SPARC Sling System for Treatment of Female Stress Urinary Incontinence in the Elderly

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1 european urology 50 (2006) available at journal homepage: Female Urology Incontinence SPARC Sling System for Treatment of Female Stress Urinary Incontinence in the Elderly Orietta Dalpiaz *, Günter Primus, Luigi Schips Medical University Graz, Department of Urology, Auenbruggerplatz 7, 8036 Graz, Austria Article info Article history: Accepted April 18, 2006 Published online ahead of print on April 27, 2006 Keywords: Stress urinary incontinence Surgical treatment Elderly Abstract Objective: To investigate the safety and efficacy of the suprapubic arch (SPARC) sling procedure for the management of stress urinary incontinence (SUI) in elderly women. Method: Forty-three women, aged yr, underwent the SPARC procedure for urodynamic SUI. Before surgery, a complete medical history was obtained and a urogynecology examination and urodynamic test were performed. The objective cure rate was evaluated by clinical and urodynamic examination at 3, 6, and 12 mo and the subjective cure rate was assessed using a visual analogue score and a global patient impression questionnaire. Results: No severe intraoperative or postoperative complications occurred. No patient referred de novo urge incontinence. Significant differences were found between the preoperative and postoperative number of daytime voidings ( p < 0.001), the pad weights and numbers of pads used ( p < 0.001), and the visual analogue score ( p = 0.021). No significant differences in preoperative and postoperative urodynamic parameters were reported. At the mean follow-up of mo (range, mo), objective and subjective cure rates were 91% and 95%, respectively. Conclusions: The SPARC procedure is effective and offers a satisfactory cure rate without significant morbidity in elderly women with SUI. # 2006 European Association of Urology. Published by Elsevier B.V. All rights reserved. * Corresponding author. Tel.: address: orietta.dalpiaz@tin.it (O. Dalpiaz). 1. Introduction Population aging is a global phenomenon as a result of increases in survival after 80 yr [1]. Urinary incontinence (UI) has been estimated to affect 11 55% of the elderly [2,3], leading to an exponential increase in the number of older and incontinent people worldwide. This population is characterised by its variety, ranging from active, working, healthy nonagenarians to chronically ill, functionally and cognitively impaired people [4]. Several age-related changes can contribute to the development, maintenance, and worsening of UI in elderly people, often due to an interaction of urinary tract pathology and /$ see back matter # 2006 European Association of Urology. Published by Elsevier B.V. All rights reserved. doi: /j.eururo

2 european urology 50 (2006) dysfunction, pelvic floor and sphincter weakness, comorbidities, and medications [5]. Reversible causes must be strictly identified and treated with the aim to restore continence or at least improve it. Thus, medical, functional, psychosocial, and quality of life considerations should enter into decisionmaking about more complex assessment and surgery by which elderly patients are able to continue functioning in their usual social environment while enjoying a good quality of life [6,7]. The basic assessment of UI in elderly people must include a careful history and physical examination with assessment of postvoid residual (PVR) urine as well as assessment of cognitive functions, mobility, and environmental factors. Thus, selected patients may benefit from further specialised assessment, including urodynamic testing in view of a surgical treatment. Since the description of the tension-free vaginal tape (TVT) procedure in 1996 [8], the interest in minimally invasive techniques for treating stress urinary incontinence (SUI) and the attractiveness to patients of such treatments has led to a number of modifications of the TVT procedure, such as the transobturator vaginal tape [9,10] and the suprapubic arch (SPARC) sling [11]. This kind of surgery is generally considered to have the advantages of low morbidity, reduced costs, and shorter hospital stay. However, large prospective series are lacking and few studies have assessed the outcome of these procedures in elderly women [12,13]. This is the first study to assess the safety and efficacy of the SPARC procedure for the management of urodynamic SUI in the elderly. 2. Methods A total of 107 consecutive patients with proven urodynamic SUI underwent the SPARC procedure at our department. From this group we report the results in 43 women older than 65 yr. Age 65 yr was the only selection criterion. Patients were evaluated according to our protocol, including history and physical examination, a bladder diary, and urodynamic tests including filling cystometry, pressure flow study, urethral pressure measurement, and postvoid residual (PVR) urine. A stress test with full bladder to obtain objective evidence of incontinence and a validated short-term pad test to quantify the volume of urine lost by weighing a perineal pad before and after some type of leakage provocation were done [14]. A pad weight gain 1 g was considered positive for the short-term pad test. Women with a genital prolapse (cystocele) of a second grade or more or with predominant urge symptoms with or without urge incontinence were excluded from the study before recruitment. Patients were considered to have mixed incontinence when symptoms of urgency were referred or detrusor overactivity was observed during urodynamic examination. All the definitions used are according to the recommendations of the International Continence Society [15,16]. The patients estimated the severity of their incontinence symptoms on a visual analogue scale with a score from 0 to 100 (0 indicating no incontinence). The SPARC procedure was performed by the same surgeon (G.P.) under spinal or general anaesthesia as previously described [11]. A parenteral antibiotic was given intraoperatively. In all cases cystoscopy was performed after both trocars had been placed to check for bladder perforation. A Foley catheter was inserted into the bladder overnight. Before the Foley catheter was withdrawn, the bladder was filled with 250 ml saline solution and uroflowmetry was performed to assess the PVR. If the PVR was significant (>200 ml), the tape was adjusted without tension under local anaesthesia. Patients were discharged when residual volume was <100 ml and then followed at 3, 6, and 12 mo and yearly thereafter. Follow-up evaluation included physical examination with stress test, a bladder diary, short-term pad test, and repeated urodynamic tests at 3, 6, and 12 mo. During the visits the patients were questioned on their continence condition or any complications and estimated the severity of their incontinence symptoms on the visual analogue scale as described. Additional questions included whether the patient would undergo the surgery again and whether she would recommend this procedure to a friend. The main outcome measures included perioperative morbidity, persistent SUI or voiding dysfunction, and persistent or de novo urge incontinence. Objective cure was defined as the absence of urine leakage during repetitive stress and pad tests and no evidence of urodynamic stress incontinence. Subjective cure was defined as absence of subjective complaints of leakage. Improvement was defined as no urine loss on the stress test plus the patient s report of some leakage but overall satisfaction. Statistical analysis was performed using the Student t test and Mann-Whitney test for parametric and nonparametric continuous data, respectively, and the x 2 test for categorical data; p < 0.05 was considered significant. 3. Results Preoperative characteristics of the 43 patients are reported in Table 1. All women were between 65 and 91 yr old. The median duration of incontinence was 8 yr (range, 1 39 yr). Nineteen women (42%) had previously undergone hysterectomy and 17 (40%) had previously undergone an ineffective surgical intervention for SUI: Burch colposuspension in 2 patients (5%), Marshall-Marchetti-Krantz (MMK) cystourethropexy in 1 patient (2%), anterior colporrhaphy in 12 (21%), and TVT in 2 (5%). Mean operative time was 43 min (range, min). Spinal or general anaesthesia was performed in 9 (21%) and 34 (79%) patients, respectively. No intraoperative bleeding was recorded. In all cases cystoscopy was performed and bladder perforation was observed in two patients (4.7%). Both patients

3 828 european urology 50 (2006) Table 1 Preoperative characteristics of the patients Characteristics Patients (N = 43) Mean age SD, yr (range) 72 6 (65 91) Mean parity SD (range) 2 4 (0 9) Mean BMI SD, kg/m Duration of incontinence, yr (range) 8 9 (1 39) No. hysterectomy (%) 19 (42) No. incontinence surgery (%) 17 (40) No. daytime frequency SD (range) 7 2 (4 12) No. nocturia SD (range) 1 2 (0 5) No. urge symptom (%) 5 (11) No. pads/d (range) 5 (2 10) Mean pad test, g (range) 45 (2 171) Median symptom severity grade SD Mean maximum flow rate SD, ml/s Mean cystometric capacity SD, ml Mean detrusor pressure at maximum flow SD, cm H 2 O Mean MUCP SD, cm H 2 O Range of postvoid residual, ml 0 80 BMI = body mass index; SD = standard deviation; MUCP = maximum urethral closure pressure at rest. had previously undergone vaginal surgery; one underwent vaginal hysterectomy and the other unsuccessful TVT for SUI. Also in these patients the catheter was removed on the first postoperative day without any complications or voiding disorders. Forty-one patients (95%) voided immediately after removal of the Foley catheter the day after the surgery. Two had a large amount of PVR urine (>200 ml) and in these patients the tape was immediately adjusted without tension under local anaesthesia. None presented urinary retention. The mean hospital stay was d (range, 1 4 d) and all patients were sent home without requiring a catheter. Table 2 shows preoperative and postoperative objective and urodynamic parameters. No tape infection or healing defect of the vaginal wall or other complications occurred. One patient presented a tape gliding; the tape was immediately removed and a new one was inserted successfully. Two patients (5%) with preoperative urge symptoms Table 3 Objective and subjective cure rate at 12 mo of follow-up had persistence of the urge component. Nobody developed de novo urge symptoms. The mean preoperative and 12-mo postoperative pad weights were 45 g and 1 g, respectively ( p < 0.001). Mean follow-up time was mo (range, mo). Forty-one (95%) patients stated that they had complete resolution of SUI. The median preoperative and postoperative visual analogue scores are reported in Table 2, reflecting a significant improvement ( p = 0.021). The objective and subjective cure rates are shown in Table 3. When asked whether they would undergo the procedure again, all patients answered yes. When asked whether they would recommend this to a friend, all patients answered yes. 4. Discussion No. (%) Objective cure rates Cured 39 (91) Improved 4 (9) Failure 0 Subjective cure rates Cured 41 (95) Improved 2 (5) Aggravated 0 This is the first paper to assess the safety and efficacy of the SPARC procedure in the elderly, including complications and objective and subjective cure ratesy. The efficacy of the vaginal slings has been reported by other authors previously looking at the relationship of age and surgical outcome. Series limited to older women report short-term cure and satisfaction rates of % [17 19]. However, prospective and large studies are lacking. Table 2 Preoperative and postoperative objective and urodynamic parameters Preoperative 3 m ( p value) 6 mo ( p value) 12 mo ( p value) No. daytime frequency SD (<0.001) 4 1(<0.001) 5 1(<0.001) No. nocturia SD (ns) 1 1 (ns) 1 1(ns) No. of pads/d SD (<0.001) 0 1(<0.001) 0 1(<0.001) Median symptom severity grade SD (0 100) (0.021) (0.021) (0.021) Mean max flow rate SD, ml/s (ns) (ns) (ns) Mean detrusor pressure at maximum flow SD, cm H 2 O (ns) (ns) (ns) Mean cystometric capacity SD, ml (ns) (ns) (ns) Mean first desire to void SD, ml (ns) (ns) (ns) Mean MUCP SD, cm H 2 O (ns) (ns) 51 21(ns) Range of postvoid residual, ml (ns) (ns) 0 40 (ns) SD = standard deviation; ns = not significant; MUCP = maximum urethral closure pressure at rest.

4 european urology 50 (2006) In this study we objectively assessed SUI based on a bladder diary, stress and pad tests, and urodynamic evaluation. Significant differences were found between the preoperative and postoperative number of day voidings ( p < 0.001) and the numbers and weights of pads used ( p < 0.001). In comparing the preoperative and postoperative urodynamic parameters, no significant difference at 3, 6, and 12 mo after surgery was reported. This could confirm the physiologic position and effect of the SPARC sling. A case-control series between TVT and SPARC showed that the SPARC tape is looser, more elastic, and more easily displaced on Valsalva manoeuvre [20]. This seems to explain the noobstructive effects on voiding and on urodynamic parameters. Furthermore, this reduction in obstructive effects does not affect the cure rates. On the contrary, other studies report a significant difference in maximal urethral closure pressure and detrusor pressure [21]. In the present study the mean hospital stay was d (range, 1 4 d). Bladder perforation occurred in 2 of 43 patients (4.7%), a rate similar to that reported by other investigators using TVT [12,13]. Two patients (5%) with preoperative urge symptoms had persistence of the urge component. No de novo urge symptoms, contrasting with the rate of 11.5% reported by Deval [11], and no urinary retention were recorded. This could be attributed to the meticulous tension-free technique and the physiologic position under the middle urethra of the SPARC sling. Gordon et al. [22] analysed the safety and efficacy of TVT surgery in elderly versus younger women with SUI. He found low rates of morbidity and high cure rates without significant change in the symptoms score for postoperative voiding difficulties in either group. Efficacy and safety are comparable in SPARC and TVT procedures in older women. Particularly, the rates of bladder injury and voiding dysfunction in our study were similar to the experience with TVT [23 27]. The SPARC sling has become less reported and less popular in the era of the transobturator approach. This new access was developed by Delorme [9] in 2001 to reduce complications seen with the retropubic approach, such as bladder perforation or vascular injury, due to blind passage of the needles in the retropubic space. A recent study on anatomic subjects describes the course of transobturator tape identifying the possible anatomic risks [28]. In our study no vascular, bowel, or nerve injuries occurred. In the SPARC procedure, the needles are finger-guided as passed through the retropubic area, remaining in contact with the pubic bone away from major pelvic vessels, lowering the risk of vascular, bowel, and nerve injuries. The literature data about slings show objective cure rates of % and subjective cure rates of 73 93% [29,30]. In our study with a mean follow-up of mo (range, mo), the objective and subjective cure rates were 91% and 95%, respectively, and they are comparable to the data reported by the French Multicenter Clinical Trial of SPARC [11]. Our enthusiastic results in this group of older women could be explained by a very careful preoperative selection of these patients, especially taking their health and mental status into consideration. Given that surgery for stress incontinence does not always produce significant complications, it may be more relevant to consider the overall impact on the quality of life of the surgery and patient satisfaction rather than the single issue of continence. In this study nobody referred de novo urge symptoms and this is important because this complication has the strongest negative impact on quality of life [31]. Furthermore, all patients responded that they would undergo the procedure again. 5. Conclusion We consider the SPARC procedure as a safe and effective for the treatment of SUI in elderly women. Its advantages include a short learning curve, a low incidence of perioperative and postoperative complications, and a high success rate with a high degree of patient satisfaction. References [1] Baltes PB, Smith J. New frontiers in the future of aging: from successful aging of the young old to the dilemmas of the fourth age. Gerontology 2003;49: [2] Hellstrom L, Ekelund P, Milsom I, Mellstrom D. The prevalence of urinary incontinence and use of incontinence aids in 85-year-old men and women. Age Ageing 1990; 19: [3] Brown JS, Seeley DG, Fong J, Black DM, Ensrud KE, Grady D. Urinary incontinence in older women: who is at risk? Study of Osteoporotic Fractures Research Group. Obstet Gynecol 1996;87: [4] Thom DH, Brown JS. Reproductive and hormonal risk factors for urinary incontinence in later life: a review of the clinical and epidemiologic literature. J Am Geriatr Soc 1998;46: [5] Resnik NM. Urinary incontinence. Lancet 1995;346:94 9. [6] Korn AP, Learman LA. Operations for stress urinary incontinence in the United States. Urology 1996;48:

5 830 european urology 50 (2006) [7] Hampel C, Artibani W, Espuña Pons M, et al. Understanding the burden of stress urinary incontinence in Europe: a qualitative review of the literature. Eur Urol 2004;46: [8] Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anaesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 1996;7:81 5. [9] Delorme E. Transobturator urethral suspension: miniinvasive procedure in the treatment of stress urinary incontinence in women. Prog Urol 2001;11: [10] Roumeguère T, Quackels Th, Bollens R, et al. Trans-obturator vaginal tape (TOT 1 ) for female stress incontinence: one year follow-up in 120 patients. Eur Urol 2005;48: [11] Deval B, Levardon M, Samain E, et al. A French multicenter clinical trial of SPARC for stress urinary incontinence. Eur Urol 2003;44: [12] Sevestre S, Ciofu C, Deval B, Traxer O, Amarenco G, Haab F. Results of the tension-free vaginal tape technique in the elderly. Eur Urol 2003;44: [13] Liapis A, Bakas P, Christopopoulos P, Giner M, Creatsas G. Tension free vaginal tape for elderly women with stress urinary incontinence. Int J Gynecol Obstet 2006;92: [14] Hahn I, Fall M. Objective quantification of stress urinary incontinence: a short, reproducible, provocative pad test. Neurol Urodyn 1991;10: [15] Abrams P, Cardozo L, Fall M, et al. Lower urinary tract function: standardisation of terminology. Neurourol Urodyn 2002;21: [16] Sand PK, Dmochowski R. Analysis of the standardisation of terminology of lower urinary tract dysfunction. Report from the Standardisation sub-committee. Neurourol Urodyn 2002;21: [17] Chaikin DC, Groutz A, Blaivas JG. Predicting the need for anti-incontinence surgery in continent women undergoing repair of severe urogenital prolapse. J Urol 2000; 163: [18] Elkadry EA, Kenton KS, FitzGerald MP, Shott S, Brubaker L. Patient-selected goals: a new perspective on surgical outcome. Am J Obstet Gynecol 2003;189: [19] Couillard DR, Deckard-Janatpour KA, Stone AR. The vaginal wall sling: a compressive suspension procedure for recurrent incontinence in elderly patients. Urology 1994; 43: [20] Dietz HP, Foote AJ, Mak HLJ, Wilson PD. TVT and SPARC suburethral slings: a case control series. Int Urogynecol J 2004;15: [21] Lo T, Horng S, Liang C, Lee S. Ultrasound and urodynamic comparison between caudocranial and craniocaudal tension free vaginal tape for stress urinary incontinence. Urology 2005;66: [22] Gordon D, Gold R, Pauzner D, Lessing JB. Groutz A. tension free vaginal tape in the elderly: is it a safe procedure? Urology 2005;65: [23] Carr LK, Walsh PJ, Abraham VE, Webster GD. Favorable outcome of pubovaginal slings for geriatric women with stress incontinence. J Urol 1997;157: [24] Hawkins E, Taylor D, Hughes-Nurse J. Long term followup of the cruciate fascial sling for women with genuine stress incontinence. BJOG 2002;109: [25] Gandhi S, Abramov Y, Kwon C, et al. TVT versus SPARC: comparison of outcomes for two midurethral tape procedures. Int Urogynecol J Pelvic Floor Dysfunct 2006;17: [26] Schostak M, Miller K, Muller M, Schrader M, Steiner U, Gottfried HW. Transvaginal bone anchors in female stress urinary incontinence: poor results. Gynecol Obstet Invest 2002;54: [27] Andonian S, Chen T, St-Denis B, Corcos J. Randomized clinical trial comparing suprapubic arch sling (SPARC) and tension-free vaginal tape (TVT): one-year results. Eur Urol 2005;47: [28] Delmas V. Anatomical risks of transobturator suburethral tape in the treatment of female stress urinary incontinence. Eur Urol 2005;48: [29] Bidmead J, Cardozo L. Sling techniques in the treatment of genuine stress incontinence. BJOG 2000;107: [30] Walsh K, Generao SE, White MJ. The influence of age on quality of life outcome in women following a tension-free vaginal tape procedure. J Urol 2004;171: [31] Sweeney DD, Leng WW. Treatment of postoperative voiding dysfunction following incontinence surgery. Curr Urol Rep 2005;6: Editorial Comment Firouz Daneshgari, Center for Female Pelvic Medicine and Reconstructive Surgery, The Cleveland Clinic, Cleveland, OH, USA The authors report the results of treating 43 women over the age of 65 yr with urodynamic stress urinary incontinence (SUI) with the suprapubic arc sling (SPARC). They gathered objective data (pad test and urodynamics) and subjective measures (visual analogue scale, 0 100) along with complaint of leakage at 3, 6, and 12 mo. The research question that was addressed is an important one: What are the outcomes of the midurethral sling in the elderly? This question deserves the full attention of the scientific community, for as the population continues to age, elderly women will constitute if they do not already a large proportion of patients who would undergo minimally invasive surgical treatment for SUI. This is because of the likelihood that agerelated remodeling of the bladder along with postmenopausal changes in the vaginal tissue would make this group of women more susceptible to potential complications of midurethral slings, for example, short- and long-term voiding dysfunction, vaginal and urethral erosions, and others. However, despite the significance of the research question, the results reported by the authors raise two serious concerns.

6 european urology 50 (2006) The authors report mean follow-up of with a range of mo. This translates to almost one patient per month during the range of mo of follow-up (42 mo) or 12 patients per year! This would indicate that either (a) this is a study of a highly selective group of patients whom the authors could follow but at the expense of others who were not followed, or (b) there was a negligible flow of such patients to the authors practice. Either assumption elicits a major concern regarding bias in the selection of the subjects. Further, the reported mean maximum urethral closure pressure of 38 cm H 2 O (in the absence of data on median or interquartile range) would indicate that these patients had rather mild SUI. 2. The reported data on complications of SPARC is not consistent with previous reports from various centres and countries. Hodroff et al. had to do sling release in 4.3% of their SPARC patients whose mean age was 60 yr [1]. A survey of 326 members of the Urological Society of Australasia revealed that the incidence of vaginal erosions, urethral erosions, and urinary retention was 1.2%, 0.6% and 6.5%, respectively, among a total of 1459 cases including 466 SPARC procedures [2]. Andonian et al. reported results of a randomised clinical trial between SPARC or TVT with 12 mo of follow-up. This Canadian group reported 23% bladder perforation; 83% objective cure rates as determined by 1-h pad test of <2 g and 49.9% 25.6% subjective cure rates as determined by Incontinence Impact Questionnaire scores for the SPARC group [3]. In view of these data, including a small randomised clinical trial, the authors report of 0 failures in both objective and subjective cure rates, and the no body report of de novo urge symptoms in an elderly population, appears too good to be believed! If after adequate scrutiny the results are confirmed, the authors should be congratulated for their work. References [1] Hodroff MA, Sutherland SE, Kesha JB, Siegel SW. Treatment of stress incontinence with the SPARC sling: intraoperative and early complications of 445 patients. Urology 2005;66: [2] Hammad FT, Kennedy-Smith A, Robinson RG. Erosions and urinary retention following polypropylene synthetic sling: Australasian survey. Eur Urol 2005;47: [3] Andonian S, Chen T, St-Denis B, Corcos J. Randomized clinical trial comparing suprapubic arch sling (SPARC) and tension-free vaginal tape (TVT): one-year results. Eur Urol 2005;47: