1320
investigation probably resulted from frustration on the part of the clinician at the lack of a certain diagnosis, or a desire to come to a diagnosis "once and for all". In a few cases the clinical records were inadequate, but in most patients who underwent inappropriate angiography or bypass grafting, review of the case notes showed that the procedure was indeed "inappropriate" by the standards set by the panel. However, two factors should also be considered. First, it is probably inevitable that discussions will make the panel more conservative than some of its individual members, whose actions in individual patients might be more aggressive than they would be prepared to admit. Second, investigation or treatment considered inappropriate by standards laid down by a panel does not necessarily mean that the clinician who managed the patient was wrong. 30% of the patients in whom coronary angiography was considered "inappropriate" were found to need coronary artery bypass surgery. But when resources are limited, waiting lists are long, and choices have to be made about whom to investigate and treat, ratings of appropriateness seem to be a reasonable way to establish guidelines. A similar proportion of patients was investigated inappropriately in two centres, while in the third fewer procedures were inappropriate by the panel’s standards. We cannot be sure that the patients from the third centre received a better (or worse) standard of care but would argue that, in the third centre, resources were used more effectively.
by ratings of appropriateness is obviously less satisfactory than audit related to clinical trial results, but is preferable to an audit in which the only arbiter of correct management is the clinical judgment of an individual. The technique we describe could readily be applied to other Audit
illnesses. We thank Dr R. E. Park and Dr J. Kinsey for data analysis and Ms M. Nashimoto for administrative help. We also thank all physicians and cardiothoracic surgeons in the Trent region for their cooperation and support. The panel comprised Mr J. S. Bailey, Dr A. R. Barlow, Mr R. K. Firmin, Dr M. J. Goldberg, Prof J. R. Hampton, Dr N. Hudson, Dr E. Jackson, Dr J. M. Rowley, and Dr P. J. Toghill. S. J. B. is a Robert Wood Johnson Research Scholar. This study was supported by a grant from the Trent regional health authority and the Department of Health and Social Security.
REFERENCES 1. Consensus development conference: coronary artery bypass graft. Br Med J 1984; 289: 1527-29. 2. Brook RH, Kosecoff JB, Park RE, Chassin MR, Winslow CM. Hampton
JR. Diagnosis and
treatment of coronary disease: comparison of doctors’ attitudes in the USA and the UK. Lancet 1988; i: 750-53. 3. Fink A, Kosecoff JB, Chassin MR, Brook RH. Consensus methods: characteristics and guidelines for use. Am J Publ Health 1984; 74: 979-83. 4. Sackman H. Delphi critique. Lexington, Massachusetts: D. C. Health, 1975. 5. Petch MC. Investigation of coronary artery disease. J R Coll Physns Lond
1986; 20: 21-24.
Endoscopic correction of primary vesicoureteric reflux by subureteric injection of polytetrafluoroethylene
91 children (143 ureters) with primary vesicoureteric reflux (VUR) treated endoscopically by subureteric injection of ’Polytef’ (polytetrafluoroethylene) paste were followed up for 2 to 5 1/2 years. 94% of the patients were treated as day cases. Reflux ceased in 113 (79%) of the 143 ureters after a single injection of polytef paste. 20% of ureters in this series required more than one
endoscopic injection of polytef paste to correct reflux. Nearly 80% of the 113 ureters corrected after a single injection of polytef required less than 0·3 ml of paste per ureter to correct reflux. 88% of ureters continue to show absence of reflux 2 to 51/2 years after endoscopic correction. More than half of the recurrences were only of grade I or grade II severity and required no treatment. 7 ureters had recurrent grade III or IV reflux and were reinjected without any difficulty. The correction of vesicoureteric reflux by endoscopic injection of polytef paste is an outpatient procedure that requires 15 min of anaesthetic time. It is safe, simple, and effective in correcting all grades of reflux. Best results are obtained when the paste is
injected precisely into the floor of the submucosal ureter.
Introduction Vesicoureteric reflux has been reported in 30 to 50% of all children presenting with urinary tract infection.1 Primary vesicoureteric reflux (VUR) is due to congenital absence or deficiency of the longitudinal muscle of the submucosal ureter, which results in upward and lateral displacement of the ureteric orifice, and hence reduction in length and obliquity of the submucosal ureter. We have been treating VUR endoscopically since 1984, after a successful experimental study in piglets.2 The procedure consists of
endoscopic injection
of
’Polytef (polytetrafluoroethylene)
paste into the lamina propria behind the submucosal ureter. Polytef paste is a suspension of biologically inert polytetrafluoroethylene particles in glycerine. After injection the glycerine is absorbed into the tissues and the polytef implant becomes firm and retains its shape and position at the injection site. The procedure has been used successfully to treat primary and secondary VUR in children.3-7 This paper reviews my personal experience of 91 children with primary vesicoureteric reflux treated
ADDRESS: National Children’s Hospital, Harcourt Street, Dublin, Ireland (P. Puri, FACS). Correspondence to Mr P. Purl, Children’s Research Centre, Our Lady’s Hospital for Sick Children, Crumlin, Dublin 12, Ireland.
1321
TABLE I-RESULTS OF ENDOSCOPIC TREATMENT OF VESICOURETERIC REFLUX IN 143 URETERS
grade II reflux, and no further 4 ureters with grade III and the 3 The given. ureters with grade IV recurrent reflux were reinjected with polytef paste. Follow-up urography or ultrasound did not reveal ureteral obstruction in any of the treated ureters. grade
I and 4 showed
treatment was
Discussion
endoscopically by subureteric injection follow-up has ranged from 2 to 5 Zyears.
of
polytef paste;
Patients and methods The 91 children (72 girls, 19 boys, mean age 58 years, range 4 months to 13 years) with primary VUR were treated between July, 1984, and December, 1987, by endoscopic subureteric injection of polytef paste at the National Children’s Hospital, Harcourt Street, Dublin. 39 patients had unilateral VUR, 52 had bilateral reflux, and 12 of these patients had refluxing duplex systems, with 2 having bilateral duplex systems. These cases represented 143 refluxing ureters. Acccording to the international classificationl of reflux none of the ureters were grade I, 7 were grade II, 85 were grade III, 41 were grade IV, and 10 were grade V. To inject the paste a disposable Puri catheter 4 or 5F (Storz, Tufflingen, W. Germany) is first filled with paste with a 1 ml tuberculin syringe with a metallic sheath and piston (Storz). The catheter is then introduced through a cystoscope (5F catheters through a 13 or 14F cystoscope and 4F catheters through a 10F cystoscope). The catheter has to be passed with the telescope removed. Under direct cystoscopic vision the needle is introduced under the bladder mucosa 2 to 3 mm below the affected ureteric orifice at the 6 o’clock position. As the paste is injected a bulge appears in the floor of the submucosal ureter. The ureteric orifice should look slit-like at the end of the procedure. The procedure has been described in detail elsewhere,.8 86 of the 91 patients were treated as day cases. Co-trimoxazole or the preoperative antibiotic was prescribed for 2 weeks after the procedure. Patients underwent micturating cystography and ultrasonography 3 months after discharge. If negative, these investigations were repeated a year after the injection and annually thereafter. These annual micturating cystograms were obtained to collect follow-up data of this new antireflux technique.
Results Table I shows the results of endoscopic treatment of vesicoureteric reflux in the 143 ureters. The only procedurerelated complication occurred in 1 patient, who had to be readmitted to the hospital because of unilateral ureteral obstruction the day after bilateral endoscopic injection for grade IV VLTR. She required a ureteric catheter for 5 days while the oedema subsided. Follow-up micturating cystogram 3 iyears later shows no evidence of reflux in this child. Nearly 80% of ureters required less than 0-3 ml of polytef paste to correct the reflux (table II). In the 2-52years of follow-up, during which 57 patients were monitored for more than 3 years, 127 (88%) ureters remained free of reflux, whereas a recurrence occurred in 16 (12%). Of the 16 ureters in which reflux recurred, 5 showed TABLE ))—TOTAL AMOUNT OF POLYTEF PASTE REQUIRED TO CORRECT VUR WITH ONE INJECTION
Treatment of primary vesicoureteric reflux by endoscopic subureteric injection of polytef paste was found simple, safe, and effective in correcting all grades of primary VUR. The principle of the procedure is exactly the same as that of open ureteroneocystostomy. The polytetrafluoroethylene implant, which becomes encapsulated by a thin fibrous capsule,2 not only produces a solid support behind the affected intravesical ureter but it also provides a firm anchorage for that part of the ureter, thereby preventing it from sliding upwards during micturition. Reflux ceased in 80% of ureters after a single injection of polytef paste. The success or failure of the procedure depends on the accuracy of the injection technique. If the needle is introduced into the lamina propria at the 6 o’clock position just proximal to the ureteric orifice, the implant will be in the floor of the submucosal ureter rather than alongside the ureter, and this in our experience invariably corrects reflux by a single injection. Moreover, if the needle is introduced into the lamina propria with pinpoint accuracy, less teflon is needed to correct reflux than if the injection were made in the wrong place---eg, detrusor muscle or alongside the ureter. I have found that nearly 80% of instances of VUR corrected with one injection of polytef paste required less than 0-3 ml of paste. The endoscopic injection technique is an outpatient procedure that requires 15 minutes of anaesthetic time and is associated with very little morbidity. In the present study 94% of the patients were managed as day cases. 20% of the ureters required more than one endoscopic injection of polytef paste to correct VUR, mostly because of injection of paste into the wrong place the first time. In view of the short anaesthetic time, the procedure can be repeated easily. 88% of ureters continue to show absence of reflux 2 to 5 2 years after endoscopic correction. More than half of the recurrences were of only grade I or grade I severity. Those with recurrent grade III or IV reflux were reinjected without any difficulty. Although follow-up in this series is short, there was no morbidity associated with this procedure apart from the fact that seven ureters required repeat injection for recurrent reflux. Most paediatric surgeons and urologists acknowledge the success of the endoscopic approach to correct vesicoureteric reflux but have been concerned with the use of polytef paste as the implanted substance. This concern primarily originated from a report9 from the Mayo Clinic of migration of polytef particles from the injection site in dogs and monkeys. The diameter of the polytetrafluoroethylene particle ranges from 4 to 100 urn, with over 90 % of particles having diameters less than 40 pm. In the Mayo study polytef paste was injected together with radioactive strontium microspheres having diameters similar to those of the polytef particles. The authors assumed that since the polytef particles were in the same injection as the strontium, they would migrate in the same way as strontium. The authors also claim to have identified polytef by the detection, with X-ray microanalysis, of fluorine in the organs. The experimental procedure in the study was good in that the object was first to identify positive sites before undertaking
1322
unnecessary electron microscopy of tissues containing no polytef. However, there is no evidence to suggest that the
microspheres migrate in the same manner as the polytef particles. The gross variation in polytef particle size suggests that these particles would behave differently from homogeneous radiolabelled microspheres. Fluorine is notoriously difficult to analyse by microanalysis since the X-ray emission from fluorine is very weak. Only large concentrations of particles would be likely to be detected by labelled
this method. After injection of polytef paste a granulomatous reaction occurs and the fibrous capsule that later forms around the polytef particles holds them in place. Kaplan16 carefully followed up 10 patients treated with subureteric teflon injections for up to 3 years with computed tomography and ultrasound scans and found no instance of an enlarging injection granuloma. Similarly Mann et al6 did not find any change in the size of the teflon granuloma on sonography in their patients in a 1-year follow-up study. Polytef paste has been injected for vocal cord surgery for over 25 years and for stress incontinence for 20 years.10-ls No untoward effects have been reported.
REFERENCES 1.
Report of the International Reflux Committee. Medical versus surgical treatment of primary vesicoureteral reflux. Pediatrics 1981; 67:
392-400. 2. Puri . O’Donnell B.
Correction
of experimentally
Long-term
use
produced
vesicoureteric reflux in the piglet by intravesical injection of Teflon. Br Med J 1984; 289: 5-7. 3. O’Donnell B, Puri P. Treatment of vesicoureteric reflux by endoscopic injection of Teflon. Br Med J 1984; 289: 7-9. 4. Puri P, O’Donnell B. Endoscopic correction of grades IV and V primary vesicoureteric reflux. J Pediatr Surg 1986; 22: 1087-91. 5. Kaplan WE, Dalton DP, Firlit CF. The endoscopic correction of reflux by polytetrafluoroethylene injection. J Urol 1987; 138: 953-55. 6. Mann CI, Jequier S, Patriquin H, LaBerge I, Homsy YL. Intramural Teflon injection of the ureter for the treatment of vesicoureteric reflux: sonographic appearance. AJR 1988; 151: 543-45. 7. Puri P, Guiney EJ, Endoscopic correction of vesicoureteric reflux secondary to neuropathic bladder. Br J Urol 1986; 58: 504-06. 8. Purl P, O’Donnell B. Endoscopic correction of vesicoureteric reflux using subureteric Teflon injection. In: Spitz L, Nixon HH, eds. Operative paediatric surgery. Sevenoaks: Butterworths, 1988: 522-27. 9. Malizia A, Reiman H, Myers R, et al. Migration and granulomatous reaction after periurethral injection of Polytef paste. JAMA 1984; 251: 3277-81. 10. Arnold GE. Alleviation of aphonia or dysphonia through intrachordial injection of teflon paste. Ann Otol Rhinol Laryngol 1963; 72: 384-95. 11. Dedo HH, Urria RD, Lawson L. Intrachordial injection of teflon in the treatment of 135 patients with dysphonia. Ann Otol Rhinol Laryngol 1973; 82: 661-67. 12. Lewy RB. Experience with vocal cord injection. Ann Otol Rhinol Laryngol 1976; 85: 440-50. 13. Politano VA. Periurethral polytetrafluoroethylene injection for urinary incontinence. J Urol 1974; 111: 180-83. 14. Schulman CC, Simon J, Wespes E, et al. Endoscopic injection of Teflon to treat urinary incontinence in women. Br Med J 1984; 288: 192. 15. Vorstman B, Lockhart J, Kaufman M, et al. Polytetrafluoroethylene injection for urinary incontinence in children. J Urol 1985; 133: 248-50. 16. Spencer J, Donaldson J, Zaontz M, Kaplan W. The sting: postoperative evaluation for granuloma development in the paediatric patient. Presented at the 83rd Annual Meeting of the American Urological Association, Boston, Massachusetts, 1988 (abstr 93).
of copper intrauterine devices
A statement from the Medical Advisory Committee of the Family Planning Association and the National Association of Family Planning Doctors
The intrauterine device (IUD) is now probably the second most commonly used reversible method of birth control, with more than 60 million users worldwide. The original devices, such as the Lippes loop, were made of inert plastic. Copper-bearing IUDs became available in the 1970s and the first two models, the copper 7 and the copper Twere soon in widespread use. In the first, second, and subsequent years after insertion they gave lower pregnancy rates than inert IUDs.4,s IUDs are thought to exert their contraceptive effect by interfering with the reproductive process before the ovum reaches the intrauterine cavity, and the presence of the copper probably potentiates this effect.6 The two early copper IUDs (copper 7 and copper T) have 200 mmz surface area of copper in the form of a thin wire wound round the stem of the device. In early models the wire was only 0-2 mm thick and after long-term use sometimes fragmented or disappeared completely. Copperbearing IUDs act by releasing copper at a mean rate of 38 ng per day. Like all devices placed in the uterus they are subject to deposition of cellular debris and of calcium and
magnesium salts but copper ions are still able to diffuse. At one time the salts were thought to reduce the effectiveness of IUDs7 but this is
not
so.8
Subsequent development of the
copper IUD has led to effective and have a longer active life devices that with a lower rate of wire fragmentation. This has been achieved firstly by increasing the wire thickness to 03 or 0-4 mm (eg, ’Multiload’), secondly by the preparation of a silver-core copper wire (eg, ’Nova-T’), and thirdly by the use of solid copper collars or sleeves, either alone as on the copper T 220C or in conjunction with copper wire as on the copper T 380 slimline. The copper T 380 slimline, with copper placed near the fundus of the uterus and in the form of sleeves, has a theoretical lifespan of up to ten years.6 Some of the copper-bearing IUDs used in the UK-the are more
ADDRESSES Family Planning Association, 27-35 Mortimer St, London W1N 7RJ, UK (Prof J. Newton, FRCOG); National Association of Family Planning Doctors, 27 Sussex Place, London NW1 4RG (Dr D. Tacchi). Correspondence to either.
investigation probably resulted from frustration on the part of the clinician at the lack of a certain diagnosis, or a desire to come to a diagnosis "once and for all". In a few cases the clinical records were inadequate, but in most patients who underwent inappropriate angiography or bypass grafting, review of the case notes showed that the procedure was indeed "inappropriate" by the standards set by the panel. However, two factors should also be considered. First, it is probably inevitable that discussions will make the panel more conservative than some of its individual members, whose actions in individual patients might be more aggressive than they would be prepared to admit. Second, investigation or treatment considered inappropriate by standards laid down by a panel does not necessarily mean that the clinician who managed the patient was wrong. 30% of the patients in whom coronary angiography was considered "inappropriate" were found to need coronary artery bypass surgery. But when resources are limited, waiting lists are long, and choices have to be made about whom to investigate and treat, ratings of appropriateness seem to be a reasonable way to establish guidelines. A similar proportion of patients was investigated inappropriately in two centres, while in the third fewer procedures were inappropriate by the panel’s standards. We cannot be sure that the patients from the third centre received a better (or worse) standard of care but would argue that, in the third centre, resources were used more effectively.
by ratings of appropriateness is obviously less satisfactory than audit related to clinical trial results, but is preferable to an audit in which the only arbiter of correct management is the clinical judgment of an individual. The technique we describe could readily be applied to other Audit
illnesses. We thank Dr R. E. Park and Dr J. Kinsey for data analysis and Ms M. Nashimoto for administrative help. We also thank all physicians and cardiothoracic surgeons in the Trent region for their cooperation and support. The panel comprised Mr J. S. Bailey, Dr A. R. Barlow, Mr R. K. Firmin, Dr M. J. Goldberg, Prof J. R. Hampton, Dr N. Hudson, Dr E. Jackson, Dr J. M. Rowley, and Dr P. J. Toghill. S. J. B. is a Robert Wood Johnson Research Scholar. This study was supported by a grant from the Trent regional health authority and the Department of Health and Social Security.
REFERENCES 1. Consensus development conference: coronary artery bypass graft. Br Med J 1984; 289: 1527-29. 2. Brook RH, Kosecoff JB, Park RE, Chassin MR, Winslow CM. Hampton
JR. Diagnosis and
treatment of coronary disease: comparison of doctors’ attitudes in the USA and the UK. Lancet 1988; i: 750-53. 3. Fink A, Kosecoff JB, Chassin MR, Brook RH. Consensus methods: characteristics and guidelines for use. Am J Publ Health 1984; 74: 979-83. 4. Sackman H. Delphi critique. Lexington, Massachusetts: D. C. Health, 1975. 5. Petch MC. Investigation of coronary artery disease. J R Coll Physns Lond
1986; 20: 21-24.
Endoscopic correction of primary vesicoureteric reflux by subureteric injection of polytetrafluoroethylene
91 children (143 ureters) with primary vesicoureteric reflux (VUR) treated endoscopically by subureteric injection of ’Polytef’ (polytetrafluoroethylene) paste were followed up for 2 to 5 1/2 years. 94% of the patients were treated as day cases. Reflux ceased in 113 (79%) of the 143 ureters after a single injection of polytef paste. 20% of ureters in this series required more than one
endoscopic injection of polytef paste to correct reflux. Nearly 80% of the 113 ureters corrected after a single injection of polytef required less than 0·3 ml of paste per ureter to correct reflux. 88% of ureters continue to show absence of reflux 2 to 51/2 years after endoscopic correction. More than half of the recurrences were only of grade I or grade II severity and required no treatment. 7 ureters had recurrent grade III or IV reflux and were reinjected without any difficulty. The correction of vesicoureteric reflux by endoscopic injection of polytef paste is an outpatient procedure that requires 15 min of anaesthetic time. It is safe, simple, and effective in correcting all grades of reflux. Best results are obtained when the paste is
injected precisely into the floor of the submucosal ureter.
Introduction Vesicoureteric reflux has been reported in 30 to 50% of all children presenting with urinary tract infection.1 Primary vesicoureteric reflux (VUR) is due to congenital absence or deficiency of the longitudinal muscle of the submucosal ureter, which results in upward and lateral displacement of the ureteric orifice, and hence reduction in length and obliquity of the submucosal ureter. We have been treating VUR endoscopically since 1984, after a successful experimental study in piglets.2 The procedure consists of
endoscopic injection
of
’Polytef (polytetrafluoroethylene)
paste into the lamina propria behind the submucosal ureter. Polytef paste is a suspension of biologically inert polytetrafluoroethylene particles in glycerine. After injection the glycerine is absorbed into the tissues and the polytef implant becomes firm and retains its shape and position at the injection site. The procedure has been used successfully to treat primary and secondary VUR in children.3-7 This paper reviews my personal experience of 91 children with primary vesicoureteric reflux treated
ADDRESS: National Children’s Hospital, Harcourt Street, Dublin, Ireland (P. Puri, FACS). Correspondence to Mr P. Purl, Children’s Research Centre, Our Lady’s Hospital for Sick Children, Crumlin, Dublin 12, Ireland.
1321
TABLE I-RESULTS OF ENDOSCOPIC TREATMENT OF VESICOURETERIC REFLUX IN 143 URETERS
grade II reflux, and no further 4 ureters with grade III and the 3 The given. ureters with grade IV recurrent reflux were reinjected with polytef paste. Follow-up urography or ultrasound did not reveal ureteral obstruction in any of the treated ureters. grade
I and 4 showed
treatment was
Discussion
endoscopically by subureteric injection follow-up has ranged from 2 to 5 Zyears.
of
polytef paste;
Patients and methods The 91 children (72 girls, 19 boys, mean age 58 years, range 4 months to 13 years) with primary VUR were treated between July, 1984, and December, 1987, by endoscopic subureteric injection of polytef paste at the National Children’s Hospital, Harcourt Street, Dublin. 39 patients had unilateral VUR, 52 had bilateral reflux, and 12 of these patients had refluxing duplex systems, with 2 having bilateral duplex systems. These cases represented 143 refluxing ureters. Acccording to the international classificationl of reflux none of the ureters were grade I, 7 were grade II, 85 were grade III, 41 were grade IV, and 10 were grade V. To inject the paste a disposable Puri catheter 4 or 5F (Storz, Tufflingen, W. Germany) is first filled with paste with a 1 ml tuberculin syringe with a metallic sheath and piston (Storz). The catheter is then introduced through a cystoscope (5F catheters through a 13 or 14F cystoscope and 4F catheters through a 10F cystoscope). The catheter has to be passed with the telescope removed. Under direct cystoscopic vision the needle is introduced under the bladder mucosa 2 to 3 mm below the affected ureteric orifice at the 6 o’clock position. As the paste is injected a bulge appears in the floor of the submucosal ureter. The ureteric orifice should look slit-like at the end of the procedure. The procedure has been described in detail elsewhere,.8 86 of the 91 patients were treated as day cases. Co-trimoxazole or the preoperative antibiotic was prescribed for 2 weeks after the procedure. Patients underwent micturating cystography and ultrasonography 3 months after discharge. If negative, these investigations were repeated a year after the injection and annually thereafter. These annual micturating cystograms were obtained to collect follow-up data of this new antireflux technique.
Results Table I shows the results of endoscopic treatment of vesicoureteric reflux in the 143 ureters. The only procedurerelated complication occurred in 1 patient, who had to be readmitted to the hospital because of unilateral ureteral obstruction the day after bilateral endoscopic injection for grade IV VLTR. She required a ureteric catheter for 5 days while the oedema subsided. Follow-up micturating cystogram 3 iyears later shows no evidence of reflux in this child. Nearly 80% of ureters required less than 0-3 ml of polytef paste to correct the reflux (table II). In the 2-52years of follow-up, during which 57 patients were monitored for more than 3 years, 127 (88%) ureters remained free of reflux, whereas a recurrence occurred in 16 (12%). Of the 16 ureters in which reflux recurred, 5 showed TABLE ))—TOTAL AMOUNT OF POLYTEF PASTE REQUIRED TO CORRECT VUR WITH ONE INJECTION
Treatment of primary vesicoureteric reflux by endoscopic subureteric injection of polytef paste was found simple, safe, and effective in correcting all grades of primary VUR. The principle of the procedure is exactly the same as that of open ureteroneocystostomy. The polytetrafluoroethylene implant, which becomes encapsulated by a thin fibrous capsule,2 not only produces a solid support behind the affected intravesical ureter but it also provides a firm anchorage for that part of the ureter, thereby preventing it from sliding upwards during micturition. Reflux ceased in 80% of ureters after a single injection of polytef paste. The success or failure of the procedure depends on the accuracy of the injection technique. If the needle is introduced into the lamina propria at the 6 o’clock position just proximal to the ureteric orifice, the implant will be in the floor of the submucosal ureter rather than alongside the ureter, and this in our experience invariably corrects reflux by a single injection. Moreover, if the needle is introduced into the lamina propria with pinpoint accuracy, less teflon is needed to correct reflux than if the injection were made in the wrong place---eg, detrusor muscle or alongside the ureter. I have found that nearly 80% of instances of VUR corrected with one injection of polytef paste required less than 0-3 ml of paste. The endoscopic injection technique is an outpatient procedure that requires 15 minutes of anaesthetic time and is associated with very little morbidity. In the present study 94% of the patients were managed as day cases. 20% of the ureters required more than one endoscopic injection of polytef paste to correct VUR, mostly because of injection of paste into the wrong place the first time. In view of the short anaesthetic time, the procedure can be repeated easily. 88% of ureters continue to show absence of reflux 2 to 5 2 years after endoscopic correction. More than half of the recurrences were of only grade I or grade I severity. Those with recurrent grade III or IV reflux were reinjected without any difficulty. Although follow-up in this series is short, there was no morbidity associated with this procedure apart from the fact that seven ureters required repeat injection for recurrent reflux. Most paediatric surgeons and urologists acknowledge the success of the endoscopic approach to correct vesicoureteric reflux but have been concerned with the use of polytef paste as the implanted substance. This concern primarily originated from a report9 from the Mayo Clinic of migration of polytef particles from the injection site in dogs and monkeys. The diameter of the polytetrafluoroethylene particle ranges from 4 to 100 urn, with over 90 % of particles having diameters less than 40 pm. In the Mayo study polytef paste was injected together with radioactive strontium microspheres having diameters similar to those of the polytef particles. The authors assumed that since the polytef particles were in the same injection as the strontium, they would migrate in the same way as strontium. The authors also claim to have identified polytef by the detection, with X-ray microanalysis, of fluorine in the organs. The experimental procedure in the study was good in that the object was first to identify positive sites before undertaking
1322
unnecessary electron microscopy of tissues containing no polytef. However, there is no evidence to suggest that the
microspheres migrate in the same manner as the polytef particles. The gross variation in polytef particle size suggests that these particles would behave differently from homogeneous radiolabelled microspheres. Fluorine is notoriously difficult to analyse by microanalysis since the X-ray emission from fluorine is very weak. Only large concentrations of particles would be likely to be detected by labelled
this method. After injection of polytef paste a granulomatous reaction occurs and the fibrous capsule that later forms around the polytef particles holds them in place. Kaplan16 carefully followed up 10 patients treated with subureteric teflon injections for up to 3 years with computed tomography and ultrasound scans and found no instance of an enlarging injection granuloma. Similarly Mann et al6 did not find any change in the size of the teflon granuloma on sonography in their patients in a 1-year follow-up study. Polytef paste has been injected for vocal cord surgery for over 25 years and for stress incontinence for 20 years.10-ls No untoward effects have been reported.
REFERENCES 1.
Report of the International Reflux Committee. Medical versus surgical treatment of primary vesicoureteral reflux. Pediatrics 1981; 67:
392-400. 2. Puri . O’Donnell B.
Correction
of experimentally
Long-term
use
produced
vesicoureteric reflux in the piglet by intravesical injection of Teflon. Br Med J 1984; 289: 5-7. 3. O’Donnell B, Puri P. Treatment of vesicoureteric reflux by endoscopic injection of Teflon. Br Med J 1984; 289: 7-9. 4. Puri P, O’Donnell B. Endoscopic correction of grades IV and V primary vesicoureteric reflux. J Pediatr Surg 1986; 22: 1087-91. 5. Kaplan WE, Dalton DP, Firlit CF. The endoscopic correction of reflux by polytetrafluoroethylene injection. J Urol 1987; 138: 953-55. 6. Mann CI, Jequier S, Patriquin H, LaBerge I, Homsy YL. Intramural Teflon injection of the ureter for the treatment of vesicoureteric reflux: sonographic appearance. AJR 1988; 151: 543-45. 7. Puri P, Guiney EJ, Endoscopic correction of vesicoureteric reflux secondary to neuropathic bladder. Br J Urol 1986; 58: 504-06. 8. Purl P, O’Donnell B. Endoscopic correction of vesicoureteric reflux using subureteric Teflon injection. In: Spitz L, Nixon HH, eds. Operative paediatric surgery. Sevenoaks: Butterworths, 1988: 522-27. 9. Malizia A, Reiman H, Myers R, et al. Migration and granulomatous reaction after periurethral injection of Polytef paste. JAMA 1984; 251: 3277-81. 10. Arnold GE. Alleviation of aphonia or dysphonia through intrachordial injection of teflon paste. Ann Otol Rhinol Laryngol 1963; 72: 384-95. 11. Dedo HH, Urria RD, Lawson L. Intrachordial injection of teflon in the treatment of 135 patients with dysphonia. Ann Otol Rhinol Laryngol 1973; 82: 661-67. 12. Lewy RB. Experience with vocal cord injection. Ann Otol Rhinol Laryngol 1976; 85: 440-50. 13. Politano VA. Periurethral polytetrafluoroethylene injection for urinary incontinence. J Urol 1974; 111: 180-83. 14. Schulman CC, Simon J, Wespes E, et al. Endoscopic injection of Teflon to treat urinary incontinence in women. Br Med J 1984; 288: 192. 15. Vorstman B, Lockhart J, Kaufman M, et al. Polytetrafluoroethylene injection for urinary incontinence in children. J Urol 1985; 133: 248-50. 16. Spencer J, Donaldson J, Zaontz M, Kaplan W. The sting: postoperative evaluation for granuloma development in the paediatric patient. Presented at the 83rd Annual Meeting of the American Urological Association, Boston, Massachusetts, 1988 (abstr 93).
of copper intrauterine devices
A statement from the Medical Advisory Committee of the Family Planning Association and the National Association of Family Planning Doctors
The intrauterine device (IUD) is now probably the second most commonly used reversible method of birth control, with more than 60 million users worldwide. The original devices, such as the Lippes loop, were made of inert plastic. Copper-bearing IUDs became available in the 1970s and the first two models, the copper 7 and the copper Twere soon in widespread use. In the first, second, and subsequent years after insertion they gave lower pregnancy rates than inert IUDs.4,s IUDs are thought to exert their contraceptive effect by interfering with the reproductive process before the ovum reaches the intrauterine cavity, and the presence of the copper probably potentiates this effect.6 The two early copper IUDs (copper 7 and copper T) have 200 mmz surface area of copper in the form of a thin wire wound round the stem of the device. In early models the wire was only 0-2 mm thick and after long-term use sometimes fragmented or disappeared completely. Copperbearing IUDs act by releasing copper at a mean rate of 38 ng per day. Like all devices placed in the uterus they are subject to deposition of cellular debris and of calcium and
magnesium salts but copper ions are still able to diffuse. At one time the salts were thought to reduce the effectiveness of IUDs7 but this is
not
so.8
Subsequent development of the
copper IUD has led to effective and have a longer active life devices that with a lower rate of wire fragmentation. This has been achieved firstly by increasing the wire thickness to 03 or 0-4 mm (eg, ’Multiload’), secondly by the preparation of a silver-core copper wire (eg, ’Nova-T’), and thirdly by the use of solid copper collars or sleeves, either alone as on the copper T 220C or in conjunction with copper wire as on the copper T 380 slimline. The copper T 380 slimline, with copper placed near the fundus of the uterus and in the form of sleeves, has a theoretical lifespan of up to ten years.6 Some of the copper-bearing IUDs used in the UK-the are more
ADDRESSES Family Planning Association, 27-35 Mortimer St, London W1N 7RJ, UK (Prof J. Newton, FRCOG); National Association of Family Planning Doctors, 27 Sussex Place, London NW1 4RG (Dr D. Tacchi). Correspondence to either.
