The Vexing Problem of Hidden Incontinence
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《新英格兰医药杂志》
Pelvic-organ prolapse occurs when pelvic organs herniate toward or through the vaginal opening. It is common and costly. Each year, nearly 200,000 women undergo surgery for prolapse; approximately 30 percent of those women will have a second operation within four years.1,2,3 The demand for treatment for pelvic-organ prolapse and other related pelvic-floor disorders, such as urinary and anal incontinence, is projected to increase by 45 percent in the next 30 years.4 Given the substantial lifetime risk of repeated operations, surgical interventions are needed that have durable benefits and do not cause other problems.
Women with symptomatic prolapse often report feelings of pressure and a bulge protruding from the vagina. Other signs of prolapse include bowel, bladder, and sexual dysfunction. The stage of prolapse is determined by comparing the position of the prolapsed vagina during a Valsalva maneuver with the position of the hymen; prolapse that is well above the hymen is rarely symptomatic.5,6 However, both the presence and the severity of symptoms are not always proportional to the severity of the prolapse and are considered to be multifactorial.5,6
Prolapse surgery is typically directed at repair of the vaginal compartments into which the pelvic organs prolapse (anterior, posterior, or apical or any combination of the three) (Figure 1). Sacrocolpopexy is a standard abdominal surgical approach for the treatment of apical prolapse. Short-term success rates for sacrocolpopexy, defined as the absence of prolapse in any compartment, range from 58 percent to 100 percent at six months to three years after surgery.7
Figure 1. Complete Vaginal and Uterine Prolapse beyond the Hymen Involving the Anterior, Apical, and Posterior Compartments.
Reproduced with the permission of John Delancey.
Abnormal bladder function is common in women with pelvic-organ prolapse and includes incontinence (stress, urge, and mixed), as well as varying degrees of urinary retention.7 In some women, urinary incontinence that would otherwise occur (sometimes called occult, latent, or hidden incontinence) is prevented by a kinking of the urethra when the bladder falls to or through the vaginal opening. Reducing prolapse in women with these conditions also relieves urethral kinking and thereby reveals symptoms of incontinence. (Accordingly, this related disorder is also called iatrogenic incontinence.) Prospective studies that define occult incontinence as loss of urine that occurs after prolapse reduction report an incidence of 36 to 80 percent.8 The problem is vexing for both surgeons and patients. Predicting which patients will benefit from a prophylactic procedure for incontinence is challenging, and data regarding the usefulness of surgery to reduce postoperative incontinence have been limited. Caution is warranted, because surgery to reduce stress incontinence has associated risks, including new-onset urge incontinence and urinary retention, and such an addition to prolapse surgery prolongs operative time and may increase the chances of intraoperative complications.
In this issue of the Journal, Brubaker et al. report the results of the Colpopexy and Urinary Reduction Efforts (CARE) trial, which was designed to assess the effects of performing surgery to reduce incontinence at the time of surgery for prolapse repair.9 Women without preoperative symptoms of stress incontinence who were undergoing surgery for pelvic-organ prolapse were randomly assigned to undergo a standard procedure to reduce incontinence, called Burch colposuspension, or to no prophylactic procedure. The study end points were the postoperative absence of symptoms of both stress incontinence and an overactive bladder, which were assessed by both objective and subjective measures that included validated and reliable measures of symptom severity and quality of life. The study was terminated early because bothersome stress incontinence was nearly twice as common among women who did not undergo Burch colposuspension as among those who did; there was no difference between the groups in the incidence of bothersome postoperative urge incontinence or of adverse events related to surgery.
The study has limitations, as acknowledged by the authors. Follow-up was short (three months for the primary outcomes); the study was stopped early; and it may not be possible to generalize the results to other commonly performed procedures to reduce incontinence, such as the minimally invasive midurethral sling procedure. Results at one year, available in a subgroup of the women in this trial, suggest that benefits are durable, but longer-term follow-up is needed to confirm this.
The findings are important for several reasons. First, prolapse is common, and the only treatment is surgery or the use of intravaginal pessaries that require regular removal and cleaning by either the patient or her provider. The study results are applicable to the many women who undergo surgery for prolapse. Whereas decisions about whether or not to perform a procedure to reduce incontinence at the time of sacrocolpopexy were previously based on opinion, this study provides solid data to support the theory that performance of a Burch colposuspension at the time of sacrocolpopexy in asymptomatic women results in better postoperative urinary control.
Surgeons have been notoriously slow in applying evidence-based practice. Randomized surgical trials are difficult to perform. The concept of randomly assigning patients to undergo or not undergo a surgical procedure challenges pillars of surgical practice: autonomy and dogma.10 Standardization of surgical technique is difficult to achieve. Not all surgeons perform all procedures equally well. Currently, there is no rigorous process for evaluating whether most surgical treatments represent advances or failures; for the assessment of surgical procedures, unlike regulation of pharmaceuticals, there is no equivalent of the Food and Drug Administration.10 In addition, studies that do assess surgical techniques frequently fail to consider results from the perspective of the patient, focusing more on correction of anatomical defects than on restoration of function and achievement of patient-centered goals.11 Few women care what their vaginas look like; more are concerned with restoring bowel, bladder, or sexual functions.
The trial reported by Brubaker et al. effectively addressed these issues. The surgical approach was standardized and described adequately so that it is reproducible. Multiple surgeons participated, making it possible to make general assumptions about the results. The design of the trial ensured that surgeons were blinded to data that normally influence their decisions to perform or not to perform a procedure to reduce incontinence at the time of sacrocolpopexy, such as the results of urodynamic testing. Finally, outcome measures included assessments by the patients of how bothersome they considered their symptoms and about changes in the quality of life.
Gynecologic surgeons routinely grapple with the question of whether or not to perform a procedure to reduce incontinence at the time of sacrocolpopexy. The results of this trial reveal that a prophylactic Burch colposuspension performed at the same time as the prolapse surgery results in improved urinary control. At the same time, the trial also serves to raise the bar for the evaluation of future surgical innovations.
No potential conflict of interest relevant to this article was reported.
Source Information
From the Department of Obstetrics and Gynecology, University of New Mexico Health Sciences Center, Albuquerque.
References
Boyles SH, Weber AM, Meyn L. Procedures for pelvic organ prolapse in the United States, 1979-1997. Am J Obstet Gynecol 2003;188:108-105.
Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol 1997;89:501-506.
Subak LL, Waetjen E, van den Eeden S, Thom DH, Vittinghoff E, Brown JS. Cost of pelvic organ prolapse surgery in the United States. Obstet Gynecol 2001;98:646-651.
Luber KM, Boero S, Choe JY. The demographics of pelvic floor disorders: current observations and future projections. Am J Obstet Gyencol 2001;184:1496-501.
Bradley CS, Nygaard IE. Vaginal wall descensus and pelvic floor symptoms in older women. Obstet Gynecol 2005;106:759-766.
Barber MD. Symptoms and outcome measures of pelvic organ prolapse. Clin Obstet Gynecol 2005;48:648-661.
Nygaard IE, McCreery R, Brubaker L, et al. Abdominal sacrocolpopexy: a comprehensive review. Obstet Gynecol 2004;104:805-823.
Haessler AL, Lin LL, Ho MH, Betson LH, Bhatia NN. Reevaluating occult incontinence. Curr Opin Obstet Gynecol 2005;17:535-540.
Brubaker L, Cundiff GW, Fine P, et al. Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence. N Engl J Med 2006;354:1557-1566.
Grimes DA. Technology follies: the uncritical acceptance of medical innovation. JAMA 1993;269:3030-3033.
Elkadry EA, Kenton KS, FitzGerald MP, Shott S, Brubaker L. Patient-selected goals: a new perspective on surgical outcome. Am J Obstet Gynecol 2003;189:1551-1557.(Rebecca G. Rogers, M.D.)
Women with symptomatic prolapse often report feelings of pressure and a bulge protruding from the vagina. Other signs of prolapse include bowel, bladder, and sexual dysfunction. The stage of prolapse is determined by comparing the position of the prolapsed vagina during a Valsalva maneuver with the position of the hymen; prolapse that is well above the hymen is rarely symptomatic.5,6 However, both the presence and the severity of symptoms are not always proportional to the severity of the prolapse and are considered to be multifactorial.5,6
Prolapse surgery is typically directed at repair of the vaginal compartments into which the pelvic organs prolapse (anterior, posterior, or apical or any combination of the three) (Figure 1). Sacrocolpopexy is a standard abdominal surgical approach for the treatment of apical prolapse. Short-term success rates for sacrocolpopexy, defined as the absence of prolapse in any compartment, range from 58 percent to 100 percent at six months to three years after surgery.7
Figure 1. Complete Vaginal and Uterine Prolapse beyond the Hymen Involving the Anterior, Apical, and Posterior Compartments.
Reproduced with the permission of John Delancey.
Abnormal bladder function is common in women with pelvic-organ prolapse and includes incontinence (stress, urge, and mixed), as well as varying degrees of urinary retention.7 In some women, urinary incontinence that would otherwise occur (sometimes called occult, latent, or hidden incontinence) is prevented by a kinking of the urethra when the bladder falls to or through the vaginal opening. Reducing prolapse in women with these conditions also relieves urethral kinking and thereby reveals symptoms of incontinence. (Accordingly, this related disorder is also called iatrogenic incontinence.) Prospective studies that define occult incontinence as loss of urine that occurs after prolapse reduction report an incidence of 36 to 80 percent.8 The problem is vexing for both surgeons and patients. Predicting which patients will benefit from a prophylactic procedure for incontinence is challenging, and data regarding the usefulness of surgery to reduce postoperative incontinence have been limited. Caution is warranted, because surgery to reduce stress incontinence has associated risks, including new-onset urge incontinence and urinary retention, and such an addition to prolapse surgery prolongs operative time and may increase the chances of intraoperative complications.
In this issue of the Journal, Brubaker et al. report the results of the Colpopexy and Urinary Reduction Efforts (CARE) trial, which was designed to assess the effects of performing surgery to reduce incontinence at the time of surgery for prolapse repair.9 Women without preoperative symptoms of stress incontinence who were undergoing surgery for pelvic-organ prolapse were randomly assigned to undergo a standard procedure to reduce incontinence, called Burch colposuspension, or to no prophylactic procedure. The study end points were the postoperative absence of symptoms of both stress incontinence and an overactive bladder, which were assessed by both objective and subjective measures that included validated and reliable measures of symptom severity and quality of life. The study was terminated early because bothersome stress incontinence was nearly twice as common among women who did not undergo Burch colposuspension as among those who did; there was no difference between the groups in the incidence of bothersome postoperative urge incontinence or of adverse events related to surgery.
The study has limitations, as acknowledged by the authors. Follow-up was short (three months for the primary outcomes); the study was stopped early; and it may not be possible to generalize the results to other commonly performed procedures to reduce incontinence, such as the minimally invasive midurethral sling procedure. Results at one year, available in a subgroup of the women in this trial, suggest that benefits are durable, but longer-term follow-up is needed to confirm this.
The findings are important for several reasons. First, prolapse is common, and the only treatment is surgery or the use of intravaginal pessaries that require regular removal and cleaning by either the patient or her provider. The study results are applicable to the many women who undergo surgery for prolapse. Whereas decisions about whether or not to perform a procedure to reduce incontinence at the time of sacrocolpopexy were previously based on opinion, this study provides solid data to support the theory that performance of a Burch colposuspension at the time of sacrocolpopexy in asymptomatic women results in better postoperative urinary control.
Surgeons have been notoriously slow in applying evidence-based practice. Randomized surgical trials are difficult to perform. The concept of randomly assigning patients to undergo or not undergo a surgical procedure challenges pillars of surgical practice: autonomy and dogma.10 Standardization of surgical technique is difficult to achieve. Not all surgeons perform all procedures equally well. Currently, there is no rigorous process for evaluating whether most surgical treatments represent advances or failures; for the assessment of surgical procedures, unlike regulation of pharmaceuticals, there is no equivalent of the Food and Drug Administration.10 In addition, studies that do assess surgical techniques frequently fail to consider results from the perspective of the patient, focusing more on correction of anatomical defects than on restoration of function and achievement of patient-centered goals.11 Few women care what their vaginas look like; more are concerned with restoring bowel, bladder, or sexual functions.
The trial reported by Brubaker et al. effectively addressed these issues. The surgical approach was standardized and described adequately so that it is reproducible. Multiple surgeons participated, making it possible to make general assumptions about the results. The design of the trial ensured that surgeons were blinded to data that normally influence their decisions to perform or not to perform a procedure to reduce incontinence at the time of sacrocolpopexy, such as the results of urodynamic testing. Finally, outcome measures included assessments by the patients of how bothersome they considered their symptoms and about changes in the quality of life.
Gynecologic surgeons routinely grapple with the question of whether or not to perform a procedure to reduce incontinence at the time of sacrocolpopexy. The results of this trial reveal that a prophylactic Burch colposuspension performed at the same time as the prolapse surgery results in improved urinary control. At the same time, the trial also serves to raise the bar for the evaluation of future surgical innovations.
No potential conflict of interest relevant to this article was reported.
Source Information
From the Department of Obstetrics and Gynecology, University of New Mexico Health Sciences Center, Albuquerque.
References
Boyles SH, Weber AM, Meyn L. Procedures for pelvic organ prolapse in the United States, 1979-1997. Am J Obstet Gynecol 2003;188:108-105.
Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol 1997;89:501-506.
Subak LL, Waetjen E, van den Eeden S, Thom DH, Vittinghoff E, Brown JS. Cost of pelvic organ prolapse surgery in the United States. Obstet Gynecol 2001;98:646-651.
Luber KM, Boero S, Choe JY. The demographics of pelvic floor disorders: current observations and future projections. Am J Obstet Gyencol 2001;184:1496-501.
Bradley CS, Nygaard IE. Vaginal wall descensus and pelvic floor symptoms in older women. Obstet Gynecol 2005;106:759-766.
Barber MD. Symptoms and outcome measures of pelvic organ prolapse. Clin Obstet Gynecol 2005;48:648-661.
Nygaard IE, McCreery R, Brubaker L, et al. Abdominal sacrocolpopexy: a comprehensive review. Obstet Gynecol 2004;104:805-823.
Haessler AL, Lin LL, Ho MH, Betson LH, Bhatia NN. Reevaluating occult incontinence. Curr Opin Obstet Gynecol 2005;17:535-540.
Brubaker L, Cundiff GW, Fine P, et al. Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence. N Engl J Med 2006;354:1557-1566.
Grimes DA. Technology follies: the uncritical acceptance of medical innovation. JAMA 1993;269:3030-3033.
Elkadry EA, Kenton KS, FitzGerald MP, Shott S, Brubaker L. Patient-selected goals: a new perspective on surgical outcome. Am J Obstet Gynecol 2003;189:1551-1557.(Rebecca G. Rogers, M.D.)