Outcome of continence procedures after failed endoscopic treatment with dextranomer-based implants (DEFLUX®).

PURPOSE: To evaluate outcome of further continence procedures after failure of endoscopic injections of dextranomer-based bulking agent. MATERIALS AND METHODS: From 1997, 89 children (3-18 years) and one young adult were treated for incontinence with 145 endoscopic injections of dextranomer. On evaluation, each patient was classified as: dry, significantly improved, or treatment failure. Eighty-five patients had at least 12 months of follow up. Out of 34 (40%) treatment failures, 24 patients had a subsequent bladder neck procedure: artificial urinary sphincter (7), bladder neck plasty (9), bladder neck closure (1), fascial sling (3). Six patients had further endoscopic treatment (including 2 after bladder neck plasty). RESULTS: At surgery, Deflux(®) paste was easily identified with minimal surrounding tissue inflammatory reaction. Artificial urinary sphincter: all 7 dry; bladder neck plasty: 7 dry, 1 improved and 1 still incontinent; 1 bladder neck closure patient dry; fascial sling: 1 significantly improved and 2 dry. Repeated endoscopic treatment: 1 dry, 1 improved and 4 failed. Eleven of the 21 (52%) patients who are either dry or improved have voiding abilities. CONCLUSION: Endoscopic injections with dextranomer do not adversely affect the outcome of further surgical procedures. Repeated injections after a previous endoscopic treatment failure have a low success rate.

Long-term effects of dextranomer endoscopic injections for treatment of urinary incontinence: an update of a prospective study of 31 patients.

PURPOSE: A prospective study was initiated 7 years previously to assess the efficacy of endoscopic dextranomer based implants for pediatric structural incontinence. Preliminary results revealed that at 3 years 50% of the patients were either dry or significantly improved. We report long-term results in the same cohort of patients. MATERIALS AND METHODS: A total of 33 children and adolescents 5 to 18 years old with severe incontinence due to sphincteric incompetence (exstrophy-epispadias complex in 13, neuropathic bladder in 16, bilateral ectopic ureter in 4) were enrolled. Of the patients 13 underwent 2 and 4 underwent 3 treatment sessions to achieve a definitive result. Mean injected volume was 3.9 ml (range 1.6 to 12) per session. At each evaluation patients were considered cured (dryness interval 4 hours), significantly improved (minimal incontinence requiring no more than 1 pad daily and no further treatment required) or treatment failures (no significant improvement). Videourodynamics were used to study the evolution of the bladder capacity, activity and compliance. A total of 31 patients were followed 3 to 7 years after the last injection. RESULTS: At 3 years after treatment 15 of 30 patients (50%) were dry or improved. One patient who had leakage after 3 years of dryness due to bladder deterioration subsequently underwent ileocystoplasty. At 4 years 12 of 25 patients (48%) were dry or improved. At 5 years 9 of 21 patients (43%) were dry, as were 4 of 11 (36%) at 6 years and 2 of 5 (40%) at 7 years of followup. The success rate according to pathological evaluation was comparable in neuropathic bladders (7 of 14, or 50%), exstrophy (3 of 6, or 50%) and epispadias (3 of 7, or 43%). Of 12 patients who underwent bladder neck plasty before the injection of bulking agent 7 (58%) were either dry or improved. The success rate was higher in males (13 of 23, or 57%) than in females (3 of 8, or 38%). Also, at puberty 2 males who were improved became dry. Bladder capacity increased in 12 of 18 initially small bladders and remained normal and stable in 9, while 4 initially dry patients had development of recurrent leakage secondary to bladder deterioration and underwent augmentation. Otherwise, there were no long-term side effects observed related to the injection of the bulking agent. CONCLUSIONS: Endoscopic treatment of severe organic urinary incontinence with dextranomer is durable for up to 7 years of followup in 40% of the patients.

The effect of endoscopic injections of dextranomer based implants on continence and bladder capacity: a prospective study of 31 patients.

PURPOSE: A prospective study was conducted to assess the efficacy of dextranomer based implants as a new bulking agent for endoscopic treatment of pediatric structural incontinence. MATERIALS AND METHODS: A total of 33 children and adolescents 5 to 18 years old with severe incontinence due to sphincteric incompetence (exstrophy-epispadias in 13, neuropathic bladder in 16, bilateral ectopic ureters in 4) were enrolled in the study. All but 1 patient wore diapers. Preoperative evaluation consisted of medical history, pad test, urine culture, urinary tract ultrasound and videourodynamics. This evaluation was repeated 6 months and 1 year after treatment and then on a yearly basis. Of the patients 14 had 2 and 1 had 3 treatment sessions to achieve a definitive result. At each evaluation the patient was considered cured-dryness interval of 4 hours confirmed by pad test, significantly improved-minimal incontinence requiring no more than 1 pad a day with less than 10 gm. leakage during pad test; and no further treatment required, and treatment failure-no significant improvement. Videourodynamics were mainly useful to study the evolution of the bladder capacity, activity and compliance. Followup after the last injection ranged from 6 to 36 months (mean 18). RESULTS: The mean injected volume was 3.9 ml. (range 1.6 to 12) and the procedure lasted a mean of 30 minutes (10 to 60). In the postoperative period 2 patients had temporary dysuria and 10 had a nonfebrile urinary tract infection. At 1 month 24 of the 33 patients (73%) were dry or improved. Two patients were subsequently excluded from study for noncompliance with followup. At 6 months 17 of 31 patients (55%), at 1 year 13 of 28 (46%), at 2 years 10 of 23 (43%) and at 3 years 10 of 20 (50%) were dry or improved. Similar success occurred in cases of neuropathic bladder (57%) and exstrophy-epispadias complex (46%). Success rate of re-treated patients was 35%. Of 13 patients with a normal initial bladder capacity 3 had a bladder decompensation requiring augmentation after 6 months. Also an increase of at least 50% in capacity was observed in 12 of 18 patients with an initial small bladder. No side effect related to the substance was observed. CONCLUSIONS: Endoscopic treatment of pediatric structural urinary incontinence with dextranomer implant, a nontoxic, nonimmunogenic, nonmigrant synthétic substance, was effective after 3 years in half of our patients. It may also be beneficial for patients with small bladder functional capacity. As the success rate decreased during the first year of followup, the result observed at 1 year seems to remain stable subsequently.