0022-5347/98/1603-0756$03.00/0 THE JOCRY.U. of URoLocy Copyright 0 1998 by AXEHICAY UROLOGIC.~ ASSOCIATIOX INC
Vol. 160. 756-758, September 1998 Priated 117 U.S.A.
THE STAMEY AND GITTES PROCEDURES: LONG-TERM FOLLOWUP IN RELATION TO INCONTINENCE TYPES AND PATIENT AGE ATSUO KONDO, KUMIKO KATO, MOMOKAZU GOTOH, MASAHIRO NARUSHIMA MASAHIKO SAITO
AND
From the Departments of Urology, Konlakl Shlmin Hospltal, Komakr and Nagoya Unruerstty Hospital, Nagoya, Japan
ABSTRACT
Purpose: W e report the long-term results of needle suspension of the bladder neck for stress incontinence. Materials and Methods: A total of 382 patients with stress incontinence underwent either the Stamey (group 1 , 3 4 2 women) o r Gittes procedure (group 2 , 4 0 ) in a nonrandomized trial. Surgical outcomes and patient satisfaction were assessed by questionnaires. Surgical outcomes were then analyzed in relation t o surgical procedures, McGuire incontinence types and patient age. Followup averaged 8.1 years for group 1 and 5.0 years for group 2. Results: Kaplan-Meier cumulative continence rates were 71.5% for the S t a m e y at 1 4 years and 37.0% for the Gittes at 6 years postoperatively (p
KEYWORDS:urinary incontinence, The Stamey procedure has been popular among urologists and gynecologists as it can be done less invasively compared to colposuspension and retropubic suspension.’ In 1987 Gittes and Loughlin modified the Stamey technique so that it could be performed on an outpatient basis.2 Although needle bladder neck suspension requires elevation of the bladder neck, this was not quantified until 1989 when we introduced spring scales to prevent overtightness or insufficient suspension.1,3,4 Our previous analysis of 394 incontinent women demonstrated a 7-year cumulative continence rate of 78% for the Stamey and a 3-year cumulative continence rate of 38% for the Gittes operation.5 In 1981 McGuire analyzed 648 incontinent women and found that more patients with type 111or intrinsic sphincter deficiency had undergone prior surgery compared to those who never had surgery.6 Few articles examined the efficacy of the Stamey technique in elderly women who were frail and suffered from possible age related weak detrusor c o n t r a ~ t i l i t y .We ~ . ~assess the long-term followup of the Stamey and Gittes procedures, and retrospectively evaluate these results as a function of McGuire incontinence types and patient age. PATIENTS AND METHODS
We treated 379 women with stress urinary incontinence with the Stamey operation between 1983 and 1993 (group l ) , and 44 patients with the Gittes operation between 1990 and 1995 (group 2). A questionnaire was mailed to all patients and long-term followup data were assessed in January 1997. Patients were asked about urinary continence, time of recurrence, urge urinary incontinence and patient satisfaction. Urinary continence was consistent with complete dryness or slight loss of urine only during strong physical exercises. The present analysis comprises 382 patients (90.3%)who replied Accepted for publication March 27, 1998
surgery, age factors
to the questionnaire, the majority of whom have been analyzed previously.5 Of the remaining 41 patients (9.7%) 27 were lost to followup, 8 died of unrelated diseases and 6 failed t o respond. Followup averaged 8.1 years (range 3.2 to 13.9) for group 1 and 5.0 years (range 1.2 to 6.8) for group 2. The elderly group, 65 years old or older, comprised 43 women (11%) and the adult group, younger than 64 years, comprised 339 (89%). Before and after operation patients were assessed by a modified 60-minute pad test9 and chain cystourethrography. Preoperatively a video urodynamic study was performed by infusing 30% contrast medium via an 8Fr 2 lumen catheter with the patient sitting. Urethral pressure profile was examined in 196 patients. Based on McGuire’s classification6 the type of stress incontinence was retrospectively evaluated by observing chain cystourethrograms and/or urethral pressure profiles without knowing surgical outcomes. Incontinence was type I in 120 patients (36%), type I1 in 151 (43%) and type I11 in 76 (21%). Classification was impossible in 35 patients. Patient characteristics are given in the table. The Stamey operation was performed using spring scales and calculating the length of a nylon loop in the majority of patients. Based on our clinical experience, the bladder neck was first elevated with 400 g. tension and its loop length was subsequently measured. If the length was shorter than 130 mm. or longer than 149 mm., it was adjusted to 130 or 149, respectively. The Gittes technique was performed by quantifying loop length into a range of 130 t o 149 mm. without adjusting loop t e n ~ i o n Unilateral .~ needle penetration was performed by the same surgeon (A. K.) in more than 90% of patients. Continence rate was assessed by Kaplan-Meier survival analysis with log rank statistical significance at p <0.05. Methods, definitions and units conform to the standards
756
757
NEEDLE BLADDER NECK SUSPENSION FOR STRESS INCONTINENCE Patient characteristics Stanley Procedure
No. pts. Mean pt. age (range) Mean body mass index (rangel hlean parity (range) No. hysterectorny/total No. ( % ) No. prior failed operatiodtotal No. (%I Mean gm./hr. 60-min. pad test (range) Mean nil. cystonietric capacity (range) No. stable bladder No. detrusor instability No. not tested Posterior urethrovesical angle degree, 170 pts. (range)
Gittes Procedure
342 51 5 (28-76) 24 (17-351 2 4 (0-8) 20/342 (6) 11/342 (3)
40 55 l(29-74) 24 ( 18-30 1 2 9 (1-8) 5/40 (131 4/40 110)
36 0 ( 0 4 4 0 5 0)’
29 5 ( 0 2-140 0)-
0 9 (0-33 617 349 i125-550)
0 5 (0-1917 372 (310-500)
297 20 25 173 1125-238)-
33 2 5 182 (149-231)’
90 (34-157)f 43 (10-100)
Cm. water max. urethral closure pressure, 196 pts. (range) Mean yrs. followup (range) 8.1 (3.2-13.9) Preoperative values. f Postoperative values immediately after surgery.
71 (33-1281~ 45 (26-63)
x -
:.l.l.IJJ.u...i
Tvoe
401
n
............I
: 73.9%
,151 m o
-7
--7
TypeD : 3 8 3 % t125mo
20
0
5
10
15
Years after Surgery
FIG. 2. Actuarial probability of recurrence of incontinence as function of 3 types of stress incontinence. Type I11 is significantly inferior to other 2 types (p <0.0001).
5.0 i1.2-6.8) ’00
lei,....
recommended by the International Continence Society, except when specifically noted.10 RESULTS
Cumulative continence rates for the 2 operations are illustrated in figure 1. The Stamey technique (71.5% at 13.8 years) was statistically superior (p <0.0001) to the Gittes operation (37.0% at 6.4 years). Figure 2 illustrates that the needle bladder neck suspension applied to type I11 incontinence (intrinsic sphincter deficiency) resulted in a significantly lower success rate (38.3% at 10.4 years) compared to type I (76.4% at 10.5 years) or I1 (73.9% at 12.6 years) (urethral hypermobility, p 0.05) (fig. 3). Immediately after surgery the amount of urine loss decreased and the posterior urethrovesical angle became narrower in both groups (see table, p <0.001). Questionnaires revealed that urge incontinence developed de novo in 12% of the women, disappeared zfter surgery in 1996, persisted in 22% and never existed in 47%, and that 45% of the patients were extremely satisfied, 34% satisfied, 16% not satisfied and 6% undefined with surgical results. Complications developed in 97 patients postoperatively (25%).Perioperative complica-
u me :
elderly 61.4% 1137 mo 1
40t 20
0
0
5
10
15
Years after Surgery
FIG. 3. Actuarial probability of recurrence of incontinence as function of patient age. Elderly did not differ significantly from adult group ( p >0.05).
tions comprised retention or difficulty in urination requiring clean intermittent catheterization for more than 2 weeks in 30 patients (8%), urge incontinence in 18 (5%), wound infection in 18, bladder tamponade in 12 and perivesical hematoma in 5. In 13 patients unilateral nylon suture was removed and 1 had a bladder stone 12 years later. DISCUSSION
Investigational methodologies and length of followup profoundly affect surgical outcomes.ll. l2 Our study demon100 strates that there was a continuous decline in success rate ...... compared to our previous analysis.5 Based on extensive meta-analyses, surgical outcomes for stress incontinence ..... have recently been reviewed. Jarvis reported that bladder Stamey : 71.5% (166mo. .......... neck suspension procedures had a n objective continence rate of 87% at a followup of 1year.l:’ Black and Downs observed that colposuspension was more effective and lasted longer than anterior colporrhaphy and needle operations.14 Leach et a1 found that retropubic suspension (84% of cureldry rates) and slings (83%) were more efficacious than transvaginal suspensions (67%) and anterior repairs (61%) for 4 years or more.15 These authors stated that they could not identify any surgical outcomes for type 111 incontinence, simply because recognition of intrinsic sphincter deficiency and urethral hypermobility is relatively new as a diagnostic entity, and there Years after Surgery is an urgent need for large, rigorous prospective studies. FIG. 1. Actuarial probability of recurrence of incontinence as function of surgical techniques. Stamey is superior to Gittes technique Although our patients underwent procedures on a nonrandomized basis and surgical outcomes were retrospectively (P ~0.0001).
2ot
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NEEDLE BLADDER NECK SUSPENSION FOR STRESS INCONTINENCE
assessed, those with intrinsic sphincter deficiency had extremely poor results (38.4%,fig. 2), which verifies the observation of McGuire.6 We believe that the quantifying procedure, advocated by Jarvis13 as an example of small technical refinements, must have had a role in satisfying 78% of our patients and in attaining a success rate of 71.5% with the Stamey procedure (fig. 1). However, its real value certainly must be assessed by a randomized control trial in the future. On the other hand, the Gittes operation resulted in a disappointing outcome for which a lack of firm buttress at the pubocervical fascia seemed to be responsible. Although urge incontinence developed de novo in 12% of the patients, this incidence is not as high as with sling operations, which had the propensity to cause flow obstruction, detrusor instability and urethral fistula.16 Griffith-Jones and Abrams recommended the Stamey procedure for elderly women with stress incontinence because of a high cure rate (82%), compatible with that obtained for younger age groups, and fewer side effects.7 Hilton and Mayne observed that the Stamey operation was more effective for women older than 65 years (77%)compared to those younger than 65 years (53%).s Since our results were not statistically different between the elderly and adult groups (fig. 31, we support the notion that elderly women without intrinsic sphincter deficiency be treated with the Stamey procedure. We conclude that the Stamey is superior to the Gittes procedure, needle suspension of the bladder neck is as effective in the elderly as in younger women and neither operation is recommended for type I11 incontinence because of unacceptably high failure rates. Drs. M. Ohmura and Y. Itoh retrospectively evaluated incontinence types of the 347 patients.
1. 2. 3. 4.
and Saito, M.: Quantifying thread tension is of clinical use in Stamey bladder neck suspension: analysis of clinical parameters. J . Urol., 141: 38, 1989. 5. Narushima, M. and Kondo. A,: Needle suspension of the bladder neck for stress urinary incontinence. Surgical results of 394 patients operated on with quantitative procedures. Jpn, J . Urol., 86: 1051, 1995. 6. McGuire, E. J.: Urodynamic findings in patients after failure of stress incontinence operations. h o g . Clin. Biol. Res., 78: 351, 1981. 7. Griffith-Jones, M. D. and Abrams, P. H.: The Stamey endoscopic bladder neck suspension in the elderly. Brit. J. Urol., 65: 170, 1990. 8. Hilton, P. and Mayne, C. J.: The Stamey endoscopic bladder neck
suspension: a clinical and urodynamic investigation, including actuarial follow-up over four years. Brit. J. Obst. Gynaec., 98: 1141, 1991. 9. Kondo, A., Ohmura, M., Itoh, Y. and Kato, K.: An auxiliary test
to supplement the 60-min pad-weighing test and the patient’s impression about the amount of urine loss. Int. Urogynecol. J., 2 22, 1991.
10. Abrams, P., Blaivas, J . G., Stanton, S. L. and Andersen, J. T.: Standardisation of terminology of lower urinary tract function. Neurourol. Urodyn., 7 403, 1988. 11. Spencer, J . R., OConor, V. J., Jr. and Schaeffer. A. J.: A comparison of endoscopic suspension of the vesical neck with SUprapubic vesicourethropexy for treatment of stress urinary incontinence. J . Urol., 1 3 7 411, 1987. 12. Trockman, B. A,, Leach, G. E., Hamilton, J., Sakamoto, M., Santiago, L. and Zimmern, P. E.: Modified Pereyra bladder neck suspension: 10-year mean follow-up using outcomes analysis in 125 patients. Brit. J. Urol., 154: 1841, 1995. 13. Jarvis, G. J.: Surgery for genuine stress incontinence. Brit. J. Obst. Gynaec., 101: 371, 1994. 14. Black, N. A. and Downs, S. H.: The effectiveness of surgery for stress incontinence in women: a systematic review. Brit. J . Urol., 7 8 497, 1996. 15. Leach. G. E., Dmochowski. R. R.. A ~ e l l .R. A,. Blaivas. J . G.. REFERENCES Hadey, H. R., Luber, K. M., Mostwin, J . L., ODonnell, P. D: and Roehrborn, C. G.: Female stress urinary incontinence Stamey, T. A.: Endoscopic suspension of the vesical neck for clinical guidelines panel summary report on surgical manageurinary incontinence. Surg., Gycec. & Obst., 1 3 6 547, 1973. ment of female stress urinary incontinence. J. Urol., 1 5 8 875, Gittes, R. F. and Loughlin, K. R.: No-incision pubovaginal sus1997. pension for stress incontinence. J. Urol., 138.568, 1987. Ashken, M. H., Abrams, P. H. and Lawrence, W. T.: Stamey 16. Weinberger, M. W. and Ostergard, D. R.: Long-term clinical and urodynamic evaluation of the polytetrafluoroethylene subureendoscopic bladder neck suspension for stress incontinence. Brit. J . Urol., 56: 629, 1984. thral sling for treatment of genuine stress incontinence. Obst. Kondo, A., Kato, K, Gotoh, M., Takaba, H., Tanaka, T., Kinjo, T. Gynec., 86: 92, 1995.