1
FEMALE PATIENTS WITH URINARY INCONTINENCE 1731 EDITORIAL COMMENT ne acknowledged purpose of this study is “to determine the pa- tient preference for, compliance with and initial outcome of either behavior modification, pharmacotherapy or surgery” based on a di- agnosis and treatment algorithm established by the AHCPR. Objec- tive 1, determining patient preferences for treatment, in my judg- ment has as much to do with the preference of the health care provider as patient preference. Imagine the following encounter. A patient with stress incontinence presents to a health care provider (nurse, physical therapist, behaviorist and so forth). He or she can teach the patient how to do some exercises (pelvic floor exercises). If done correctly, the patient has a 75% chance of improvement and a 16% chance of cure. Only 1 hour is needed to spend with the health care provider, and the patient need only do the exercises and return in 6 weeks. The condition cannot be made worse, there are no complications or side effects and no more tests are needed. If surgery is chosen there is an approldmately 80% chance of cure but the cure might be temporary. There is a 30% chance of complicationsand the patient could even die. The patient also must undergo a test in which a tube is inserted into the bladder. Which would she choose? Alter- natively, imagine that a woman has stress incontinence. She can do pelvic floor exercises if she wishes but there is no more than a 1 in 10 chance for temporary cure. She will almost certainly still be incon- tinent and still have to wear pads. If surgery is done the chances for cure are close to 90%, there is a slight chance of complications and pads will no longer be necessary. Now, which would she choose? Based on the data cited by the AHCPR, either of these scenarios could be presented to the patient. The crux of the issue is not really patient preference at all but how one obtains informed consent based on the best approximation of the facts. What are the fads? In fact, we really do not know. Simply, there are virtually no long-term results with behavior modification or pharmacotherapy, and only a handful of long-term studies on the results of surgery. Until we have some facts, how can we advise our patients? This is for each physician to decide based on his or her own experience and expertise. Who should be obtaining this informed consent? Any health care provider may suffice according to the guidelines. I would prefer a knowledgeable physician who has an intimacy with all of the thera- peutic modalities. The guidelines further recommend that the least invasive treatments be attempted first, even before a definitive di- agnosis is made. The appropriateness of this statement depends on the results. If 75% of the patients are improved (and satisfied with the treatment) there is nothing wrong but if all of the patients remain incontinent and dissatisfied, and become resigned to a life of diapers much is wrong. The statement undermines the very fabric of health care, that is the trust and confidence that patients should have in their physicians, and the knowledgeable and caring doctors with the scope and breadth of knowledge and expertise to provide the most appropriate and effective treatment for each patient. Patient compliance with behavior modification in this study was not good: of 92 women 40 (43%) did not even return for followup. With respect to efficacy of behavioral therapy, the authors cite that 32 Of52 patients (62%) who returned for at least 1 followupVisit were improved (32 of 92, or 35% if one considers the “no shows” as failures) and 6 of 52 (11%) were cured, which compares to a loo40 cure/ improvement rate for surgery. Followup ranged from only 1 to 12 months (mean 6). In my judg- ment, this interval is much too short to evaluate therapeutic e5cacy. k a n patient age was 64 years and the actuarial survival rate was well over 20 years. With an initial curdimprovement rate of 41% (38 of92 patients) for all who chose behavioral therapy, do the authors believe that this treatment is likely to be effective for most Patients in the final decades of their lives? I do not know how effective any treatment for incontinence is for a follOmpmeasured in years and decades rather than months but I am confidentthat a substantial number of patients derive long-term benefits postoperatively. I am not as confident about pelvic floor I agree that patients should be offered treatment options and that the least invasive therapy that achieves long-term efficacy (as measured by patient satisfaction) is most reasonable. However, there should be an expectation that most patients can be dry if they choose, and we should have the data to substantiate therapeutic claims. Those data are simply nonexistent and should become the subject of intense scientific investigation. Jerry G. Blaivas Lkpartment of Surgery1 Urology New York Hospital-Come11 Medical Center New York, New York REPLY BY AUTHORS Today many patients are informed about their problems before consultation and they present to the urologist with questions that need to be addressed. Although surgery offers the best results for curing stress urinary incontinence, one should be cautious since complications occur (that is urinary retention, difficulty emptying, exacerbation or development of irritative symptoms of urgency and so forth). Although one may cure stress incontinence symptoms, the emer- gence of urge symptoms may not improve the overall patient quality of life. Recently Hunskaar and Vinsnes suggested that urge symp- toms are associated with more impairment of the quality of life (especially sleep and rest, and visiting places) than symptoms of stress incontinence.’ In addition, long-term outcome studies reported at the recent American Urological Association convention are dis- turbing since they showed that less than 50% of patients were completely dry after surgery.= In 1 study 26% of treatment failures occurred more than 2 years after initial surgery.2 Therefore, one needs to be cautious in estimating cure rates, particularly pertaining to lasting continence and the possibility of introducing or exacerbat- ing other symptoms. In our hands behavior therapy is inexpensive, reversible and easy to acquire. Our study did not include expensive adjuncts, such as biofeedback and electrical stimulation. For patients with urge incon- tinence or mixed urinary incontinence with a predominant urge component, there is no good surgical option and the hallmark of therapy is pharmacological and/or behavioral. Although we agree that long-term studies are needed on all options, to date the data gathered and the options presented in the AHCPR guidelines are the only information available that was compiled by a multidisciplinary team and endorsed by professional organizations, including the American Urological Association. As we report, the treatment options in our study were well re- ceived by our subjects, and, in fact, even those who had a precon- ceived notion of what treatment they should receive chose to partic- ipate in the study. However, the lesson that we learned is that patients must be screened to ensure high motivation and compliance. A well meaning and highly motivated support staff should ale0 be in place. It is appropriate for caregivers with expertise in urinary incontinence to offer options to Patients. However, as urologists we are in the best position to treat these patients since we can offer all options, including surgery, in contrast to others who can offer only limited options. 1. Hunskaar. S. and Vines, A: The quality of life in women with 2. 3. 4. urinary .incontinence as measured by the sickness impact pro- file. J. Amer. Geriatr. Soc., 39: 378,1991. Rodriguez, R., Partin, A. W., Mostwin, J. L. and Kavoussi,.L. R.: Long term follow-up of surg~cally treated stress unnary mcon- tinence (SUI). J. Urol., part 2,163: 43lA, abstract 810, 1995. hmier, P. A, Kaplan, E. P., Djavan, B. and Roehrborn, C. G.: Long-term outcomes of women following transvaginal bladder neck suspension for stress urinary incontinence. J. Urol., part 2,153:43% abstract 811,1995. Knispel, H. H., Klh, R., Siegmann, K and Miller, K.: Results with the Stamey procedure in 251 consecutive patients with genuine urinary stress incontinence. J. Urol., part 2, 153: 43lA, abstract 812,1995.

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FEMALE PATIENTS WITH URINARY INCONTINENCE 1731 EDITORIAL COMMENT

ne acknowledged purpose of this study is “to determine the pa- tient preference for, compliance with and initial outcome of either behavior modification, pharmacotherapy or surgery” based on a di- agnosis and treatment algorithm established by the AHCPR. Objec- tive 1, determining patient preferences for treatment, in my judg- ment has as much to do with the preference of the health care provider as patient preference. Imagine the following encounter. A patient with stress incontinence presents to a health care provider (nurse, physical therapist, behaviorist and so forth). He or she can teach the patient how to do some exercises (pelvic floor exercises). If done correctly, the patient has a 75% chance of improvement and a 16% chance of cure. Only 1 hour is needed to spend with the health care provider, and the patient need only do the exercises and return in 6 weeks. The condition cannot be made worse, there are no complications or side effects and no more tests are needed. If surgery is chosen there is an approldmately 80% chance of cure but the cure might be temporary. There is a 30% chance of complications and the patient could even die. The patient also must undergo a test in which a tube is inserted into the bladder. Which would she choose? Alter- natively, imagine that a woman has stress incontinence. She can do pelvic floor exercises if she wishes but there is no more than a 1 in 10 chance for temporary cure. She will almost certainly still be incon- tinent and still have to wear pads. If surgery is done the chances for cure are close to 90%, there is a slight chance of complications and pads will no longer be necessary. Now, which would she choose?

Based on the data cited by the AHCPR, either of these scenarios could be presented to the patient. The crux of the issue is not really patient preference at all but how one obtains informed consent based on the best approximation of the facts. What are the fads? In fact, we really do not know. Simply, there are virtually no long-term results with behavior modification or pharmacotherapy, and only a handful of long-term studies on the results of surgery. Until we have some facts, how can we advise our patients? This is for each physician to decide based on his or her own experience and expertise.

Who should be obtaining this informed consent? Any health care provider may suffice according to the guidelines. I would prefer a knowledgeable physician who has an intimacy with all of the thera- peutic modalities. The guidelines further recommend that the least invasive treatments be attempted first, even before a definitive di- agnosis is made. The appropriateness of this statement depends on the results. If 75% of the patients are improved (and satisfied with the treatment) there is nothing wrong but if all of the patients remain incontinent and dissatisfied, and become resigned to a life of diapers much is wrong. The statement undermines the very fabric of health care, that is the trust and confidence that patients should have in their physicians, and the knowledgeable and caring doctors with the scope and breadth of knowledge and expertise to provide the most appropriate and effective treatment for each patient.

Patient compliance with behavior modification in this study was not good: of 92 women 40 (43%) did not even return for followup. With respect to efficacy of behavioral therapy, the authors cite that 32 Of52 patients (62%) who returned for a t least 1 followup Visit were improved (32 of 92, or 35% if one considers the “no shows” as failures) and 6 of 52 (11%) were cured, which compares to a loo40 cure/ improvement rate for surgery.

Followup ranged from only 1 to 12 months (mean 6). In my judg- ment, this interval is much too short to evaluate therapeutic e5cacy. k a n patient age was 64 years and the actuarial survival rate was well over 20 years. With an initial curdimprovement rate of 41% (38 of92 patients) for all who chose behavioral therapy, do the authors

believe that this treatment is likely to be effective for most Patients in the final decades of their lives?

I do not know how effective any treatment for incontinence is for a follOmp measured in years and decades rather than months but I am confident that a substantial number of patients derive long-term benefits postoperatively. I am not as confident about pelvic floor

I agree that patients should be offered treatment options

and that the least invasive therapy that achieves long-term efficacy (as measured by patient satisfaction) is most reasonable. However, there should be an expectation that most patients can be dry if they choose, and we should have the data to substantiate therapeutic claims. Those data are simply nonexistent and should become the subject of intense scientific investigation.

Jerry G. Blaivas Lkpartment of Surgery1 Urology New York Hospital-Come11 Medical Center New York, New York

REPLY BY AUTHORS

Today many patients are informed about their problems before consultation and they present to the urologist with questions that need to be addressed. Although surgery offers the best results for curing stress urinary incontinence, one should be cautious since complications occur (that is urinary retention, difficulty emptying, exacerbation or development of irritative symptoms of urgency and so forth).

Although one may cure stress incontinence symptoms, the emer- gence of urge symptoms may not improve the overall patient quality of life. Recently Hunskaar and Vinsnes suggested that urge symp- toms are associated with more impairment of the quality of life (especially sleep and rest, and visiting places) than symptoms of stress incontinence.’ In addition, long-term outcome studies reported at the recent American Urological Association convention are dis- turbing since they showed that less than 50% of patients were completely dry after surgery.= In 1 study 26% of treatment failures occurred more than 2 years after initial surgery.2 Therefore, one needs to be cautious in estimating cure rates, particularly pertaining to lasting continence and the possibility of introducing or exacerbat- ing other symptoms.

In our hands behavior therapy is inexpensive, reversible and easy to acquire. Our study did not include expensive adjuncts, such as biofeedback and electrical stimulation. For patients with urge incon- tinence or mixed urinary incontinence with a predominant urge component, there is no good surgical option and the hallmark of therapy is pharmacological and/or behavioral. Although we agree that long-term studies are needed on all options, to date the data gathered and the options presented in the AHCPR guidelines are the only information available that was compiled by a multidisciplinary team and endorsed by professional organizations, including the American Urological Association. As we report, the treatment options in our study were well re-

ceived by our subjects, and, in fact, even those who had a precon- ceived notion of what treatment they should receive chose to partic- ipate in the study. However, the lesson that we learned is that patients must be screened to ensure high motivation and compliance. A well meaning and highly motivated support staff should ale0 be in place. It is appropriate for caregivers with expertise in urinary incontinence to offer options to Patients. However, as urologists we are in the best position to treat these patients since we can offer all options, including surgery, in contrast to others who can offer only limited options.

1. Hunskaar. S. and V i n e s , A: The quality of life in women with

2.

3.

4.

urinary .incontinence as measured by the sickness impact pro- file. J. Amer. Geriatr. Soc., 39: 378, 1991.

Rodriguez, R., Partin, A. W., Mostwin, J. L. and Kavoussi,.L. R.: Long term follow-up of surg~cally treated stress unnary mcon- tinence (SUI). J. Urol., part 2,163: 43lA, abstract 810, 1995.

h m i e r , P. A, Kaplan, E. P., Djavan, B. and Roehrborn, C. G.: Long-term outcomes of women following transvaginal bladder neck suspension for stress urinary incontinence. J. Urol., part 2,153: 43% abstract 811,1995.

Knispel, H. H., K l h , R., Siegmann, K and Miller, K.: Results with the Stamey procedure in 251 consecutive patients with genuine urinary stress incontinence. J. Urol., part 2, 153: 43lA, abstract 812, 1995.