- Email: [email protected]
Re: Periurethral Injection of Autologous Fat for the Treatment of Sphincteric Incontinence
162
LETTERS TO THE EDITOR
to achieve rectal continence with a program of regular bowel evacuation. Any acceleration of intestinal transit is detrimental to rectal control.'-4 After reading this report, I continue to stand by my recommendation to avoid the use of the ileocecal segment in myelomeningocele patients. Respectfully, Ricardo Gonzalez Department of Urologic Surgery Section of Pediatric Urology University of Minnesota Medical School Box 45 Mayo Memorial Building 420 Delaware Street, S.E. Minneapolis, Minnesota 55455 1. Gonzalez, R., Sidi, A. A. and Zhang, G.: Urinary undiversion: indications, techniques and results in 50 cases. J. Urol., 136: 13,1986. 2. Gonzalez, R. and Cabral, B. H. P.: Rectal continence &r enterocystoplasty. Dial. Ped. Urol., 10: 4,December 1987. 3. Gonzalez, R. and Sidi, A. A: The use of bowel in the reconstruction of the urinary tract in children. In: Modem Technics in Surgery. Edited by R. Ehrlieh. Mount Kisko, New York: Futura Publishing Co., pp. 42.1-42.21, 1988. 4. Gonzalez, R.: Bladder augmentation with sigmoid or descending colon. In: Reconstructive Urology. Edited by G. Webster, R. Kirby, L. King and B. Goldwasser. Oxford Blackwell Scientific, vol. 1, chapt. 30,p. 433, 1993.
Reply by Authors. Only patients 4, 9 and 11 of the 12 patients mentioned in our article had myelomeningocele and, in contrast to the comment of Doctor Gonzalez, stool frequency did not increase in any of these patients. To date, we have reconstructed the ileocecal valve during continent urinary diversion in 10 patients with myelomeningocele. Four patients have identical bowel habits &r urinary diversion and ileocecal reconstruction, and stool frequency has even normalized in 4 suffering from diarrhea preoperatively. Only 2 of these 10 patients have irregular defecations: 1 underwent diversion only 7 weeks ago and 1 has constipation and diarrhea, although preoperatively he had diarrhea 3 to 4 times a day! The implementation of alternative forms of urinary diversion as suggested by Gonzalez whereby the reservoir is constructed from ileum does not decrease the risk of diarrhea in myelomeningocele patients, since a substantial amount of small bowel must be resected during these procedures. We are currently undertaking experiments to determine intestinal transit time preoperatively, and after continent urinary diversion and ileocecal valve reconstruction. Nonetheless, with experience with 40 myelomeningocele patients in our entire series of more than 400 Mainz pouch I operations, ileocecal valve reconstruction produces the most beneficial clinical results in myelomeningocele patients.
RE: VESICAL LITHIASIS: OPEN SURGERY VERSUS CYSTOLITHOTRIPSY VERSUS EXTRACORPOREAL SHOCK WAVE THERAPY V. Bhatia and C. S. Biyani J . Urol., 151:660-662, 1994
To the Editor. I do not believe that extracorporeal shock wave lithotripsy (ESWL*) has any role in the treatment of bladder stones. There is no substitute for lithotripsy done under direct vision. ESWL will not completely fragment stones in all cases and, therefore, cystoscopy may be required. With the advent of laser lithotripsy and more refined electrohydraulic lithotripsy techniques, I do not believe there is any excuse for performing ESWL on a patient with bladder stones. Perhaps in Kuwait City this is an option that patients will accept. However, in Columbus, Ohio I doubt if most of our patients
* Dornier Medical Systems, Inc., Marietta, Georgia.
would accept 45 minutes of ESWL therapy to the genital region. I know I would not. Respectfully, William J. Somers Division of Urology Ohio State University Medical Center 456 West 10th Avenue Columbus, Ohio 43210-1228
Reply by Authors. We certainly have electrohydraulic lithotripsy, ultrasound and laser lithotripsy in our department and a comparative study with ESWL for vesical stones is under consideration for publication. We do not consider ESWL to be a panacea for vesical stones but continue to be convinced about its simplicity, safety and low complication rate over transurethral endoscopic techniques.' We also perform strictly outpatient ESWL for bladder stones in select patients insisting on noninvasive therapy.2 We believe t h a t the salient advantages of ESWL are avoidance of anesthesia, shortest catheterization time and minimal hospital stay. We, of course, do not recommend it as a n absolute substitute for direct vision lithotripsy but do include it in our therapeutic options for vesical stones.
1. Bhatia, V. and Biyani, C. S.: A comparative analysis of cystolithotripsy and ESWL for bladder stones. Int. Urol. Nephrol., in press. 2. Bhatia, V. and Biyani, C. S.: Outpatient ESWL therapy for vesical lithiasis. Jap. J. Endourol. ESWL, in press.
RE: PERIURETHRAL INJECTION OF AUTOLOGOUS FAT FOR THE TREATMENT OF SPHINCTERIC INCONTINENCE R. P. Santarosa and J. G. Blaiuas
J. Urol., 151: 607-611, 1994 To the Editor. The authors presented their early experience with periurethral injection of autologous fat in treating sphincteric incontinence. Their conclusions, however, seem to be excessively optimistic. The injection of autologous fat is not a new idea. The method was actually tested 100 years ago' and subsequently abandoned because of discouraging long-term results? As stated by the authors, the ultimate fate of the injected fat is the subject of controversy. In our opinion, the answer depends on the nature of aspirated material, which is approximately 25% blood3 and the remainder consists of fragments with destroyed fat cells at the periphery. It seems difficult to suppose that fat cells removed by strong aspiration can tolerate the trauma of harvesting and transplantation without undergoing cellular lysis. Moreover, the injection of broken cell pieces and fat causes mainly a foreign body reaction that, at best, could result in total resorption of the injected material in the long term.4 The implant of fat tissue has a rationale if unimpaired adipose lobules are used and all artifacts due to fragmentation during harvest are avoided. McFarland postulated that reimplanted fat derives nutrients osmotically from surrounding extracellular fluid before vascularization by host blood vessel^.^ Nevertheless, a good perfusion supposes the existence of favorable volume-to-surface ratio as in small adipose tissue fragment reimplantation. In the proposed technique fat fragments are pressed together so that the theoretical advantages of a favorable volume-to-surface ratio is lost. It is also noteworthy that the fragments have no anatomical relationship, so that revascularization of 1 fragment does not affect adjacent fragments, since there is no vascular connection between them. This results in extensive necrosis in the adipose tissue graft. The report released in 1987 by the Ad Hoc Committee on New Procedures of the American Society of Plastic and Reconstructive Surgeons concluded that only 30% of injected fat can be expected to survive for 1 year.6 A preliminary report by Weber indicated only a 10% survival rate of fat graft^.^ Presently, it appears that little, if any, of the injected autologous fat survives a t the new site for 1year.' The long-term persistence of oil cysts makes it obvious why failure of the graft may not be fully apparent until months after implantation. This finding also helps to explain the good short-term and discouraging long-term results of autologous fat injections reported in the literature. The report by the authors of a n 84% overall success rate a t 1 year seems even more impressive because the results are different from
LETTERS TO THE EDITOR those of other series cited in the article. Others have reported a good result in only 23% of the patients a t 1 year:-” whereas Appell did not use autologous fat a t all.’’ Moreover, these results have been obtained with a 16 gauge needle for harvesting the fat, which is surprising if one considers that among the conditions that must be met to decrease injury to the adipose tissue one of the most important is the use of a large needle (10to 12 gauge) and that, despite all of these precautions, the survival of free fat graft is generally reported to be poor. Respectfully, Francesco Aragona and Walter Artibani Institute of Urology University of Padova Via Giustiniani, 2 35128-Padova, Italy 1. Neuber, F.: Fettransplantation. Kongr. Verhandl. Deutsch. Gesellsch. Chir., 22: 66, 1893. 2. Illouz, Y.G.: Present results of fat injection. Aesth. Plast. Surg., 1 2 175, 1988. 3. Hetter, G.P.: The Theory and Practice of Blunt Suction Lipectomy. Boston: Little, Brown & Co., 1984. 4. Smahel, J.: Aspiration lipectomy and adipose tissue injection: 1 4 126,1991. pathophysiologic commentary. Eur. J. Plast. S 5. McFarland, J. E.: The free autogenous fat grafty’comparison of the fat “pearl”and fat “cell”graft in an animal model. Ophthal. Plast. Reconstr. Sur 4 41, 1988. 6. American Society of PTistic and Reconstructive Surgeons: Report on autologous fat trans lantation. ASPRS Ad-Hoc Committee on New Procedures, geptember 30, 1987.Plast. Surg. Nurs., ?: 140, 1987. 7. Weber, J. R.: Fat grafts: do they work? In: Proceedings of the Annual Meeting of the Lipolysis Society of North America, Los Angeles, California, 1986. 8. Essek, R.: Transplantation of purified autologous fat: a 3-year follow-up is disappointing. Plast. Reconstr. Surg., 87: 219,1991. 9. Gonzalez Garibay, S., Jimeno, C., York, M., Gomez, P. and Bormell, S.: Endoscopic autotransplantation of fat tissue in the treatment of urinary incontinence in the female. J. d’urol., 96: 363,1989. 10. Gonzalez de Garibay, A. S., CastilloJimenco, J. M., Villanueva-Perez, I., Figuerido-Garmendia, E., Vigata-Lopez, M. J. and Sebastian-Borruel, J. L.: Treatment of urinary stress incontinence using paraurethral injection of autologous fat. Arch. Es . Urol., 44:595,1991. 11. Santiago &nzalez de Garibay, A. M., Castro Morrondo, J., Castillo Jimeno, J. M., Sanchez Robles, I. and Sebastifln Borruel, J. L.: Endoscopic injection of autologous adipose hssue in the treatment of female incontinence. Arch. Esp. Urol., 42.143,1989. 12. Appell, R. A.: Injectables for urethral incompetence. World J. Urol., 8: 208, 1990.
Reply by Autbrs. We stand by the “surprisi&‘ results that we reported, since they were as objective as possible based on patient reported diaries, pad tests and examination. However, we agree with the tone of this Letter and did not intend our report to be viewed as “excessively optimistic.” The success rate that we reported is comparable to the results of other periurethral injectables. However, in all of these series (including ours) it would be more accurate to describe the ”successes”as improvements. We are not strong advocates of the penurethral injection of any substance to treat stress incontinence but we do believe that these techniques are promising and q u i r e more clinical research. Presently, we believe that approximately 30% of women with intrinsic sphincter deficiency w i l l be continent after 2 to 3 fat injections during 1 to 2 years and that they will probably require more injections with time. What this really indicates is that we need to develop a standadzed method of obtaining data and reporting results so that the true meaning of words like “SUCC~SS”and ”improvement”can be realized. Only then will we be able to determine what works and what does not.
RE: ORAL TERBUTALINE FOR THE TREATMENT OF PRIAPISM
F. E. Govier, E. Jonsson and D. Kramer-Levien
J. Urol., 151: 878-879, 1994 To the Editor. The authors conclude that terbutaline was not an effective agent for the treatment of pharmacologically induced pria-
163
pism based upon a study of 24 patients, of whom only 16 were treated with terbutaline. Their study had 2 major problems: 1) the small number of patients in each treatment arm and 2)the low, inadequate iosage (2.5mg. and 5 mg.) of terbutaline used. We had shown that terbutaline was effective in treating pharma~ologicallyinduced prolonged erections in our previously published study of 75 patients randomized to terbutaline, pseudoephedrine or placebo.’ Terbutaline caused detumescence in 36% of 25 patients treated with either 5 or 10 mg. (repeat dose) compared to only 12% in patients receiving placebo (p <0.05). The authors had a surprisingly high incidence of detumescence with placebo (44%).The higher placebo response rate could be due partly to delaying intervention until 4 hours after erections were induced while we intervened after only 3 hours. It might also reflect the lower dose of prostaglandin E l used in their study (only 8.33 pg./ml.). The authors showed that 44% of the patients responded to placebo, 57% responded to 2.5 mg. and 63% responded to 5 mg., for a 19% attributable response rate (drug response minus placebo response). Our study had a 24% attributable response rate (36% minus 12% equals 24%). If their study had been properly powered to show a 20% attributable response rate in the presence of such a large placebo response, their results would have been statistically significant. Thus, even their limited data also confirm a response to terbutaline. Terbutaline was successful in achieving detumescence in 36% of our treated patients (24% with a single 5 mg. dose and an additional 12% with a repeat 5 mg. dose 15 minutes later). Their response rate would have probably been higher if they had repeated the 5 mg.dose. Because there is little morbidity in patients without significant coronary artery disease or hypersensitivity to these drugs, we recommend terbutaline for our patients with pharmacologically induced prolonged erections to prevent priapism. The benefits of oral medical therapy for prolonged erections are significant. Therapy can be instituted earlier since the oral terbutaline can be self-administered at home. The costa of managing this complication are decreased by limiting those who need to seek medical treatment in the emergency room. Therefore, we usually supply our patients on the pharmacological erection program with a small number of terbutaline tablets to administer at home under physician direction if a prolonged erection occurs. The use of terbutaline has decreased the number of patients who require drainage or injection with phenylephrine. Although not 100% effective, terbutaline has been shown to be effective for approximately a third of our patients. Therefore, it should be considered as first line intervention for pharmacologically induced prolonged erections. Respectmy, Franklin C. Lowe Department of Urology St. Luke’s1 Roosevelt Hospital Center New York, New York 10019 and Jonathan P. Jarow Department of Urology Bowman Gray School of Medicine Winston-Salem, North Carolina 27157 1. Lowe, F. C. and Jarow, J. P.: Placebo-controlled study of oral terbutaline and pseudoephedrine in management of prostaglandin El-induced prolonged erections. Urology, 42:51, 1993.
Reply by Authors. We would first like to acknowledge an error in our original abstract. We stated that Doetor Bondil had reported terbutaline as an effective treatment and this is incorrect. Bondil, in a Letter to the Editor, questioned the rationale for use of terbutaline at all in this situation.’ Our apologies to him for this oversight. Doetors Lowe and Jarow have raised concerns about the small numbers of patients in each treatment arm and a power of only 15%. We agree with these concerns and so stated in the article. End points for our study, in addition to the need for standard therapy (aspiration and/or a-adrenergics) were interval to detumescence in the group that responded. We found no difference in interval to detumescence in the placebo group (4.16hours) versus the 2.5 mg. (4.25 hours) and 5.0mg. (4.25hours) terbutaline groups. A combination of no dose response, absolutely no difference in interval to detumescence in the nontreated group and no statistically signiscant difference in the need for standard therapy led us to end our study prematurely and conclude that terbutaline was not effective. As to an inadequate dosage, this may be a valid point. When our
LETTERS TO THE EDITOR
to achieve rectal continence with a program of regular bowel evacuation. Any acceleration of intestinal transit is detrimental to rectal control.'-4 After reading this report, I continue to stand by my recommendation to avoid the use of the ileocecal segment in myelomeningocele patients. Respectfully, Ricardo Gonzalez Department of Urologic Surgery Section of Pediatric Urology University of Minnesota Medical School Box 45 Mayo Memorial Building 420 Delaware Street, S.E. Minneapolis, Minnesota 55455 1. Gonzalez, R., Sidi, A. A. and Zhang, G.: Urinary undiversion: indications, techniques and results in 50 cases. J. Urol., 136: 13,1986. 2. Gonzalez, R. and Cabral, B. H. P.: Rectal continence &r enterocystoplasty. Dial. Ped. Urol., 10: 4,December 1987. 3. Gonzalez, R. and Sidi, A. A: The use of bowel in the reconstruction of the urinary tract in children. In: Modem Technics in Surgery. Edited by R. Ehrlieh. Mount Kisko, New York: Futura Publishing Co., pp. 42.1-42.21, 1988. 4. Gonzalez, R.: Bladder augmentation with sigmoid or descending colon. In: Reconstructive Urology. Edited by G. Webster, R. Kirby, L. King and B. Goldwasser. Oxford Blackwell Scientific, vol. 1, chapt. 30,p. 433, 1993.
Reply by Authors. Only patients 4, 9 and 11 of the 12 patients mentioned in our article had myelomeningocele and, in contrast to the comment of Doctor Gonzalez, stool frequency did not increase in any of these patients. To date, we have reconstructed the ileocecal valve during continent urinary diversion in 10 patients with myelomeningocele. Four patients have identical bowel habits &r urinary diversion and ileocecal reconstruction, and stool frequency has even normalized in 4 suffering from diarrhea preoperatively. Only 2 of these 10 patients have irregular defecations: 1 underwent diversion only 7 weeks ago and 1 has constipation and diarrhea, although preoperatively he had diarrhea 3 to 4 times a day! The implementation of alternative forms of urinary diversion as suggested by Gonzalez whereby the reservoir is constructed from ileum does not decrease the risk of diarrhea in myelomeningocele patients, since a substantial amount of small bowel must be resected during these procedures. We are currently undertaking experiments to determine intestinal transit time preoperatively, and after continent urinary diversion and ileocecal valve reconstruction. Nonetheless, with experience with 40 myelomeningocele patients in our entire series of more than 400 Mainz pouch I operations, ileocecal valve reconstruction produces the most beneficial clinical results in myelomeningocele patients.
RE: VESICAL LITHIASIS: OPEN SURGERY VERSUS CYSTOLITHOTRIPSY VERSUS EXTRACORPOREAL SHOCK WAVE THERAPY V. Bhatia and C. S. Biyani J . Urol., 151:660-662, 1994
To the Editor. I do not believe that extracorporeal shock wave lithotripsy (ESWL*) has any role in the treatment of bladder stones. There is no substitute for lithotripsy done under direct vision. ESWL will not completely fragment stones in all cases and, therefore, cystoscopy may be required. With the advent of laser lithotripsy and more refined electrohydraulic lithotripsy techniques, I do not believe there is any excuse for performing ESWL on a patient with bladder stones. Perhaps in Kuwait City this is an option that patients will accept. However, in Columbus, Ohio I doubt if most of our patients
* Dornier Medical Systems, Inc., Marietta, Georgia.
would accept 45 minutes of ESWL therapy to the genital region. I know I would not. Respectfully, William J. Somers Division of Urology Ohio State University Medical Center 456 West 10th Avenue Columbus, Ohio 43210-1228
Reply by Authors. We certainly have electrohydraulic lithotripsy, ultrasound and laser lithotripsy in our department and a comparative study with ESWL for vesical stones is under consideration for publication. We do not consider ESWL to be a panacea for vesical stones but continue to be convinced about its simplicity, safety and low complication rate over transurethral endoscopic techniques.' We also perform strictly outpatient ESWL for bladder stones in select patients insisting on noninvasive therapy.2 We believe t h a t the salient advantages of ESWL are avoidance of anesthesia, shortest catheterization time and minimal hospital stay. We, of course, do not recommend it as a n absolute substitute for direct vision lithotripsy but do include it in our therapeutic options for vesical stones.
1. Bhatia, V. and Biyani, C. S.: A comparative analysis of cystolithotripsy and ESWL for bladder stones. Int. Urol. Nephrol., in press. 2. Bhatia, V. and Biyani, C. S.: Outpatient ESWL therapy for vesical lithiasis. Jap. J. Endourol. ESWL, in press.
RE: PERIURETHRAL INJECTION OF AUTOLOGOUS FAT FOR THE TREATMENT OF SPHINCTERIC INCONTINENCE R. P. Santarosa and J. G. Blaiuas
J. Urol., 151: 607-611, 1994 To the Editor. The authors presented their early experience with periurethral injection of autologous fat in treating sphincteric incontinence. Their conclusions, however, seem to be excessively optimistic. The injection of autologous fat is not a new idea. The method was actually tested 100 years ago' and subsequently abandoned because of discouraging long-term results? As stated by the authors, the ultimate fate of the injected fat is the subject of controversy. In our opinion, the answer depends on the nature of aspirated material, which is approximately 25% blood3 and the remainder consists of fragments with destroyed fat cells at the periphery. It seems difficult to suppose that fat cells removed by strong aspiration can tolerate the trauma of harvesting and transplantation without undergoing cellular lysis. Moreover, the injection of broken cell pieces and fat causes mainly a foreign body reaction that, at best, could result in total resorption of the injected material in the long term.4 The implant of fat tissue has a rationale if unimpaired adipose lobules are used and all artifacts due to fragmentation during harvest are avoided. McFarland postulated that reimplanted fat derives nutrients osmotically from surrounding extracellular fluid before vascularization by host blood vessel^.^ Nevertheless, a good perfusion supposes the existence of favorable volume-to-surface ratio as in small adipose tissue fragment reimplantation. In the proposed technique fat fragments are pressed together so that the theoretical advantages of a favorable volume-to-surface ratio is lost. It is also noteworthy that the fragments have no anatomical relationship, so that revascularization of 1 fragment does not affect adjacent fragments, since there is no vascular connection between them. This results in extensive necrosis in the adipose tissue graft. The report released in 1987 by the Ad Hoc Committee on New Procedures of the American Society of Plastic and Reconstructive Surgeons concluded that only 30% of injected fat can be expected to survive for 1 year.6 A preliminary report by Weber indicated only a 10% survival rate of fat graft^.^ Presently, it appears that little, if any, of the injected autologous fat survives a t the new site for 1year.' The long-term persistence of oil cysts makes it obvious why failure of the graft may not be fully apparent until months after implantation. This finding also helps to explain the good short-term and discouraging long-term results of autologous fat injections reported in the literature. The report by the authors of a n 84% overall success rate a t 1 year seems even more impressive because the results are different from
LETTERS TO THE EDITOR those of other series cited in the article. Others have reported a good result in only 23% of the patients a t 1 year:-” whereas Appell did not use autologous fat a t all.’’ Moreover, these results have been obtained with a 16 gauge needle for harvesting the fat, which is surprising if one considers that among the conditions that must be met to decrease injury to the adipose tissue one of the most important is the use of a large needle (10to 12 gauge) and that, despite all of these precautions, the survival of free fat graft is generally reported to be poor. Respectfully, Francesco Aragona and Walter Artibani Institute of Urology University of Padova Via Giustiniani, 2 35128-Padova, Italy 1. Neuber, F.: Fettransplantation. Kongr. Verhandl. Deutsch. Gesellsch. Chir., 22: 66, 1893. 2. Illouz, Y.G.: Present results of fat injection. Aesth. Plast. Surg., 1 2 175, 1988. 3. Hetter, G.P.: The Theory and Practice of Blunt Suction Lipectomy. Boston: Little, Brown & Co., 1984. 4. Smahel, J.: Aspiration lipectomy and adipose tissue injection: 1 4 126,1991. pathophysiologic commentary. Eur. J. Plast. S 5. McFarland, J. E.: The free autogenous fat grafty’comparison of the fat “pearl”and fat “cell”graft in an animal model. Ophthal. Plast. Reconstr. Sur 4 41, 1988. 6. American Society of PTistic and Reconstructive Surgeons: Report on autologous fat trans lantation. ASPRS Ad-Hoc Committee on New Procedures, geptember 30, 1987.Plast. Surg. Nurs., ?: 140, 1987. 7. Weber, J. R.: Fat grafts: do they work? In: Proceedings of the Annual Meeting of the Lipolysis Society of North America, Los Angeles, California, 1986. 8. Essek, R.: Transplantation of purified autologous fat: a 3-year follow-up is disappointing. Plast. Reconstr. Surg., 87: 219,1991. 9. Gonzalez Garibay, S., Jimeno, C., York, M., Gomez, P. and Bormell, S.: Endoscopic autotransplantation of fat tissue in the treatment of urinary incontinence in the female. J. d’urol., 96: 363,1989. 10. Gonzalez de Garibay, A. S., CastilloJimenco, J. M., Villanueva-Perez, I., Figuerido-Garmendia, E., Vigata-Lopez, M. J. and Sebastian-Borruel, J. L.: Treatment of urinary stress incontinence using paraurethral injection of autologous fat. Arch. Es . Urol., 44:595,1991. 11. Santiago &nzalez de Garibay, A. M., Castro Morrondo, J., Castillo Jimeno, J. M., Sanchez Robles, I. and Sebastifln Borruel, J. L.: Endoscopic injection of autologous adipose hssue in the treatment of female incontinence. Arch. Esp. Urol., 42.143,1989. 12. Appell, R. A.: Injectables for urethral incompetence. World J. Urol., 8: 208, 1990.
Reply by Autbrs. We stand by the “surprisi&‘ results that we reported, since they were as objective as possible based on patient reported diaries, pad tests and examination. However, we agree with the tone of this Letter and did not intend our report to be viewed as “excessively optimistic.” The success rate that we reported is comparable to the results of other periurethral injectables. However, in all of these series (including ours) it would be more accurate to describe the ”successes”as improvements. We are not strong advocates of the penurethral injection of any substance to treat stress incontinence but we do believe that these techniques are promising and q u i r e more clinical research. Presently, we believe that approximately 30% of women with intrinsic sphincter deficiency w i l l be continent after 2 to 3 fat injections during 1 to 2 years and that they will probably require more injections with time. What this really indicates is that we need to develop a standadzed method of obtaining data and reporting results so that the true meaning of words like “SUCC~SS”and ”improvement”can be realized. Only then will we be able to determine what works and what does not.
RE: ORAL TERBUTALINE FOR THE TREATMENT OF PRIAPISM
F. E. Govier, E. Jonsson and D. Kramer-Levien
J. Urol., 151: 878-879, 1994 To the Editor. The authors conclude that terbutaline was not an effective agent for the treatment of pharmacologically induced pria-
163
pism based upon a study of 24 patients, of whom only 16 were treated with terbutaline. Their study had 2 major problems: 1) the small number of patients in each treatment arm and 2)the low, inadequate iosage (2.5mg. and 5 mg.) of terbutaline used. We had shown that terbutaline was effective in treating pharma~ologicallyinduced prolonged erections in our previously published study of 75 patients randomized to terbutaline, pseudoephedrine or placebo.’ Terbutaline caused detumescence in 36% of 25 patients treated with either 5 or 10 mg. (repeat dose) compared to only 12% in patients receiving placebo (p <0.05). The authors had a surprisingly high incidence of detumescence with placebo (44%).The higher placebo response rate could be due partly to delaying intervention until 4 hours after erections were induced while we intervened after only 3 hours. It might also reflect the lower dose of prostaglandin E l used in their study (only 8.33 pg./ml.). The authors showed that 44% of the patients responded to placebo, 57% responded to 2.5 mg. and 63% responded to 5 mg., for a 19% attributable response rate (drug response minus placebo response). Our study had a 24% attributable response rate (36% minus 12% equals 24%). If their study had been properly powered to show a 20% attributable response rate in the presence of such a large placebo response, their results would have been statistically significant. Thus, even their limited data also confirm a response to terbutaline. Terbutaline was successful in achieving detumescence in 36% of our treated patients (24% with a single 5 mg. dose and an additional 12% with a repeat 5 mg. dose 15 minutes later). Their response rate would have probably been higher if they had repeated the 5 mg.dose. Because there is little morbidity in patients without significant coronary artery disease or hypersensitivity to these drugs, we recommend terbutaline for our patients with pharmacologically induced prolonged erections to prevent priapism. The benefits of oral medical therapy for prolonged erections are significant. Therapy can be instituted earlier since the oral terbutaline can be self-administered at home. The costa of managing this complication are decreased by limiting those who need to seek medical treatment in the emergency room. Therefore, we usually supply our patients on the pharmacological erection program with a small number of terbutaline tablets to administer at home under physician direction if a prolonged erection occurs. The use of terbutaline has decreased the number of patients who require drainage or injection with phenylephrine. Although not 100% effective, terbutaline has been shown to be effective for approximately a third of our patients. Therefore, it should be considered as first line intervention for pharmacologically induced prolonged erections. Respectmy, Franklin C. Lowe Department of Urology St. Luke’s1 Roosevelt Hospital Center New York, New York 10019 and Jonathan P. Jarow Department of Urology Bowman Gray School of Medicine Winston-Salem, North Carolina 27157 1. Lowe, F. C. and Jarow, J. P.: Placebo-controlled study of oral terbutaline and pseudoephedrine in management of prostaglandin El-induced prolonged erections. Urology, 42:51, 1993.
Reply by Authors. We would first like to acknowledge an error in our original abstract. We stated that Doetor Bondil had reported terbutaline as an effective treatment and this is incorrect. Bondil, in a Letter to the Editor, questioned the rationale for use of terbutaline at all in this situation.’ Our apologies to him for this oversight. Doetors Lowe and Jarow have raised concerns about the small numbers of patients in each treatment arm and a power of only 15%. We agree with these concerns and so stated in the article. End points for our study, in addition to the need for standard therapy (aspiration and/or a-adrenergics) were interval to detumescence in the group that responded. We found no difference in interval to detumescence in the placebo group (4.16hours) versus the 2.5 mg. (4.25 hours) and 5.0mg. (4.25hours) terbutaline groups. A combination of no dose response, absolutely no difference in interval to detumescence in the nontreated group and no statistically signiscant difference in the need for standard therapy led us to end our study prematurely and conclude that terbutaline was not effective. As to an inadequate dosage, this may be a valid point. When our