PURPOSE: To describe a technique for urodynamic diagnosis of detrusor sphincter dyssynergia (DSD) using urethral pressure measurements and examine potential associations between urethral pressure and bladder physiology among patients with DSD. METHODS: Multiple sclerosis (MS) and spinal cord injured (SCI) patients with known DSD diagnosed on videourodynamics (via electromyography or voiding cystourethrography) were retrospectively identified. Data from SCI and MS patients with detrusor overactivity (DO) without DSD were abstracted as control group. Urodynamics tracings were reviewed and urethral pressure DSD was defined based on comparison of DSD and control groups. RESULTS: Seventy-two patients with DSD were identified. Sixty-two (86%) had >20 cm H₂O urethral pressure amplitude during detrusor contraction. By comparison, 5 of 23 (22%) of control group had amplitude of >20 cm H₂O during episode of DO. Mean duration of urethral pressure DSD episode was 66 seconds (range, 10–500 seconds) and mean urethral pressure amplitude was 73 cm H₂O (range, 1–256 cm H₂O). Longer (>30 seconds) DSD episodes were significantly associated with male sex (81% vs. 50%, P=0.013) and higher bladder capacity (389 mL vs. 219 mL, P=0.0004). Urethral pressure amplitude measurements during DSD were not associated with significant urodynamic variables or neurologic pathology. CONCLUSIONS: Urethral pressure amplitude of >20 cm H2O during detrusor contraction occurred in 86% of patients with known DSD. Longer DSD episodes were associated with larger bladder capacity. Further studies exploring the relationship between urethral pressure measurements and bladder physiology could phenotype DSD as a measurable variable rather than a categorical observation.
Ataxia* ; Diagnosis* ; Electromyography ; Humans ; Male ; Multiple Sclerosis ; Pathology ; Phenotype ; Physiology ; Retrospective Studies ; Spinal Cord ; Spinal Cord Injuries ; Urinary Bladder ; Urodynamics*

OBJECTIVETo describe the design and application of cluster randomized controlled method on typhoid Vi vaccine trial, and to assess the effect of implementation.

METHODSSimple size calculation of cluster-randomized trial was used to determine the sample size of the two groups and a vaccination campaign was conducted. The study group was given typhoid Vi vaccine and the control group was given meningococcal A vaccine.

RESULTSAccording to sample size calculation, a total sample of 96,121 participants was required and the study areas were divided into 108 clusters. In practice, 53 study clusters with 44,054 participants and 54 control clusters with 48,422 participants were stratified and matched according to size, location (urban or rural), characteristics (school, department, factory, demography) were randomized respectively. Confounding factors of two groups including age, sex, resident area, income, level of education were compared. It was found that the ratio of all confounding factors between the two groups were comparable and balanced.

CONCLUSIONConfounding factors can be better controlled between study group and the control group by applying cluster-randomized method on vaccine trail which enabled the intervention to be more scientifically evaluated; The implementation of cluster randomization trial was simple and easy to be accepted.

Adolescent ; Adult ; Child ; Child, Preschool ; China ; Cluster Analysis ; Female ; Humans ; Male ; Mass Vaccination ; organization & administration ; Middle Aged ; Polysaccharides, Bacterial ; immunology ; Typhoid Fever ; prevention & control ; Typhoid-Paratyphoid Vaccines ; immunology ; Vaccination

OBJECTIVETo evaluate the safety of a group A + C meningococcal polysaccharide vaccine as part of a phase IV clinical trial.

METHODSThe study area was divided into 108 clusters according to the principle of cluster randomization, stratified and paired sampling methods. 54 out of 108 clusters served as observation groups were administered A + C vaccine, while the rest 54 groups were administered Vi polysaccharide vaccine. An adverse event surveillance system was established to monitor the adverse events following the vaccination campaign. Identical form and methods were used for data collection to investigate the adverse events following the vaccination of both A+ C vaccine and Vi vaccine.

RESULTS34,543 people were vaccinated, including 18,167 of whom received A + C vaccine, while the other 16,376 received Vi vaccine. The rates of immediate injection reaction and unsolicited non-serious adverse events from A + C vaccine group were 0.44% and 0.38% while of Vi vaccine group were 0.79% and 0.73% respectively. At the solicited adverse event survey on 3-day-post-vaccination, 1239 vaccinees were followed-up including 771 received A + C vaccine and 468 received Vi vaccine. The local injection reaction rate of A + C vaccine group on the 1st day was significantly higher (X2 = 13.98, P = 0.0002) than that of Vi vaccine group. Neither the local injection reaction rate nor the system reaction rate between both groups was significantly different on 2nd and 3rd day, post vaccination. It was not statistically different when comparing fever onset rate between those who received vaccine and those who did not, in each vaccine group. There were no serious adverse events observed.

CONCLUSIONResults showed that the side effects of A + C vaccine and the Vi vaccine were mild and safe for vaccination campaigns targeting on populations at different age.

Adolescent ; Adult ; Age Distribution ; Child ; Child, Preschool ; Female ; Humans ; Male ; Meningococcal Vaccines ; adverse effects ; immunology ; Middle Aged ; Polysaccharides, Bacterial ; immunology ; Sex Distribution ; Young Adult