- Email: [email protected]
Effect of Preoperative Voiding Mechanism on Success Rate of Autologous Rectus Fascia Suburethral Sling Procedure
Effect of Preoperative Voiding Mechanism on Success Rate of Autologous Rectus Fascia Suburethral Sling Procedure CHERYL B. IGLESIA, MD, SUSAN SHOTT, PhD, DEE E. FENNER, MD, AND LINDA BRUBAKER, MD Objective: To evaluate the efficacy of the rectus fascia suburethral sling procedure and to determine whether preoperative voiding caused by the Valsalva maneuver is a risk factor for short-term objective failure. Methods: This study is a retrospective chart review of 50 patients who underwent the suburethral sling procedure with rectus fascia at our institution between March 1994 and August 1996. All patients had genuine stress incontinence with intrinsic sphincteric deficiency or urethral hypomobility. Preoperative multichannel urodynamics were measured in all patients, and postoperative urodynamic testing was done at 3 months in 48 patients. Results: Ninety-four percent of patients were cured subjectively of stress urinary incontinence at 3 months. Objective cure was found by urodynamic measurements in 73% of the 48 patients who underwent postoperative testing. There was an increased risk of objective failure in patients whose voiding preoperatively was caused by the Valsalva maneuver. Objective failure was found at 3 months in 54% of the 13 patients in the Valsalva group, compared with 17% of the 35 in the non-Valsalva group (P 5 .011). Patients in the Valsalva group also tended to have longer durations of postoperative catheterization than did patients in the non-Valsalva group (P 5 .049). Conclusion: The rectus fascia suburethral sling procedure appears to be an effective operation for the treatment of genuine stress incontinence in carefully selected patients. However, patients who are identified preoperatively as voiding because of the Valsalva maneuver have a higher failure rate for this procedure. (Obstet Gynecol 1998;91:577– 81. © 1998 by The American College of Obstetricians and Gynecologists.)
The suburethral sling procedure is an established operation for the treatment of genuine stress incontinence.1 From the Sections of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, and Biostatistics, Department of Neurosurgery, Rush-Presbyterian-St. Luke’s Medical Center, Chicago, Illinois.
VOL. 91, NO. 4, APRIL 1998
This operation has been used in patients with recurrent genuine stress urinary incontinence, urethral hypomobility, or urethral hypermobility with intrinsic sphincter deficiency, as defined by low leak-point pressures or low maximal urethral closure pressures.2– 6 Patients with low–leak-point-pressure and low– closure-pressure urethras may have a higher risk of failure when standard urethropexy procedures are done.7 Intrinsic urethral sphincter deficiency may be caused by extensive perineal nerve damage to the striated urethral sphincter through vaginal delivery, chronically increased pressure on the pelvic floor from severe asthma, chronic cough, obesity, constipation, and previous antiincontinence procedures that include anterior vaginal wall dissection.8 –11 The purpose of this study was to evaluate the efficacy and side effects of the rectus fascia suburethral sling and to determine whether preoperative urodynamic or clinical variables are related to objective outcome.
Materials and Methods From March 1994 to August 1996, suburethral sling procedures were performed in 50 patients at RushPresbyterian-St. Luke’s Medical Center by three attending surgeons and fellows under the direct supervision of the attending surgeons. A retrospective review of these patients’ charts was performed. All patients underwent a preoperative directed urogynecologic history and physical examination, review of a 24-hour urinary diary, postvoid residual check within 10 minutes of a spontaneous void, cotton-swab test for urethral hypermobility, and multichannel urodynamic evaluation recorded on the Life-Tech (Model 1106 Urolab; Life-Tech, Inc, Houston, TX) or Wiest-Merkur (Model 4000; WiestMerkur, Munich, Germany). All terminology conforms
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577
to the recommendations made by the International Continence Society unless otherwise stated.12 Cystometry was performed at a filling rate of 80 mL/min with the patient in the seated upright position in a birthing chair. A dual-tip micro-transducer catheter measured urethral and vesical pressures and a singletip catheter measured abdominal pressure transvaginally or transrectally (SUPC 3805 and 7805; Millar Instruments, Houston, TX). Static and cough urethral pressure profiles were obtained with the patient in the sitting, 45° upright position, at maximal cystometric capacity. Genuine stress incontinence was diagnosed if urine loss was demonstrated with coughing at maximal cystometric capacity in the absence of a detrusor contraction. Low urethral closure pressure was defined as a maximal urethral closure pressure of 20 cm H2O or less at maximal capacity in the seated position. Pressureflow studies were performed at maximal cystometric capacity. Maximal abdominal pressure caused by the Valsalva and maximal detrusor pressure values used in the study were the maximum values obtained during pressure-flow studies. Patients with an abdominal pressure increase of at least a 10 cm H2O, compared with the baseline abdominal pressure, during voiding were considered to belong to the Valsalva group. Patients with maximal urethral closure pressures of less than or equal to 20 cm H2O were considered to have intrinsic sphincter deficiency. Urethral hypermobility or hypomobility was not used as a criterion for intrinsic sphincter deficiency. All patients had genuine stress incontinence. Suburethral sling procedures were performed in patients with low urethral closure pressures and in patients with normal urethral closure pressures and no urethral hypermobility. No patients with both hypermobility and urethral closure pressures greater than 20 cm H2O underwent this procedure. Suburethral sling procedures with rectus fascia were performed using a two-team vaginal and abdominal approach. From an abdominal midline or Pfannenstiel incision, a rectangular graft of rectus fascia was excised (approximately 1.5–2 cm wide by 8 –10 cm long). The four graft corners were tagged with 2-0 Gore-Tex (polytetrafluoroethylene; W. L. Gore & Assoc, Flagstaff, AZ) or 2-0 Prolene (polypropylene; Ethicon, Somerville, NJ) sutures. If previous retropubic dissections had been performed, the Retzius space was entered and any adhesions between the bladder or urethra and symphysis pubis were taken down using sharp dissection. The rectus fascia was closed with running delayed absorbable suture, either Maxon (polyglyconate; SherwoodDavis & Geck, Danbury, CT) or PDS (polydioxanone; Ethicon). The vaginal mucosa then was dissected from the underlying fascia, and the paraurethral spaces were
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developed bilaterally. The retropubic space was entered vaginally using a combination of sharp and blunt dissection. A separate stab incision then was made along the inferior portion of the closed rectus fascia sheath, and a uterine packing forceps was guided through with the surgeon’s index finger into the vaginal incision. The fascial sling tags then were brought up bilaterally. The midportion of the sling was stabilized in position with interrupted 2-0 polyglycolic acid suture (Dexon; Sherwood-Davis & Geck) at the urethrovesical junction and bladder base. The arms of the graft were secured to the rectus fascia by drawing the Gore-Tex sutures through both sides of the stab wound. Graft tension was described as mere placement by one attending surgeon and was guided until a cotton-tipped swab at the urethrovesical junction created an angle of 0° from horizontal for the other two attendings. Cystourethroscopy was performed before the sling was secured to the rectus fascia, to detect any lower urinary tract injury and to ensure sling positioning at the bladder neck. The sling was not tied down to rectus fascia or secured suburethrally until good placement, bladder integrity, and ureteral efflux were confirmed cystourethroscopically. A 14-French Rutner suprapubic balloon catheter (Cook/Ob/Gyn, Spencer, IN) was placed in all patients under direct cystoscopic guidance. The skin was closed with skin staples in most cases. All patients received preoperative antibiotics, usually 1 g of intravenous cefoxitin, preoperatively and 12 hours later. Voiding trials began on postoperative day 1. The suprapubic catheter was removed when the postvoid residual volume was less than one-fourth of the voided volume (usually less than 100 mL) over 48 hours. Patients were taught intermittent self-catheterization techniques if they were unable to void spontaneously or if the residual volumes remained elevated at 3 weeks postoperatively. At 12 weeks postoperatively, 48 patients returned for questioning about pelvic floor symptoms, including lower urinary tract function, and for multichannel urodynamic evaluation (17 patients) or single-channel urodynamic studies (31 patients). The single-channel cystometrogram was performed with the patient in the standing position, using the Life-Tech Model 1101MC urodynamic machine with a 10 French filling catheter and a 4 French bladder pressure catheter (Life-Tech, Inc). Postoperative urodynamic evidence of genuine stress urinary incontinence was considered objective failure, regardless of symptoms. SPSS 6 (Statistical Package for Social Sciences; SPSS, Inc, Chicago, IL) was used for data management and statistical analysis. Groups were compared with respect to nominal data using the x2 test of association; with
Obstetrics & Gynecology
Table 1. Summary of Reports on Suburethral Slings With Fascia No. of patients
Study 15
Fascia type
McGuire and Lytton
52
Rectus fascia
Parker et al16
50
Fascia lata
Beck and Lai17 Beck et al4 Rottenberg et al18
88 170 36 67
Fascia lata Fascia lata Homologous dura mater Rectus fascia
108
Rectus fascia
Blaivas and Jacobs19
Muller et al20
Kreder and Austin6
28
Rectus fascia or fascia lata
Mason and Roach21
63
Rectus fascia
Zaragoza22
60
Rectus fascia
Handa et al23
16
Allogenic fascia lata
Govier et al24
32
Fascia lata
Indication
Cure rate (%)
Previous surgery unsuccessful in 42 patients or urethral pressure ,10 cm H2O Previous surgery unsuccessful in 47 patients Previous surgery unsuccessful Previous surgery unsuccessful Previous surgery unsuccessful in 16 patients Previous surgery unsuccessful, “neurogenic bladder,” diverticulum/urethrovaginal fistula Previous surgery unsuccessful in 72 patients
Previous surgery unsuccessful or abdominal leak-point and video-urodynamics Leak-point pressure and videourodynamics of open bladder neck Video-urodynamics and leakpoint pressure MUCP ,20 cm H2O or recurrent stress incontinence with UVJ hypermobility Leak-point pressure ,50 cm H2O
Follow-up (y)
80 (subjective)
2.3
84 (subjective)
mean 10 (1–21)
89 (subjective) 98 (subjective) 89 (objective)
0.5–2 0.5–10 0.5
82 (subjective)
mean 3.5 (1– 8)
62 if previous surgery unsuccessful; 78 if no previous surgery (both subjective) 81 (subjective)
mean 5
mean 1.8
93 (subjective)
0.9
95 (subjective)
2.1
86 (subjective) 77 (objective)
0.5–1
87 (subjective)
mean 1.2
MUCP 5 maximal urethral closure pressure; UVJ 5 urethrovesical junction.
respect to nonnominal, statistically nonnormal data using the nonparametric Mann-Whitney test; and with respect to normally distributed data using pooledvariance or separate-variance t tests. The Levene test was done to determine whether the pooled-variance or separate-variance t test should be used. All statistical tests were two-sided, with a .05 significance level. Means are presented as mean 6 standard deviation. The sample size of 48 patients with postoperative evaluations ensured 80% power for detecting a fairly large effect (Cohen’s effect size w 5 0.41), based on the x2 test of association with a .05 significance level.13
Results Patients had a mean age of 64 6 11 years (range 39 – 86), a mean weight of 163 6 31 lb (range 115–268), and a mean vaginal parity of 2.8 6 1.8 (range 0 –9). Only four patients were nulliparous. Eighty-eight percent were postmenopausal, and 67% of postmenopausal patients
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were undergoing estrogen replacement therapy. Most patients (94%) were white. Forty-four patients (88%) had intrinsic sphincter deficiency, with hypermobile urethras in 60% and hypomobile urethras in the remainder. Twenty-six patients (52%) underwent the rectus fascia suburethral sling procedure alone, and the other 24 patients had a total of 56 concomitant procedures: 14 posterior colporrhaphies, 11 anterior colporrhaphies, ten transvaginal enterocele repairs, six sacrospinous ligament suspensions, four vaginal hysterectomies, three abdominal hysterectomies, two sacrocolpopexies, two abdominal cul-de-sac obliterations, two anal sphincteroplasties, one paravaginal repair, and one abdominoplasty. Twenty-four patients (48%) underwent primary sling procedures, and 26 patients had a total of 43 previous anti-incontinence surgeries: 21 anterior repairs, ten Burch procedures, eight needle suspensions, two collagen injections, one Gore-Tex sling procedure, and one paravaginal repair.
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The only intraoperative complication was an incidental cystotomy, which was recognized immediately and repaired transvaginally. No patients required blood transfusions. Postoperative complications consisted of wound infection (two patients), intraperitoneal urine extravasation (one patient), deep venous thrombosis (one patient), and long-term urinary retention requiring sling arm release (one patient).14 At 3 months, 47 patients (94%) reported subjective cure of stress incontinence. Based on urodynamic evaluation, the objective cure rate for the 48 patients with complete follow-up was 73%. Of the two patients who did not return for the 3-month evaluation, one was still incontinent and the other was subjectively continent. Preoperative urethrovesical junction mobility was not related to objective cure rate (P 5 .71). In the 20 patients with preoperatively stable bladders and urodynamic follow-up, the incidence of postoperative detrusor instability was 30%. Sixty-seven percent of these patients with de novo detrusor instability required postoperative pharmacologic treatment. Twenty-eight (58%) of the patients with urodynamic follow-up had preoperative uninhibited bladder contractions, which resolved after surgery in 43% of these patients. The mean duration of postoperative suprapubic catheterization or intermittent self-catheterization was 21 6 18 days (median 14, range 2–76). There was no statistically significant difference between patients who were cured objectively and patients who were not cured objectively with respect to the duration of postoperative catheterization (P 5 .29). The 13 patients with postoperative urodynamic evaluation who were identified preoperatively as voiding because of the Valsalva maneuver had a 54% rate of objective failure, compared with a rate of only 17% for the 35 patients with postoperative urodynamic evaluation and no such preoperative voiding component (P 5 .011). Patients in the Valsalva group also tended to have longer durations of postoperative catheterization (median 23 days) than did patients in the non-Valsalva group (median 14 days) (P 5 .049). The difference between patients in the Valsalva group and those in the non-Valsalva group with respect to objective cure rate cannot be accounted for by potential confounding variables for which data were obtained. There were no statistically significant differences between patients in the Valsalva group and those in the non-Valsalva group with respect to age, weight, parity, postmenopausal status, previous incontinence surgery, concomitant procedures, preoperative urethrovesical junction hypermobility, or preoperative presence of uterine prolapse, cuff prolapse, cystocele, enterocele, or rectocele (P $ .17).
580 Iglesia et al
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Discussion Our subjective and objective 3-month cure rates are similar to cure rates reported for sling procedures using other autologous tissues (Table 1). This technique appears to be associated with minimal morbidity. The higher objective failure rate and longer durations of postoperative catheterization among patients in the Valsalva group suggest that immediate postoperative Valsalva maneuvers may impair sling integrity by causing stress along the sling attachments to the anterior abdominal wall. Sutures attaching the sling to the abdominal wall may be pulled out of the rectus fascia anchor or through the corners of the rectus patch. The data warrant cautioning patients about an increased risk of surgical failure for those whose voiding is caused by the Valsalva maneuver. It also may be necessary to teach patients to stop such voiding preoperatively, perhaps through the use of biofeedback with abdominal surface electrodes.
References 1. Hohenfellner R, Petrie F. Sling procedures. In: Stanton SL, Tanagho E, eds. Surgery of female incontinence. 2nd ed. New York: Springer-Verlag, 1986:105–13. 2. Morgan JE. The Marlex sling operation for the treatment of recurrent stress urinary incontinence: A 16-year review. Am J Obstet Gynecol 1985;151:224 – 6. 3. Horbach NS. Suburethral sling procedures. In: Ostergard DR, Bent AE, eds. Urogynecology and urodynamics: Theory and practice. 3rd ed. Baltimore: Williams & Wilkins, 1991:449 –58. 4. Beck RP, McCormick RN, Nordstrom L. The fascia lata sling procedure for treating recurrent genuine stress incontinence of urine. Obstet Gynecol 1988;72:699 –703. 5. Ghoniem GM, Shaaban A. Sub-urethral slings for treatment of stress urinary incontinence. Int Urogynecol J 1994;5:228 –39. 6. Kreder KJ, Austin JC. Treatment of stress urinary incontinence in women with urethral hypermobility and intrinsic sphincteric deficiency. J Urol 1996;156:1995– 6. 7. Bowen LW, Sand PK, Ostergard DR, Franti CE. Unsuccessful Burch retropubic urethropexy: A case-controlled urodynamic study. Am J Obstet Gynecol 1989;160:452– 8. 8. Benson JT, McClellan E. The effect of vaginal dissection on the pudendal nerve. Obstet Gynecol 1993;82:387–9. 9. Zivkovic F, Tamussino K, Ralph G, Schied G, Auer-Grumbach M. Long-term effects of vaginal dissection on the innervation of the striated urethral sphincter. Obstet Gynecol 1996;87:257– 60. 10. Stanton SL, Cardoza L, Williams JE, Ritchie D, Allan V. Clinical and urodynamic features of failed incontinence surgery in the female. Obstet Gynecol 1978;51:515–20. 11. McGuire EJ, Wan J. Pubovaginal slings. In: Hurt WG, ed. Urogynecologic surgery. Gaithersburg, Maryland: Aspen Publications, 1992:97–105. 12. Abrams P, Blaivas JG, Stanton SL, Andersen JT. The standardization of terminology of lower urinary tract function recommended by the International Continence Society. Int Urogynecol J 1990;1: 45– 8. 13. Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. Hillsdale, NJ: Erlbaum, 1988.
Obstetrics & Gynecology
14. Brubaker L. Suburethral sling release. Obstet Gynecol 1995;86: 686 – 8. 15. McGuire EJ, Lytton B. Pubovaginal sling procedure for stress incontinence. J Urol 1978;119:82– 4. 16. Parker RT, Addison WA, Wilson CJ. Fascia lata urethrovesical suspension for recurrent stress urinary incontinence. Am J Obstet Gynecol 1979;135:843–52. 17. 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;142:649 –51. 18. Rottenberg RD, Weil A, Brioschi PA, Bischof P, Krauer F. Urodynamic and clinical assessment of the Lyodura sling operation for urinary stress incontinence. Br J Obstet Gynaecol 1985;92:829 –34. 19. Blaivas JG, Jacobs BZ. Pubovaginal fascial sling for the treatment of complicated stress urinary incontinence. J Urol 1991;145:1214 – 8. 20. Muller SC, Steinbach FM, Maurer FM, Melchior SW, Stein R, Hohenfellner R. Long-term results of fascial sling procedure. Int Urogynecol J 1993;4:199 –203. 21. Mason RC, Roach M. Modified pubovaginal sling for treatment of intrinsic sphincteric deficiency. J Urol 1996;156:1991– 4. 22. Zaragoza MR. Expanded indications for the pubovaginal sling: Treatment of type 2 or 3 stress incontinence. J Urol 1996;156: 1620 –2. 23. Handa VL, Jensen JK, Germain MM, Ostergard DR. Banked
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human fascia lata for the suburethral sling procedure: A preliminary report. Obstet Gynecol 1996;88:1045–9. 24. Govier FE, Gibbons RP, Correa RJ, Weissman RM, Pritchett TR, Hefty TR. Pubovaginal slings using fascia lata for the treatment of intrinsic sphincter deficiency. J Urol 1997;157:117–21.
Address reprint requests to:
Cheryl B. Iglesia, MD Section of Urogynecology Celebration Health and Florida Hospital 400 Celebration Place, Suite B200 Celebration, FL 34747 E-mail: [email protected]
Received July 21, 1997. Received in revised form December 5, 1997. Accepted December 12, 1997. Copyright © 1998 by The American College of Obstetricians and Gynecologists. Published by Elsevier Science Inc.
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The suburethral sling procedure is an established operation for the treatment of genuine stress incontinence.1 From the Sections of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, and Biostatistics, Department of Neurosurgery, Rush-Presbyterian-St. Luke’s Medical Center, Chicago, Illinois.
VOL. 91, NO. 4, APRIL 1998
This operation has been used in patients with recurrent genuine stress urinary incontinence, urethral hypomobility, or urethral hypermobility with intrinsic sphincter deficiency, as defined by low leak-point pressures or low maximal urethral closure pressures.2– 6 Patients with low–leak-point-pressure and low– closure-pressure urethras may have a higher risk of failure when standard urethropexy procedures are done.7 Intrinsic urethral sphincter deficiency may be caused by extensive perineal nerve damage to the striated urethral sphincter through vaginal delivery, chronically increased pressure on the pelvic floor from severe asthma, chronic cough, obesity, constipation, and previous antiincontinence procedures that include anterior vaginal wall dissection.8 –11 The purpose of this study was to evaluate the efficacy and side effects of the rectus fascia suburethral sling and to determine whether preoperative urodynamic or clinical variables are related to objective outcome.
Materials and Methods From March 1994 to August 1996, suburethral sling procedures were performed in 50 patients at RushPresbyterian-St. Luke’s Medical Center by three attending surgeons and fellows under the direct supervision of the attending surgeons. A retrospective review of these patients’ charts was performed. All patients underwent a preoperative directed urogynecologic history and physical examination, review of a 24-hour urinary diary, postvoid residual check within 10 minutes of a spontaneous void, cotton-swab test for urethral hypermobility, and multichannel urodynamic evaluation recorded on the Life-Tech (Model 1106 Urolab; Life-Tech, Inc, Houston, TX) or Wiest-Merkur (Model 4000; WiestMerkur, Munich, Germany). All terminology conforms
0029-7844/98/$19.00 PII S0029-7844(98)00029-5
577
to the recommendations made by the International Continence Society unless otherwise stated.12 Cystometry was performed at a filling rate of 80 mL/min with the patient in the seated upright position in a birthing chair. A dual-tip micro-transducer catheter measured urethral and vesical pressures and a singletip catheter measured abdominal pressure transvaginally or transrectally (SUPC 3805 and 7805; Millar Instruments, Houston, TX). Static and cough urethral pressure profiles were obtained with the patient in the sitting, 45° upright position, at maximal cystometric capacity. Genuine stress incontinence was diagnosed if urine loss was demonstrated with coughing at maximal cystometric capacity in the absence of a detrusor contraction. Low urethral closure pressure was defined as a maximal urethral closure pressure of 20 cm H2O or less at maximal capacity in the seated position. Pressureflow studies were performed at maximal cystometric capacity. Maximal abdominal pressure caused by the Valsalva and maximal detrusor pressure values used in the study were the maximum values obtained during pressure-flow studies. Patients with an abdominal pressure increase of at least a 10 cm H2O, compared with the baseline abdominal pressure, during voiding were considered to belong to the Valsalva group. Patients with maximal urethral closure pressures of less than or equal to 20 cm H2O were considered to have intrinsic sphincter deficiency. Urethral hypermobility or hypomobility was not used as a criterion for intrinsic sphincter deficiency. All patients had genuine stress incontinence. Suburethral sling procedures were performed in patients with low urethral closure pressures and in patients with normal urethral closure pressures and no urethral hypermobility. No patients with both hypermobility and urethral closure pressures greater than 20 cm H2O underwent this procedure. Suburethral sling procedures with rectus fascia were performed using a two-team vaginal and abdominal approach. From an abdominal midline or Pfannenstiel incision, a rectangular graft of rectus fascia was excised (approximately 1.5–2 cm wide by 8 –10 cm long). The four graft corners were tagged with 2-0 Gore-Tex (polytetrafluoroethylene; W. L. Gore & Assoc, Flagstaff, AZ) or 2-0 Prolene (polypropylene; Ethicon, Somerville, NJ) sutures. If previous retropubic dissections had been performed, the Retzius space was entered and any adhesions between the bladder or urethra and symphysis pubis were taken down using sharp dissection. The rectus fascia was closed with running delayed absorbable suture, either Maxon (polyglyconate; SherwoodDavis & Geck, Danbury, CT) or PDS (polydioxanone; Ethicon). The vaginal mucosa then was dissected from the underlying fascia, and the paraurethral spaces were
578 Iglesia et al
Suburethral Sling Efficacy
developed bilaterally. The retropubic space was entered vaginally using a combination of sharp and blunt dissection. A separate stab incision then was made along the inferior portion of the closed rectus fascia sheath, and a uterine packing forceps was guided through with the surgeon’s index finger into the vaginal incision. The fascial sling tags then were brought up bilaterally. The midportion of the sling was stabilized in position with interrupted 2-0 polyglycolic acid suture (Dexon; Sherwood-Davis & Geck) at the urethrovesical junction and bladder base. The arms of the graft were secured to the rectus fascia by drawing the Gore-Tex sutures through both sides of the stab wound. Graft tension was described as mere placement by one attending surgeon and was guided until a cotton-tipped swab at the urethrovesical junction created an angle of 0° from horizontal for the other two attendings. Cystourethroscopy was performed before the sling was secured to the rectus fascia, to detect any lower urinary tract injury and to ensure sling positioning at the bladder neck. The sling was not tied down to rectus fascia or secured suburethrally until good placement, bladder integrity, and ureteral efflux were confirmed cystourethroscopically. A 14-French Rutner suprapubic balloon catheter (Cook/Ob/Gyn, Spencer, IN) was placed in all patients under direct cystoscopic guidance. The skin was closed with skin staples in most cases. All patients received preoperative antibiotics, usually 1 g of intravenous cefoxitin, preoperatively and 12 hours later. Voiding trials began on postoperative day 1. The suprapubic catheter was removed when the postvoid residual volume was less than one-fourth of the voided volume (usually less than 100 mL) over 48 hours. Patients were taught intermittent self-catheterization techniques if they were unable to void spontaneously or if the residual volumes remained elevated at 3 weeks postoperatively. At 12 weeks postoperatively, 48 patients returned for questioning about pelvic floor symptoms, including lower urinary tract function, and for multichannel urodynamic evaluation (17 patients) or single-channel urodynamic studies (31 patients). The single-channel cystometrogram was performed with the patient in the standing position, using the Life-Tech Model 1101MC urodynamic machine with a 10 French filling catheter and a 4 French bladder pressure catheter (Life-Tech, Inc). Postoperative urodynamic evidence of genuine stress urinary incontinence was considered objective failure, regardless of symptoms. SPSS 6 (Statistical Package for Social Sciences; SPSS, Inc, Chicago, IL) was used for data management and statistical analysis. Groups were compared with respect to nominal data using the x2 test of association; with
Obstetrics & Gynecology
Table 1. Summary of Reports on Suburethral Slings With Fascia No. of patients
Study 15
Fascia type
McGuire and Lytton
52
Rectus fascia
Parker et al16
50
Fascia lata
Beck and Lai17 Beck et al4 Rottenberg et al18
88 170 36 67
Fascia lata Fascia lata Homologous dura mater Rectus fascia
108
Rectus fascia
Blaivas and Jacobs19
Muller et al20
Kreder and Austin6
28
Rectus fascia or fascia lata
Mason and Roach21
63
Rectus fascia
Zaragoza22
60
Rectus fascia
Handa et al23
16
Allogenic fascia lata
Govier et al24
32
Fascia lata
Indication
Cure rate (%)
Previous surgery unsuccessful in 42 patients or urethral pressure ,10 cm H2O Previous surgery unsuccessful in 47 patients Previous surgery unsuccessful Previous surgery unsuccessful Previous surgery unsuccessful in 16 patients Previous surgery unsuccessful, “neurogenic bladder,” diverticulum/urethrovaginal fistula Previous surgery unsuccessful in 72 patients
Previous surgery unsuccessful or abdominal leak-point and video-urodynamics Leak-point pressure and videourodynamics of open bladder neck Video-urodynamics and leakpoint pressure MUCP ,20 cm H2O or recurrent stress incontinence with UVJ hypermobility Leak-point pressure ,50 cm H2O
Follow-up (y)
80 (subjective)
2.3
84 (subjective)
mean 10 (1–21)
89 (subjective) 98 (subjective) 89 (objective)
0.5–2 0.5–10 0.5
82 (subjective)
mean 3.5 (1– 8)
62 if previous surgery unsuccessful; 78 if no previous surgery (both subjective) 81 (subjective)
mean 5
mean 1.8
93 (subjective)
0.9
95 (subjective)
2.1
86 (subjective) 77 (objective)
0.5–1
87 (subjective)
mean 1.2
MUCP 5 maximal urethral closure pressure; UVJ 5 urethrovesical junction.
respect to nonnominal, statistically nonnormal data using the nonparametric Mann-Whitney test; and with respect to normally distributed data using pooledvariance or separate-variance t tests. The Levene test was done to determine whether the pooled-variance or separate-variance t test should be used. All statistical tests were two-sided, with a .05 significance level. Means are presented as mean 6 standard deviation. The sample size of 48 patients with postoperative evaluations ensured 80% power for detecting a fairly large effect (Cohen’s effect size w 5 0.41), based on the x2 test of association with a .05 significance level.13
Results Patients had a mean age of 64 6 11 years (range 39 – 86), a mean weight of 163 6 31 lb (range 115–268), and a mean vaginal parity of 2.8 6 1.8 (range 0 –9). Only four patients were nulliparous. Eighty-eight percent were postmenopausal, and 67% of postmenopausal patients
VOL. 91, NO. 4, APRIL 1998
were undergoing estrogen replacement therapy. Most patients (94%) were white. Forty-four patients (88%) had intrinsic sphincter deficiency, with hypermobile urethras in 60% and hypomobile urethras in the remainder. Twenty-six patients (52%) underwent the rectus fascia suburethral sling procedure alone, and the other 24 patients had a total of 56 concomitant procedures: 14 posterior colporrhaphies, 11 anterior colporrhaphies, ten transvaginal enterocele repairs, six sacrospinous ligament suspensions, four vaginal hysterectomies, three abdominal hysterectomies, two sacrocolpopexies, two abdominal cul-de-sac obliterations, two anal sphincteroplasties, one paravaginal repair, and one abdominoplasty. Twenty-four patients (48%) underwent primary sling procedures, and 26 patients had a total of 43 previous anti-incontinence surgeries: 21 anterior repairs, ten Burch procedures, eight needle suspensions, two collagen injections, one Gore-Tex sling procedure, and one paravaginal repair.
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The only intraoperative complication was an incidental cystotomy, which was recognized immediately and repaired transvaginally. No patients required blood transfusions. Postoperative complications consisted of wound infection (two patients), intraperitoneal urine extravasation (one patient), deep venous thrombosis (one patient), and long-term urinary retention requiring sling arm release (one patient).14 At 3 months, 47 patients (94%) reported subjective cure of stress incontinence. Based on urodynamic evaluation, the objective cure rate for the 48 patients with complete follow-up was 73%. Of the two patients who did not return for the 3-month evaluation, one was still incontinent and the other was subjectively continent. Preoperative urethrovesical junction mobility was not related to objective cure rate (P 5 .71). In the 20 patients with preoperatively stable bladders and urodynamic follow-up, the incidence of postoperative detrusor instability was 30%. Sixty-seven percent of these patients with de novo detrusor instability required postoperative pharmacologic treatment. Twenty-eight (58%) of the patients with urodynamic follow-up had preoperative uninhibited bladder contractions, which resolved after surgery in 43% of these patients. The mean duration of postoperative suprapubic catheterization or intermittent self-catheterization was 21 6 18 days (median 14, range 2–76). There was no statistically significant difference between patients who were cured objectively and patients who were not cured objectively with respect to the duration of postoperative catheterization (P 5 .29). The 13 patients with postoperative urodynamic evaluation who were identified preoperatively as voiding because of the Valsalva maneuver had a 54% rate of objective failure, compared with a rate of only 17% for the 35 patients with postoperative urodynamic evaluation and no such preoperative voiding component (P 5 .011). Patients in the Valsalva group also tended to have longer durations of postoperative catheterization (median 23 days) than did patients in the non-Valsalva group (median 14 days) (P 5 .049). The difference between patients in the Valsalva group and those in the non-Valsalva group with respect to objective cure rate cannot be accounted for by potential confounding variables for which data were obtained. There were no statistically significant differences between patients in the Valsalva group and those in the non-Valsalva group with respect to age, weight, parity, postmenopausal status, previous incontinence surgery, concomitant procedures, preoperative urethrovesical junction hypermobility, or preoperative presence of uterine prolapse, cuff prolapse, cystocele, enterocele, or rectocele (P $ .17).
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Discussion Our subjective and objective 3-month cure rates are similar to cure rates reported for sling procedures using other autologous tissues (Table 1). This technique appears to be associated with minimal morbidity. The higher objective failure rate and longer durations of postoperative catheterization among patients in the Valsalva group suggest that immediate postoperative Valsalva maneuvers may impair sling integrity by causing stress along the sling attachments to the anterior abdominal wall. Sutures attaching the sling to the abdominal wall may be pulled out of the rectus fascia anchor or through the corners of the rectus patch. The data warrant cautioning patients about an increased risk of surgical failure for those whose voiding is caused by the Valsalva maneuver. It also may be necessary to teach patients to stop such voiding preoperatively, perhaps through the use of biofeedback with abdominal surface electrodes.
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human fascia lata for the suburethral sling procedure: A preliminary report. Obstet Gynecol 1996;88:1045–9. 24. Govier FE, Gibbons RP, Correa RJ, Weissman RM, Pritchett TR, Hefty TR. Pubovaginal slings using fascia lata for the treatment of intrinsic sphincter deficiency. J Urol 1997;157:117–21.
Address reprint requests to:
Cheryl B. Iglesia, MD Section of Urogynecology Celebration Health and Florida Hospital 400 Celebration Place, Suite B200 Celebration, FL 34747 E-mail: [email protected]
Received July 21, 1997. Received in revised form December 5, 1997. Accepted December 12, 1997. Copyright © 1998 by The American College of Obstetricians and Gynecologists. Published by Elsevier Science Inc.
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