Complications of Synthetic Midurethral Slings: Is There a Relevant Discrepancy Between Observational Data and Clinical Trials?

CONTEXT: The complications of synthetic midurethral slings (MUSs) in women with stress urinary incontinence (SUI) have become a globally debated issue. OBJECTIVE: To systematically review the short- and long-term complications of mesh slings reported in observational data compared with clinical trial data, to determine whether the complication rates from clinical trials reflects "real-world" observational data. EVIDENCE ACQUISITION: PubMed and Cochrane Library were searched. Methods as detailed in Preferred Reporting Items for Systematic Reviews and Meta-analyses and Cochrane Handbook for Systematic Reviews of Interventions were followed. EVIDENCE SYNTHESIS: Thirty registries/databases including 709 335 MUS procedures (1-22 yr of follow-up) were identified. MUS procedures were associated with intraoperative bladder perforation in 0.86-3.6%, urethral perforation in 0-0.1%, vascular injury in 0.04-0.1%, voiding lower urinary tract symptoms (LUTS) in 1.47-3.5%, vaginal exposure in 0.2-1.9%, and reoperation in up to 9% of cases. Forty-three randomised clinical trials were identified, including 6284 women who underwent MUS procedures and 2177 women who underwent other interventions (1-10 yr of follow-up). MUS procedures were associated with urinary tract perforation in 2.58%, vaginal injury in 1.43%, de novo voiding LUTS in 4.37%, de novo storage LUTS in 5.41%, mesh extrusion/exposure (vaginal/urinary tract) in 2.54%, dyspareunia in 2.26%, pain (pelvic/suprapubic/perineal) in 2.83%, and reoperation for complications required in 1.82% of cases. Meta-analyses of the randomised controlled trials revealed that retropubic MUSs were associated with more events of urinary tract perforation (risk ratio [RR] 9.81, 95% confidence interval [CI] 5.05-19.04, high certainty of evidence [COE]) and voiding LUTS (RR 1.57, 95% CI 1.19-2.07, high COE) than transobturator MUSs. MUSs were associated with more events of pain than mini-slings (RR 1.72, 95% CI 1.04-2.87, moderate COE). CONCLUSIONS: Short- and long-term data on complications of polypropylene mesh used for female SUI are fairly comparable when using outcome data from well-designed clinical trials or from less structured prospective or retrospective registries. Comparisons have to be made with caution since the two systems of data collection are inherently incomparable. This knowledge should be incorporated in the discussion on how to implement polypropylene mesh for female stress incontinence. PATIENT SUMMARY: In order to know whether mesh tapes used for treating stress incontinence work well and are safe, high-quality information is important. It appears that well-designed clinical studies give similar results to large registration databases. These data should be interpreted with caution in view of the different ways the information was collected. These results will help physicians and patients understand the risks of mesh tapes.

Proper understanding of recurrent stress urinary incontinence treatment in women (PURSUIT): a randomised controlled trial of endoscopic and surgical treatment.

BACKGROUND: Women with stress urinary incontinence (SUI) experience urine leakage with physical activity. Currently, the interventional treatments for SUI are surgical, or endoscopic bulking injection(s). However, these procedures are not always successful, and symptoms can persist or come back after treatment, categorised as recurrent SUI. There are longstanding symptoms and distress associated with a failed primary treatment, and currently, there is no consensus on how best to treat women with recurrent, or persistent, SUI. METHODS: A two-arm trial, set in at least 20 National Health Service (NHS) urology and urogynaecology referral units in the UK, randomising 250 adult women with recurrent or persistent SUI 1:1 to receive either an endoscopic intervention (endoscopic bulking injections) or a standard NHS surgical intervention, currently colposuspension, autologous fascial sling or artificial urinary sphincter. The aim of the trial is to determine whether surgical treatment is superior to endoscopic bulking injections in terms of symptom severity at 1 year after randomisation. This primary outcome will be measured using the patient-reported International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-UI-SF). Secondary outcomes include assessment of longer-term clinical impact, improvement of symptoms, safety, operative assessments, sexual function, cost-effectiveness and an evaluation of patients' and clinicians' views and experiences of the interventions. DISCUSSION: There is a lack of high-quality, randomised, scientific evidence for which treatment is best for women presenting with recurrent SUI. The PURSUIT study will benefit healthcare professionals and patients and provide robust evidence to guide further treatment and improve symptoms and quality of life for women with this condition. TRIAL REGISTRATION: International Standard Randomised Controlled Trials Number (ISRCTN) registry ISRCTN12201059. Registered on 09 January 2020.

Bulking for stress urinary incontinence in men: A systematic review.

AIMS: An updated literature review on outcomes in men treated with currently commercially available bulking agents was performed to determine whether this is a reasonable option in selected patients. METHODS: The review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses framework of systematic reviews. A comprehensive search of PubMed, Medline, and Embase was undertaken. Abstracts were independently screened by two investigators to include men with stress urinary incontinence treated with a peri-urethral injection of bulking agents currently available in the market. RESULTS: Only eight original articles met the inclusion criteria. The bulking agents used were Macroplastique in five studies (total 123 patients), Opsys, Durasphere, and Urolastic in one study each (10, 7, and 2 patients, respectively). Only one study was randomized; Macroplastique vs AUS in men with mild or total incontinence. The included populations were heterogeneous and encompassed endoscopic, perineal, abdominal and laparoscopic prostate surgery as well as spinal cord injuries and urethral sphincter insufficiency. Significant dissimilarity was evident for the duration of incontinence (9-108 months), mean volume of bulking agent used (2.3-13.5 mL), number of cushions (1-5), depth and position of the cushions. The outcomes varied significantly, with reported dry rates between 0% and 83%. Outcomes were limited by relatively short follow-up in most studies. CONCLUSION: Following initial enthusiasm and then dismay with collagen-based compounds, sparse and heterogeneous literature data were produced on newer non-migrating and nonabsorbable bulking agents. Some studies have suggested encouraging, if short term outcomes, however, future studies are needed in this field to support recommendations for widespread use.

Female urethral stricture: a contemporary series.

PURPOSE: To report the etiology, presenting symptoms and outcomes of the different treatments performed in female patients with recurrent urethral stricture. MATERIALS AND METHODS: Twenty-six patients with refractory LUTS were diagnosed with a urethral stricture. The symptoms, the treatment performed and the outcomes were prospectively recorded. Sixteen patients were treated with a urethroplasty using a buccal mucosal graft (BMG) in 14 cases (54 %) and a vaginal flap in 2 (8 %). Urethral dilatation, optical urethrotomy and meatoplasty were performed in 8 (31 %), 1 (3.8 %) and 1 (3.8 %) patients, respectively. RESULTS: Strictures were idiopathic in 11 patients (42 %). Previous urethral instrumentation and traumatic vaginal delivery were the commonest causes of urethral stricture (42 and 15 %, respectively). The most frequent symptoms were reduced flow (93 %), detrusor overactivity (50 %) and UTIs (42 %). The stricture was cured in 93 % of patients treated with a BMG urethroplasty and in all the patients in which a vaginal flap urethroplasty was performed. In the same group, the improvement in urethral pain was observed in the 67 and the 88 % of patients were cured from recurrent UTIs. All the patients treated with urethral dilatation needed further dilatations; hence, the cure of the stricture was achieved in none of them. Improvement in urethral pain, UTIs and detrusor activity was not recorded in the latter group. CONCLUSION: Urethroplasty in its various forms has demonstrated in the present series the highest cure rate for the treatment of recurrent urethral stricture.

Aggressive Angiomyxoma of the Bladder Neck Requiring Local Excision and Mitrofanoff Formation.

Aggressive angiomyxoma is a rare mesenchymal tumour predominantly affecting the female pelvis and perineum but has also been described in males. This tumour can often present a diagnostic challenge and has a propensity for local recurrence after surgical excision. We present an unusual case of aggressive angiomyxoma arising from the bladder of a female patient which required local excision and Mitrofanoff formation.

["Flowsecure" artificial urinary sphincter: a new adjustable artificial urinary sphincter concept with conditional occlusion for stress urinary incontinence]. / Esfínter Urinario Artificial "FlowSecure": un nuevo concepto de esfínter artificial regulable y con oclusión condicional para la incontinencia urinaria de esfuerzo.

INTRODUCTION: To spread de concept of a new artificial urinary sphincter with conditional occlusion for stress incontinence. The new prototype was conceived and designed in The Institute of Urology and Nephrology of London by Professor Craggs M. and Professor Mundy A.R. METHODS: The FlowSecure sphincter consists of an adjustable pressure-regulating balloon, a stress relief reservoir, a control pump and valve assembly unit with self-sealing port and a urethral cuff. The pressure regulating balloon determinates de operating pressure of the device; the pressure is adjustable in the range 0-80 cm H2O and can be altered by injection or removal of normal saline through the self sealing port. The stress relief balloon transmits transient intrabdominal pressure to the cuff during periods of stress. An adjustable circular urethral cuff minimises creasing and possible stress fractures. RESULTS: The device is implanted as a one-piece assembly which is pre-filled with sterile saline. The surgical technique is simple and associated with little handling, reducing risk of infection and potential assembly errors. The adjustable pressure regulating balloon in association with the stress relief reservoir enables the cuff occluding pressure to be set at a low range, therefore reducing the risk for atrophy and erosion. DISCUSSION: The new FlowSecure urinary artificial sphincter with conditional occlusion is designed to provide good continence rates adjusting regulating pressures when needed and conceived to reduce the risk of potential complications associated with excessive occluding pressures and mechanical failures.

Esfínter Urinario Artificial 'FlowSecure(TM)': un nuevo concepto de esfínter artificial regulable y con oclusión condicional para la incontinencia urinaria de esfuerzo / 'Flowsecure(TM)' artificial urinary sphincter: a new adjustable urinary sphincter concept with conditional occlusion for stress urinary incontinence

Introducción: Difundir el concepto de un nuevo esfínter urinario artificial con oclusión condicional para el tratamiento de la incontinencia urinaria de esfuerzo. El prototipo fue concebido y diseñado por los profesores Craggs M. y Mundy A.R. en el Instituto de Urología y Nefrología de Londres. Materiales y Métodos: El esfínter FlowSecure es un prototipo de una sola pieza de silicona llena de suero salino que consta de: 1) Un reservorio regulador de presión, 2) un reservorio de asistencia al estrés, 3) una bomba de control con un puerto autosellable y 4) un manguito. El reservorio regulador determina la presión de la prótesis y se puede ajustar desde 0 a 80 cm H2O mediante la inyección o extracción de líquido a través del puerto autosellable (oclusión basal). El reservorio de asistencia al estrés transmite de forma reversible los aumentos de la presión intra-abdominal durante los periodos de esfuerzo (oclusión condicional). Resultados: La técnica quirúrgica de implantación es simple, reduciendo la posibilidad de infección y errores de ensamblaje. La asociación en serie de un reservorio regulador de presión con un reservorio de asistencia al estrés permite establecer presiones de oclusión basal bajas y el aumento condicional de la misma durante los periodos de estrés, reduciendo el riesgo de atrofia y erosión. Tras la implantación, la presión es ajustable dependiendo de las necesidades clínicas del paciente. Discusión: El esfínter FlowSecure está diseñado para corregir la incontinencia ajustando la presión de oclusión según las necesidades individuales de cada paciente, así como para reducir las complicaciones asociadas al exceso de presión de oclusión y los fallos mecánicos

Introduction: To spread de concept of a new artificial urinary sphincter with conditional occlusion for stress incontinence. The new prototype was conceived and designed in The Institute of Urology and Nephrology of London by Professor Craggs M. and Professor Mundy A.R. Methods: The FlowSecure sphincter consists of an adjustable pressure-regulating balloon, a stress relief reservoir, a control pump and valve assembly unit with self-sealing port and a urethral cuff. The pressure regulating balloon determinates de operating pressure of the device; the pressure is adjustable in the range 0-80 cm H2O and can be altered by injection or removal of normal saline through the self sealing port. The stress relief balloon transmits transient intrabdominal pressure to the cuff during periods of stress. An adjustable circular urethral cuff minimises creasing and possible stress fractures. Results: The device is implanted as a one-piece assembly which is pre-filled with sterile saline. The surgical technique is simple and associated with little handling, reducing risk of infection and potential assembly errors. The adjustable pressure regulating balloon in association with the stress relief reservoir enables the cuff occluding pressure to be set at a low range, therefore reducing the risk for atrophy and erosion. Discussion: The new FlowSecure urinary artificial sphincter with conditional occlusion is designed to provide good continence rates adjusting regulating pressures when needed and conceived to reduce the risk of potential complications associated with excessive occluding pressures and mechanical failures

Standing the test of time: the long-term results of urethroplasty.

The principle indication for urethral surgery is stricture disease. There are a number of factors that influence the outcome of surgery including location of the stricture, stricture length, aetiology, previous surgery and selection of procedure. Outcomes for different techniques are summarised. The gold standard remains anastomotic urethroplasty, where appropriate, with patch urethroplasty or two-stage stage procedures for more complicated strictures especially the penile urethra.

Stomal complications of ileal conduits are significantly higher when formed in women with intractable urinary incontinence.

PURPOSE: The ileal conduit is held to be the safest and simplest form of urinary diversion. There are few reports about long-term problems after ileal conduit formation, especially intractable urinary incontinence in females. We reviewed long-term stomal complications in patients with an ileal conduit. MATERIALS AND METHODS: Notes on 93 consecutive patients in whom an ileal conduit was created were reviewed. Information was collected on patient demographics, indications for an ileal conduit and long-term complications, in particular parastomal and incisional hernias, stomal retraction, stenosis or prolapse and the development of a redundant loop. Mean followup available was 63.4 months (range 1 to 434). RESULTS: A total of 33 males with a mean age of 60.1 years (range 2 to 78) and 60 females with a mean age of 48.2 years (range 4 to 79) underwent ileal conduit diversion. The main indications for an ileal conduit were intractable incontinence in 44 patients (47%), cancer in 31 (33%) and interstitial cystitis in 8 (9%). In male, continent female and incontinent female patients A parastomal hernia developed in 3 (9%), 2 (9.5%) and 12 (31%), an incisional hernia developed in 1 (3%), 1 (4.8%) and 2 (5%), stomal retraction developed in 0, 2 (9.5%) and 12 (31%), stomal stenosis developed in 0 (0%), 1 (4.8%) and 6 (15.4%), and a redundant loop developed in 0 (0%), 2 (9.5%) and 5 (12.8%), respectively. A total of 23 patients (24.7%) required further surgery for stomal problems with 13 (57%) requiring more than 1 reoperation, of whom 9 were incontinent females. CONCLUSIONS: An ileal conduit is associated with a stomal complication rate of 34.4% (61% in incontinent females and 18% in other patients) and a 4.3% incisional hernia rate. Reoperation is required for stomal complications in 24.7% of cases. Stomal complication rates and reoperation rates vary by sex and the indication for ileal conduit, and they are significantly higher for those performed for intractable urinary incontinence in females.

The morbidity of buccal mucosal graft harvest for urethroplasty and the effect of nonclosure of the graft harvest site on postoperative pain.

PURPOSE: We assess the medium and long-term morbidity of buccal mucosal graft (BMG) harvest for urethroplasty, and evaluate the effect of nonclosure of the graft harvest site on postoperative pain. MATERIALS AND METHODS: A questionnaire was mailed to 110 men who underwent BMG urethroplasty between January 1, 1997 and August 31, 2002. Demographic data and side effects of BMG harvest, including oral pain, sensation and intake, were assessed postoperatively. A prospective study was then performed to compare 20 unselected men whose BMG donor site was closed with a group of 20 men in whom it was left open using a 5-point analog pain score that was completed twice daily for the first 5 postoperative days. RESULTS: A total of 49 men with a median age of 49 years (range 23 to 73) returned questionnaires relating to 57 BMG harvests. Of the graft harvests 47 (83%) were associated with postoperative pain, which was worse than expected in 24 (51%). Of the 57 patients 51 (90%) resumed oral liquid intake within 24 hours and 44 (77%) resumed normal diet within 1 week. Postoperative side effects included perioral numbness in 39 (68%) patients with 15 (26%) having residual numbness after 6 months, initial difficulty with mouth opening in 38 (67%) with 5 (9%) having persistent problems, changes in salivation in 6 (11%) and mucous retention cyst that required excision in 1 (2%). The men in the prospective donor site study had a median age of 51 years (range 24 to 70). Mean pain score for patients with donor site closure was 3.68 and was significantly higher than that for patients without donor site closure (2.26, p < 0.01). CONCLUSIONS: Buccal mucosal graft harvest is not a pain-free procedure. Closure of the harvest donor site appears to worsen this pain and it may be best to leave harvest sites open. The main long-term complications are perioral numbness, persistent difficulty with mouth opening and change in salivary function.

Repeat urethrotomy and dilation for the treatment of urethral stricture are neither clinically effective nor cost-effective.

PURPOSE: We developed an algorithm for the management of urethral stricture based on cost-effectiveness. MATERIALS AND METHODS: United Kingdom medical and hospital costs associated with the current management of urethral stricture were calculated using private medical insurance schedules of reimbursement and clean intermittent self-catheterization supply costs. These costs were applied to 126 new patients treated endoscopically for urethral stricture in a general urological setting between January 1, 1991 and December 31, 1999. Treatment failure was defined as recurrent symptomatic stricture requiring further operative intervention following initial intervention. Mean followup available was 25 months (range 1 to 132). RESULTS: The costs were urethrotomy/urethral dilation 2,250.00 pounds sterling (3,375.00 dollars, ratio 1.00), simple 1-stage urethroplasty 5,015.00 pounds sterling (7,522.50 dollars, ratio 2.23), complex 1-stage urethroplasty 5,335.00 pounds sterling (8,002.50 dollars, ratio 2.37) and 2-stage urethroplasty 10,370 pounds sterling (15,555.00 dollars, ratio 4.61). Of the 126 patients assessed 60 (47.6%) required more than 1 endoscopic retreatments (mean 3.13 each), 50 performed biweekly clean intermittent self-catheterization and 7 underwent urethroplasty during followup. The total cost per patient for all 126 patients for stricture treatment during followup was 6,113 pounds sterling (9,170 dollars). This cost was calculated by multiplying procedure cost by the number of procedures performed. A strategy of urethrotomy or urethral dilation as first line treatment, followed by urethroplasty for recurrence yielded a total cost per patient of 5,866 pounds sterling (8,799 dollars). CONCLUSIONS: A strategy of initial urethrotomy or urethral dilation followed by urethroplasty in patients with recurrent stricture proves to be the most cost-effective strategy. This financially based strategy concurs with evidence based best practice for urethral stricture management.

The outcome of renal denervation for managing loin pain haematuria syndrome.

OBJECTIVE: To evaluate the outcome of renal denervation for the treatment of loin pain-haematuria syndrome (LPHS), a rare syndrome of unknown cause associated with debilitating and intractable loin pain. PATIENTS AND METHODS: The case notes of 32 patients having 41 renal denervations were reviewed. Data collected included patient demographics, possible causes, cure or not after renal denervation, time to recurrence of pain after denervation and further operative intervention for managing LPHS. RESULTS: Full data were available for 24 patients (13 women; median age 43 years, range 28-74) having 33 denervations (eight bilateral and one repeat) with a median follow-up of 39.5 months. Most patients had no identifiable underlying cause although many had initially been diagnosed as having stone disease (42%) or pyelonephritis (25%), but with no corroborative evidence. All patients had been extensively investigated and had normal urine samples and cytology, and no abnormality on intravenous urography, renal tract ultrasonography and isotopic renography. Twenty-four renal denervations (73%) were followed by recurrent ipsilateral pain at a median (range) of 11 (0-120) months after surgery. Nine denervations (25%) in six men and two women were curative (median follow-up 16.5 months). Of those with recurrent pain, nine (38%) proceeded to nephrectomy, of whom three then developed loin pain on the contralateral side and two developed disabling wound pain. The analgesic requirement was less after eight non-curative denervations. There were no significant postoperative complications. CONCLUSIONS: Renal denervation has only a 25% success rate for managing pain associated with LPHS and should be used cautiously for this indication. Men had more benefit from the treatment; a third of patients had less requirement for analgesic after non-curative denervation.

Pregnancy after lower urinary tract reconstruction for congenital abnormalities.

OBJECTIVE: To evaluate the effect of pregnancy on renal function, and the effect of congenital urinary tract abnormality and reconstruction on pregnancy and delivery. PATIENTS AND METHODS: The case notes were reviewed of 20 women (median age 32.5 years) who had had 29 live babies. Data collected included patient demographics, congenital urological abnormality, urological reconstructive procedure(s) and any subsequent urological complications. Pregnancy details, including urological and obstetric complications, presentation and mode of delivery, were obtained via a postal questionnaire from the relevant obstetrician. RESULTS: Seven patients had exstrophy-epispadias, seven spinal dysraphism, two sacral agenesis, and one each cerebral palsy, epispadias, imperforate anus and small bladder with vesico-ureteric reflux and congenital incontinence. They had had a mean (range) of 5.7 (1-12) urological reconstructive procedures each. Patients with exstrophy-epispadias had significantly more operations (mean 7.8) than those with spinal dysraphism (mean 4.14) or other diagnoses (mean 2.6) (P < 0.01). At the last follow-up 13 patients had an enterocystoplasty, six a neobladder and one an ileal conduit. Pregnancy-related urological complications were urinary tract infection in 15, upper tract obstruction requiring nephrostomy and stent in three, Mitrofanoff difficulties in two and pyelonephritis in one. There was no significant deterioration in glomerular filtration rate or serum creatinine after pregnancy. Only 10 of the births were normal or assisted vaginal deliveries. Seven patients had emergency and 12 had elective Caesarean sections for obstetric indications, including four breech births in the seven patients with vesical exstrophy. CONCLUSIONS: Pregnancy has no long-term effect on renal function and does not compromise reconstruction. Although there is a substantial complication rate and an increased need for Caesarean section, pregnancy in women with lower urinary tract reconstruction for congenital urological abnormalities is ultimately safe for both mother and baby. Interdisciplinary co-operation is desirable for a successful outcome.

The type of urethroplasty for a pelvic fracture urethral distraction defect cannot be predicted preoperatively.

PURPOSE: Pelvic fracture urethral distraction defects (PFUDDs) are generally treated surgically by a so-called progression approach consisting of 4 steps to achieve a tension-free bulboprostatic anastomosis. Implicitly the need for each step in turn is predictable according to the length of the defect on preoperative x-ray. MATERIALS AND METHODS: In 62 evaluable patients with PFUDD the length of the radiological defect was compared with the surgical steps that subsequently proved necessary to achieve a tension-free bulboprostatic anastomosis. RESULTS: Except at the extremes of length there was no association between defect length and the scale of the surgery performed. CONCLUSIONS: Surgeons preparing to repair an apparently short PFUDD cannot assume that simple repair is all that is necessary.

The problems of penile urethroplasty with particular reference to 2-stage reconstructions.

PURPOSE: We evaluate the anecdotal high revision rate of 2-stage urethroplasty. MATERIALS AND METHODS: The short-term revision rates after 1-stage (139 cases) and 2-stage (103) urethroplasties were compared. RESULTS: There were 4 revisions after 1-stage urethroplasty (4 of 139, 3%) and all involved the penile urethra (20%). The revision rate was 37.8% after stage 1 and 25.3% after stage 2 and of 2-stage urethroplasty 85%, involved the penile urethra. CONCLUSIONS: Although 2-stage has a significantly lower re-stricture rate than 1-stage urethroplasty for complex strictures in the penile urethra, it does so at the expense of a significantly higher revision rate particularly of the penile urethra.

The long-term results of urethroplasty.

PURPOSE: We update our long-term data on the effectiveness of urethroplasty. MATERIALS AND METHODS: A total of 166 patients operated on before 1990 are currently under followup or lived at least 10 years after surgery. Anastomotic urethroplasty was performed in 82 patients and substitution urethroplasty in 84. RESULTS: The 5, 10 and 15-year re-stricture rates after anastomotic urethroplasty were 12%, 13% and 14%, respectively, and the complication rate was 7%. The 5, 10 and 15-year re-stricture rates after substitution urethroplasty were 21%, 31% and 58%, respectively, and the complication rate was 33%. CONCLUSIONS: The results of anastomotic urethroplasty are good and sustained in the long term, while the results of substitution urethroplasty deteriorate steadily with time and there is definite room for improvement. An anastomotic repair should be performed in preference to a substitution repair when possible.

Effect of antibiotics on enterocystoplasty urinary nitrosamine levels.

OBJECTIVES: To evaluate the microbiologic characteristics of enterocystoplasty urine and assess the influence of bacteria type and effect of prophylactic and therapeutic antibiotic administration on the urinary nitrosamine levels of patients with enterocystoplasty. Nitrosamines have been implicated in the development of cancer in patients with an enterocystoplasty. Urinary tract infection (UTI) is associated with elevated nitrosamine levels. METHODS: Urine samples were collected to determine the urinary nitrosamine levels and for microscopy, culture, and sensitivity from 42 patients with an enterocystoplasty and 6 normal controls. A subgroup of 5 enterocystoplasty patients with proven UTI was also evaluated by measuring the urinary nitrosamine levels before and after a therapeutic course of antibiotics. RESULTS: Of the 42 cystoplasty patients, 22 had a proven UTI; none of the controls had one. Sixteen of the cystoplasty patients were taking prophylactic antibiotics and had mean N-nitrosamine levels equivalent to the control levels. The mean nitrosamine levels were highest in patients with a UTI (1.9 micromol/L). Escherichia coli was the most common infecting organism (11 patients) and resulted in the highest mean nitrosamine levels (2.1 micromol/L). The nitrosamine levels fell with UTI treatment to within the control range. CONCLUSIONS: UTI occurs in 51% of enterocystoplasty patients and is associated with elevated mean urinary nitrosamine levels. E. coli is the infecting organism in 50% of cases. Antibiotic prophylaxis reduces the nitrosamine levels to those of the controls. UTI treatment results in a rapid reduction of elevated nitrosamine levels to control levels.