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Comparison of long-term outcomes of autologous fascia lata slings with Suspend Tutoplast fascia lata allograft slings for stress incontinence
American Journal of Obstetrics and Gynecology (2005) 192, 1677–81
www.ajog.org
Comparison of long-term outcomes of autologous fascia lata slings with Suspend Tutoplast fascia lata allograft slings for stress incontinence Andrew W. McBride, MD,a,b,d,* R. Mark Ellerkmann, MD,b Alfred E. Bent, MD,b Clifford F. Melick, PhDc Department of Obstetrics, Gynecology and Reproductive Sciences, University of Maryland Medical System,a Departments of Gynecologyb and Surgery,c Greater Baltimore Medical Center, Baltimore, Md, and Exempla Saint Joseph Hospital,d Denver, Colo
KEY WORDS Stress incontinence Suburethral sling Allograft Autograft
Objective: This study was undertaken to compare the objective and subjective long-term surgical outcomes in patients receiving Tutoplast fascia lata allograft slings with those receiving autograft slings for the treatment of stress urinary incontinence (SUI). Study design: We reviewed all patients (n = 71) undergoing suburethral sling with either autologous fascia lata (n = 39) or Tutoplast fascia lata (n = 32) for urodynamic stress incontinence (USI) from October 1, 1998, to August 1, 2001. Results: Of the original 71 patients, 47 were evaluated by objective and/or subjective means at a minimum of 2 years after surgery. Subjective quality of life measures, subjective continence, maximum urethral closure pressure, and bladder neck mobility were not different between the 2 groups. USI was demonstrated in 41.7% of allograft patients compared with no autograft patients (P = .007). Conclusion: Although patient reported cure of SUI is high for both sling types, USI recurs at a significantly higher rate in Tutoplast slings compared with autologous slings. Ó 2005 Mosby, Inc. All rights reserved.
The suburethral sling procedure, first described by von Giordano in 1907, has been modified over time to its current status as a reliable and long-lasting treatment for stress urinary incontinence (SUI).1 In the past,
Supported by an unrestricted grant by Mentor. Presented at the Joint Scientific Meeting of the Society of Gynecologic Surgeons and the American Urogynecologic Society, San Diego, Calif, July 29-31, 2004. * Reprint requests: Andrew W. McBride, MD, Mountain States Gynecology and Continence Center, 2005 Franklin St, Midtown 2, Suite 600, Denver, CO 80205. E-mail: [email protected] 0002-9378/$ - see front matter Ó 2005 Mosby, Inc. All rights reserved. doi:10.1016/j.ajog.2005.01.078
suburethral slings have been used primarily for the treatment of intrinsic sphincter deficiency (ISD) or recurrent SUI. With most cure and improvement rates ranging from 84% to 92%1 and proven durability, the sling has become widely used for all types of stress incontinence. Traditionally, autologous slings have been constructed from fascia obtained from the abdominal rectus fascia or tensor fascia lata. These autografts have the benefit of a significantly decreased risk of rejection or erosion when compared to synthetic slings.2 Cosmetic concerns and the discomfort associated with harvesting these materials, as well as the additional operating time
1678 have resulted in surgeons seeking alternative materials. Many synthetic, allogenic, and xenogenic materials have been developed and advocated for use as suburethral slings in recent years. Human cadaveric allografts have been used with the hope of a low risk of erosion and rejection compared with synthetic slings, while maintaining outcomes similar to autografts. Suspend Tutoplast (Mentor Co., Santa Barbara, CA) is a commercially available solvent dehydrated fascia lata harvested and processed by a standardized method. We began offering Tutoplast allograft slings as an alternative to autologous slings in 1998 to patients with stress incontinence. The purpose of this study is to evaluate and compare the long-term objective and subjective outcomes in a cohort of women receiving either an autologous fascia lata or allograft fascia lata suburethral sling for urodynamic stress incontinence (USI).
Study design Approval from the Greater Baltimore Medical Center Institutional Review Board was obtained before starting the study. Between October 1, 1998, and August 1, 2001, case list and chart review revealed 71 patients that underwent suburethral sling procedures with fascia lata for urodynamically proven stress incontinence by the senior authors (A.E.B. and R.M.E.). Only patients who received full length slings from either autologous fascia lata (n = 39) or Tutoplast allograft fascia lata (n = 32) and demonstrated USI were considered for study enrollment. Preoperative evaluation in all patients included voiding diary, intake history and physical, complete urogynecologic pelvic examination and grading of prolapse by the Pelvic Organ Prolapse Quantitation (POPQ) examination, and Q-tip urethral mobility assessment. Only patients who underwent multichannel urodynamics including voiding studies, cystometry with Valsalva leak point pressures (VLPP), and urethral profilometry were eligible. Choice of anti-incontinence procedure and material used, as well as other concomitant procedures, was made by the operating physician and patient preference after counseling. Autologous fascia lata slings (autografts) were constructed by harvesting a 2-cm wide strip of fascia from the patient’s tensor fascia lata. A strip of sufficient length was harvested such that the sling could be secured to the rectus fascia on both sides of the midline after placement under the proximal urethra. Generally, midline vaginal epithelial incisions underlying the proximal urethra were used for access to the periurethral space and space of Retzius and passage of the sling. The sling was placed loosely under the proximal urethra and secured by 3 to 4 interrupted delayed absorbable sutures. Each sling end was then secured to the rectus fascia with prolypropylene sutures. Full-length allograft slings were constructed from Tutoplast, solvent
McBride et al dehydrated, gamma-irradiated cadaveric fascia lata. Allograft strips of either 18 ! 2 cm or 12 ! 4 cm were used to construct full-length slings that were placed under the proximal urethra in an identical fashion to autografts. Suprapubic catheters were placed in all patients through separate stab incisions at the termination of the procedure. Adjunctive hysterectomy or prolapse repair was generally performed after harvesting but before sling placement. All procedures were performed by or under the supervision of A.E.B. or R.M.E. Investigational follow-up was initiated with a general mailing to all patients eligible for study enrollment soliciting their participation. Enrolled patients returned for an interview by a single investigator who gathered the pertinent medical and surgical history. This investigator (A.W.M.) was not involved in the original surgery and not blinded to which sling type the patient received. This same person administered the short form of the Incontinence Impact Questionnaire (IIQ-7), the short form of the Urogenital Distress Inventory (UDI-6), and questions regarding patient reported stress continence status (Stamey continence grading), pads used per day, and incontinent episodes per day. Patients who returned for examination and urodynamics were given the questions and allowed to complete them on their own. Patients declining examination were administered the questions over the phone. Preoperative and postoperative urodynamic evaluation was performed with the use of a Laborie System with Millar 8F duel channel intravesical catheter and an 8F intravaginal/intrarectal catheter in the seated upright position. Multichannel urodynamics were performed according to the International Continence Society Guidelines in the seated upright position by a single examiner not involved in the original surgery and not blinded to which procedure the patient underwent (A.W.M.). The few modifications included assessment of VLPP at 150, 200, and 300 mL. If no leakage occurred with Valsalva, filling was halted at 300 mL, the intravesical catheter was removed, and the patient was asked to stand and forcefully cough 3 times. Filling was then resumed after placement of the intravesical catheter until maximum cystometric capacity. Cystometric capacity, bladder compliance, VLPPs, results of standing stress test, and presence or absence of detrusor overactivity was recorded. Recurrence of USI was defined as observed leakage at the time of coughing or straining during cystometry or standing stress test. Resting urethral pressure profiles were obtained with a profilometer withdrawing the urethral catheter from the full bladder at 1 mm/s. The patients were then moved to a different examining chair to have urethral mobility assessment with Q-tip (at rest and maximal strain) and pelvic examination with POP-Q performed in the supine lithotomy position. Statistical analysis was performed with SSPS 11.5 (SSPS Inc, Chicago, Ill). P values were calculated with
McBride et al Table I slings
1679
Characteristics of patients receiving suburethral
Autograft Demographic/characteristic (n = 26)
Allograft (n = 21)
Mean age (y) Parity Prior hysterectomy Prior urologic or prolapse surgery Current HRT/ERT use Body mass index (kg/m) Current smoker Current therapy for OAB Follow-up (mo) Other procedures at time of sling placement
60.7 G 10.5 2.2 G 1.0 53.8% 46.2%
74.0 G 7.4 .000 3.67 G 1.5 .000 61.9% NS 38.1% NS
60.0% 28.3 G 4.0 11.5% 3.8% 42.4 G 9.6 46.2%
47.6% NS 29.7 G 3.5 NS 0 NS 4.8% NS 35.2 G 7.2 .007 90.5% .002
P
HRT, Hormone replacement therapy, ERT, estrogen replacement therapy.
Pearson’s c2 test, Fisher exact test, or the independent samples t test (with Levine’s test for equality of variances), as appropriate. The point-biserial correlation coefficient (rpb) was used to examine relationships between nominaldichotomous measures and ratio measures. An alpha value of less than .05 was considered significant.
Results Of the original 71 patients deemed eligible for the study, 47 returned for evaluation with either objective and/or subjective instruments. The remaining 24 were lost to follow-up or declined entry into the study. Evaluation with examination, urodynamics, and questionnaires was performed on 12 allograft patients and 17 autograft patients. An additional 9 patients in each group completed subjective evaluation. Demographic and preoperative patient characteristics are detailed in Table I. The mean age and parity was significantly greater in the allograft group compared with the autograft group. Other pertinent medical, surgical, and demographic data did not differ significantly between the 2 groups. Mean follow-up was significantly longer for the autograft group (42.4 G 9.6 months) compared with the allograft group (35.2 G 7.2, P = .007). Also, significantly more patients in the allograft group underwent other surgical repairs at time of sling placement compared with the autograft group. Preoperative exam and urodynamic findings are listed in Table II. No differences were seen between the 2 groups in terms of preoperative urethral mobility by Qtip test, maximum urethral closure pressure (MUCP), incidence of detrusor overactivity, bladder capacity, or diagnosis of intrinsic sphincteric deficiency by either VLPP or MUCP. Table III compares the preoperative and postoperative urodynamic and examination findings, as well as the changes in the values between initial
Table II teristics
Preoperative urodynamic and examination charac-
Urodynamic or examination finding
Autograft (n = 26)
Allograft (n = 21)
P
Q-Tip deflection 54.3 G 14.9 53.3 G 13.6 NS (straining angle-resting) Mean MUCP (cm H2O) 28.0 G 12.1 33.1 G 22.8 NS Urodynamic detrusor 16.7% 15.0% NS overactivity Cystometric bladder 456.3 G 143.0 456.4 G 142.9 NS capacity (mL) mean ISD, any 66.7% 40.0% NS 20.2% NS ISD by VLPP %60 cm H2O 45.8% ISD by MUCP %20 cm H2O 41.7% 20.2% NS
and return examinations. No significant differences were demonstrated between the 2 groups in reference to MUCP or urethral mobility determined by Q-tip examination. Five of the 12 (41.7%) allograft patients returning for examination demonstrated USI compared with none of the 17 autograft patients (0, P = .007). Recurrence of USI within the allograft group was moderately related to age (phi = 0.412; P = .026), and moderately inversely related to preoperative VLPP at 200 mL (rpb = ÿ0.589; P = .01). Subjective outcomes from suburethral sling patients are given in Table IV. No significant differences were seen in mean IIQ-7 or UDI-6 scores between the 2 groups. Subscore analysis of questions 1 and 2 of the UDI-6 revealed no significant difference in the number of patients with a raw score of 3 or more, suggesting clinical overactive bladder (OAB). Overall subjective stress continence was reported by 92.3% of autograft patients and 90.5% of allograft patients. No significant difference was seen between the 2 groups in terms of self-reported incontinence episodes. One or no incontinence episodes per day were reported by 84.6% of autograft patients and 90.5% of allograft patients. Patient-reported mean pad use, though, was statistically greater in the allograft group compared with the autograft group.
Comment The suburethral sling has become an increasingly common procedure for the treatment of hypermobile SUI. Long-term data have demonstrated that slings are comparable if not superior to retropubic bladder neck suspensions for the treatment of hypermobile stress incontinence.3 Cadaveric grafts have been used as a substitute for autologous slings to decrease patient morbidity and operating time, as well as avoid erosion problems seen with some synthetic slings. Most clinical data regarding the outcomes of allogenic slings have been favorable. Handa et al4 reported an
1680 Table III
McBride et al Comparison of preoperative and postoperative examination and urodynamic parameters
Urodynamic or examination finding Q-Tip deflection (degrees): Preoperative Postoperative Mean change (post minus pre) Recurrent urodynamic stress incontinence Cystometric bladder capacity (mL): % O300 at postoperative examination Preoperative mean Postoperative mean Preoperative detrusor overactivity Postoperative detrusor overactivity MUCP (cm H2O): Preoperative mean Postoperative mean Mean change (post minus pre)
Autograft (n = 17)
Allograft (n = 12)
P
54.3 G 14.9 12.1 G 10.2 ÿ41.7 G 16.8 0.0%
53.3 G 13.6 18.1 G 12.5 ÿ34.2 G 14.0 41.7%
NS NS NS .007
88.2% 456.3 G 143.0 414.3 G 105.6 16.7% 11.8%
91.7% 456.4 G 142.9 341.1 G 59.9 15.0% 25.0%
NS NS .041 NS NS
28.0 G 12.1 37.1 G 16.7 12.6 G 20.8
33.1 G 22.8 40.4 G 27.5 12.6 G 20.6
Table IV Self-reported and subjective outcomes from suburethral sling procedures Subjective and QoL findings
Autograft (n = 26)
Allograft (n = 21)
Mean IIQ-7 score Mean UDI-6 score Clinical OAB Mean Stamey Stress Continence Grade Mean pad use/day Mean incontinence episodes/day Stamey Stress Continence Grade: Grade 0 Grade 1 Grade 2 or 3 Pad use/day: None 1 2 or more Incontinence episodes/day: None 1 2 or more
10.3 G 1.5 4.1 G 6.8 20.9 G 16.9 20.6 G 14.7 15.4% 14.3% 0.08 G 0.272 0.14 G 0.478
NS NS NS NS
0.29 G 0.493 0.90 G 1.1 0.56 G 0.75 0.71 G 1.1
.024 NS
P
NS 92.3% 7.7% 0.0%
90.5% 4.8% 4.8%
73.1% 26.9% 0.0%
42.9% 38.1% 19.0%
57.7% 26.9% 15.4%
52.4% 38.1% 9.5%
.027
NS
QoL, Quality of life.
early series with an 86% subjective and 79% objective cure rate in patients receiving banked fascia lata suburethral slings. Since then, the majority of series using allograft slings have reported subjective cure rates from 63% to 96%,5-7 but with no controls and no objective evaluation. The few studies that have had controls have all been retrospective and had no significant difference in subjective cure and improvements between allograft and
NS NS NS
autograft patients.8-10 Aside from the current study, the only other recent study with objective follow-up and controls demonstrated urodynamic cure of SUI in only 16.7% of 12 patients receiving freeze-dried allograft slings compared with 70% of patients receiving rectus autograft slings.11 The 2 retrospective series that used Tutoplast allograft as slings reported subjective improvement or cure rates of 96% of 26 patients at 15 months and 72.2% of 18 at 9.2 months.5,12 The strengths of the current study include the use of both subjective and objective data obtained on the study group and a concurrent control group. The long-term follow-up period, uniform surgical methods, and use of a single type of allograft also add validity to the study. The retrospective nature and small number of returning patients in each cohort, due primarily to the long followup and rigorous return evaluation, add selection bias and do limit the study. Nonetheless, this study did show a significant difference in the objective cure rates between allografts and autografts, despite subjective cure rates that were similar to each other and to cure rates of previous studies. These results must be tempered by the inequities of the 2 groups, namely, the significantly older, more parous allograft group that underwent more concurrent repairs than the autograft group. This difference alone may explain some of the results, as the allograft group could be more prone to the classic ‘‘lead-pipe,’’ fixed urethra as the cause of continued SUI. This, however, may not account for the complete discrepancy in the outcomes between the 2 groups, as the objective recurrence of SUI was so much greater in the allograft group. The cleaning, processing, and preservation of various allografts used as slings for stress incontinence is varied, and may account for some of the discrepancies in findings between various series.13-15 The clinical studies
McBride et al examining the use of allograft fascia as suburethral slings in the treatment of stress incontinence have been marred by short-term follow-up, absence of objective outcome measures, lack of controls, and variations in allograft type precluding universal applicability of results. Researchers who are skeptical of allografts as slings have suggested that absorption of the allograft without replacement of native tissue may account for some failures.16 This study, though, demonstrated good support of the bladder neck, despite recurrence of USI. Whatever the cause of the failure, patients who desire allograft suburethral slings should be counseled regarding the possible risk of long-term objective failures as demonstrated in this study. This may be more pertinent for older patients undergoing more concomitant procedures. Unfortunately, these are the patients that are ideal for allografts. To verify the findings of this study and justify the continued use of allografts as slings, prospective, randomized trials comparing autografts with allografts need to be completed.
References 1. Kubic K, Horbach NS. Suburethral sling procedures and treatment of complicated stress incontinence. In: Bent AE, Ostergard DR, Cundiff GW, Swift SE, editors. Ostergard’s urogynecology and pelvic floor dysfunction. Philadelphia: Lippincott, Williams & Wilkins; 2003. p. 468-93. 2. Leach GE, Dmochowski RR, Appell RA, Blaivas JG, Hadley HR, Luber KM, et al. Femal Stress Urinry Incontinence Clinical Management Guidelines Panel summary report on surgical management of female stress urinary incontinence. J Urol 1997;158: 875-80.
1681 3. Bezerra CA, Bruschini H. Suburethral sling operations for urinary incontinence in women. Cochrane Database Syst Rev 2001;3: CD001754. 4. Handa VL, Jensen JK, Germain MM, Ostergard DR. Banked human fascia lata for the suburethral sling procedure: a preliminary report. Obstet Gynecol 1996;88:1045-9. 5. Elliot DS, Boone TB. Is fascia lata allograft material trustworthy for pubovaginal sling repair? Urology 2000;56:772-6. 6. Amundsen CL, Visco AG, Ruiz H, Webster GD. Outcome in 104 pubovaginal slings using freeze-dried allograft fascia lata from a single tissue bank. Urology 2000;56(suppl 6A):2-8. 7. Walsh IK, Nambirajan T, Donellan SM, Mahendra V, Stone AR. Cadaveric fascia lata pubovaginal slings: early results on safety, efficacy, and patient satisfaction. BJU Int 2002;90:415-9. 8. Wright EJ, Iselin CE, Carr LK, Webster GD. Pubovaginal sling using cadaveric allograft fascia for the treatment of intrinsic sphincter deficiency. J Urol 1998;160:759-62. 9. Brown SL, Govier FE. Cadaveric versus autologous fascia lata for the pubovaginal sling: surgical outcome and patient satisfaction. J Urol 2000;164:1633-7. 10. Flynn BJ, Yap WT. Pubovaginal sling using allograft fascia lata versus autograft fascia for all types of stress urinary incontinence: 2 year minimum follow up. J Urol 2002;167:608-12. 11. Soergel TM, Shott S, Heit M. Poor surgical outcome after fascia lata allograft slings. Int Urogynecol J 2001;12:247-53. 12. Huang Y, Lin AT, Chen K, Pan C, Chang LS. High failure rate using allograft fascia lata in pubovaginal sling surgery for female stress urinary incontinence. Urology 2001;58:943-6. 13. Gallentine ML, Cespedes RD. Review of cadaveric allografts in urology. Urology 2002;59:318-24. 14. Lemer ML, Chaikin DC, Blaivas JG. Tissue strength analysis of autologous and cadaveric allografts for the pubovaginal sling. Neurourol Urodyn 1999;18:487-503. 15. Hinton R, Jinnah RH, Johnson C, Warden K, Clarke HJ. A biomechanical analysis of solvent-dehydrated and freeze-dried human fascia allografts. Am J Sports Med 1992;20:607-11. 16. Fitzgerald MP, Mollenhauer J, Bitterman P, Brubaker L. Functional failure of fascia lata allografts. Am J Obstet Gynecol 1999;181:1339-46.
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Comparison of long-term outcomes of autologous fascia lata slings with Suspend Tutoplast fascia lata allograft slings for stress incontinence Andrew W. McBride, MD,a,b,d,* R. Mark Ellerkmann, MD,b Alfred E. Bent, MD,b Clifford F. Melick, PhDc Department of Obstetrics, Gynecology and Reproductive Sciences, University of Maryland Medical System,a Departments of Gynecologyb and Surgery,c Greater Baltimore Medical Center, Baltimore, Md, and Exempla Saint Joseph Hospital,d Denver, Colo
KEY WORDS Stress incontinence Suburethral sling Allograft Autograft
Objective: This study was undertaken to compare the objective and subjective long-term surgical outcomes in patients receiving Tutoplast fascia lata allograft slings with those receiving autograft slings for the treatment of stress urinary incontinence (SUI). Study design: We reviewed all patients (n = 71) undergoing suburethral sling with either autologous fascia lata (n = 39) or Tutoplast fascia lata (n = 32) for urodynamic stress incontinence (USI) from October 1, 1998, to August 1, 2001. Results: Of the original 71 patients, 47 were evaluated by objective and/or subjective means at a minimum of 2 years after surgery. Subjective quality of life measures, subjective continence, maximum urethral closure pressure, and bladder neck mobility were not different between the 2 groups. USI was demonstrated in 41.7% of allograft patients compared with no autograft patients (P = .007). Conclusion: Although patient reported cure of SUI is high for both sling types, USI recurs at a significantly higher rate in Tutoplast slings compared with autologous slings. Ó 2005 Mosby, Inc. All rights reserved.
The suburethral sling procedure, first described by von Giordano in 1907, has been modified over time to its current status as a reliable and long-lasting treatment for stress urinary incontinence (SUI).1 In the past,
Supported by an unrestricted grant by Mentor. Presented at the Joint Scientific Meeting of the Society of Gynecologic Surgeons and the American Urogynecologic Society, San Diego, Calif, July 29-31, 2004. * Reprint requests: Andrew W. McBride, MD, Mountain States Gynecology and Continence Center, 2005 Franklin St, Midtown 2, Suite 600, Denver, CO 80205. E-mail: [email protected] 0002-9378/$ - see front matter Ó 2005 Mosby, Inc. All rights reserved. doi:10.1016/j.ajog.2005.01.078
suburethral slings have been used primarily for the treatment of intrinsic sphincter deficiency (ISD) or recurrent SUI. With most cure and improvement rates ranging from 84% to 92%1 and proven durability, the sling has become widely used for all types of stress incontinence. Traditionally, autologous slings have been constructed from fascia obtained from the abdominal rectus fascia or tensor fascia lata. These autografts have the benefit of a significantly decreased risk of rejection or erosion when compared to synthetic slings.2 Cosmetic concerns and the discomfort associated with harvesting these materials, as well as the additional operating time
1678 have resulted in surgeons seeking alternative materials. Many synthetic, allogenic, and xenogenic materials have been developed and advocated for use as suburethral slings in recent years. Human cadaveric allografts have been used with the hope of a low risk of erosion and rejection compared with synthetic slings, while maintaining outcomes similar to autografts. Suspend Tutoplast (Mentor Co., Santa Barbara, CA) is a commercially available solvent dehydrated fascia lata harvested and processed by a standardized method. We began offering Tutoplast allograft slings as an alternative to autologous slings in 1998 to patients with stress incontinence. The purpose of this study is to evaluate and compare the long-term objective and subjective outcomes in a cohort of women receiving either an autologous fascia lata or allograft fascia lata suburethral sling for urodynamic stress incontinence (USI).
Study design Approval from the Greater Baltimore Medical Center Institutional Review Board was obtained before starting the study. Between October 1, 1998, and August 1, 2001, case list and chart review revealed 71 patients that underwent suburethral sling procedures with fascia lata for urodynamically proven stress incontinence by the senior authors (A.E.B. and R.M.E.). Only patients who received full length slings from either autologous fascia lata (n = 39) or Tutoplast allograft fascia lata (n = 32) and demonstrated USI were considered for study enrollment. Preoperative evaluation in all patients included voiding diary, intake history and physical, complete urogynecologic pelvic examination and grading of prolapse by the Pelvic Organ Prolapse Quantitation (POPQ) examination, and Q-tip urethral mobility assessment. Only patients who underwent multichannel urodynamics including voiding studies, cystometry with Valsalva leak point pressures (VLPP), and urethral profilometry were eligible. Choice of anti-incontinence procedure and material used, as well as other concomitant procedures, was made by the operating physician and patient preference after counseling. Autologous fascia lata slings (autografts) were constructed by harvesting a 2-cm wide strip of fascia from the patient’s tensor fascia lata. A strip of sufficient length was harvested such that the sling could be secured to the rectus fascia on both sides of the midline after placement under the proximal urethra. Generally, midline vaginal epithelial incisions underlying the proximal urethra were used for access to the periurethral space and space of Retzius and passage of the sling. The sling was placed loosely under the proximal urethra and secured by 3 to 4 interrupted delayed absorbable sutures. Each sling end was then secured to the rectus fascia with prolypropylene sutures. Full-length allograft slings were constructed from Tutoplast, solvent
McBride et al dehydrated, gamma-irradiated cadaveric fascia lata. Allograft strips of either 18 ! 2 cm or 12 ! 4 cm were used to construct full-length slings that were placed under the proximal urethra in an identical fashion to autografts. Suprapubic catheters were placed in all patients through separate stab incisions at the termination of the procedure. Adjunctive hysterectomy or prolapse repair was generally performed after harvesting but before sling placement. All procedures were performed by or under the supervision of A.E.B. or R.M.E. Investigational follow-up was initiated with a general mailing to all patients eligible for study enrollment soliciting their participation. Enrolled patients returned for an interview by a single investigator who gathered the pertinent medical and surgical history. This investigator (A.W.M.) was not involved in the original surgery and not blinded to which sling type the patient received. This same person administered the short form of the Incontinence Impact Questionnaire (IIQ-7), the short form of the Urogenital Distress Inventory (UDI-6), and questions regarding patient reported stress continence status (Stamey continence grading), pads used per day, and incontinent episodes per day. Patients who returned for examination and urodynamics were given the questions and allowed to complete them on their own. Patients declining examination were administered the questions over the phone. Preoperative and postoperative urodynamic evaluation was performed with the use of a Laborie System with Millar 8F duel channel intravesical catheter and an 8F intravaginal/intrarectal catheter in the seated upright position. Multichannel urodynamics were performed according to the International Continence Society Guidelines in the seated upright position by a single examiner not involved in the original surgery and not blinded to which procedure the patient underwent (A.W.M.). The few modifications included assessment of VLPP at 150, 200, and 300 mL. If no leakage occurred with Valsalva, filling was halted at 300 mL, the intravesical catheter was removed, and the patient was asked to stand and forcefully cough 3 times. Filling was then resumed after placement of the intravesical catheter until maximum cystometric capacity. Cystometric capacity, bladder compliance, VLPPs, results of standing stress test, and presence or absence of detrusor overactivity was recorded. Recurrence of USI was defined as observed leakage at the time of coughing or straining during cystometry or standing stress test. Resting urethral pressure profiles were obtained with a profilometer withdrawing the urethral catheter from the full bladder at 1 mm/s. The patients were then moved to a different examining chair to have urethral mobility assessment with Q-tip (at rest and maximal strain) and pelvic examination with POP-Q performed in the supine lithotomy position. Statistical analysis was performed with SSPS 11.5 (SSPS Inc, Chicago, Ill). P values were calculated with
McBride et al Table I slings
1679
Characteristics of patients receiving suburethral
Autograft Demographic/characteristic (n = 26)
Allograft (n = 21)
Mean age (y) Parity Prior hysterectomy Prior urologic or prolapse surgery Current HRT/ERT use Body mass index (kg/m) Current smoker Current therapy for OAB Follow-up (mo) Other procedures at time of sling placement
60.7 G 10.5 2.2 G 1.0 53.8% 46.2%
74.0 G 7.4 .000 3.67 G 1.5 .000 61.9% NS 38.1% NS
60.0% 28.3 G 4.0 11.5% 3.8% 42.4 G 9.6 46.2%
47.6% NS 29.7 G 3.5 NS 0 NS 4.8% NS 35.2 G 7.2 .007 90.5% .002
P
HRT, Hormone replacement therapy, ERT, estrogen replacement therapy.
Pearson’s c2 test, Fisher exact test, or the independent samples t test (with Levine’s test for equality of variances), as appropriate. The point-biserial correlation coefficient (rpb) was used to examine relationships between nominaldichotomous measures and ratio measures. An alpha value of less than .05 was considered significant.
Results Of the original 71 patients deemed eligible for the study, 47 returned for evaluation with either objective and/or subjective instruments. The remaining 24 were lost to follow-up or declined entry into the study. Evaluation with examination, urodynamics, and questionnaires was performed on 12 allograft patients and 17 autograft patients. An additional 9 patients in each group completed subjective evaluation. Demographic and preoperative patient characteristics are detailed in Table I. The mean age and parity was significantly greater in the allograft group compared with the autograft group. Other pertinent medical, surgical, and demographic data did not differ significantly between the 2 groups. Mean follow-up was significantly longer for the autograft group (42.4 G 9.6 months) compared with the allograft group (35.2 G 7.2, P = .007). Also, significantly more patients in the allograft group underwent other surgical repairs at time of sling placement compared with the autograft group. Preoperative exam and urodynamic findings are listed in Table II. No differences were seen between the 2 groups in terms of preoperative urethral mobility by Qtip test, maximum urethral closure pressure (MUCP), incidence of detrusor overactivity, bladder capacity, or diagnosis of intrinsic sphincteric deficiency by either VLPP or MUCP. Table III compares the preoperative and postoperative urodynamic and examination findings, as well as the changes in the values between initial
Table II teristics
Preoperative urodynamic and examination charac-
Urodynamic or examination finding
Autograft (n = 26)
Allograft (n = 21)
P
Q-Tip deflection 54.3 G 14.9 53.3 G 13.6 NS (straining angle-resting) Mean MUCP (cm H2O) 28.0 G 12.1 33.1 G 22.8 NS Urodynamic detrusor 16.7% 15.0% NS overactivity Cystometric bladder 456.3 G 143.0 456.4 G 142.9 NS capacity (mL) mean ISD, any 66.7% 40.0% NS 20.2% NS ISD by VLPP %60 cm H2O 45.8% ISD by MUCP %20 cm H2O 41.7% 20.2% NS
and return examinations. No significant differences were demonstrated between the 2 groups in reference to MUCP or urethral mobility determined by Q-tip examination. Five of the 12 (41.7%) allograft patients returning for examination demonstrated USI compared with none of the 17 autograft patients (0, P = .007). Recurrence of USI within the allograft group was moderately related to age (phi = 0.412; P = .026), and moderately inversely related to preoperative VLPP at 200 mL (rpb = ÿ0.589; P = .01). Subjective outcomes from suburethral sling patients are given in Table IV. No significant differences were seen in mean IIQ-7 or UDI-6 scores between the 2 groups. Subscore analysis of questions 1 and 2 of the UDI-6 revealed no significant difference in the number of patients with a raw score of 3 or more, suggesting clinical overactive bladder (OAB). Overall subjective stress continence was reported by 92.3% of autograft patients and 90.5% of allograft patients. No significant difference was seen between the 2 groups in terms of self-reported incontinence episodes. One or no incontinence episodes per day were reported by 84.6% of autograft patients and 90.5% of allograft patients. Patient-reported mean pad use, though, was statistically greater in the allograft group compared with the autograft group.
Comment The suburethral sling has become an increasingly common procedure for the treatment of hypermobile SUI. Long-term data have demonstrated that slings are comparable if not superior to retropubic bladder neck suspensions for the treatment of hypermobile stress incontinence.3 Cadaveric grafts have been used as a substitute for autologous slings to decrease patient morbidity and operating time, as well as avoid erosion problems seen with some synthetic slings. Most clinical data regarding the outcomes of allogenic slings have been favorable. Handa et al4 reported an
1680 Table III
McBride et al Comparison of preoperative and postoperative examination and urodynamic parameters
Urodynamic or examination finding Q-Tip deflection (degrees): Preoperative Postoperative Mean change (post minus pre) Recurrent urodynamic stress incontinence Cystometric bladder capacity (mL): % O300 at postoperative examination Preoperative mean Postoperative mean Preoperative detrusor overactivity Postoperative detrusor overactivity MUCP (cm H2O): Preoperative mean Postoperative mean Mean change (post minus pre)
Autograft (n = 17)
Allograft (n = 12)
P
54.3 G 14.9 12.1 G 10.2 ÿ41.7 G 16.8 0.0%
53.3 G 13.6 18.1 G 12.5 ÿ34.2 G 14.0 41.7%
NS NS NS .007
88.2% 456.3 G 143.0 414.3 G 105.6 16.7% 11.8%
91.7% 456.4 G 142.9 341.1 G 59.9 15.0% 25.0%
NS NS .041 NS NS
28.0 G 12.1 37.1 G 16.7 12.6 G 20.8
33.1 G 22.8 40.4 G 27.5 12.6 G 20.6
Table IV Self-reported and subjective outcomes from suburethral sling procedures Subjective and QoL findings
Autograft (n = 26)
Allograft (n = 21)
Mean IIQ-7 score Mean UDI-6 score Clinical OAB Mean Stamey Stress Continence Grade Mean pad use/day Mean incontinence episodes/day Stamey Stress Continence Grade: Grade 0 Grade 1 Grade 2 or 3 Pad use/day: None 1 2 or more Incontinence episodes/day: None 1 2 or more
10.3 G 1.5 4.1 G 6.8 20.9 G 16.9 20.6 G 14.7 15.4% 14.3% 0.08 G 0.272 0.14 G 0.478
NS NS NS NS
0.29 G 0.493 0.90 G 1.1 0.56 G 0.75 0.71 G 1.1
.024 NS
P
NS 92.3% 7.7% 0.0%
90.5% 4.8% 4.8%
73.1% 26.9% 0.0%
42.9% 38.1% 19.0%
57.7% 26.9% 15.4%
52.4% 38.1% 9.5%
.027
NS
QoL, Quality of life.
early series with an 86% subjective and 79% objective cure rate in patients receiving banked fascia lata suburethral slings. Since then, the majority of series using allograft slings have reported subjective cure rates from 63% to 96%,5-7 but with no controls and no objective evaluation. The few studies that have had controls have all been retrospective and had no significant difference in subjective cure and improvements between allograft and
NS NS NS
autograft patients.8-10 Aside from the current study, the only other recent study with objective follow-up and controls demonstrated urodynamic cure of SUI in only 16.7% of 12 patients receiving freeze-dried allograft slings compared with 70% of patients receiving rectus autograft slings.11 The 2 retrospective series that used Tutoplast allograft as slings reported subjective improvement or cure rates of 96% of 26 patients at 15 months and 72.2% of 18 at 9.2 months.5,12 The strengths of the current study include the use of both subjective and objective data obtained on the study group and a concurrent control group. The long-term follow-up period, uniform surgical methods, and use of a single type of allograft also add validity to the study. The retrospective nature and small number of returning patients in each cohort, due primarily to the long followup and rigorous return evaluation, add selection bias and do limit the study. Nonetheless, this study did show a significant difference in the objective cure rates between allografts and autografts, despite subjective cure rates that were similar to each other and to cure rates of previous studies. These results must be tempered by the inequities of the 2 groups, namely, the significantly older, more parous allograft group that underwent more concurrent repairs than the autograft group. This difference alone may explain some of the results, as the allograft group could be more prone to the classic ‘‘lead-pipe,’’ fixed urethra as the cause of continued SUI. This, however, may not account for the complete discrepancy in the outcomes between the 2 groups, as the objective recurrence of SUI was so much greater in the allograft group. The cleaning, processing, and preservation of various allografts used as slings for stress incontinence is varied, and may account for some of the discrepancies in findings between various series.13-15 The clinical studies
McBride et al examining the use of allograft fascia as suburethral slings in the treatment of stress incontinence have been marred by short-term follow-up, absence of objective outcome measures, lack of controls, and variations in allograft type precluding universal applicability of results. Researchers who are skeptical of allografts as slings have suggested that absorption of the allograft without replacement of native tissue may account for some failures.16 This study, though, demonstrated good support of the bladder neck, despite recurrence of USI. Whatever the cause of the failure, patients who desire allograft suburethral slings should be counseled regarding the possible risk of long-term objective failures as demonstrated in this study. This may be more pertinent for older patients undergoing more concomitant procedures. Unfortunately, these are the patients that are ideal for allografts. To verify the findings of this study and justify the continued use of allografts as slings, prospective, randomized trials comparing autografts with allografts need to be completed.
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1681 3. Bezerra CA, Bruschini H. Suburethral sling operations for urinary incontinence in women. Cochrane Database Syst Rev 2001;3: CD001754. 4. Handa VL, Jensen JK, Germain MM, Ostergard DR. Banked human fascia lata for the suburethral sling procedure: a preliminary report. Obstet Gynecol 1996;88:1045-9. 5. Elliot DS, Boone TB. Is fascia lata allograft material trustworthy for pubovaginal sling repair? Urology 2000;56:772-6. 6. Amundsen CL, Visco AG, Ruiz H, Webster GD. Outcome in 104 pubovaginal slings using freeze-dried allograft fascia lata from a single tissue bank. Urology 2000;56(suppl 6A):2-8. 7. Walsh IK, Nambirajan T, Donellan SM, Mahendra V, Stone AR. Cadaveric fascia lata pubovaginal slings: early results on safety, efficacy, and patient satisfaction. BJU Int 2002;90:415-9. 8. Wright EJ, Iselin CE, Carr LK, Webster GD. Pubovaginal sling using cadaveric allograft fascia for the treatment of intrinsic sphincter deficiency. J Urol 1998;160:759-62. 9. Brown SL, Govier FE. Cadaveric versus autologous fascia lata for the pubovaginal sling: surgical outcome and patient satisfaction. J Urol 2000;164:1633-7. 10. Flynn BJ, Yap WT. Pubovaginal sling using allograft fascia lata versus autograft fascia for all types of stress urinary incontinence: 2 year minimum follow up. J Urol 2002;167:608-12. 11. Soergel TM, Shott S, Heit M. Poor surgical outcome after fascia lata allograft slings. Int Urogynecol J 2001;12:247-53. 12. Huang Y, Lin AT, Chen K, Pan C, Chang LS. High failure rate using allograft fascia lata in pubovaginal sling surgery for female stress urinary incontinence. Urology 2001;58:943-6. 13. Gallentine ML, Cespedes RD. Review of cadaveric allografts in urology. Urology 2002;59:318-24. 14. Lemer ML, Chaikin DC, Blaivas JG. Tissue strength analysis of autologous and cadaveric allografts for the pubovaginal sling. Neurourol Urodyn 1999;18:487-503. 15. Hinton R, Jinnah RH, Johnson C, Warden K, Clarke HJ. A biomechanical analysis of solvent-dehydrated and freeze-dried human fascia allografts. Am J Sports Med 1992;20:607-11. 16. Fitzgerald MP, Mollenhauer J, Bitterman P, Brubaker L. Functional failure of fascia lata allografts. Am J Obstet Gynecol 1999;181:1339-46.