Glutaraldehyde Cross-linked Bovine Collagen Research Articles

Injectable biomaterials for the treatment of stress urinary incontinence: their potential and pitfalls as urethral bulking agents

Injectable urethral bulking agents composed of synthetic and biological biomaterials are minimally invasive treatment options for stress urinary incontinence (SUI). The development of an ideal urethral bulking agent remains challenging because of clinical concerns over biocompatibility and durability. Herein, the mechanical and biological features of injectable urethral biomaterials are investigated, with particular emphasis on their future potential as primary and secondary treatment options for SUI. A literature search for English language publications using the two online databases was performed. Keywords included "stress urinary incontinence", "urethral bulking agent" and "injectable biomaterial". A total of 98 articles were analysed, of which 45 were suitable for review based on clinical relevance and importance of content. Injectable biomaterials are associated with a lower cure rate and fewer postoperative complications than open surgery for SUI. They are frequently reserved as secondary treatment options for patients unwilling or medically unfit to undergo surgery. Glutaraldehyde cross-linked bovine collagen remains the most commonly injected biomaterial and has a cure rate of up to 53 %. Important clinical features of an injectable biomaterial are durability, biocompatibility and ease of administration, but achieving these requirements is challenging. In carefully selected patients, injectable biomaterials are feasible alternatives to open surgical procedures as primary and secondary treatment options for SUI. In future, higher cure rates may be feasible as researchers investigate alternative biomaterials and more targeted injection techniques for treating SUI.

Multicenter Prospective Randomized 52-Week Trial of Calcium Hydroxylapatite Versus Bovine Dermal Collagen for Treatment of Stress Urinary Incontinence

To evaluate the safety and effectiveness of soft-tissue augmentation of the urethral sphincter with calcium hydroxylapatite (CaHA; Coaptite) compared with glutaraldehyde cross-linked bovine collagen (Contigen) in female patients with stress urinary incontinence due to intrinsic sphincter deficiency and without associated urethral hypermobility. This 12-month prospective, randomized, comparative, multicenter, single-blind, parallel, clinical trial of CaHA and collagen for soft-tissue augmentation of the urethral sphincter in the treatment of stress urinary incontinence enrolled 296 women. Up to five injections were performed in the first 6 months of the trial. Twelve-month postinjection efficacy data were available for 231 patients. The results indicated that CaHA and collagen were both well tolerated in this study. No systemic adverse events were observed with either product. We used the Stamey Urinary Incontinence Scale to grade the improvement, which was the primary endpoint of the study. At 12 months, 83 (63.4%) of 131 CaHA patients compared with 57 (57.0%) of 100 collagen patients showed improvement of one Stamey grade or more (P = 0.34). More CaHA patients required only one injection (n = 60; 38.0%) during the study compared with the Contigen patients (n = 36; 26.1%; P = 0.034). Also, the average total volume of material injected during the course of the study was less for CaHA than for collagen (4.0 mL versus 6.6 mL, respectively; P <0.0001). The results of the study have demonstrated that Coaptite is an appropriate and well-tolerated treatment for patients with incontinence due to intrinsic sphincter deficiency. This new soft-tissue augmentation material has a good safety profile and appears to provide durable improvement.

Calcification of Glutaraldehyde Cross-Linked Collagen in Bladder Neck Injections in Children With Incontinence: A Long-Term Complication

We report the incidence of calcifications developing at the bladder neck/urethra in pediatric patients treated with glutaraldehyde cross-linked collagen for urinary incontinence. We reviewed charts of patients treated with glutaraldehyde cross-linked collagen injections for urinary incontinence between 1994 and 1999. Etiology of incontinence, pertinent medical history, operative details and postoperative imaging were examined. Of 31 patients 4 (13%) had development of submucosal calcifications in the bladder neck/urethra. All 4 patients had received multiple injections of glutaraldehyde cross-linked collagen for incontinence secondary to neurogenic bladder. The calcifications were confirmed surgically. Pathology reports available for 2 of 4 patients showed chronic inflammation without dysplasia or malignant changes. Mean followup was significantly different between calcified and noncalcified cases (10.3 vs 7.2 years, p = 0.009), as was total volume of collagen injected (21 vs 12 cc, p = 0.012). Mean time to diagnosis of calcifications was 8.8 years (range 7 to 11) after first injection. A total of 24 patients without calcification underwent bladder imaging at a mean of 6.8 years (+/-2.2) after glutaraldehyde cross-linked collagen injection, which was not significantly different than the time to diagnosis (p = 0.089). The number of injections was not significantly different between the 2 groups (p = 0.426). Of our patients 13% had development of calcifications at the site of prior glutaraldehyde cross-linked collagen injections for incontinence. These calcifications were surrounded by chronic inflammation. Patients who have undergone glutaraldehyde cross-linked collagen injections may benefit from long-term followup with bladder imaging to detect and follow calcifications at prior injection sites.

INITIAL EXPERIENCE WITH THE TRANSURETHRAL SELF-DETACHABLE BALLOON SYSTEM FOR URINARY INCONTINENCE IN PEDIATRIC PATIENTS

No AccessJournal of UrologyReconstruction1 Sep 2000INITIAL EXPERIENCE WITH THE TRANSURETHRAL SELF-DETACHABLE BALLOON SYSTEM FOR URINARY INCONTINENCE IN PEDIATRIC PATIENTS DAVID A. DIAMOND, STUART B. BAUER, ALAN B. RETIK, and ANTHONY ATALA DAVID A. DIAMONDDAVID A. DIAMOND More articles by this author , STUART B. BAUERSTUART B. BAUER More articles by this author , ALAN B. RETIKALAN B. RETIK More articles by this author , and ANTHONY ATALAANTHONY ATALA More articles by this author View All Author Informationhttps://doi.org/10.1016/S0022-5347(05)67222-9AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: A new endoscopic technique to treat urinary incontinence in children using a self-detachable balloon device was studied. Materials and Methods: The study includes 11 patients with a mean age of 14.6 years and all of whom had intrinsic sphincter deficiency due to myelomeningocele in 9, spinal artery bleed in 1 and cloacal exstrophy in 1. All patients were on clean intermittent catheterization preoperatively and postoperatively. Endoscopic balloon treatment was performed on an outpatient basis. A mean of 5 balloons (range 2 to 8) were placed per patient. All patients underwent formal urodynamic study preoperatively and at 6 weeks and 6 months following balloon placement. Results: Of the 9 patients without prior bladder neck surgery 7 had improvement in urodynamic parameters, including urethral pressure profile in all 7 and functional bladder capacity in 6, 4 were markedly improved clinically and 2 were dry. Two patients with prior bladder neck surgery were clinically unchanged following balloon placement, although 1 had urodynamic improvement. Conclusions: Our initial experience with the transurethral self-detachable balloon system as a minimally invasive outpatient procedure to treat urinary incontinence in children has been encouraging. To date this procedure appears most applicable to the patient who has not undergone surgery and has a neurogenic etiology for urinary incontinence. References 1 : Exstrophy-epispadias complex in bladder anomalies. In: . Philadelphia: Saunders1998. Google Scholar 2 : Urethral lengthening with anterior bladder wall flap for urinary incontinence: a new approach. J Urol1994; 152: 803. Google Scholar 3 : Management of urinary incontinence by bladder tube urethral lengthening and submucosal implantation. J Urol1990; 144: 559. Link, Google Scholar 4 : Experience with the Kropp anti-incontinence procedure. J Urol1989; 141: 1160. Link, Google Scholar 5 : Use of the AS800 device in exstrophy and epispadias. J Urol1988; 140: 1202. Link, Google Scholar 6 : Detachable self-sealing membrane system for the endoscopic treatment of incontinence. J Urol1997; 158: 1045. Link, Google Scholar 7 : The long-term results of artificial sphincters in children. J Urol1991; 146: 396. Link, Google Scholar 8 : Polytetrafluoroethylene injection for urinary incontinence in children. J Urol1985; 133: 248. Link, Google Scholar 9 : Glutaraldehyde cross-linked bovine collagen in exstrophy/epispadias complex. J Urol1993; 150: 631. Link, Google Scholar 10 : Endoscopic treatment of vesico-ureteric reflux and urinary incontinence: technical problems in the paediatric patient. Br J Urol1995; 75: 538. Google Scholar 11 : Treatment of urinary incontinence in children by endoscopically directed bladder neck injection of collagen. J Urol1996; 156: 637. Link, Google Scholar 12 : Endoscopic treatment for urinary incontinence in children with a congenital neuropathic bladder. Br J Urol1998; 82: 694. Crossref, Medline, Google Scholar 13 : Failure to obtain durable results with collagen implantation in children with urinary incontinence. J Urol1997; 157: 2306. Link, Google Scholar 14 : Endoscopic treatment of urinary incontinence in children with primary epispadias. Br J Urol1998; 81: 309. Crossref, Medline, Google Scholar 15 : Migration and granulomatous reaction after periurethral injection of polytef (Teflon). JAMA1984; 251: 32. Google Scholar From the Department of Urology, Children’s Hospital, Harvard Medical School, Boston, Massachusetts© 2000 by American Urological Association, Inc.FiguresReferencesRelatedDetails Volume 164Issue 3 Part 2September 2000Page: 942-946 Advertisement Copyright & Permissions© 2000 by American Urological Association, Inc.Keywordsurethrapediatricsurinary incontinenceendoscopyMetricsAuthor Information DAVID A. DIAMOND More articles by this author STUART B. BAUER More articles by this author ALAN B. RETIK More articles by this author ANTHONY ATALA More articles by this author Expand All Advertisement PDF downloadLoading ...

Failure to Obtain Durable Results with Collagen Implantation in Children with Urinary Incontinence

Purpose We studied the efficacy and durability of injection of glutaraldehyde cross-linked bovine collagen for treating urinary incontinence in children. Materials and Methods From April 1994 to July 1995, 12 boys and 8 girls 4 to 18 years old (mean age 9.5) underwent endoscopically directed collagen injections into the bladder neck. Followup ranged from 9 to 23 months (mean 15.2). The etiology of incontinence included myelodysplasia in 12 patients, exstrophy/epispadias in 4, and epidural abscess, sacral agenesis, imperforate anus and posterior urethral valves in 1 each. Results Collagen was injected once in 9 patients, twice in 10 and 3 times in 1. Injected volume ranged from 3 to 18 cc (mean 7.3). Followup urodynamic studies were available for 10 patients. Leak point pressure increased from 28.7 to 34.9 cm. water. One patient (5%) was dry, 5 (25%) had improvement, 10 (50%) had transient improvement for 2 to 90 days (mean 52) and 4 (20%) remained incontinent. Five children underwent bladder neck sling procedures. In 1 patient transient sciatic nerve irritation developed due to gluteal hematoma. Conclusions The previously reported high success rate of collagen injection for urinary incontinence in children is unsupported by this study. Improvement in continence was temporary or inadequate in the majority of patients. Collagen therapy may only delay the need for surgery for managing organic urinary incontinence in children.

Transurethral collagen injection for treatment of postprostatectomy urinary incontinence in men

Objectives. Transurethral injection of glutaraldehyde cross-linked bovine collagen has recently been advocated as a potentially useful treatment modality for management of urinary incontinence. The reported clinical experience with urethral collagen injection in adult males has been limited. Methods. This study summarizes the current literature and reviews the clinical results of collagen injection in a group of 25 men with incontinence after either transurethral or radical prostatectomy. Results. The overall results in this series were disappointing. Only 2 patients (8%) achieved significant improvement with this treatment. Eight patients (32%) experienced minimal improvement in symptoms, and 15 (60%) remained incontinent with no improvement in symptoms after collagen injection. The number of injection procedures and volume of collagen material implanted did not correlate with clinical outcome. Five patients (20%) have subsequently required placement of an artificial urinary sphincter to control their incontinence. Conclusions. We conclude that transurethral injection of glutaraldehyde cross-linked bovine collagen has a limited role in the management of urinary incontinence in adult men after prostatectomy.

Physical and Histological Behavior of a New Injectable Collagen (GAX 65) Implanted into the Submucosal Space of the Mini-Pig Bladder

The aim of our study was to analyze the physical and histological behavior of a second generation collagen (GAX 65*) in the mini-pig bladder, comparing it to the commonly used substance for injection (GAX 35*). GAX 65 is a glutaraldehyde cross-linked bovine collagen with a collagen concentration of 65 mg./ml. This much higher collagen concentration could be achieved due to sophisticated manufacturing technology. In 18 mini-pigs 2 to 4, 1 ml. deposits of GAX 65 and 35, respectively, were implanted into the submucosal space of the surgically opened bladder. The animals were sacrificed at months 1, 2, 4 and 6. The elevation (height equals protrusion of the implant into the bladder) and volume of the implants were measured and calculated immediately after injection and at necropsy. Histology was performed. The GAX 65 implants had a lesser decrease of elevation and volume during the 6-month observation period. Histology showed that the invasion of endogenous fibroblasts into the GAX 35 and 65 implants, and the formation of porcine collagen types I and III were almost identical. Clinically GAX 65 has better elevation properties than GAX 35 although statistical analysis did not show any significant difference (p = 0.07 to 0.25). However, preservation of the volume of the GAX 65 implant was significantly superior (p < or = 0.05) compared to that of GAX 35. Therefore, GAX 65 will most probably prove to be an excellent substance for the endoscopic treatment of vesicoureteral reflux and incontinence in children.

Physical and Histological Behavior of a New Injectable Collagen (GAX 65) Implanted into the Submucosal Space of the Mini-Pig Bladder

The aim of our study was to analyze the physical and histological behavior of a second generation collagen (GAX 65*) in the mini-pig bladder, comparing it to the commonly used substance for injection (GAX 35*). GAX 65 is a glutaraldehyde cross-linked bovine collagen with a collagen concentration of 65 mg./ml. This much higher collagen concentration could be achieved due to sophisticated manufacturing technology. In 18 mini-pigs 2 to 4, 1 ml. deposits of GAX 65 and 35, respectively, were implanted into the submucosal space of the surgically opened bladder. The animals were sacrificed at months 1, 2, 4 and 6. The elevation (height equals protrusion of the implant into the bladder) and volume of the implants were measured and calculated immediately after injection and at necropsy. Histology was performed. The GAX 65 implants had a lesser decrease of elevation and volume during the 6-month observation period. Histology showed that the invasion of endogenous fibroblasts into the GAX 35 and 65 implants, and the formation of porcine collagen types I and III were almost identical. Clinically GAX 65 has better elevation properties than GAX 35 although statistical analysis did not show any significant difference (p = 0.07 to 0.25). However, preservation of the volume of the GAX 65 implant was significantly superior (p less than or equal to 0.05) compared to that of GAX 35. Therefore, GAX 65 will most probably prove to be an excellent substance for the endoscopic treatment of vesicoureteral reflux and incontinence in children.

Submucosal Bladder Neck Injections of Glutaraldehyde Cross-Linked Bovine Collagen for the Treatment of Urinary Incontinence in Patients with the Exstrophy/Epispadias Complex

During the last 7 years 19 patients underwent 33 transurethral injections of glutaraldehyde cross-linked bovine collagen into the bladder neck for stress incontinence. Of the 15 patients 14 have classic bladder exstrophy, 3 have complete male epispadias and 2 have cloacal exstrophy. The procedure was performed after a Young-Dees-Leadbetter bladder neck reconstruction in 15 patients and before it in 4. Injections were repeated in 10 patients after a mean of 12 months. After a mean followup of 26 months (range 9 to 84) improvement of continence was noted in 10 of 19 patients (53 percent) of whom 4 have significant improvement. Of the 8 patients whose condition failed to improve after collagen injections 6 underwent additional successful surgery to achieve urinary continence. Of the 10 patients who underwent repeated collagen injections 9 (90 percent) had additional improvement. Although there were no complications related to the injected collagen itself, postoperative complications developed in 2 patients. Submucosal injection of collagen to the bladder neck is simple and safe, and has a reasonable success rate. Thus, it may be used to improve continence in patients with the exstrophy/epispadias complex who lack full control after appropriate reconstructive surgery.

Endoscopic treatment of vesico-ureteric reflux and urinary incontinence: technical problems in the paediatric patient.

Bovine collagen has been successfully used for the endoscopic treatment of urinary incontinence (UI) and vesico-ureteric reflux (VUR) in children for more than 8 years, although its long-term efficacy has sometimes been questioned. Its failure is generally ascribed either to technical difficulties or to instability of collagen at the site of the implant. To assess the efficacy of the procedure we evaluated the children treated at this hospital between 1990 and 1993. A total of 156 children, aged 5 months to 13 years, were treated for VUR. Over the same period, 25 patients aged between 2 and 14 years (nine with neuropathic bladder and 16 with exstrophy-epispadias complex who were still incontinent after bladder neck reconstruction) had periurethral or pericervical glutaraldehyde cross-linked bovine collagen injection for UI. Five more children with exstrophy-epispadias complex (aged 1-3 years) underwent periurethral collagen injection to stimulate bladder enhancement and allow subsequent bladder neck reconstruction. In children treated for VUR, a single injection proved successful in 72.2% of cases (127 ureters); a second collagen injection raised the success rate to 81%. Continence improved in all nine neuropathic bladders and in 10 of 16 children with exstrophy-epispadias complex treated for UI after bladder neck reconstruction. In four of the five exstrophy-epispadias complex patients who were treated to stimulate bladder enhancement, bladder capacity increased by 25%. Endoscopic treatment of VUR seems to be a valid alternative to open surgery, even though concerns remain about the long-term efficacy of collagen implantation. An important distinction should be made between early and late failure of the procedure. Early failure, which we define as persistence of reflux, is usually due to incorrect technique or technical difficulties. Late failure, or recurrence of reflux, which has previously been attributed to the biodegradability of collagen, seems to be due to the displacement of the injected collagen. Micturition itself or high bladder pressure (such as detrusor instability) could be responsible for the displacement of the injected collagen medially and distally, where it can no longer support the submucosal ureteric tunnel. In the treatment of urinary incontinence, both the implant technique and the choice of the site of injection seem to have a considerable effect on the results. In our experience, endoscopic collagen injection is effective in the treatment of both urinary incontinence and VUR in paediatric patients. Accurate selection of patients and technical adjustments and refinements are essential to obtain the best results.

Histological Behavior of Glutaraldehyde Cross-Linked Bovine Collagen Injected Into the Human Bladder for the Treatment of Vesicoureteral Reflux

Endoscopic subureteral collagen injection has become an accepted means for the treatment of vesicoureteral reflux in children. The aim of this study was to evaluate the histological behavior of glutaraldehyde cross-linked bovine collagen implants. The specimens were harvested from 29 patients who underwent reimplant surgery 2 to 30 months (mean 9.5) after unsuccessful subureteral injection therapy.In addition to routine hematoxylin and eosin staining, a new staining method (solophenyl red 3BL) able to demonstrate selectively neoformation of types I and III human collagen, was applied. Invasion of host fibroblasts into the bovine implant and the formation of endogenous types I and III collagen were demonstrated in all 29 cases. Adverse histological reactions were rare and, if present, they were predominantly of an inflammatory nature.

Glutaraldehyde Cross-Linked Bovine Collagen in Exstrophy/Epispadias Complex

We injected endoscopically 0.75 to 2.5cc of cross-linked bovine collagen at the 3, 9 and 12 o’clock positions of the urethra or bladder neck of 9 children with epispadias and 7 with exstrophy. This procedure was performed in 10 children who were still incontinent after a Young-Dees operation. In 6 girls collagen was injected submucosally before bladder neck surgery to increase outlet resistance and to gain bladder capacity. A repeat injection was given to 3 patients after 1 year. Continence improved in 9 of the 10 cases injected after surgery of the bladder neck. Of the 6 children who underwent collagen treatment before reconstruction of the lower urinary tract capacity increased an average of 47% in 2 years in 5 and the procedure failed in 1. Submucosal injection of collagen is helpful in modulating outflow resistance and increasing bladder volume after primary closure of exstrophic bladders. Patients with small bladders following closure, who would otherwise be candidates for augmentation cystoplasty, may gain adequate bladder size with collagen injection.

Endoscopic subureteric collagen injection (SCIN): a new alternative treatment of vesicoureteric reflux in children

Endoscopic subureteric injection has become an accepted form of treatment for vesicoureteric reflux in children in selected cases. However, the commonly injected substance Teflon has raised doubts as to its long-term safety. Glutaraldehyde cross-linked bovine collagen, which is not associated with the feared side effects of Teflon (granuloma formation, particle migration), seems to be an adequate replacement. At the Departement of Paediatric Surgery of the Basel University Children's Hospital 54 patients with a total of 82 refluxing units were treated with the subureteric collagen injection (SCIN) in the period between June 88 and August 90; 45 patients were female and 9 were male. The average age at treatment was 4.9 years (2 months– 15.2 years). Micturating cystourethrograms performed 3 months after injection showed disapperance of reflux in 61.3% (49 ureters).If improvement to grade I and II reflux was included, the success rate increased to 77.5%. After two SCIN procedures 77.6% of the ureters became free of reflux. Including improvement to grade I and II reflux, the success rate increased to 83.8%. The mean follow-up time was 11.5 months (2–27 months). Injection-related complications were not observed. Although the overall results were not as good as those after surgical correction of reflux and the long-term effects of the collagen implants are not yet known, SCIN seems to be a simple alternative treatment for vesicoureteric reflux in children.

Long-term histological results following glutaraldehyde cross-linked collagen injection into the suburothelial space of the mini-pig bladder

Endoscopic correction of vesicoureteric reflux by subureteric injection has become an accepted method of treatment in selected cases. Its efficacy has been demonstrated in the treatment of well over 1,000 ureters. However, there are doubts as to the long-term safety of the commonly injected substance Teflon. Glutaraldehyde cross-linked bovine collagen, a biodegradable substance, was suggested as an alternative material for injection. The aim of this study was to evaluate the histological long-term behavior of glutaraldehyde cross-linked bovine collagen injected into the mini-pig bladder. One hundred and eight deposits of cross-linked collagen, each containing 0.2 ml (n = 36) or 0.6 ml (n = 72) collagen paste, were injected into the suburothelial space of the bladders of 24 mini-pigs. The histological behavior of the implants was studied at monthly intervals over a period of 12 months. After only 2 months a marked invasion of host fibroblasts and formation of endogenous type I and III collagen could be observed. Over 12 months the invasion of fibroblasts and the formation of new collagen increased dramatically. No migration of collagen particles into the local lymphatic system could be observed. A new staining technique (solophenyl red 3BL) was introduced to selectively demonstrate type I and III collagen fibres. In addition, the efficacy of the subureteric collagen injections could be demonstrated by successfully treating reflux that was iatrogenically induced in the mini-pig bladders.

Results of endoscopic subureteral collagen injection for reflux correction in pigs and dogs

The efficacy of endoscopic correction of reflux with the use of Teflon has been proven, but there are safety concerns because of granuloma formation and particle migration. Using glutaraldehyde cross-linked (GAX-) bovine collagen as an alternate biomaterial, animal experiments were performed with 6 female pigs and 20 beagle dogs. Primary and experimentally-induced vesicoureteral reflux was treated by endoscopic injection of bovine GAX-collagen (Zyplast) submucosally at the ureteric orifice. Radiographic controls after 6, 8, or 12 months revealed successful reflux correction in 14 of 19 treated ureters of dogs. After the animals were killed, pathohistological evaluation demonstrated persistence of the collagen depot at the site of injection even after 12 months, although not in all cases, without inflammatory or foreign-body tissue reaction. No evidence of particle migration was found. Invasion of fibroblasts and fibrocytes into the collagen depot and capillary vessel formation appeared the same after the different time intervals, and there was no difference between the two animal species. The biocompatibility of purified bovine GAX-collagen makes it an alternative to Teflon for reflux correction.

Endoscopic injection of glutaraldehyde cross-linked bovine dermal collagen for correction of vesicoureteral reflux : M.P. Leonard, D.A. Canning, C.A. Peters, et al. J Urol 145:115–119, (January), 1991

Endoscopic injection of glutaraldehyde cross-linked bovine dermal collagen for correction of vesicoureteral reflux : M.P. Leonard, D.A. Canning, C.A. Peters, et al. J Urol 145:115–119, (January), 1991

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.

Local tissue reaction to the subureteral injection of glutaraldehyde cross-linked bovine collagen in humans : M.P. Leonard, D.A. Canning, J.I. Epstein, et al. J Urol 143:1209–1212, (June), 1990

Local tissue reaction to the subureteral injection of glutaraldehyde cross-linked bovine collagen in humans : M.P. Leonard, D.A. Canning, J.I. Epstein, et al. J Urol 143:1209–1212, (June), 1990

Local Tissue Reaction to the Subureteral Injection of Glutaraldehyde Cross-Linked Bovine Collagen in Humans

Although the technique of subureteral injection has been widely accepted as an alternative to reimplantation in the treatment of vesicoureteral reflux, the choice of the material to be used is controversial. We have used glutaraldehyde cross-linked bovine collagen to correct vesicoureteral reflux within the context of a Food and Drug Administration approved investigational study. We report the local tissue reaction to the implanted collagen in 7 patients who underwent reimplantation 3 to 19 months after failed endoscopic therapy. Glutaraldehyde cross-linked bovine collagen engendered a minimal localized inflammatory reaction without causing granuloma formation. Subsequent reimplantation was not hindered by the presence of the implant materials.