The Institute on Methods and Protocols for Advancement of Clinical Trials in ADRD (IMPACT-AD): A Novel Clinical Trials Training Program.

BACKGROUND: Alzheimer's Disease and Related Dementias (ADRD) clinical trials require multidisciplinary expertise in medicine, biostatistics, trial design, biomarkers, ethics, and informatics. OBJECTIVES: To provide focused interactive training in ADRD clinical trials to a diverse cadre of investigators. DESIGN: The Institute on Methods and Protocols for Advancement of Clinical Trials in ADRD (IMPACT-AD) is a novel multidisciplinary clinical trial training program funded by the National Institute on Aging and the Alzheimer's Association with two educational tracks. The Professionals track includes individuals who fill a broad variety of roles including clinicians, study coordinators, psychometricians, and other study professionals who wish to further their knowledge and advance their careers in ADRD trials. The Fellowship track includes current and future principal investigators and focuses on the design, conduct and analysis of ADRD clinical trials. SETTING: The 2020 inaugural iteration of IMPACT-AD was held via Zoom. PARTICIPANTS: Thirty-five trainees (15 Fellowship track; 20 Professionals track) were selected from 104 applications (34% acceptance rate). Most (n=25, 71%) identified as female. Fifteen (43%) were of a non-white race; six (18%) were of Hispanic ethnicity; eight (23%) indicated they were the first person in their family to attend college. MEASUREMENTS: Participants completed daily evaluations as well as pre- and post-course assessments of learning. RESULTS: Across topic areas, >90% of trainees evaluated their change in knowledge based on the lectures as "very much" or "somewhat increased." The mean proportion correct responses in pre- and post-course assessments increased from 55% to 75% for the Professionals track and from 54% to 78% for the Fellowship track. CONCLUSIONS: IMPACT-AD successfully launched a new training opportunity amid a global pandemic that preliminarily achieved the goals of attracting a diverse cohort and providing meaningful training. The course is funded through 2025.

Antiluteogenic effects of serial prostaglandin F2α administration in cycling mares.

A single dose of PGF2α does not consistently induce luteolysis in the equine CL until at least 5 days after ovulation, leading to the erroneous assumption that the early CL is refractory to the luteolytic effects of PGF2α. We hypothesized that serial administration of PGF2α in early diestrus would induce a return to estrus similar to mares treated with a single injection in mid-diestrus, and fertility of the induced estrus would not differ. The objectives of the study were to evaluate the effects of the 2 approaches as reflected by: (1) concentrations of plasma progesterone; (2) interovulatory and treatment-to-ovulation intervals; (3) the proportion of mares pregnant after artificial insemination. The study consisted of a balanced crossover design in which 10 reproductively normal Quarter Horse Mares were exposed to 2 treatments on 2 consecutive reproductive cycles. At detected ovulation (Day 0), mares were randomly allotted to 1 of 2 treatment groups: I, mid-diestrus treatment, administration of a single 10-mg dose of dinoprost tromethamine (PGF2α) im on Day 10; II, early diestrus treatment, administration of 10-mg PGF2α im twice daily on Days 0, 1, and 2 and once daily on Days 3 and 4. Mares in estrus and with a follicle 35 mm or greater in diameter were artificially inseminated with at least 2 billion motile sperm from a fertile stallion. Pregnancy was defined as detection of a growing embryonic vesicle on 2 consecutive examinations approximately 14 days after ovulation. Serial plasma samples were collected throughout the study period, and concentration of plasma progesterone was determined by RIA. A mixed-model ANOVA for repeated measures was used to analyze hormonal data. Interovulatory and treatment-to-ovulation intervals were compared by a paired t test and fertility by a McNemar chi-square analysis. All mares in group I underwent luteolysis after PGF2α administration denoted by mean (±SD) concentration of plasma progesterone of 0.25 ± 0.21 ng/mL detected 2 days after treatment. In group II, mean concentration of plasma progesterone remained below 1.0 ng/mL during treatment and until the onset of the next estrus. The mean interovulatory interval in group I was 18.5 ± 2.0 days compared with 13.1 ± 3.7 days in group II (P < 0.01). Treatment-to-ovulation intervals were 8.5 ± 2.0 days and 13.1 ± 3.7 days for groups I and II, respectively (P < 0.05). In both groups, 9 of 10 mares were pregnant (P = 1.0). Serial PGF2α administration beginning at ovulation consistently prevented luteal function in 10 of 10 mares in the present study without adversely affecting pregnancy rate of post-treatment cycles.

Complete testis-epididymis nonfusion anomaly: a typical association with cryptorchid testis.

INTRODUCTION: Fusion anomalies of the testis and epididymis are associated with cryptorchidism. We present an analysis of the fusion anomalies of the epididymis in cryptorchid boys. PATIENTS AND METHODS: We performed a retrospective review of patients presenting with undescended testes between 1986 and 1993. Patients were stratified among four groups based on the degree of testis-epididymis nonfusion. RESULTS: A total of 880 testes were eligible for review, of which 93% (815/880) had normal fusion, 3.6% (32/880) had epididymal head nonfusion, 2% (19/880) had epididymal tail nonfusion, and 1.6% (14/880) had complete nonfusion. Increasing degree of nonfusion was associated with higher perioperative testes position. Head and tail nonfusion were observed together with a contralateral descended testis, but less frequently than in bilateral undescended testes (p = 3.89 × E-10). Complete nonfusion was not observed in the contralateral descended testes in unilateral cryptorchid boys. CONCLUSIONS: Different degrees of fusion anomalies of the epididymis are associated with unilateral and bilateral undescended testis, indicating that nonfusion anomalies interact with epididymal-testicular descent because of impaired epididymal function.

Quality assurance guidelines for surgical outreach programs: a 20-year experience.

Numerous American volunteer organizations travel throughout the developing world, providing surgical services to those in need. Medical staff who undertake such missions must contend with the realities inherent to providing healthcare abroad. Inadequate medical facilities and equipment, coupled with a short mission duration and the lack of substantial integration with the local medical community, greatly increase the risk of unnecessary medical complications. At present, there is no definitive set of quality assurance guidelines for the surgical outreach community. This report draws on 20 years of outreach experience to recommend a set of quality assurance guidelines for surgical outreach missions.

[Urethral valves. Fate of the bladder and upper urinary tract]. / UrethralklappenSchicksal der Blase und des oberen Harntrakts.

Posterior urethral valve is a condition that leads to characteristic changes in the bladder and upper tracts. The bladder develops hypertrophic changes including muscular hypertrophy, dilatation of the prostatic urethra (keyhole appearance), and progressive hydroureteronephrosis. The voiding cystourethrogram confirms the diagnosis and documents vesicoureteral reflux and accompanying bladder changes. The follow-up of the serum creatinine level is a parameter for renal recovery. In our opinion, primary endoscopic ablation of the valves followed by a wait-and-see attitude is the most efficacious management of posterior urethral valves. The development of the bladder function is controlled by ultrasound and voiding cystourethrogram. Urodynamics provide a formal and objective means of assessing bladder function, but should be carefully applied in infants. Valve ablation in a neonate with significant reflux and a markedly trabeculated bladder can remodel itself remarkably within the 1st year of life. The persistence of hydronephrosis, bladder wall thickening and trabeculation, and persistent elevation of serum creatinine can all be harbingers that a degree of bladder outlet obstruction persists and one needs to rule out a persistent anatomic obstruction. At what point a functional obstruction occurs and which management is reasonable are still issues of debate and require the vigilance of a pediatric urologist to sort out. Dysfunctions of the bladder such as hyperreflexia, hypertonic, small capacity bladder, sphincter incompetence and/or myogenic failure should be adequately treated.

Odor familiarity and female preferences for males in a threatened primate, the pygmy loris Nycticebus pygmaeus: applications for genetic management of small populations.

Here we use sexual selection theory to develop a logistically simple, yet effective, method for the manipulation of female reproductive behavior for conservation goals. Mate choice leading to nonrandom mating patterns can exacerbate the loss of genetic diversity in small populations. On theoretical grounds, females should choose high-quality mates. A prediction stemming from chemical communication theory is that competitive males will be better able to saturate an area with scent marks. If this is true, females should mate preferentially with males whose odors they encounter most frequently. We tested this hypothesis with the pygmy loris, Nycticebus pygmaeus, a threatened and poorly studied nocturnal prosimian. For several weeks females were exposed repeatedly to the urine from a particular male, and were then allowed to choose between a male whose odors were familiar and one whose odors were novel. Females showed an unusually strong preference for the familiar-odor male, as indicated by several behavioral measures of mate preference. Conservation managers can use this method as a tool to obtain reproductive pairings that will maximize genetic compatibility and diversity. For example, unsuccessful males may be given the opportunity to reproduce. In captive populations, studbook managers often select pairs in order to optimize outbreeding, but these selected pairings may not coincide with the preferences of the individual animals involved. Although several authors have made theoretical arguments for manipulating mate choice for conservation, this is a novel test of a proximate mechanism that can be manipulated, cultivating applications rather than mere implications.

Mother-infant interactions in slow lorises (Nycticebus bengalensis) and pygmy lorises (Nycticebus pygmaeus).

The study had three purposes: (1) to obtain information about mother-infant interactions in a rarely studied nocturnal prosimian, the pygmy loris (Nycticebus pygmaeus); (2) to compare pygmy lorises with a closely related and better-studied nocturnal prosimian, the Bengal slow loris (Nycticebus bengalensis); and (3) to determine how the presence of a second offspring affected mother-infant interactions in pygmy lorises. Three Bengal slow loris mothers and 3 pygmy loris mothers served as subjects, along with their 10 offspring (4 Bengal slow loris singletons, 2 pygmy loris singletons and 2 sets of pygmy loris twins). Observations were carried out in a zoo research facility for the first 24 weeks of the infants' lives. Although the two species differ in size and reproductive patterns, mother-infant interactions were similar. The primary modes of infant and adult contact were ventral and passive contact, respectively. Mothers parked their infants from the first week, and infants followed from the second week. Mothers displayed little protection or rejection, and there was little aggression. Infants solicited play and social grooming from their mothers. Pygmy loris mothers engaged in social grooming and play with their infants more frequently and for longer periods if the infant was a singleton rather than a twin.

SEPT5_v2 is a parkin-binding protein.

Mutations in parkin are associated with various inherited forms of Parkinson's disease (PD). Parkin is a ubiquitin ligase enzyme that catalyzes the covalent attachment of ubiquitin moieties onto substrate proteins destined for proteasomal degradation. The substrates of parkin-mediated ubiquitination have yet to be completely identified. Using a yeast two-hybrid screen, we isolated the septin, human SEPT5_v2 (also known as cell division control-related protein 2), as a putative parkin-binding protein. SEPT5_v2 is highly homologous to another septin, SEPT5, which was recently identified as a target for parkin-mediated ubiquitination. SEPT5_v2 binds to parkin at the amino terminus and in the ring finger domains. Several lines of evidence have validated the putative link between parkin and SEPT5_v2. Parkin co-precipitates with SEPT5_v2 from human substantia nigra lysates. Parkin ubiquitinates SEPT5_v2 in vitro, and both SEPT5_v1 and SEPT5_v2 accumulate in brains of patients with ARJP, suggesting that parkin is essential for the normal metabolism of these proteins. These findings suggest that an important relationship exists between parkin and septins.

The use of vesicostomy as permanent urinary diversion in the child with myelomeningocele.

PURPOSE: Treatment of the child with myelomeningocele presents the urologist with many challenges. While vesicostomies are usually used for temporary bladder drainage until continent reconstruction is performed, we have a population of postpubertal patients with myelomeningocele in whom vesicostomies have been preserved. We review our experience with these older children. MATERIALS AND METHODS: A search of our database of 350 patients with myelodysplasia identified 23 with urinary diversion accomplished by permanent vesicostomy. Those who had undergone vesicostomy after age 11 years were designated as group 1. Those who received a vesicostomy early in life that was maintained post puberty were designated as group 2. Indications for vesicostomy, upper tract status before and after vesicostomy, recurrent infections and complications were noted. Upper tract status was determined by serial ultrasounds during routine followup. RESULTS: Group 1 was comprised of 5 patients with mean age at vesicostomy of 17 years and a mean followup interval of 5.2 years. Group 2 was comprised of 18 patients with mean age of vesicostomy at 2.6 years and mean followup interval of 13 years. Hydronephrosis resolved in all children from both groups. Vesicostomy revision was required in 1 patient secondary to prolapse. Other complications included mild prolapse that did not require revision, stenosis requiring revision 5 months after the initial procedure and an early bilateral ureterovesical obstruction that resolved. Of the patients 33% had recurrent upper tract calculi. CONCLUSIONS: While the goal of achieving urinary continence is well worth striving for in the child with myelomeningocele, it is not realistic for all patients. We believe that permanent cutaneous vesicostomy is an acceptable alternative that the reconstructive surgeon should consider. This reliable and simple technique ensures safe decompression of the upper urinary tracts, while avoiding the complications of urinary diversion using segments of bowel.

Co-association of parkin and alpha-synuclein.

Parkin and alpha-synuclein are two proteins that are associated with the pathophysiology of Parkinson's disease (PD). Parkin is present in Lewy bodies and axonal spheroids in brains affected by PD, and mutations in parkin cause hereditary forms of Parkinsonism. Alpha-synuclein is a major component of Lewy bodies and is associated with rare cases of PD. We now show that parkin binds to alpha-synuclein, including conditions associated with alpha-synuclein aggregation. Parkin and alpha-synuclein complexes were observed in BE-M17 cells under basal conditions, in BE- M17 cells under oxidative conditions and in brains from control or PD donors. Double staining of PD brains shows parkin and alpha-synuclein co-localize to the same pathological structures (both Lewy bodies and axonal spheroids). These results suggest that parkin interacts with alpha-synuclein and could contribute to the pathophysiology of PD more generally than was previously considered.

Buccal mucosal grafts: lessons learned from an 8-year experience.

PURPOSE: We evaluated our 8-year experience with buccal mucosal grafts in complex hypospadias and epispadias repair. MATERIALS AND METHODS: We reviewed the records of 29 patients in whom a total of 30 buccal mucosal grafts were placed as part of urethral reconstruction between 1991 and 1999. At surgery 16 tubes and 14 onlays were constructed and 24 of 30 repairs involved the meatus. All patients were followed at least 6 months postoperatively (median 5.3 years). Beginning in 1995 meatal design was enlarged to a racquet handle shape and patients were asked to perform meatal self-dilation for 6 months postoperatively. RESULTS: Complications developed in 17 of our 30 cases (57%) and reoperation was done in 10 (33%). All complications were evident by 11 months postoperatively except 1 that presented as recurrent stricture disease at 3 years. Complications developed in 5 and 12 of 15 patients who underwent surgery between 1995 and 1999, and before 1995, respectively (p = 0.027). No patient has had meatal stenosis since 1995. Complications included meatal stenosis in 5 cases, stricture in 7, glanuloplasty, meatal and complete graft breakdown in 1 each, and fistula in 2. Onlays were more likely to result in stricture than tube grafts (6 of 14 cases versus 1 of 16, p = 0.034). CONCLUSIONS: The complication and reoperation rates of buccal mucosal grafts are 57% and 33% at 5 years of followup. Changes in meatal design and temporary postoperative meatal dilation have improved the outcome in the last 5 years. Buccal mucosa remains a good choice in patients who require extragenital skin for urethral reconstruction.

Abnormal germ cell development in cryptorchidism.

BACKGROUND: Previous studies suggest that two fundamental, probably androgen-dependent, steps in maturation of germ cells normally occur in the prepubertal testis: the disappearance of gonocytes (the fetal stem cell pool) and the appearance of adult dark spermatogonia (the adult stem cell pool) at 2-3 months of age and the appearance of primary spermatocytes (the onset of meiosis) at 4-5 years. Previous studies of small series of cryptorchid boys suggest that both steps are defective in undescended testes and to a lesser degree in descended testes contralateral to unilaterally undescended testes. The purpose of this study is to confirm the previous findings of defective germ cell maturation in a large series of boys with unilateral undescended testes. PATIENTS: Seven hundred and sixty-seven boys with unilateral cryptorchidism who had orchidopexy and bilateral testicular biopsies between birth and 9 years of age were studied. MATERIALS AND METHODS: Total and differential germ cell counts were performed on semithin histologic sections of the biopsies. The results from the undescended and contralateral descended testes were compared using the Wilcoxon signed-rank test and the Wilcoxon-Whitney-Mann U test. RESULTS: Gonocytes failed to disappear and adult dark spermatogonia failed to appear in undescended testes under 1 year of age indicating a defect in the first step in maturation at 2-3 months resulting in failure to establish an adequate adult stem cell pool. Primary spermatocytes failed to appear in undescended testes and appeared in only 19% of contralateral descended testes at 4-5 years of age indicating a defect in the onset of meiosis. CONCLUSION: Unilaterally undescended testes fail to establish an adequate adult stem cell pool which normally occurs at 2-3 months of age and fail to establish adequate meiosis which normally occurs at 4-5 years of age. Similar but less severe changes are seen in the contralateral descended testes. Defects in the two pubertal steps in germ cell maturation are associated with reduced total germ cell counts.

Hormonal therapy for the subfertility of cryptorchidism.

BACKGROUND: The subfertility of cryptorchidism correlates with severely reduced total germ cell counts in prepubertal testicular biopsies of undescended testes. Reduced total germ cell counts are associated with defects in the two prepubertal steps in maturation and proliferation in germ cells: first, the transformation of the fetal stem cell pool (gonocytes) into the adult stem cell pool (adult dark spermatogonia) at two to three months of age and, second, the transformation of adult dark spermatogonia into primary spermatocytes (meiosis) at 4-5 years. The defects in maturation are associated with blunting of the normal surges in gonadotropins and testosterone. Prepubertal treatment with gonadotropin-releasing hormones would theoretically trigger normal germ cell maturation and proliferation and thereby improve total germ cell counts and improve fertility. Prepubertal treatment of cryptorchidism with the GnRH analogue Buserelin has resulted in improved total germ cell counts and improved spermiograms. The purpose of this report is to describe the results of treatment of cryptorchidism with the GnRH analogue Naferelin. PATIENTS: Twelve boys with cryptorchidism, 6 unilateral and 6 bilateral, and severely reduced germ cell counts in testicular biopsies were treated with Naferelin following successful orchidopexy and bilateral testicular biopsies. Response of the total germ cell counts was assessed in follow-up bilateral biopsies within 5 months of completing the hormonal therapy. RESULTS: Eight of the 12 boys (5 of the 6 with unilateral and 3 of the 6 with bilateral cryptorchidism) showed improvement in the total germ cell counts in one or both testes. All 8 had a poor prognosis for fertility pretreatment and a good prognosis for fertility posttreatment. Of the 5 with unilateral cryptorchidism who improved, 2 showed improvement in both testes; and 3, only in the contralateral descended testes. All 3 of the boys with bilateral cryptorchidism who improved showed improvement in both testes. Testes with absence of germ cells and older patients tended to show no improvement. Of the 6 contralateral descended, 5 (83%) improved, and of the 18 undescended testes, 8 (44%) improved. CONCLUSIONS: In this preliminary study, Naferelin therapy appears to induce improvement in the total germ cell counts and the prognosis for future fertility in 75% of patients.

Multi-institutional experience with the gastrointestinal composite reservoir.

PURPOSE: We evaluated multi-institutional experience with the gastrointestinal composite reservoir in patients with metabolic acidosis, the short bowel syndrome, severe pelvic radiation and/or renal insufficiency. MATERIALS AND METHODS: At 4 institutions 33 patients underwent construction of a gastrointestinal composite reservoir, including 19 with the short bowel syndrome, 13 with metabolic acidosis and 7 who also had renal insufficiency. A total of 16 patients underwent conversion of a previous diversion and the remaining 17 received new urinary diversion. Charts were reviewed for the metabolic impact of the gastrointestinal reservoir as well as any long-term sequelae. RESULTS: At a mean followup of 54 months there was a significant (p < or =0.05) improvement in mean preoperative and postoperative serum chloride (106 versus 102 mEq./l.), serum bicarbonate (23.3 versus 25 mEq./l.) and serum pH (7.36 versus 7.4). Mean serum creatinine did not significantly differ during followup in patients with normal renal function or renal insufficiency. Complications were not different than those of standard intestinal or gastric reservoirs. CONCLUSIONS: The gastrointestinal reservoir has provided an excellent metabolic balance in a large series of compromised patients with few side effects. We believe that the gastrointestinal composite reservoir represents the urinary diversion of choice when standard intestinal urinary reservoirs cannot be created in the setting of metabolic acidosis, the short bowel syndrome and severe pelvic radiation. However, the value of the gastrointestinal composite in the setting of renal insufficiency remains undetermined.

Intravesical Jackson-Pratt drain for urinary diversion after augmentation cystoplasty.

PURPOSE: Augmentation cystoplasty has become a primary form of bladder management in children with a noncompliant bladder. Excellent urinary drainage is required for anastomotic healing and the removal of mucous buildup. Suprapubic drainage traditionally involves a Malecot catheter, although poor irrigation and dislodgment of this type of catheter are well-known complications. We report the placement of an intravesical Jackson-Pratt drain for urinary diversion in augmented bladders. MATERIALS AND METHODS: We reviewed our use of an intravesical Jackson-Pratt drain for urinary diversion between 1995 and 1999 in 17 patients. Postoperative catheter drainage and irrigation characteristics were assessed as well as catheter related complications. RESULTS: Average patient age was 13 years (range 3 to 27). The majority of patients underwent ileal (11) or sigmoid (4) cystoplasty and 1 each underwent composite and ureteral cystoplasty. Drains remained in place an average of 27 days (range 6 to 57). All patients had excellent drainage during the postoperative period. Irrigation was subjectively easier than with a Malecot catheter. Average cost of a latex-free Malecot catheter was 2.7-fold that of a Jackson-Pratt drain. No catheters became nonfunctional before removal, although 1 was inadvertently pulled during patient transfer. CONCLUSIONS: A Jackson-Pratt drain provides excellent urinary drainage in patients undergoing augmentation cystoplasty. Multiple openings along the tube seem to improve irrigation in contrast to the single opening in a Malecot catheter, which often aspirates a region of the augmented bladder. The ready availability, decreased cost, ease of irrigation, increased pliability with decreased chance of dislodgment and lack of latex make an intravesical Jackson-Pratt drain a superior choice for augmented neurogenic bladder.

The histopathology of iatrogenic cryptorchid testis: an insight into etiology.

PURPOSE: Iatrogenic undescended testis may develop after inguinal hernia repair, presumably as a result of mechanical tethering of the testis or cord in scar tissue. Because some true cryptorchid testes appear to be completely descended at birth and later ascend during childhood, some iatrogenic undescended testes may be low lying undescended testes. To determine whether iatrogenic undescended testes may be unrecognized cryptorchid testes at herniorrhaphy we examined biopsies of iatrogenic undescended testes and the corresponding contralateral descended testis. MATERIALS AND METHODS: Between 1985 and 1999 bilateral testis biopsies were obtained at orchiopexy in 37 boys 1.5 to 11.8 years old who previously underwent inguinal hernia correction. Histomorphometric analysis of germ cell counts was performed on the undescended and contralateral descended testes, and compared to the count in bilateral biopsies of 37 age and position matched patients with true unilateral cryptorchidism. RESULTS: There were no significant differences in volume or total and differential germ cell counts in the undescended and contralateral descended testes in the study groups and age matched controls with primary unilateral cryptorchidism. The mean number of germ cells per tubule in the undescended testis in patients with a greater than 5-year interval from herniorrhaphy to orchiopexy was significantly decreased compared to those with an operative interval of less than 5 years (0.27 +/- 0.33 versus 0.93 +/- 1.4, p = 0.026). CONCLUSIONS: Some patients with iatrogenic undescended testis may have an unrecognized low cryptorchid testis. Careful physical examination before and after inguinal surgery is recommended. The early repair of iatrogenic undescended testis is warranted to prevent further damage.

Laser tissue soldering for hypospadias repair: results of a controlled prospective clinical trial.

PURPOSE: Laser tissue soldering has been shown to provide safe and effective tissue closure by creating an immediate leak-free anastomosis with minimal scar formation. We compared the results of laser tissue soldering and conventional suturing for hypospadias repair. MATERIALS AND METHODS: A consecutive group of 138 boys 4 months to 8 years old (mean age 15 months) was divided into a standard suturing (84) and a sutureless laser (54) hypospadias repair group. Urethral repair was defined as simple (Thiersch-Duplay or Snodgrass) and complex (onlay island flap or tube) in 101 and 37 cases, respectively. Laser tissue soldering was performed with 50% human albumin solder doped with 2.5 mg./ml. indocyanine green dye using an 808 nm. diode laser at 0.5 W. In the laser group sutures were used for tissue alignment only. At surgery neourethral and penile length, operative time for neourethral construction and the number of sutures or throws were measured. Postoperatively patients were examined for complications of wound healing, stricture or fistula. RESULTS: Mean patient age, urethral defect severity, type of repair, neourethral length and stenting time plus or minus standard error of mean were not significantly different in the 2 groups. Mean operative time was a fifth as long for laser tissue soldering in simple and complex hypospadias repair compared to controls (1.5 +/- 0.1 and 5.1 +/- 0.3 versus 8.5 +/- 0.8 and 26.7 +/- 1.7 minutes, respectively, p <0.001). The mean number of sutures used for tissue alignment in the laser group for simple and complex repair was significantly less than in controls (3.0 +/- 0.2 and 8.2 +/- 0.6 versus 8.5 +/- 0.8 and 23.2 +/- 1.5, respectively, p <0.001). All patients were followed a mean of 12 months (minimum 6, maximum 22). The complication rate was 4.7% in the laser group and 10.7% in controls with fistula in 2 of 54 cases, and fistula and meatal stenosis in 7 and 2 of 84, respectively. CONCLUSIONS: These preliminary results indicate that laser tissue soldering for hypospadias repair may be performed in almost sutureless fashion and more rapidly than conventional suturing. The ease of the laser technique and the lower complication rate in the laser group indicate that laser tissue soldering is an acceptable means of tissue closure in hypospadias repair.