Clinical Outcome of Fascial Slings for Female Stress Incontinence

Clinical Outcome of Fascial Slings for Female Stress Incontinence Sling procedures are effective surgical options for all types of stress urinary incontinence. journalArticle control,type,controle,urinary incontinence,stresse,incontinent,bladdr,bengn, urinary incontinence stress,incont,bldder,incotinence,incontinece,stess,cntrol,controlle,benign,incontininence,incontenance,stresss,incintinence,unrinary,incontinance,incontenence,benighn,tension,stress incontinence,bennign,incontinince,urine,blader,inconcontince,incontince,bladder,incontience,incontinency,bladdder,incontnence,lack,urgency Patricia de Rossi, MD Patricia de Rossi, MD, Staff Physician, Department of Obstetrics and Gynecology, Universidade de Sao Paulo de Rossi P. Clinical Outcome of Fascial Slings for Female Stress Incontinence. MedGenMed 4(2), 2002 [formerly published in Medscape Women's Health eJournal 7(3), 2002]. Available at: http://www.medscape.com/viewarticle/432820. Medscape Medscape General Medicine 05/07/2002 4 2 <H3>Abstract and Introduction</H3><h4>Abstract</h4> We studied 27 women with urodynamically proven stress urinary incontinence who had undergone surgery using fascial sling technique. During a mean follow-up of 20 months, all patients were continent. We observed a significant statistical reduction of urge symptoms. De novo detrusor hyperactivity and sensitive urgency were observed in 7.4% and 3.7% of patients, respectively. Two patients developed urinary flow problems. One patient had a bladder perforation during dissection. Urinary retention was observed in 3.7% and resolved spontaneously in 48 hours. We conclude that in the treatment of female urinary stress incontinence, slings promote clinical cure with few complications.<h4>Introduction</h4> Stress urinary incontinence (SUI) is a common medical problem seen in gynecologic practice. Treatment options may be conservative or surgical. For women with severe SUI or previous treatment failure, surgical treatment is generally the selected option. The American Urological Association defined the Burch procedure as a gold standard for best short-term and long-term results for SUI caused by urethral hypermobility.[1] In low-pressure urethra or intrinsic sphincter deficiency, slings are better options because they promote good urethral closure and support. Therefore, many authors are expanding indications for slings to all types of SUI.[2] Cure rates vary from 75% to 95%.[3,4] Early complications are urge symptoms and development of voiding disorders.[5] Late complications are persistent urinary retention needing clean intermittent catheterization and hyperactive bladder. The aim of this study was to investigate the clinical outcome of fascial slings in terms of leakage, urge symptoms, and voiding pattern and to perform urodynamic evaluation of postoperative symptomatic women. <H3>Materials and Methods</H3> Between 1998 and 2001, 27 women underwent fascial sling for stress urinary incontinence at Hospital das Clinicas of Sao Paulo University, Sao Paulo, Brazil. The same surgical team, the author included, operated on all patients. The Local Ethics Committee of the hospital approved the study. All patients had undergone urodynamic investigation to confirm SUI before their operation. Urodynamic evaluation entailed uroflowmetry, cystometry, pressure-flow study, and determination of Valsalva leak point pressure (VLPP). Recommendations of International Continence Society (ICS) were used, except where indicated.[6] All patients had SUI. Nineteen patients had urge symptoms; 6 of these patients had sensory urgency during bladder filling. None of the patients had demonstrated involuntary bladder contractions or detrusor instability. VLPP was 4-80 (mean, 50.5). For 22 women, VLPP </= 60 cmH2O was the indication for a sling (intrinsic sphincter deficiency). For those with VLPP > 60 cmH2O, the indication for sling procedure (and not a Burch procedure) was additional clinical morbidity, such as asthma, obesity, diabetes, or chronic lung disease. At time of operation, the mean age of patients was 50.6 years (range, 35-68); the mean parity, 3.6 (range, 0-11); and mean body mass index (BMI), 30.0 (range, 20.8-37.6). Twelve patients were obese (BMI >/= 30) and 13 were overweight (25 < BMI < 30). No patient had severe (grade ) genital prolapse.[7] Fifteen women had undergone previous SUI operation: 42.8%, vaginal approach (anterior colporrhaphy, Kelly-Kennedy plication); 3.7%,Burch procedure; and 3.7%, Gittes needle suspension. The performed operation was a modified fascial sling with rectus abdominis fascia using a Cobb-Radge needle.[8,9] By a transverse suprapubic incision, an 8 x 2 cm strip of fascia of rectus abdominalis was excised and then sutured in the longitudinal extremities with No. 0 polypropylene (Prolene, Ethicon Endo-Surgery, Inc., Cincinnati, Ohio) (Figure 1). The fascial wound was sutured with uninterrupted No. 0 delayed absorbable sutures (Vicryl, Ethicon).<center><img src="art-wh432820.fig1.jpg" width="452" height="253" BORDER="1"></center><blockquote>Figure 1. Strip of rectus abdominalis fascia with sutures.</blockquote> The vaginal approach entailed an inverted V-shaped incision between external urethral meatus and bladder neck after local infusion of 2 mL of saline. With Metzenbaum's scissors, the pubourethral ligament was ruptured (Figure 2) and the Retzius' space achieved by digital dissection. A triangle-shaped vaginal flap was then dissected downward to bladder neck.<center><img src="art-wh432820.fig2.jpg" width="400" height="320" BORDER="1"></center><blockquote>Figure 2. Vaginal dissection of Retzius' space with Metzenbaum's scissors.</blockquote> The Cobb-Radge needle was passed through suprapubical fascia to vaginal incision (Figure 3) and the strip sutures were pulled back (Figure 4). After cystoscopy had ruled out bladder or urethral perforation, the sling was fixed on the underneath periurethral fascia with 2 No. 4 Vicryl sutures (Figure 5). Sling sutures were tied without tension 1.5 cm apart from the aponeurosis and then tied together in the midline.<center><img src="art-wh432820.fig3.jpg" width="400" height="261" BORDER="1"></center><blockquote>Figure 3. Cobb-Radge needle passing through suprapubical fascia to vaginal incision.</blockquote> <center><img src="art-wh432820.fig4.jpg" width="471" height="277" BORDER="1"></center><blockquote>Figure 4. Sling sutures pulling back.</blockquote> <center><img src="art-wh432820.fig5.jpg" width="466" height="308" BORDER="1"></center><blockquote>Figure 5. Adjusting the sling behind vesical neck.</blockquote> The vaginal mucosa were closed with absorbable sutures. A No.14 Foley catheter was placed through the urethra. The abdominal wound was closed with No. 4-0 nylon sutures. At follow-up visits, all patients were assessed by medical history and reporting of symptoms of urine leakage, urge symptoms, or voiding problems. Each patient was asked in a standardized fashion whether she had leakage of urine during coughing, sneezing, jumping, or lifting heavy objects. If so, we asked how many times it occurred and how much urine was excreted in each episode. All women underwent gynecologic examination and were submitted to a stress test with a comfortably full bladder, as deemed by the patients themselves. To be considered continent, a patient had to have had no complaint of urine leakage and a negative result on the stress test. Any leakage was noted as a clinical diagnosis of urinary incontinence, and the patient was referred for urinalysis, urine culture, and urodynamic studies. The patients who had urgency, frequency, nocturia, or voiding problems after the surgery were also referred for urinary tract infection assessment and urodynamic evaluation. All patients were evaluated at 1, 6, and 12 months. Some patients have had a further visit, with mean follow-up time of 20 months. <h4>Statistics</h4> Analysis was performed using Student's t test, with P < .05 as level of significance. <H3>Results</H3><h4>Urinary Incontinence</h4> All patients were dry after surgery (P < .0005). No patient complained of stress incontinence. The provocative test was negative in all subjects. <h4>Urge Symptoms</h4> The number of patients with urge symptoms declined significantly after surgery (<a href="432820_tab.html#Table 1." target="tables" onclick="resizewin('tables',500,500)">Table 1</a>). De novo detrusor instability occurred in 2 patients (7.4%). Five patients had sensory urgency in the 6-month postoperative urodynamic evaluation. Five of these patients already had experienced sensory urgency before surgery, and only 1 patient had de novo sensory urgency (3.7%).<h4>Voiding Problems</h4> Only 2 patients developed voiding problems after surgery (<a href="432820_tab.html#Table 2." target="tables" onclick="resizewin('tables',500,500)">Table 2</a>). Prolonged urinary retention was not observed.<h4>Early Complications</h4> Early complications were rare. One patient with previous external radiotherapy for ovarian cancer had a bladder perforation. Urinary tract infection was observed in 1 patient (<a href="432820_tab.html#Table 3." target="tables" onclick="resizewin('tables',500,500)">Table 3</a>).<h4>Urodynamic Evaluation</h4> Eight patients remained symptomatic at 6-month follow-up visit and were referred for a urodynamic evaluation. Urinary tract infection was excluded by urinalysis and urine culture. Urodynamic diagnoses are listed in <a href="432820_tab.html#Table 4." target="tables" onclick="resizewin('tables',500,500)">Table 4</a>.<H3>Discussion </H3> The treatment of women with urinary incontinence improved after urodynamic diagnosis of intrinsic sphincter deficiency. McGuire and colleagues[10] studied a group of patients with poor surgical outcome and concluded that the presence of a low-pressure urethra indicated a poor prognosis. Later McGuire and Lytton[11] proposed a surgical treatment for these patients with the sling procedure. This operation consisted of using a strip of rectus abdominalis muscle aponeurosis to support the proximal urethra and bladder neck. Cure rates of slings are between 75% and 85%. In 1997, the American Urological Association Incontinence Panel defined sling procedures as first-line surgical option for SUI.[1] Besides giving urethral co-optation, the sling also corrects frequently associated bladder neck hypermobility. Many authors are using slings for all types of SUI.[12-14] As for other surgical procedures for SUI, slings may reduce urge symptoms, possibly secondary to repositioning of bladder neck and correction of genital prolapse. Serels and colleagues[15] reported a 75% cure of urge symptoms after sling procedure. On the other hand, some patients may develop urge symptoms and voiding problems after surgery. These complications are proportional to the degree of tension applied to the sling sutures and associated with use of a synthetic sling. Urinary retention as a result of excessive sling tension is more frequent in the beginning of the surgeon's learning curve.[16] The patients of even experienced surgeons may face overactive bladder after surgery. These symptoms may be transitory, but in women who remain symptomatic, the negative impact on their quality of life is usually significant. These aspects must be extensively discussed with the patient before surgery, especially if incontinence is not severe. Postoperative voiding difficulties must also be discussed.[4,17,18] Voiding disturbances are difficult to predict before surgery.[19,20] Low urinary flow with high postvoiding volume may cause recurrent urinary tract infections. Intermittent clean catheterization or surgical liberation of urethra (urethrolysis) may be necessary.[21] The clinical outcome in our patients after fascial sling for SUI was pretty good. After a mean follow-up time of 20 months, all patients reported urinary continence and remained dry with provocative testing. Criteria of cure for SUI are not well standardized.[22] Some authors use questionnaires[23]; others prefer telephone interviews.[24] Clinical evaluation with medical history and physical examination is also used.[25] Urodynamic evaluation may not be necessary for asymptomatic patients after surgery, even though it was performed in this study.[23,25] Before surgical procedure, 19 patients had urge symptoms. After surgery, there was a significant reduction of these symptoms with a 14.8% rate after 2 years. These results are comparable to those reported by others.[13,22,26,27] However, our result conflicts with the 62% rate of sustained urgency reported by Haab and coworkers.[28] Use of synthetic material may be associated with a greater rate of urge symptoms.[29] Sensory urgency was diagnosed in 22% of our patients with urge symptoms. Two of these patients became asymptomatic after surgery. Two patients developed voiding symptoms with incomplete bladder emptying and poor urinary flow. Urodynamic evaluation demonstrated that 1 patient had a mild obstructive pattern with large postvoiding residual volume and the other patient had detrusor hypocontractility. These results are similar to those reported by Cross and colleagues[3] and by Morgan and coworkers.[27] There is no urodynamic pattern that precludes voiding problems after surgery.[20] Perhaps this is attributable to restoration of the continence mechanism.[16] No patient needed intermittent catheterization or urethrolysis. The only patient who complained of urinary retention had a spontaneous resolution after 48 hours. Transitory urinary retention may affect as many as 60% of women who undergo the sling procedure.[13] Persistent retention is rarer (2% to 3%).[2,3] In our study, we excluded patients with detrusor instability, because there is no consensus regarding options for surgical treatment of patients with this condition.[30] On the other hand, some patients may develop detrusor instability just after surgery.[31] Carr and colleagues[26] reported a 10% rate of de novo bladder hyperactivity in patients aged older than 70 years, which is similar to our results. These investigators used anticholinergic drugs and bladder training with good results. De novo sensory urgency was observed in only 1 patient. There are few data about this urodynamic diagnosis after slings; Zaragoza reported 12%.[13] The only surgical complication was a bladder perforation during dissection of Retzius's space. This occurred in a 66-year-old woman who had undergone pelvic radiotherapy for ovarian cancer. Nevertheless, the surgery went on without any other problem. A Foley catheter was put in place for 7 days. <H3>Conclusion</H3> Sling procedures are effective surgical options for all types of SUI. They have good cure rates and few complications. Slings also resolve urge symptoms in a significant number of patients. Patricia de Rossi, MD, has no significant financial interests to disclose. <a name="Table 1."><h3>Table 1. Frequency of Urge Symptoms Before and After Sling Procedure</h3></a> <blockquote><center><table border="1" cellpadding="3" cellspacing="3"><tr valign="top"><td>Time</td><td>Number of Patients (N = 27)</td><td>Percentage (%)</td></tr><tr valign="top"><td>Preoperative </td><td>19</td><td>70.4 (P < .05)</td></tr><tr valign="top"><td>1 month</td><td>10</td><td>37.0 (P < .05)</td></tr><tr valign="top"><td>6 months</td><td>8</td><td>29.6</td></tr><tr valign="top"><td>12 months</td><td>6</td><td>22.2</td></tr><tr valign="top"><td>> 12 months</td><td>4</td><td>14.8</td></tr></table></center></blockquote> <a name="Table 2."><h3>Table 2. Frequency of Voiding Problems Before and After Sling Procedure</h3></a> <blockquote><center><table border="1" cellpadding="3" cellspacing="3"><tr valign="top"><td>Time</td><td>Number of Patients (N = 27)</td><td>Percentage (%)</td></tr><tr valign="top"><td>Preoperative </td><td>0</td><td>0 (P < .05)</td></tr><tr valign="top"><td>1 month</td><td>1</td><td>3.7 (P < .05)</td></tr><tr valign="top"><td>6 months</td><td>1</td><td>3.7</td></tr><tr valign="top"><td>12 months</td><td>2</td><td>7.4</td></tr><tr valign="top"><td>> 12 months</td><td>2</td><td>7.4</td></tr></table></center></blockquote> <a name="Table 3."><h3>Table 3. Early Complications After Sling Procedure</h3></a> <blockquote><center><table border="1" cellpadding="3" cellspacing="3"><tr valign="top"><td>Complication</td><td>Number of Patients (N = 27)</td></tr><tr valign="top"><td>Bladder perforation</td><td>1</td></tr><tr valign="top"><td>Urinary tract infection</td><td>1</td></tr><tr valign="top"><td>Urinary retention > 2 days</td><td>1</td></tr><tr valign="top"><td>Total</td><td>3</td></tr></table></center></blockquote> <a name="Table 4."><h3>Table 4. Urodynamic Diagnoses After Surgery</h3></a> <blockquote><center><table border="1" cellpadding="3" cellspacing="3"><tr valign="top"><td>Urodynamic Diagnosis</td><td>Number of Patients (N = 27)</td><td>Percentage (%)</td></tr><tr valign="top"><td>Sensory urgency </td><td>5</td><td>18.5</td></tr><tr valign="top"><td>Bladder hyperactivity</td><td>2</td><td>7.4</td></tr><tr valign="top"><td>Normal</td><td>1</td><td>3.7</td></tr><tr valign="top"><td>Total</td><td>8</td><td>29.6</td></tr></table></center></blockquote> <ol><li>Leach GE, Dmochowski RR, Appell RA, et al. Female Stress Urinary Incontinence Clinical Guidelines Panel summary report on surgical management of female stress urinary incontinence. The American Urological Association. J Urol. 1997;158:875-880. <li>Chaikin DC, Rosenthal J, Blaivas JG. Pubovaginal fascial sling for all types of stress incontinence: long-term analysis. J Urol. 1998;160:1312-16. <li>Cross CA, Cespedes RD, McGuire EJ. 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