Is the role of Burch colposuspension fading away in this epoch for treating female urinary incontinence?

Transcription

1 Int Urogynecol J (2007) 18: DOI /s x ORIGINAL ARTICLE Is the role of Burch colposuspension fading away in this epoch for treating female urinary incontinence? SooCheen Ng & Yi-Torng Tee & Kwong-Pang Tsui & Gin-Den Chen Received: 14 September 2006 / Accepted: 4 November 2006 / Published online: 1 December 2006 # International Urogynecology Journal 2006 Abstract The role of Burch colposuspension as the primary surgical treatment of stress urinary incontinence has been challenged by less invasive new surgical methods. The aim of this study was to evaluate the long-term results of Burch colposuspension in terms of subjective self-reported outcomes. Between 1993 and 1997, 159 women who underwent Burch colposuspension as the first operation for treating urodynamic stress incontinence were recruited for this study. We recorded the findings of preoperative and postoperative urodynamic studies and early postoperative complications or adverse effects related to the operation. In 2005, after a median follow-up of 10 years, telephone interviews were carried out and 152 (95.5%) women responded. Two main questions were asked of these women to evaluate the overall impression of improvement after the operation. Eighty-four (55.3%) women were dry according to their subjective reports, 55 (36.2%) women had improved, and 13 (8.5%) women had failed after an 8- to 12-year follow-up. One hundred and twenty-five (82.2%) women were satisfied with the outcome of the operation and 27 (17.8%) women were not. Among these 27 women, 16 (59.2%) women complained of urinary frequency and 9 (33.3%) women complained of urinary urgency as the reasons for their dissatisfaction. Our long-term subjective outcomes revealed that Burch colposuspension is an S. Ng : Y.-T. Tee : G.-D. Chen (*) Department of Obstetrics and Gynecology, Chung Shan Medical University Hospital, 110, Section 1, Chien-Kuo N. Road, Taichung 40201, Taiwan gdchen@hotmail.com K.-P. Tsui Department of Obstetrics and Gynecology, Cheng Ching Hospital, Taichung, Taiwan effective alternative surgery for urodynamic proven stress incontinence. Keywords Burch colposuspension. Long-term subjective outcome. Urodynamic stress incontinence Introduction Burch colposuspension has been one of the most popular anti-incontinence operations since the 1980s due to the success rate of this procedure. It is considered by most to be an effective surgical procedure for treating female urodynamic-proven stress incontinence in the UK, with success rates of up to 90% reported by surgeons [1]. This procedure accentuated the pressure transmission ratio, most marked in the proximal urethra, and caused better transmission of the abdominal pressure to the urethra [2]. To achieve this goal, the following procedures are mandatory to determine the success of this operation: (1) suburethral support, (2) height of elevation of the bladder neck, and (3) stability of fixation of the proximal urethra [3]. Therefore, voiding difficulty, urinary retention, pelvic organ prolapse, and de novo detrusor instability (i.e., detrusor overactivity, new term approved by the International Continence Society, ICS, in 2002) occur as unexpected results of a urethral obstruction due to overcorrection of the anatomical defect of the anterior vaginal wall [4, 5]. The original Burch procedure has undergone modifications to minimize its complications while maintaining its efficacy [6]. However, the postoperative complications of Burch colposuspension such as voiding dysfunction (3 32%), de novo detrusor instability (3.4 18%), and pelvic organ prolapse (3 17%) are still unavoidable [5].

2 938 Int Urogynecol J (2007) 18: In the past decade, the trend for anti-incontinence surgery is toward a less invasive procedure. A number of new designs using less invasive mid-urethral vaginal tape procedures have challenged the status of the Burch colposuspension. The innovative, less invasive procedures have gained wide acceptance and also offer improved safety and shorter hospital stays while maintaining the efficacy of traditional surgery [7]. Meanwhile, these new surgical techniques seem to achieve improved results with lower morbidity and quicker recovery times than the conventional techniques [8]. Many of the newly developed procedures have been reported to have promising results, with a success rate of better than 90%, for treating female urinary incontinence [9 11]. In this new era, the current role of Burch colposuspension for the surgical treatment of female urinary incontinence needs further clarification. This article attempts to reevaluate the long-term results of Burch colposuspension in terms of subjective selfreported outcomes in our practice. We will discuss the future role of Burch colposuspension for the treatment of stress urinary incontinence in the current tides of less invasive surgical innovations. Materials and methods From July 1993 to June 1997, 159 women who underwent Burch colposuspension as the first operation for treating urodynamic-proven stress incontinence at Chung Shan Medical University Hospital were recruited for this study. We reviewed the hospital chart records for preoperative and postoperative urodynamic studies, early postoperative complications, or adverse effects related to this procedure. All postoperative urodynamic studies were performed between 3 to 9 months after the surgery. The objective outcomes were assessed with the results of a postoperative urodynamic study and a pad test recommended by ICS in 1988 [12] and was defined as dry (no urine leakage episodes) or failure. The subjective outcome of the operation was measured by the patients self-reports as successful, improved (>50% improvement in urine leakage episodes), or failure of treatment. The long-term subjective outcomes were assessed by a nursing coordinator who interviewed patients by telephone from February to May Regarding the patient s overall impression of the procedure, two main questions were asked of these women. For the patient s perception of the operation s outcome: Do you consider this operation to be: successful, improvement, or a failure? If you consider it a failure, when did it start to fail? For present satisfaction: Compare your present situation with that before the operation, do you feel satisfied with the outcome, and if not, when did your dissatisfaction begin and what are the symptoms that bother you? There were 152 (95.5%) women who responded to the telephone interview. One woman died 5 years after the operation due to cardiovascular disease and six women could not be reached due to migration. In this retrospective study, all Burch procedures and the concomitant pelvic operations were performed by the same operator (G.D.C). We modified the Burch operation by making a small incision (no more than 10 cm for Burch procedure) and sutured the paravaginal endopelvic fascia with two pairs of stitches (1-O Ethibond, Johnson & Johnson) along the bladder as described previously in detail by Sun et al. [13]. The first sutures were anchored aside the bladder neck with 1 cm between them on each side. The second sutures were anchored to the paravaginal endopelvic fascia along the bladder (with a distance of 1 to 1.5 cm between each suture). Each of the four sutures passed through the paravaginal fascia and was secured to the overlying Cooper s ligament. There were about 2 to 3 cm between these two pairs of sutures. The surgeon placed two fingers in the vagina to determine the proper depth of suture placement. The second stitches were fixed in order to elevate the paravaginal endopelvic fascia as high as possible to the Cooper s ligament. The first stitch at the level of the bladder neck was tied to stabilize the paravaginal fascia and to avoid further lifting of the bladder neck. A suprapubic catheter was inserted at the time of surgery. The suprapubic catheter was clamped 48 h after surgery and removed when post-micturition residuals were below 50 ml. All patients were asked to followup at the outpatient department 1 week after being discharged. Postoperative voiding difficulty was classified as the patient experiencing hesitancy to void, a weak stream, or a discontinuous flow with a peak flow rate (Qmax) of less than 12 ml/s or residual urine of more than 100 ml. Patients follow-ups were conducted postoperatively every 3 months for 1 year to assess the success rate of the operation. Any lower urinary tract symptoms that presented after surgery were recorded in the charts. Delayed voiding difficulty was noted if the patient complained of voiding difficulty at the time of the postoperative follow-up. SPSS software (version 10.0, SPSS, Chicago, IL) was used for data analysis. Student s t test was used to compare continuous data between groups. Chi-square test was used to compare nominal data between groups. The Wilcoxon sign-rank test was used to compare preoperative and postoperative nonparametric variables. Kalpan Meier analysis was used to demonstrate the operative outcomes and self-reported satisfaction. A P value less than 0.05 was considered to be a statistically significant difference.

3 Int Urogynecol J (2007) 18: Results The mean age of our relevant patients was 45.6±9.3 years (range years) at the time of operation. The mean body mass index was 24.8±3.4 kg/m 2. Median of parity was 3 (range 1 11). All patients had a history of vaginal deliveries. The patient s characteristics and their concomitant operations are shown in Table 1. The preoperative pad test for urinary leakage, recommended by ICS (1988), was 42.4±28.8 g (n=152). In total, 97.3% (148/152) of the patients had a postoperative urodynamic study between 3 to 9 months postoperatively. One hundred thirty-one (88.5%) of the 148 women were dry on the postoperative pad test. There was a significant difference in the mean preoperative and mean postoperative urine leakage measures by pad test (44.6± 28.4 g vs 10.9±9.8 g; p<0.05, n=19). No leakage was seen on the stress test with maximal cystometric capacity during urodynamic following up in 96.6% (143/148) of the women. Urodynamic studies revealed that 33 (22.3%, N= 148) patients had de novo detrusor overactivity. Ten (6.6%) patients developed postoperative voiding difficulty, including five patients with a post void residual urine volume of greater than 100 ml and five patients with a peak flow rate (Qmax) of less than 12 ml/s. Fifteen (9.9%) patients complained of inguinal pain after the operation (postcolposuspension syndrome). The median hospital stay was 8 days (range 4 22). The median postoperative bladder training time was 4 days (range 2 11). The preoperative and postoperative urodynamic parameters of our patients are shown in Table 2. Table 1 Characteristics of study subjects Parameters Number of cases Table 2 The preoperative and postoperative urodynamic parameters (n=148) Parameter Preoperative Postoperative Exercise pad test (g) 44.6±28.4* 10.4±9.8* (n=19) Residual urine (ml) 18.5± ±32.8 Peak flow rate (ml/s) 28.9±20.2* 20.7±6.5* First desire to void (ml) 138±24.3* 131.1±27.4* Maximum capacity (ml) 313.5±49.6* 288.7±48.7* Maximum void pressure (mmhg) 38.8± ±14.4 Stress maximum urethral closure pressure (mmhg) 56.9±19.6* 67.7±21.5* Values are presented as mean±sd. Pair t test and the Wilcoxon signed-rank test were used for analysis. *P<0.05 The median follow-up interval after the operation is 10 years (range 8 12 years). Of the 152 women who were available for follow-up, the subjective self-reported outcomes (telephone interview February to May 2005) were dry in 55.3% (n=84) of the patients, improved in 36.2% (n=55) of the patients, and failed in 8.5% (n=13) of the patients. Eleven of the 13 patients (84.6%) reported subjective failure during the first year after the operation (Fig. 1, Kaplan Meier survival plots). There were 82.2% (n=125) of women who felt satisfied with the outcome of the Burch operation (Fig. 1). Twenty-seven (17.8%) of the patients were dissatisfied with this procedure (2 women in the success group, 13 women in the improved group, and 12 women in the failure group) because of worsening of lower urinary tract symptoms (Table 3). Of the 27 women in the dissatisfied group, 16 (59.2%) women complained of urinary frequency, 9 (33.3%) women complained of urinary urgency, 6 (22.2%) women had voiding difficulty and 6 N % Age at operation (years), mean±sd 45.6±9.3 BMI (kg/m 2 ) 24.84±3.4 Parity, median (range) 3 (1 11) Vaginal delivery Menopause On hormone replacement therapy DM with or without H/T Pre-operative SUI Grade Grade Grade Associated operation Hysterectomy with or without salpingoophorectomy Sacrocolpopexy or sacrospinous fixation Posterior colporrhaphy Denominators differ because of missing data. Fig. 1 Kaplan Meier survival analysis of the outcome of Burch colposuspension after median follow-up of 10 years; n=152. a Cumulative subjective success rate. b Cumulative satisfaction rate

4 940 Int Urogynecol J (2007) 18: Table 3 Symptoms reported in patients who were dissatisfied after Burch Colposuspension (on median follow-up 10 years; n=27) Symptoms Number of patients (%) Urinary frequency 16 (59.2%) Urgency 9 (33.3%) Voiding difficulty 6 (22.2%) Stress incontinence 6 (22.2%) Bearing down sensation 3 (11.1%) Suprapubic pain 2 (7.4%) Dysuria 3 (11.1%) (22.2%) had persistent or recurrent stress incontinence. There was no significant difference in the preoperative coexistence of detrusor overactivity between the two groups (19.6% for satisfied group vs 29.6% for dissatisfied group; p>0.05,χ 2 test). Discussion In the last century, colposuspension was considered to be the most appropriate first-line treatment for most women with stress urinary incontinence and other surgical procedures tailored to suit individual women [14]. However, in this new era, less invasive techniques have been introduced for the treatment of female urinary incontinence. Compared with these new techniques, which provide a safer, timesaving alternative, a shorter hospital stay, less morbidity, and a promising cure rate, the Burch colposuspension could become obsolete. However, the initial enthusiasm for these new procedures have yet to be supported by the short-term results and still need conclusive evidence on long-term success [15]. After a systematic review, Burch colposuspension has gained higher popularity due to the high cure rate [16]. There seems to be controversy over whether the continence rate after a Burch colposuspension declined with time [17 20]. Alcalay et al. [17] reported that the cure rate declines over the years, from 92% after 1 year to 69% after 10 years. El-Toukhy et al. [19] demonstrated that the cure rate at years (62%) is significantly lower than at 2 years (82.3%). In the current study, after a 10-year follow-up, we found that 55.3% of the women were completely dry, 36.2% women had improved, and only 8.5% of the women considered the operation to be a failure according to selfreported symptoms of urinary leakage. For most of our patients, subjective failure due to persistent or recurrence of stress urinary incontinence was noted in the first year after Burch colposuspension (Fig. 1, Kaplan Meier survival plots). The success rate reached a plateau from the 1st to the 12th postoperative years. Our results are consistent with others publications [18, 21, 22]. Regarding the long-term subjective cure rate in terms of urinary leakage, our subjective cure rate (55.3%) is higher than that of Kjolhede (44%, median 14 years after the Burch colposuspension) and Drouin et al. [23] (44%, 7.6 years of the mean follow-up). After an 84-month follow-up, Tegerstedt et al. [24] reported 54% of their patients were completely dry, 35% had a small leakage, and 11% had frequent leakage. Their results are similar to ours. In contrast, the subjective cure rate in our patients is lower than that of Herbertsson and Iosif [21] (90.3% cure rate, mean follow-up of 9.4 years), Kulseng-Hanssen and Berild [25] (73% patients did not leak during stress test, mean follow-up of 7.5 years), and Langer et al. [22] (93% cure rate, mean follow-up of 12.4 years). In addition to focusing on urinary leakage, if we asked the patient Do you feel satisfied with the outcome of this procedure? we found that 82.2% (125/152) of the women felt satisfied with the outcome of the Burch operation (Fig. 1, Kaplan Meier survival plots). However, it seems that continence is not the only decisive postoperative criterion of success after Burch colposuspension. In the Filbeck et al. [26] study, 75.4% of the women were continent after Burch colposuspension, 19.3% of the women had mild incontinence requiring one to two sanitary pads daily, and 5.3% of the women with moderate incontinence, which required three to five pads daily. All patients showed a significant improvement in postoperative quality of life. Despite persistent incontinence after the operation, the satisfaction rate was comparable to that of continent patients. Their results might support our finding that most of our patients with an improvement in urinary leakage (36.2%, 55/152) still felt satisfied with the outcome of Burch colposuspension. Besides urinary leakage (six patients), there were other combined lower urinary symptoms such as overactive bladder symptoms or delayed voiding difficulty that may have caused the dissatisfaction (Table 3). The incidence of de novo detrusor overactivity in this study was 22.3%, which was much higher than the mean frequency of 9.6% (range 4 to 18%), as reported by Jarvis [1]. However, a recent study by Bombieri et al. [27] found that the incidence of de novo detrusor overactivity was high at 21.4%. In addition, two women with a stable bladder at 3 months had developed detrusor overactivity at 1 year. The incidence of de novo detrusor overactivity at 1 year was 12.7% in Bombieri s study. There may be no strong association between the high incidence of de novo detrusor overactivity and the excessive bladder neck elevation during the procedure. The incidence of postoperative voiding difficulty was only 6.6% in our study. After a median follow-up of 10 years, urinary frequency (16/27, 59.2%) and urgency (9/27, 33.3%) were the two most frequent complaints that caused dissatisfaction with the outcome of the operation in our group. These findings

5 Int Urogynecol J (2007) 18: strengthen our opinion that stress urinary incontinence is not the only condition to be considered in the evaluation of long-term efficacy in anti-incontinence surgery. Burch colposuspension may be beneficial in the surgical management of women with uterovaginal prolapse and coexisting stress urinary incontinence. Sze et al. [28] reported a significantly higher incidence of recurrent prolapse and lower urinary tract symptoms in the vaginal group (sacrospinous fixation with transvaginal needle suspension) than in the abdominal group (abdominal sacrocolpopexy with Burch colposuspension) in patients treated for vaginal vault prolapse. Benson et al. [29] also reported a higher incidence of recurrent prolapse in patients with vaginal vault prolapse treated with the vaginal approach in a prospective randomized study. In contrast, Cosson et al. [30] reported that only 35% of their patients were completely dry at 7 years follow-up, after a combined Burch procedure and abdominal sacrocolpopexy using synthetic mesh. In patients with pelvic organ prolapse without preoperative stress incontinence who chose to be treated with abdominal sacrocolpopexy, additive Burch colposuspension could decrease the incidence of postoperative stress incontinence. Brubaker et al. [31] reported a lower incidence of stress incontinence after abdominal sacrocolpopexy in the patients randomized to receive additive Burch colposuspension. The role of Burch colposuspension as a primary treatment for stress incontinence has been challenged by the innovation of new surgical methods in this new era. The new surgical techniques can achieve improved results with lower morbidity and quicker recovery times than the conventional techniques [8]. A multicentered randomized trial was conducted to compare tension-free vaginal tape (TVT) with colposuspension and the results were reported by Ward et al. [9, 10]. They found that TVT is associated with more operative complication than colposuspension, but colposuspension is associated with more postoperative complications and longer recovery. The cure rate of stress leakage at 6 months was 59% in the vaginal tape arm and 53% in the colposuspension arm. The objective cure rate at 2 years was 63% in the vaginal tape arm and 51% in the colposuspension arm. The future role of Burch colposuspension seems to depend on the outcome of the long-term follow-up studies of minimally invasive anti-incontinence surgeries. Since the short-term success rate of Burch colposuspension is equal with that of minimally invasive antiincontinence surgery, it should have a place as a first-line anti-incontinence procedure for those patients who need to undergo concomitant pelvic surgical procedures such as a hysterectomy or pelvic reconstructive surgery or where TVT is not relevant in the future. In the meantime, the postoperative hospital stay after Burch colposuspension could be reduced with the early removal of the transurethral catheter [13]. In conclusion, our study provides strong long-term results for Burch colposuspension in terms of patient s subjective self-reported outcomes. Burch colposuspension is still an effective alternative surgical method in the primary surgical treatment of urodynamic stress incontinence, especially where minimally invasive techniques are not eligible. Acknowledgements We thank Miss I-Ying Cheng and Sau-Long Chau for collecting the patients data and follow-up of the patients postoperative outcomes. References 1. Jarvis GJ (1994) Surgery for genuine stress incontinence. Br J Obstet Gynaecol 101: Hilton P, Stanton SL (1983) A clinical and urodynamic assessment of the Burch colposuspension for genuine stress incontinence. Br J Obstet Gynaecol 90: Petri E (2002) Retropubic cystourethropexies. In: Cardozo L, Staskin D (eds) Textbook of female urology and urogynecology. Martin Dunitz, London, pp Germain MM, Ostergard DR (1996) Retropubic surgical approach for correction of genuine stress incontinence. In: Ostergard DR, Bent AE (eds) Urogynecology and urodynamics, 4th edn. Williams and Wilkins, Baltimore, MD, pp Webster GD, Guralnick ML (2002) Retropubic suspension surgery for female incontinence. In: Walsh PC, Retik AB, Vaughan ED Jr, Wein Aj (eds) Campell s urology, 8th edn. Sauders, Philadelphia, PA, pp Tanagho EA (1976) Colpocystourethropexy: the way we do it. J Urol 1116: Green J, Herschorn S (2005) The contemporary role of Burch colposuspension. Curr Opin Urol 15: Balmforth J, Cardozo LD (2003) Trends toward less invasive treatment of female stress urinary incontinence. Urology 62(Suppl 4A): Ward K, Hilton P, UK and Ireland TVT trial group (2002) Prospective multicentre randomized trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ 325(7355): Ward K, Hilton P, UK and Ireland TVT trial group (2004) A prospective multicentre randomized trial of tension-free vaginal tape and colposuspension for primary urodynamic stress incontinence: two-year follow-up. Am J Obstet Gynecol 190 (2): Nilsson CG, Falconer C, Rezapour M (2004) Seven-year followup of the tension-free vaginal tape procedure for treatment of urinary incontinence. Obstet Gynecol 104: Abrams P, Blaivas JG, Stanton SL et al (1988) The International Continence Society Committee on Standardisation of Terminology: the standardization of terminology of lower urinary tract function. Scand J Urol Nephrol 5: Sun MJ, Chang SY, Lin KC, Chen GD (2004) Is an indwelling catheterr necessary for bladder drainage after modified Burch colposusoension? Int Urogynecol J Pelvic Floor Dysfunct 15: Bidmead J, Cardozo L (2000) Short cut to continence? Lancet 355:

6 942 Int Urogynecol J (2007) 18: Cugudda A, Terrone C, Crivellaro S, Rossetti SR (2002) Long term results of Burch colposuspension and anterior colpoperineorraphy in the treatment of stress urinary incontinence and cystocele. Ann Urol (Paris) 36: Black NA, Downs SH (1996) The effectiveness of surgery for stress incontinence in women: a systematic review. Br J Urol 78: Alcalay M, Monga A, Stanton SL (1995) Burch colposuspension: a year follow-up. Br J Obstet Gynaecol 102: KjØlhede P, Ryden G (1994) Prognostic factors and long-term results of the Burch colposuspension. Acta Obstet Gynecol Scand 73: El-Toukhy T, Mahadevan S, Davies AE (2000) Burch colposuspension: a 10 to 12 years follow-up. J Obstet Gynaecol 20: KjØlhede P (2005) Long-term efficacy of Burch colposuspension: a 14-year follow-up study. Acta Obstet Gynecol Scand 84: Herbertsson G, Iosif CS (1993) Surgical results and urodynamic studies 10 years after retropubic colpourethrocystopexy. Acta Obstet Gynecol Scand 72: Langer R, Lipshitz Y, Halperin R, Pansky M, Bukovsky I, Sherman D (2001) Long-term (10 15 years) follow-up after Burch colposuspension for urinary stress incontinence. Int Urogynecol J 12: Drouin J, Tessier J, Bertrand PE, Schick E (1999) Burch colposuspension: long-term results and review of published reports. Urology 54: Tegerstedt G, Sjoberg B, Hammarstrom M (2001) Clinical outcome or abdominal urethropexy-colposuspension: a long-term follow-up. Int Urogynecol J 12: Kulseng-Hanssen S, Berild GH (2002) Subjective and Objective Incontinence 5 to 10 years after Burch colposuspension. Neurourol Urodyn 21(2): Filbeck T, Ullrich T, Pichlmeier U, Kiel HJ, Wieland WF, Roessler W (1999) Correlation of persistent stress urinary incontinence with quality of life after suspension procedures: is continence the only decisive postoperative criterion of success? Urology 54: Bombieri L, Freeman RM, Perkins EP, Williams MP, Shaw SR (2002) Why do women have voiding dysfunction and de novo detrusor instability after colposuspension? Br J Obstet Gynaecol 109: Sze EHM, Kohli N, Miklos JR, Roat T, Karram MM (1999) A retrospective comparison of abdominal sacrocolpopexy with Burch colposuspension versus sacrospinous fixation with transvaginal needle suspension for the management of vaginal vault prolapse and coexisting stress incontinence. Int Urogynecol J 10: Benson TJ, Lucente V, McClellan E (1996) Vaginal versus abdominal reconstruction surgery for the treatment of pelvic support defects: a prospective randomized study with long-term outcome evaluation. Am J Obstet Gynecol 175: Cosson M, Boukerrou M, Narducci F, Occelli B, Querleu D, Crépin (2003) Long-term results of the Burch procedure combined with abdominal sacrocolpopexy for treatment of vault prolapse. Int Urogynecol J 14: Brubaker L, Cundiff GW, Fine P, Nygaard I, Richter HE, Visco AG et al (2006) Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence. N Engl J Med 354: