Endoscopic injection of glutaraldehyde cross-linked bovine dermal collagen for correction of vesicoureteral reflux.
From November 1986 through May 1989, a Food and Drug Administration approved investigational study was done to assess the safety and efficacy of glutaraldehyde cross-linked bovine dermal collagen in the endoscopic treatment of vesicoureteral reflux. Over-all, 57 patients (92 ureters) were treated. The majority of ureters (68.5%) had grade II to III/V vesicoureteral reflux (international classification). One treatment was given in 61.4% of the patients, while 33.3% required 2 and 5.3% required 3 treatments. Nonduplicated/primarily refluxing ureters comprised 68.5% of the total, while 13% were duplex/primarily refluxing and 18.5% were surgical failures. The procedures were performed on an outpatient basis in all but 3 patients. Patients were evaluated by voiding cystourethrogram and renal/bladder sonography before and after treatment at 1 month and 1 year. Cure at 1 month after the last treatment was achieved in 75% of the ureters. Among the ureters cured at 1 month the cure persisted in 79% at 1 year after treatment. Cure at 1 year was achieved in 65% of all ureters evaluated, regardless of the status at 1 month. Procedure-related morbidity was minimal and there were no adverse reactions to the implant substance. Thus, glutaraldehyde cross-linked bovine dermal collagen appears to be safe and effective in the endoscopic treatment of vesicoureteral reflux.
Leonard
M P
MP
Division of Pediatric Urology, James Buchanan Brady Urological Institute, Johns Hopkins Hospital, Baltimore, Maryland.
Canning
D A
DA
Peters
C A
CA
Gearhart
J P
JP
Jeffs
R D
RD
D000818:Animals; D002417:Cattle; D002648:Child; D003094:Collagen / Q000008:administration & dosage* / Q000009:adverse effects; D003432:Cross-Linking Reagents; D020684:Cystoscopes; D003558:Cystoscopy / Q000379:methods; D004341:Drug Evaluation; D005260:Female; D005500:Follow-Up Studies; D005976:Glutaral / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D009824:Ointments; D014513:Ureter / Q000002:abnormalities; D014718:Vesico-Ureteral Reflux / Q000188:drug therapy* / Q000209:etiology
D003432:Cross-Linking Reagents; D009824:Ointments; D003094:Collagen; D005976:Glutaral