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Biomedical subjects

Pamela I Ellsworth

Publications and source records attributed to Pamela I Ellsworth.

5 recordsLinked to original sources
PubMed2005

Use of tolterodine in children with neurogenic detrusor overactivity: relationship between dose and urodynamic response.

PURPOSE: Three exploratory studies were conducted to investigate the pharmacokinetics (PK) and safety of tolterodine in children 1 month to 15 years old with neurogenic detrusor overactivity. We urodynamically evaluated the dose and concentration effects of tolterodine to establish safe and effective dosing regimens. MATERIALS AND METHODS: Three open-label, dose escalating studies were conducted in children with stable neurological disease and detrusor overactivity. In studies 1 (patient aged 1 month to 4 years) and 2 (5 to 10 years) patients received 0.03, 0.06 and 0.12 mg/kg tolterodine solution day twice daily for 4 weeks each. In study 3 (patient age 11 to 15 years) patients received 2, 4 and 6 mg tolterodine extended-release capsules once daily for 4 weeks each. PK was assessed after 8 weeks, urodynamic assessments were conducted after each 4-week dosing period and 3-day micturition diaries were completed. RESULTS: Patients in studies 1 (19) and 2 (15) showed some dose related increases in volume to first detrusor contraction and cystometric bladder capacity. In study 3 (11 patients) there were no obvious dose-response relationships. PK results from studies 1 and 2 suggest that there was no apparent effect of age (< or =10 y) on these parameters. In study 3 time of maximum observed serum concentration and apparent terminal half-life were delayed, which is consistent with the extended-release formulation. Tolterodine was well tolerated, and there was no apparent relationship between tolterodine dose and adverse events in any study. CONCLUSIONS: These results support the safety of age and body weight adjusted dosing regimens for further clinical evaluation of tolterodine in children with neurogenic detrusor overactivity.

Adolescent↗
PubMed2005

Time from dosing to sexual intercourse attempts in men taking tadalafil in clinical trials.

OBJECTIVE: To determine whether patients with erectile dysfunction (ED) and treated with tadalafil use the 36-h duration of effect of the drug, and to discern if the timing of intercourse attempts is influenced by patient age, baseline severity of ED, or previous experience with sildenafil citrate. PATIENTS AND METHODS: In 11 multicentre, double-blind, placebo-controlled studies, 2102 patients with ED were randomized to a maximum of one dose per day of tadalafil 10 or 20 mg (1464 men), or placebo (638 men) with no time restrictions before attempting sexual activity after the dose. A post hoc analysis was used to determine the proportion of men with ED who attempted sexual intercourse during various intervals (>0 to < or = 1, >1 to < or = 4, and >4 to < or = 36, including >12 to < or = 36 h) after dosing with tadalafil or placebo over a 12-week period. Patients were stratified by age, baseline severity of ED, and previous history of sildenafil use. RESULTS: Of patients in different age groups and various ED severity, > or = 79% and > or = 53% chose to attempt sexual intercourse at least once during the 12-week treatment period at 4-36 and 12-36 h, respectively, after taking tadalafil. Regardless of previous experience with sildenafil, about a third of patients using tadalafil attempted intercourse a mean of at least once per week at 4-36 h after the dose over 12 weeks. Furthermore, 58% of patients attempted intercourse at least once during two intervals (>1 to < or = 4 h and >12 to < or = 36 h) after separate doses of tadalafil. CONCLUSION: Regardless of age, ED severity, or previous experience with sildenafil, most patients attempted sexual intercourse at least once at 12-36 h after one dose of tadalafil over a 12-week treatment period. Furthermore, by engaging in sexual intercourse at both earlier and later intervals after separate doses, most patients on treatment did not adhere to a fixed schedule of intimacy and thus took advantage of the 36-h duration.

Adult↗
PubMed2004

Time course and histology of urethrocutaneous fistula formation in a porcine model of urethral healing.

OBJECTIVE: Urethrocutaneous fistula is a well-known complication of hypospadias surgery and is reported in 5-10% of repairs. Using a previously described juvenile pig model, we present a histological analysis of the healing of the ventral aspect of the urethral repair and describe the histological mechanism of fistula formation. MATERIALS AND METHODS: Twelve juvenile pigs underwent ventral, longitudinal urethral incision and closure over a 5-French feeding tube. The ventral aspect was closed in running fashion using two closure techniques and three suture types in each animal. Three animals were sacrificed on postoperative day 3, three on day 5, three on day 12, one on day 14, and two on day 21. Closure was one-layered incorporating urethral mucosa in the animals sacrificed on days 3, 5, and 21. An extra-mucosal suture technique was used in the group sacrificed on day 12. Sections of the penis were cut, paraffin embedded, and treated with Hematoxylin and Eosin staining. RESULTS: Fistulae were seen in 12 specimens and in association with each suture type. Fewer sections of the extra-mucosal technique showed fistulization. Fistulae lined with immature epithelium were seen by day 5. Mature fistulae were observed by day 12. Skin epithelium and urethral mucosa migrated along suture tracts. By days 12 and 21, in addition to mature fistulae, several sections showed well-healed ventral repairs with clearly extramucosal suture tracts. CONCLUSIONS: Fistula formation begins early in the healing process after ventral urethral repair. Incorporation of urethral mucosa in the ventral repair is a substrate for fistula formation with rapid migration of urethral mucosa and skin epithelium into suture tracts. The importance of a multi-layered repair and extra-mucosal suture technique are thus emphasized with respect to urethral repair. Whether the mucosal or dermal migration along suture tracts can be attenuated or prevented by changing the biochemical environment awaits further investigation.

Animals↗
PubMedDate not supplied

The cryptorchid testis.

Advances in surgical technique, pediatric anesthesia and histologic evaluation of the cryptorchid testis in conjunction with the known associations with infertility, testicular cancer and other risks have led to earlier management of the undescended testicle. It is hoped that this paradigm shift will lead to improved fertility and decreased risk of malignancy. The results of earlier intervention will require future evaluation as the fertility and malignancy status of children undergoing orchidopexy today will be unknown for possibly decades. We will review the current literature regarding the classification, epidemiology, diagnostic approach, and management of cryptorchidism, as well as the risks of cryptorchidism including infertility and malignancy.

Cryptorchidism↗