Efficacy and Safety of VA106483 in Elderly Males
NocturiaA double blind, placebo-controlled, dose ranging study in males over the age of 65, who have a history of nocturia. The study will investigate pharmacodynamic outcomes (urine volumes and osmolality, circulating coagulation factors and haemodynamics) and pharmacokinetics, of both single and multiple oral doses of VA106483 at three dose levels, under conditions of controlled hydration.
Bioavailability of [14C]-SK-1404 ADME & IV Microtracer Study
NocturiaThe primary objectives of the study are: To determine the absolute bioavailability of SK-1404 To assess the mass balance recovery after a single oral (PO) dose of carbon-14 (14C)-SK-1404 To provide plasma, urine and faecal samples for metabolite profiling and structural identification The secondary objectives of the study are: To determine the routes and rates of elimination of [14C]-SK-1404 To identify the chemical structure of each metabolite with an exposure (AUC) of more than 10% of circulating total radioactivity To explore the intravenous (IV) pharmacokinetics (PK) of [14C]-SK-1404 To further explore the PO PK of SK-1404 To provide additional safety and tolerability information for SK-1404
Validation of Capillary Serum Sodium Levels
NocturiaProspective interventional study to determine sodium levels in capillary blood via finger prick. The goal is to determine if this technique is suitable and equal to a standard venous blood collection for the analysis of blood sodium levels.The purpose is to compare both sodium levels to determine if they are equal so the technique can be used in a clinical setting for people who need regular blood collections for the determination of sodium, for example after the start of desmopressin use.
The Effect of Gender on Antidiuresis - Evaluated by Graded Low Dose Desmopressin Infusion
Gender Difference in V2 Receptor Function in Response to dDAVP InfusionNocturia1 moreThere is substantial evidence that women throughout life have significantly lower plasma levels of the antidiuretic hormone vasopressin (pAVP) compared to men. The importance of this is not yet fully elucidated, but in relation to the observations of lower pAVP levels, no significant difference in renal response parameters was found. This could be interpreted an increased renal sensitivity in females compared to males. The theory of increased renal sensitivity in females is supported by a few pharmacodynamic studies currently available on this topic. However none of the studies was designed with the purpose of investigate the gender difference. The aim of this study is to investigate possible gender differences in the renal sensitivity to dDAVP and the effect of age on these differences. This will be done by low dose graded infusion of the synthetic AVP analog dDAVP. Participants are 80 healthy volunteers equally distributed between four age groups, 8-10 years of age, 16-18 years of age, 25-40 years og age and 65+ years of age.
Impact of Behavioral Treatment of Insomnia on Nighttime Urine Production
Sleep FragmentationPoor Quality Sleep2 moreNocturia is prevalent in older adults and it vastly reduces quality of life. Yet its treatment remains inadequate because its causes are not well understood, especially nocturnal polyuria or increased urine production at night. This study, which builds on the investigators' ongoing research, would be the first of its kind to explore the role of sleep in nighttime urine production. The findings will contribute important knowledge to guide development of better targeted and more effective therapy for this prevalent and morbid condition.
Study of Minirin Melt® in Adult Patients With Nocturia
NocturiaObservation of safety and efficacy of Minirin Melt® in adult patients with nocturia
Melatonin for Nocturia in Parkinson's Disease
Parkinson's DiseaseNocturiaThis is an an open label clinical trial of sustained-release Melatonin 2mg once daily for 12 weeks in patients with Parkinsons's Disease reporting nocturia, defined as getting up regularly at night > twice to pass urine. The primary objective of this study is to evaluate the effects of exogenous melatonin on bother related to nocturia. Secondary objectives are to evaluate: 1) Mean night time urinary frequency 2)Volume of urine voided at night 3)Incontinence and other lower urinary tract symptoms (LUTS) 3)Quality of sleep 4) Quality of life 5) Sleep disturbance of partners 6)Safety
NOGO for an Overactive Bladder
Overactive BladderNocturiaThis is a double-blind, randomized and placebo-controlled study to evaluate the safety and effectiveness of NoGo, a standardized extract from Angelica archangelica, on overactive bladder
Discovering the Effect of Venous Insufficiency on Nocturia
NocturiaVenous Insufficiency of Leg1 moreWith this prospective controlled trial, we hope to obtain more information about the coexistence between venous insufficiency and nocturia. In our opinion, venous insufficiency (CEAP 2-3a) leads to an increase in fluid accumulation in the lower limbs due to moving around all day. When laying down during nighttime, this fluid is reabsorbed into the systimic fluid pool, leading to an increase in diuresis and thus an increase in nocturnal voiding. Aim of this study is observe difference in nocturnal frequency and urine production before and after surgical treatment of venous insufficiency.
Evaluation of Solifenacin in the Treatment of OAB Symptoms in Patients Who Have Successfully Undergone...
Urinary FrequencyUrinary Urgency1 moreThe purpose of this study is to demonstrate that solifenacin post-operatively improves irritative symptoms in men whose obstructive symptoms have been relieved with the GreenLight laser outpatient procedure.