ABSTRACT
BACKGROUND: Otosclerosis affects health-related quality of life (HRQOL). Until now, measurements have only been performed using audiometric data or non-validated quality of life questionnaires. OBJECTIVE: The objective of this study was to develop the first validated disease-specific HRQOL measuring instrument to determine HRQOL in otosclerosis. MATERIALS AND METHODS: After sequential analysis and item reduction of the initial Stapesplasty Outcome Test 47 (SPOT-47), the SPOT-25 was validated prospectively on 52 otosclerosis patients undergoing stapes surgery. In addition to the overall score, four subscores were defined (hearing function, tinnitus, social restrictions, mental condition). RESULTS: The SPOT-25 showed a high internal consistency (Cronbach's α > 0.7), allowed discrimination between otosclerosis patients and healthy subjects, and demonstrated acceptable test-retest reliability (r = 0.85). After stapes surgery, the HRQOL improved significantly. The responsiveness was high. CONCLUSION: The SPOT-25 is the first validated disease-specific instrument for HRQOL measurement in otosclerosis patients. It should be used routinely for quality control.
Subject(s)
Otosclerosis , Outcome Assessment, Health Care , Quality of Life , Stapes Surgery , Humans , Reproducibility of Results , Surveys and QuestionnairesABSTRACT
PURPOSE: Inhibiting cyclic guanosine monophosphate metabolism may induce penile erection during concomitant nitric oxide production. Vardenafil hydrochloride is a new, highly selective, potent cyclic guanosine monophosphate phosphodiesterase 5 inhibitor. We determined the oral effectiveness of vardenafil in a simple and quantitative conscious rabbit model. MATERIALS AND METHODS: Vardenafil was given orally to conscious rabbits. Erection was assessed in a time dependent manner by measuring the length of the uncovered penile mucosa. Erection was evaluated in the absence and presence of intravenous sodium nitroprusside, a nitric oxide donor. RESULTS: Vardenafil induced dose dependent penile erection in conscious rabbits after the oral administration of 1 to 30 mg./kg. The efficacy of vardenafil was potentiated and effective doses were significantly reduced by the simultaneous administration of sodium nitroprusside. CONCLUSIONS: The effect of vardenafil on penile erection after oral administration was clearly demonstrated in the conscious rabbit model. The time course and early onset of activity indicate that it may be useful for treating erectile dysfunction. Potentiation of the effect by the nitric oxide donor sodium nitroprusside implies that it would have enhanced activity during sexual arousal, when nitric oxide is produced endogenously. The clinical development of this product for erectile dysfunction is proceeding.
