter themselves, and then seen on a weekly basis until it was appropriate to remove the catheter. At the end of 1998 all women who had undergone a cruciate fascial sling between 1979 and 1996 were sent a questionnaire, which included a pre-validated symptom severity score 32. In addition the questionnaire asked the women to compare their current bladder problems with how they think they were before surgery (graded as cured, much better, a little better, not changed and worse). They were asked if they had had further surgery for bladder or prolapse problems (if so, when and where), whether they have to catheterise themselves and, if not, if they had any trouble emptying their bladder. Those women who felt that their surgery had failed were asked to indicate how long they thought it had worked for. Non-responders were sent a second questionnaire. Open-ended questions invited the women to comment on whether they experienced complications and to make further comments. Operative details for 103 women treated between 1979 and 1992 was obtained from data collected at the time of the previous audit study. Details for the later women were obtained by reviewing the case records. Urodynamics had been performed pre-operatively in all women; however, at the time of the original audit the results had been inconsistently recorded. We were unable to obtain these notes again, thus urodynamic data was not collected from the later women.

5 FOLLOW UP OF FASCIAL CRUCIATE SLING FOR GSI 331 Fig. 2. Passing the strips of fascia beneath the pubic symphysis. To attempt to determine factors associated with success, outcome was dichotomised into success where the woman said that her symptoms were cured, or much improved, and failure where the woman felt that her symptoms were slightly improved, the same or worse. In addition, the symptom severity index was calculated as previously described 32. Results were analysed using SPSS Version 9 for Windows. Kaplan Meier curves were used to compare the success between women who had previous surgery and those in whom the sling was a primary operation. Multiple regression was used to determine the factors affecting incontinence score. RESULTS Over this time period there were 246 sling procedures performed in women with genuine stress incontinence. Questionnaires were returned from 198 women, giving an 80% response rate. Of the 48 non-responders nine questionnaires were returned as address unknown, five were

6 332 E. HAWKINS ET AL. Fig. 3. The sling in place. deceased and four were returned as blank forms. Follow up was from two to 18 years, median six years. There were 20 women for whom the old notes could not be traced and so there was no information on previous surgery, or intraoperative complications. Of the others, significant haemorrhage requiring blood transfusion occurred in seven women (4%), six women developed a wound infection (3%), bladder perforation complicated the procedure in three women (who all remain cured), and two women required a post-operative sling release to enable them to void (both cured with no long term voiding problem). The characteristics of the women are shown in Table 2. Overall 155 (78%) felt that they were cured or much improved. Table 3 summarises the symptom severity score as compared with the woman s impression of the degree of improvement. Despite considering themselves improved, 13 women continued to have moderate or severe symptoms of stress incontinence. These women were also considered as failures giving an overall success rate of 72%.

7 FOLLOW UP OF FASCIAL CRUCIATE SLING FOR GSI 333 Table 2. Details of women in study. n ¼ 198. Mean (%) [Range] Age at time of surgery (years) 51.3 [36 75] Weight at time of follow up (kg) 69 [44 130] BMI at time of follow up (kg/m 2 ) 26 [18 49] Secondary surgery 46* (26) Primary surgery 132* (74) No. on HRT at time of follow up 85 (43) Concomitant surgery Abdominal hysterectomy 6 (3) Vaginal hysterectomy with or without repair 21 (11) Posterior repair 2 (1) Incisional hernia repair 1 (0.5) * Data missing on 20 women. There were 132 women who had the sling performed as primary surgery for their stress incontinence, of whom 97 were cured or improved (74%, 95% CI 70% 81%). Of the 46 women who had had previous surgery, 31 were cured or improved (67%, 95% CI 54% 81%). The approximate duration of success is shown in Fig. 4; the timing of failure was estimated as the minimum duration of success, from the women s response to the question on how long their operation had worked for. Thus, where the woman thought the operation had worked for five to 10 years, it was counted as a failure at five years. One hundred and three women were followed up for six years or more, amongst this group the operation had failed in 29, of whom 16 thought it had lasted between five and 10 years. Using multiple regression there was no relationship between symptom severity score and age at the time of surgery, duration of follow up, current weight or body mass index, previous surgery for stress incontinence or concomitant surgery. Three women need to perform intermittent self-catheterisation, of the others the duration of catheterisation ranged from five days to six weeks, with a median of eight days. Overall, 127 women (66%) report never having any problems emptying their bladder while 18 women (9%) often or always find it difficult to empty their bladder. Urgency symptoms were common with 42 women responding that they often or always leaked urine when they could not get to the toilet on time and 40 women noting that they could hold on for less than two minutes when they had an urge to urinate. In total 57 women (29%) suffered from one or other symptom of urgency. Of these women, only 20 (35%) were improved as compared with 122 of the 141 women (87%) without symptoms of urgency, a highly significant difference ( P < on Fisher s exact test). When asked if they had any complications from the operation, 22 women suffered from abdominal pain that they attributed to the surgery, eight women suffered from recurrent urinary tract infections, six women complained of a loss of abdominal tone and nine women had an incisional hernia. One of these women felt that her quality of life was made worse following the operation despite being cured of her incontinence. Eight women have had subsequent prolapse or incontinence surgery. One woman, considering herself slightly improved with a symptom severity score of five, has had macroplastique injections, and one women, counted as unchanged and not completing a symptom severity score, had a colposuspension two years after her sling procedure. The other six women have had posterior repairs. DISCUSSION This study demonstrates that it is possible to obtain useful information about the long term effectiveness of stress incontinence surgery within a District General Hospital. The main difficulties encountered were in obtaining the hospital notes, which resulted in some loss of data. Our results are disappointing compared with other studies that have reported cure of stress incontinence in over 90% of women using sling procedures 6,9,31, However, all these studies report on both shorter follow up and use non-validated methods of assessing subjective improvement. For a number of these authors women are considered cured even if they suffer continuing incontinence, as long as that incontinence is due to detrusor instability 6,36 39.In Table 3. Comparison of responses to how do you think your bladder symptoms are compared with before the operation with symptom severity score. Symptom severity score Total n (%) 0: Cure 1 4: Mild : Moderate : Severe Woman s perception of current symptoms compared with preoperative Cure (41) Much better (38) Little better (15) No change (4) Worse (2) Total: n (%) 62 (31) 70 (36) 24 (12) 24 (12) 15 (8) 2 (1) 197

8 334 E. HAWKINS ET AL. Fig. 4. Long-term outcome of the sling procedure, comparing women in whom the sling was their first operation for stress incontinence and women having the sling as a secondary procedure. our study urgency was strongly associated with failure of the operation. However, as we were unable to obtain the pre-operative urodynamic data and post-operative urodynamics were not feasible we cannot know how many of these women had new or persistent detrusor instability. Other authors have noted that new and persistent urge incontinence due to detrusor instability is the most commonly quoted reason for failure of surgery in the literature 46, and accounts for a significant percentage of dissatisfaction with the results of surgery 44. In selecting the tool to determine outcome of surgery we elected to use a previous validated questionnaire that provided information on the woman s perception of her symptoms and a measure of their severity. Although the International Continence Society recommends a three-day voiding diary we were concerned that requesting women to complete it would be intrusive and result in a reduction in the response rate. They also recommend using the domains of clinician s observations, quality of life and socioeconomic measures as outcome measures for research in women with lower urinary tract symptoms 47. However, in the domain of clinicians observations there are no tests that have proven adequate reproducibility. We felt that the constructs of quality of life and socio-economic costs are affected by lifestyle and so both pre and post-operative data would be required to draw meaningful conclusions. It is apparent from Table 1 that no other researchers have been able to measure across all the domains. Most authors consider the woman s opinion of the surgery and quote a subjective cure rate. However, the methods used to assess this are variable, with some reports giving no information 4,8,14,23,34,48 52, while others use chart review 43,53, patient interviews or questionnaires that have not been validated 7,10,15,16,18,19,21,25 27,29,33,37 39,54,55. Some authors feel that subjective cure is unimportant and report only objective cure as assessed by one-hour pad test 56, urodynamics 6,20,35,41,57 59, or provocative testing with varying amounts in the bladder 5,9,17,40. Where both subjective and objective testing are reported the objective cure rate is usually less than the subjective, but this may be due to the use of non-validated methods of subjective assessment 22,24,28,44,60,61. Haab et al. 62 developed a questionnaire that has been used to assess the results of surgery by other authors 11,12. Although test retest reliability and face validity were assessed, there was only a limited assessment of internal consistency. Re-examining a subgroup of women from a study that reported a 92% success rate from fascial sling procedures using this questionnaires 11,62, the authors found that the use of voiding diaries and chart review resulted in a lower success rate than the questionnaire 63,64. Other authors have used questionnaires where the validation has been incomplete 13,65,66 ; questions pertaining to stress incontinence had low internal consistency 65. In contrast, Black et al. 32 developed the questionnaire in this study from a review of other questionnaires,

9 FOLLOW UP OF FASCIAL CRUCIATE SLING FOR GSI 335 observation of outpatients and detailed interview studies. It was piloted, and tested for test retest reliability, internal consistency, convergent and discriminant validity. Both the King s group and the Bristol group have produced questionnaires that have undergone similar rigorous validation 67,68. The King s questionnaire focuses on quality of life issues rather than symptom severity 68, and as discussed above, would not give meaningful information in the absence of pre-operative data. The Bristol questionnaire includes both a symptom severity section and a quality of life section 67. The symptom severity section is five pages long, and comprises 20 questions, 16 of which are sub-divided into two sections. As we needed to ask additional questions to clarify how successful the woman thought the operation was and to obtain information on height and weight that was not in the notes, we felt that the questionnaire would become excessively long, with a possible reduction in response rate. In addition, the Black questionnaire had been used to assess the outcome of surgery for stress incontinence in the North Thames region, providing some data with which our results could be compared 1. The results of that study were disappointing in comparison with the literature, as only 28% of women reported themselves completely dry 12 months after surgery. With 31% of our women completely dry, our results compare favourably, however, direct comparisons are impossible, as we had no pre-operative data on the severity of symptoms. In our study, detailed breakdown of the responses from this questionnaire demonstrate that a significant proportion of women who claim to be cured still have some symptoms (albeit these are usually mild), and some women claim to be only much improved despite not admitting to any symptoms. Interestingly, women who claim to be only a little bit improved suffer similar symptoms to those women who are the same or worse following surgery. Women s retrospective recall of time of failure may not be reliable 62, thus there is some inaccuracy in the survival curves. Nonetheless, it is apparent that the operation has good durability, although inevitably there will be some failures with long term follow up. Unlike the colposuspension 69 there is little difference between the success rate in women in whom the sling procedure is their first operation for incontinence and those who have had previous failed surgery, although this may be due to small numbers. Thus, this study refutes the suggestion that inherent connective tissue weakness in women with stress incontinence compromises the long term results of sling surgery using the rectus sheath 3. A major disadvantage with the use of rectus fascia is the need for a Pfanensteil incision, and the long term problems of wound pain and herniation due to the fascial defect. Synthetic materials cause problems with erosion 26,41,57,70, granulation tissue formation 17,71, and vesicovaginal fistulae 29. Cadaveric fascia has been proposed as a suitable alternative, with short term results suggesting a satisfactory outcome 43,60,72. However, in one study, eight of 32 women required re-operation for recurrent incontinence and in seven of these there was histological evidence of degeneration of the allograft 73. In contrast, in five women requiring revision of a rectus fascial sling there was no evidence of degeneration, even four years after placement 74. Although animal experiments suggest that there is little difference in viability between free and pedicled rectus fascia 75, we preferred to use pedicled strips as it obviates the need to attach the sheath at the abdominal end. We were unable to find any factors that correlated with long term failure. Other authors have noted an increased failure rate of stress incontinence surgery in women who were overweight 27. In our study, although there was no difference in the success rate between normal or overweight women and obese (with a body mass index over 30), there were wide confidence intervals. Thus the odds ratio for success of surgery in normal or overweight women compared with obese women (body mass index over 30) was 1.05 (95% CI ). Only one woman had a body mass index over 45 (morbidly obese) and she was improved. Voiding symptoms are common after any anti-incontinence procedure. Reported rates vary widely in the literature from 3% 32% for colposuspension and 2% 37% for sling procedures 2. Such an enormous variability reflects the difficulty in assessing voiding difficulties in women. Although our rates of significant voiding problems were low, more than 40% of women will have at least an occasional problem in emptying her bladder. CONCLUSION This study shows that the cruciate sling procedure, using the woman s own rectus fascia, provides an effective long term treatment for women with stress incontinence. Fears of high failure rates due to the inherent weakness of connective tissue in these women are unfounded. There were no factors that correlated with long term failure, but this may have been due to small numbers. References 1. Black N, Griffiths J, Pope C, Bowling A, Abel P. Impact of surgery for stress incontinence on morbidity: cohort study. BMJ 1997;315: Jarvis GJ. Surgery for genuine stress incontinence. Br J Obstet Gynaecol 1994;101: Bidmead J, Cardozo L. Sling techniques in the treatment of genuine stress incontinence. Br J Obstet Gynaecol 2000;107: McLaren HC. Late results from sling operations. J Obstet Gynaecol Br Cmnwlth 1968;75: Low JA. Management of severe anatomic deficiencies of urethral

10 336 E. HAWKINS ET AL. sphincter function by a combined procedure with a fascia lata sling. Am J Obstet Gynecol 1969;105: McGuire E, Lytton B. Pubovaginal sling procedures for genuine stress incontinence. J Urol 1978;119: Zacharin RF. Abdominoperineal urethral suspension in the management of recurrent stress incontinence of urine. Obstet Gynecol 1983; 62: McIndoe GA, Jones RW, Grieve BW. The Aldridge sling procedure in the treatment of urinary stress incontinence. Aust N Z J Obstet Gynaecol 1987;27: Beck RP, McCormick S, Nordstrom L. The fascia lata sling procedure for treating recurrent stress incontinence. Obstet Gynecol 1988; 72: Blaivas JG, Jacobs BZ. Pubovaginal fascial sling for the treatment of complicated stress urinary incontinence. J Urol 1991;145: Chaikin DC, Rosenthal J, Blaivas JC. Pubovaginal fascial sling for all types of stress urinary incontinence: long term analysis. J Urol 1998; 160: Hassouna ME, Ghoniem GM. Long-term outcome and quality of life after modified pubovaginal sling for intrinsic sphincteric deficiency. Urology 1999;53: Morgan Jr TO, Westney OL, McGuire EJ. Pubovaginal sling: 4-year outcome analysis and quality of life assessment. J Urol 2000;163: Viljoen AC. The vaginal strips sling operation. An alternative procedure for urinary incontinence. S Afr Med J 1990;77: Litwiller SE, Nelson RS, Fone PD, Kim KB, Stone AR. Vaginal wall sling: long-term outcome analysis of factors contributing to patients satisfaction and surgical success. J Urol 1997;157: Kaplan SA, Te AE, Young GPH, Andrade A, Cabelin MA, Ikeguchi EF. Prospective analysis of 373 consecutive women with stress urinary incontinence treated with a vaginal wall sling: the Columbia Cornell university experience. J Urol 2000;164: Iosif CS. Sling operation for urinary incontinence. Acta Obstet Gynecol Scand 1985;64: Bryans FE. Marlex gauze hammock sling operation with Cooper s ligament attachment in the management of recurrent stress urinary incontinence. Am J Obstet Gynecol 1979;133: Morgan J, Farrow G, Stewart F. The Marlex sling operation for the treatment of recurrent stress incontinence: a sixteen year review. Am J Obstet Gynecol 1985;151: Drutz HP, Buckspan M, Flax S, Mackie L. Clinical and urodynamic re-evaluation of combined abdomino-vaginal Marlex sling operation for recurrent stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 1990;1: Morgan JE, Heritz DM, Stewart FE, Connolly JC, Farrow GA. The polypropylene pubovaginal sling for the treatment of recurrent stress urinary incontinence. J Urol 1995;154: Amaye-Obu FA, Drutz HP. Surgical management of recurrent stress urinary incontinence: A 12-year experience. Am J Obstet Gynecol 1999;181: Goldman JA, Eckerling B, Ovadia J. Modified sling operation for stress urinary incontinence. Ten-year experience. Int Surg 1973;58: Weinberger MW, Ostergard DR. Long-term clinical and urodynamic evaluation of the polytetrafluoroethylene suburethral sling for treatment of genuine stress incontinence. Obstet Gynecol 1995;86: Yamada T, Arai G, Masuda H, Tsukamoto T. The correction of type 2 stress incontinence with a polytetrafluoroethylene patch sling: 5-year mean follow up. J Urol 1998;160: Choe JM, Staskin DR. Gore-Tex patch sling: 7 years later. Urology 1999;54: Brieger G, Korda A. The effect of obesity on the outcome of successful surgery for genuine stress incontinence. Aust NZ J Obstet Gynaecol 1992;32: Chin YK, Stanton SL. A follow up of silastic sling for genuine stress incontinence. Br J Obstet Gynaecol 1995;102: Kersey J. The gauze hammock sling operation in the treatment of stress incontinence. Br J Obstet Gynaecol 1983;90: McGuire EJ, O Connell HE. Surgical treatment of intrinsic urethral dysfunction. Slings. Urol Clin North Am 1995;22: Aldridge AH. Transplantation of fascia for the relief of urinary incontinence. Am J Obstet Gynecol 1942;44: Black N, Griffiths J, Pope C. Development of a symptom severity index and a symptom impact index for stress incontinence in women. Neurourol Urodyn 1996;15: Zaragoza MR. Expanded indications for the pubovaginal sling: treatment of type 2 or 3 stress incontinence. J Urol 1996;156: Kaufman JM. Fascial sling for stress urinary incontinence. South Med J 1982;75: Kuo HC. Videourodynamic results after pubovaginal sling procedure for stress urinary incontinence. Urology 1999;54: Cross CA, Cespedes RD, McGuire EJ. Our experience with pubovaginal slings in patients with stress urinary incontinence. J Urol 1998; 159: Kaplan SA, Santarosa RP, Te AE. Comparison of fascial and vaginal wall slings in the management of intrinsic sphincter deficiency. Urology 1996;47: Mason CR, Roach M. Modified pubovaginal sling for treatment of intrinsic sphincter deficiency. J Urol 1997;156: Carr LK, Walsh PJ, Abraham VE, Webster GD. Favorable outcome of pubovaginal slings for geriatric women with stress incontinence. J Urol 1997;157: Enzelsberger H, Helmer H, Schatten C. Comparison of Burch and lyodura sling procedures for repair of unsuccessful incontinence surgery. Obstet Gynecol 1996;88: Young SB, Rosenblatt PL, Pingeton DM, Howard A, Baker SO. The Mersilene mesh suburethral sling: a clinical and urodynamic evaluation. Am J Obstet Gynecol 1995;173: Henriksson L, Ulmsten U. A urodynamic evaluation of the effects of abdominal urethrocystopexy and vaginal sling urethroplasty in women with stress incontinence. Am J Obstet Gynecol 1978;131: Wright EJ, Iselin CE, Carr LK, Webster GD. Pubovaginal sling using cadaveric allograft fascia for the treatment of intrinsic sphincter deficiency. J Urol 1998;160: Fulford SC, Flynn R, Barrington J, Appanna T, Stephenson TP. An assessment of the surgical outcome and urodynamic effects of the pubovaginal sling for stress incontinence and the associated urge syndrome. J Urol 1999;162: Golomb J, Shenfeld O, Shelhav A, Ramon J. Suspended pubovaginal fascial sling for the correction of complicated stress urinary incontinence. Eur Urol 1997;32: Beck RP, Lai AR. Results in treating 88 cases of recurrent urinary stress incontinence with the Oxford fascia lata sling procedure. Am J Obstet Gynecol 1982;142: Lose G, Fantl JA, Victor A, et al. Outcome measures for research in adult women with symptoms of lower urinary tract dysfunction. Neurourol Urodyn 1998;17: Parker TR, Addison AA, Wilson J. Fascia lata urethrovesical suspension for recurrent stress urinary incontinence. Am J Obstet Gynecol 1979;135: Ghoniem GM. Modified rectus fascial suburethral sling. Tech Urol 1996;2: Ridley JH. Appraisal of the Goebell Frangenheim Stoeckel sling procedure. Am J Obstet Gynecol 1966;95: Moir JC. The gauze hammock operation (A modified Aldridge sling procedure). J Obstet Gynaecol Br Cmnwlth 1968;75: McLennan MT, Melick CF, Bent AE. Clinical and urodynamic predictors of delayed voiding after fascia lata suburethral sling. Obstet Gynecol 1998;92: McLennan MT, Bent AE. Fascia lata suburethral sling vs. Burch retropubic urethropexy. A comparison of morbidity. J Reprod Med 1998; 43: Govier FE, Gibbons RP, Correa RJ, Weissman RM, Pritchett TR,

11 FOLLOW UP OF FASCIAL CRUCIATE SLING FOR GSI 337 Hefty TR. Pubovaginal slings using fascia lata for the treatment of intrinsic sphincter deficiency. J Urol 1997;157: Breen JM, Geer BE, May GE. The fascia lata suburethral sling for treating recurrent urinary stress incontinence. Am J Obstet Gynecol 1997;177: Richmond DH, Sutherst JR. Burch colposuspension or sling for stress incontinence? A prospective study using transrectal ultrasound. Br J Urol 1989;64: Barbalias G, Liatsikos E, Barbalias D. Use of slings made of indigenous and allogenic material (Goretex) in type III urinary incontinence and comparison between them. Eur Urol 1997;31: Jarvis GJ, Fowlie A. Clinical and urodynamic assessment of the procine dermis bladder sling in the treament of genuine stress incontinence. Br J Obstet Gynaecol 1985;92: Barbalias GA, Liatsikos EN, Athanasopoulos A. Gore-Tex sling urethral suspension in type III female urinary incontinence: clinical results and urodynamic changes. Int Urogynecol J Pelvic Floor Dysfunct 1997;8: Handa VL, Jensen JK, Germain MM, Ostergard DR. Banked human fascia lata for the suburethral sling procedure: a preliminary report. Obstet Gynecol 1996;88: Sand PK, Winkler H, Blackhurst DW, Culligan PJ. A prospective randomized study comparing modified Burch retropubic urethropexy and suburethral sling for treatment of genuine stress incontinence with low-pressure urethra. Am J Obstet Gynecol 2000;182: Haab F, Trockman BA, Zimmern PE, Leach GE. Results of pubovaginal sling for the treatment of intrinsic sphincteric deficiency determined by questionnaire analysis. J Urol 1997;158: Chaikin DC, Blaivas JG, Rosenthal JE, Weiss JP. Results of pubovaginal sling for stress incontinence: a prospective comparison of 4 instruments for outcome analysis. J Urol 1999;162: Groutz A, Blaivas JG, Rosenthal JE. A simplified urinary incontinence score for the evaluation of treatment outcomes. Neurourol Urodyn 2000;19: Shumaker SA, Wyman JF, Uebersax JS, McClish D, Fantl JA. Health-related quality of life measures for women with urinary incontinence: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program in Women (CPW) Research Group. Qual Life Res 1994;3: Continence Program for Women Research Group, Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl A. Short Forms to Assess Life Quality and Symptom Distress for Urinary Incontinence in Women: The Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Neurourol Urodyn 1995;14: Jackson S, Donovan I, Brookes S, Eckford S, Swithinbank L, Abrams P. The Bristol Female Lower Urinary Tract Symptoms questionnaire: development and pschometric testing. Br J Urol 1996; 77: Kelleher CJ, Cardozo LD, Khullar V, Salvatore S. A new questionnaire to assess the quality of life of urinary incontinent women. Br J Obstet Gynaecol 1997;104: Alcalaly M, Monga A, Stanton SL. Burch colposuspension: a year follow up. Br J Obstet Gynaecol 1995;102: Myers DL, LaSala CA. Conservative surgical management of Mersilene mesh suburethral sling erosion. Am J Obstet Gynecol 1998;179: Bent AE, Ostergard DR, Zwick-Zaffuto M. Tissue reaction to expanded polytetrafluoroethylene suburethral sling for urinary incontinence: clinical and histologic study. Am J Obstet Gynecol 1993;169: Brown SL, Govier FE. Cadaveric versus autologous fascia lata for the pubovaginal sling: surgical outcome and patient satisfaction. J Urol 2000;164: Fitzgerald MP, Mollenhauer J, Brubaker L. Failure of allograft suburethral slings. BJU Int 1999;84: Fitzgerald MP, Mollenhauer J, Brubaker L. The fate of rectus fascia suburethral slings. Am J Obstet Gynecol 2000;183: Fokaefs ED, Lampel A, Hohenfellner M, Lazica M, Thuroff JW. Experimental evaluation of free versus pedicled fascial flaps for sling surgery of urinary stress incontinence. J Urol 1997;157: Appendix For each of the questions below please tick the most appropriate box: 1. Since you had your bladder sling operation at Peterborough District Hospital, have you had any other operations for bladder problems or for a prolapse? Yes [ ] (go to 1a) No [ ] (go to question 2) (a) Approximately how long ago was the operation? (b) What sort of operation was it? (c) Where did you have it done? These questions ask about your bladder symptoms over the last year. 2. How do you think your bladder problems are (as compared with before the operation)? [ ] Cured [ ] Much better [ ] A little better [ ] Not changed [ ] Worse 3. How long do you think the operation worked (i.e. for how long do you think your bladder symptoms were better for)? [ ] It is still working [ ] It worked at least ten years. [ ] It worked at least five years, but not as long as ten [ ] It worked at least three years, but not as long as five years [ ] It worked at least a year, but not as long as three years [ ] It worked at first, but the bladder problem returned within a year [ ] It never worked 4. How often do you leak urine? [ ] Never [ ] Once a month [ ] 2 4 times a month [ ] Once a week [ ] 2 4 times a week

12 338 E. HAWKINS ET AL. [ ] Once a day [ ] More than once a day How many times per day? 5. How would you describe the amount of urine you usually leak? [ ] Not applicable/no leakage [ ] Damp/a few drops [ ] Wet/a small amount [ ] Quite wet/cupful (i.e. soaks a pad/sanitary towel) [ ] Very wet/floods 6. How many pads or sanitary towels do you use? None or more a week a week a day a day a day [] [] [] [] [] [] 7. Do you ever wet or leak on...? No Yes Coughing [ ] [ ] Sneezing [ ] [ ] Laughing [ ] [ ] Getting out of bed [ ] [ ] Climbing steps or stairs [ ] [ ] Not applicable Lifting something [] [] [] (like heavy shopping bags) Physical activity [] [] [] (like rushing to catch a bus) Keeping fit/sports activity [ ] [ ] [ ] Sexual intercourse [ ] [ ] [ ] 8. Do you ever leak urine when you can t get to the toilet on time? [ ] Never [ ] Occasionally [ ] Often [ ] All the time 9. When you feel the need to urinate, how long can you usually hold on? [ ] Not at all [ ] Less than 2 minutes [ ] Between 2 and 5 minutes [ ] Between 6 and 10 minutes [ ] More than 10 minutes 10. In the past week how often have you leaked urine? Not at all A few About half Most of the Always times of the time time [] [] [] [] [] 11. Do you have to catheterise yourself? []No [ ] Occasionally (twice a week or less often) [ ] Sometimes (not every day, but more than twice a week) [ ] Most times (once or twice a day) [ ] All the time (more than twice a day) [ ] I have a permanent catheter 12. If you don t catheterise yourself, do you have any trouble emptying your bladder? []No [ ] Occasionally [ ] Sometimes [ ] Often [ ] All the time 13. Have you had any problems from the operation? Yes [ ] No [ ] Please specify: 14. How much has the operation changed your life: [ ] Much worse [ ] A little bit worse [ ] It hasn t made much difference [ ] It has improved a bit [ ] It has improved a lot Finally a few questions about yourself: 15. Do you take any hormone replacement therapy (HRT)? [ ] Yes []No [ ] Not sure 16. How much do you weigh? 17. How tall are you? 18. What is your date of birth? 19. Do you have any comments: Thank you very much for your time in completing this questionnaire. Please check that you have answered all the questions and return it in the envelope provided. Accepted 12 November 2001