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Craig Niederberger

Publications and source records attributed to Craig Niederberger.

At least 19 recordsLinked to original sources

Detection of 90K/MAC-2BP in the seminal plasma of infertile males with accessory gland infection and the autoimmune pathogenetic hypothesis.

The purpose of the study was to evaluate 90K/MAC-2BP, a glycoprotein member of the Scavenger Receptor Cystein Rich superfamily, in the seminal plasma of infertile male patients with male accessory gland infection in order to investigate a putative autoimmune pathogenesis. 90K seminal concentration and sperm parameters were evaluated in 50 patients with male accessory gland infection at baseline and after cycles of treatment with Levofluoxacin 500 mg daily for 15 days plus serratiopeptidase 10 mg daily for 30 days. Treatment was continued for up to 6 cycles in cases of persistant bacteriospermia and/or clinical and ejaculatory signs of the disease. Patients with persistant male accessory gland infection after 6 cycles were defined as nonresponders. The same parameters were evaluated at baseline and after a 2-month period in 30 healthy controls. Patients with male accessory gland infection showed impaired sperm parameters and had lower seminal 90K concentration compared to controls. After treatment, seminal 90K level significantly increased in patients compared to controls. Twenty-two patients responded to treatment (44%), while 28 were nonresponders (56%). No difference in pretreatment and posttreatment sperm parameters and seminal 90K was observed between the 2 subgroups. Thirteen patients (26%) had identifiable bacteriospermia: significantly less pretreatment seminal 90K was observed compared to patients without bacteriospermia. Seminal 90K is decreased in patients with male accessory gland infection, and may be restored by a treatment with quinolones. However, the clinical utility of a 90K assay in these patients remains uncertain, as its level is not predictive of response to treatment.

Adult↗

Erectile dysfunction--an observable marker of diabetes mellitus? A large national epidemiological study.

PURPOSE: We examined whether men with erectile dysfunction are more likely to have diabetes mellitus than men without erectile dysfunction, and whether erectile dysfunction can be used as an observable early marker of diabetes mellitus. MATERIALS AND METHODS: Using a nationally representative managed care claims database from 51 health plans and 28 million members in the United States, we conducted a retrospective cohort study to compare the prevalence rates of diabetes mellitus between men with erectile dysfunction (285,436) and men without erectile dysfunction (1,584,230) during 1995 to 2001. Logistic regression models were used to isolate the effect of erectile dysfunction on the likelihood of having diabetes mellitus with adjustment for age, region and 7 concurrent diseases. RESULTS: The diabetes mellitus prevalence rates were 20.0% in men with erectile dysfunction and 7.5% in men without erectile dysfunction. With adjustment for age, region and concurrent diseases, the odds ratio of having diabetes mellitus between men with erectile dysfunction and without erectile dysfunction was 1.60 (p <0.0001). With adjustment for regions and concurrent diseases, the age specific odds ratios ranged from 2.94 (p <0.0001, age 26 to 35) to 1.05 (p = 0.1717, age 76 to 85). CONCLUSIONS: Men with erectile dysfunction were more than twice as likely to have diabetes mellitus as men without erectile dysfunction. Erectile dysfunction is an observable marker of diabetes mellitus, strongly so for men 45 years old or younger and likely for men 46 to 65 years old, but it is not a marker for men older than 66 years.

Adolescent↗

Multi-institutional validation of vasectomy reversal predictor.

PURPOSE: Some urologists who perform vasectomy reversals are not experienced with performing VE. A model to preoperatively identify patients who may require referral to an experienced VE surgeon was created (). We tested the model at multiple institutions. MATERIALS AND METHODS: The model had previously been designed in 483 patients who underwent vasectomy reversal at 1 institution (100% sensitive and 59% specific for predicting the need for VE). It was based on time since vasectomy and patient age. We tested it prospectively in 33 patients and retrospectively in a total of 312 at 6 other institutions. The predictive accuracy of the model was compared to using a simple duration from vasectomy cutoff alone, as is used in clinical practice. RESULTS: The model had 84% sensitivity and 58% specificity for detecting the need for VE in a total of 345 patients at 7 institutions. If using only a duration from vasectomy cutoff of 10 years to predict the need for VE, sensitivity was only 69%. At a cutoff of 4 years sensitivity was 99% but specificity was only 23%. Thus, the model performed better than any specific duration cutoff alone. CONCLUSIONS: The predictive model provides 84% sensitivity for detecting patients who may require VE during vasectomy reversal across 7 institutions (58% specificity). The model more accurately predicts the need for VE than using a specific duration from vasectomy cutoff alone.

Adult↗

Efficacy and safety of tadalafil across ethnic groups and various risk factors in men with erectile dysfunction: Use of a novel noninferiority study design.

AIM: This U.S. multicenter open-label study used a noninferiority trial design to assess the efficacy of tadalafil 20 mg to treat erectile dysfunction (ED) in the black American and Hispanic groups compared with a reference group of Caucasians. A secondary objective was to demonstrate the efficacy and safety of tadalafil 20 mg in various populations of men with ED. METHODS: A total of 1,911 patients with ED were enrolled into eight predefined groups: (1-3) Caucasian (Reference group), Black American, or Hispanic patients, < or =65 years of age with no diabetes mellitus or depression; (4) patients with depression, < or =65 years of age, no diabetes; (5) patients with diabetes, < or =65 years of age, no depression; (6) patients >65 years of age, no diabetes or depression; (7) patients who met enrollment criteria but were not included in any other group; and (8) patients with ED due to traumatic spinal cord injury. The study had a 4-week run-in period, followed by a 12-week treatment period with tadalafil taken as needed, up to one dose/day, prior to sexual activity. Change from baseline to endpoint in the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) was used to determine noninferiority of groups 2 and 3 from group 1. Secondary efficacy measures included other IIEF domains and Sexual Encounter Profile (SEP). RESULTS: Noninferiority analyses based on the EF domain score showed that tadalafil was as efficacious in the Hispanic and Black American groups as in the Reference group. Patients in each of the eight groups had a significant change from baseline (P < 0.001) in the IIEF EF domain score and positive responses to SEP Questions 1-5. The most common treatment-emergent adverse events reported by patients in all eight groups were headache, nasal congestion, dyspepsia, flushing, and back pain. CONCLUSION: Tadalafil 20 mg was as efficacious in the Hispanic and black American groups as in the Caucasian/Reference group. Tadalafil was efficacious and well tolerated in each of the groups studied in this trial.

Adult↗

Effect of cryptorchidism and retractile testes on male factor infertility: a multicenter, retrospective, chart review.

This multicenter retrospective chart review study performed on 162 cryptorchid patients and on 34 subjects with retractile testes suggests that cryptorchidism and retractile testes can alter spermatogenesis, with more serious damage observed in bilateral cryptorchidism. This spermatogenetic impairment is probably related to the lack of an appropriate or timely surgical correction.

Adult↗