Active clinical trials for "Polyuria"

After the treatment of urogenital cancer, a person may develop lymphoedema of the leg(s) and/ or midline region. Lymphoedema is the result of a dysfunction in the lymphatic system and is characterized by excessive retention of lymphatic fluid in the interstitial compartment, adipose deposition and chronic tissue inflammation resulting in fibrosis. Clinical symptoms include abnormal tissue swelling, sensation of limb heaviness, erythema, pain, and impaired limb function. The added value of manual lymph drainage, applied in patients with mild (early) lower limb lymphoedema and in addition to skin care, exercises and a compression stocking, has never been investigated. Therefore, the objective of this randomised controlled pilot trial is to investigate the feasibility of a trial about the added value of manual lymph drainage (to skin care, exercises and wearing compression stocking) in patients with mild (early) lower limb lymphoedema. In fact, the investigators want to determine the sample size for a trial investigating the effectiveness of MLD and want to investigate the feasibility of the study design.

The aim of this study is to investigate whether oral urea stimulates copeptin release and, if so, whether it may provide a novel diagnostic test in the differentiation between AVP-D (Arginine vasopressin deficiency) and PP (primary polydipsia).

After the treatment of urogenital cancer, a person may develop lymphoedema of the leg(s) and/ or midline region. Clinical symptoms include abnormal tissue swelling, sensation of limb heaviness, erythema, pain, and impaired limb function. Lymphoedema can have a negative impact on quality of life (QoL) and the impact of lymphoedema on the cancer treatment decision making process is underestimated. A limited number of studies have evaluated the incidence rate of midline and leg lymphoedema after surgery for urogenital cancers and have investigated the prognostic variables. In addition, to the researchers knowledge, no evidence exists regarding which (combination of) clinical measuring methods are most sensitive to detect early lymphoedema at the lower limbs after the treatment of urogenital cancer. Therefore, in this prospective observational study, the epidemiology (i.e. incidence/ prevalence rate and prognostic variables) and the detection methods of lower limb lymphoedema after pelvic lymph node dissection for urogenital cancer will be investigated. Additionally, the epidemiology of nocturia and nocturnal polyuria will be studied (since this information is also missing in literature).

Alarm-treatment as well as Desmopressin, a synthetic analogue of human vasopressin, are considered the only evidence-based medicine (EBM) IA treatments in monosymptomatic nocturnal enuresis (MNE). Desmopressin exists in three different formulations for ambulant use: nasal spray, tablet and lyophilisate (MELT) each with differences in bioavailability (spray 2%, tablet 0.2%, MELT 0.5%). There 's insufficient evidence to confirm the actually used bioequivalent doses ( 10µg spray = 120µg MELT= 0.2mg tablet). Although so frequently used, very few pharmacokinetic and -dynamic data on desmopressin are available for children. Due to prolonged half life, associated with waterintoxication,the nasal spray has a black box warning from the FDA and is no longer recommended . For some authors oral formulations appear to be a safer alternative. However, based on clinical experience of less response rate with oral formulations, lower biodisponibility is suspected. Adult research confirms low bioavailability of tablets but also show major influences by food-intake and changes in gastro-intestinal motility. To achieve maximum efficacy, recommendations are to take desmopressin tablet 1 hour before bedtime and 2 hours after meal: this is unrealistic in schoolaged children since there never is 3 hours between evening meal and bedtime. In 2005 a dose response study demonstrated superior pharmaco-kinetic and dynamic properties for desmopressin Lyophilisate MELT formula. Since these results implicate superior action of MELT, often a change to MELT is recommended if there is a suboptimal response with tablet: sublingual absorption would eliminate the influence of food-intake. However, for this statement there's no evidence, since these tests were all conducted in children in fasting condition. Only one clinical study demonstrates bioequivalence for MELT and tablet. Hypothesis is that desmopressin MELT formulation has a better bioavailability when administered together with meal due to its sublingual absorption.

Nocturia is defined as waking one or more times to void during the period between going to bed with the intention of sleeping and waking with the intention of arising.The pathophysiology of nocturia is multifactorial and can be complex. Therefore it is important to adopt a systematic approach to identify the possible causal factors of nocturia and to treat them accordingly. Patients with nocturia can be categorized as having one of the following three disorders: (1) nocturnal polyuria (NP) in which the voided urine volume during the hours of sleep exceeds 35% of the 24-hr output, (2) low nocturnal bladder capacity (NBC) causing a nocturnal urinary volume greater than the bladder capacity, (3) or mixed nocturia, a combination of the preceding two categories. Desmopressin, a synthetic analogue of the antidiuretic hormone (ADH), has been used for many years to treat diabetes insipidus and primary nocturnal enuresis.More recently, it is also known to be effective against nocturia with NP by decreasing night-time urine production.However, it may be associated with an increased risk of developing hyponatremia due to water retention, especially in elderly patients.In the present study, we investigated the safety and efficacy of oral desmopressin for the treatment of mixed nocturia in patients with both NP and a low NBC.

The objective of this study is to find out what the pharmacokinetic/dynamic (PK/PD) characteristics of desmopressin melt are in nocturia patients (compared to healthy volunteers and children). The main questions the investigators want to answer are: Are differences related to the pathophysiological factors involved in nocturia? Are there age/gender/size differences? Can the investigators identify patients who are likely to develop hyponatraemia? Can the investigators individualize treatment and reduce risk for hyponatraemia? Day 1: Patient is being hospitalized in the morning General anamnesis and clinical examination Uroflow and residue measurements (3x) Sober blood sample, to determine plasma concentrations of Na+, Cl-, osmolality and creatinin Day 1-2: - In the evening at 20h: start (with empty bladder!) 24h miction-incontinence-residue registration: urine collections every 3 hours (every portion of urine within a period of 3 hours must be collected in the same collection device), with: registration of volumes and measurement urinary concentrations of Na+, Cl-, osmolality and creatinin Measurement of blood pressure during 24h Day 2-3: In the evening at 19h (day 2): drink 15mL/kg water At 20h: take desmopressin melt 120µg + start: 24h miction-incontinence-residue registration: registration of volumes and measurement urinary concentrations of Na+, Cl-, osmolality and creatinin (U1-U7) Measurement of blood pressure during 24h Collection of urine:U1 at 19h, U2 at 20h, together with intake of first desmopressin melt, U3 at 21h = 1h after desmopressin melt intake, U4 at 22h = 2 after desmopressin melt intake,U5 at 23h = 3h after desmopressin melt intake, U6 at 2h (day 3) = 6h after desmopressin melt intake, U7 at 8h = 12h after desmopressin melt intake Blood samples for blood levels of desmopressin: 1h, 2h, 3h, 6h after desmopressin melt intake, 12h after desmopressin melt intake + plasma concentrations of Na+, Cl-, osmolality and creatinin (safety profile) At 8h in the morning (day 3): drink 15mL/kg water + collection of urine per hour during 3h with measurement of urinary concentrations of Na+, Cl-, osmolality and creatinin: U8 at 9h, U9 at 10h, U10 at 11h Patient can go home on day 3, unless he is at high risk for side effects, high-risk patients are hospitalized for 7 days

The objective of this study is to find out what the pharmacodynamic (PD) characteristics of desmopressin melt are in nocturia patients (compared to healthy volunteers and children). The main questions the investigators want to answer are: Are differences related to the pathophysiological factors involved in nocturia? Are there age/gender/size differences? Can the investigators identify patients who are likely to develop hyponatraemia? Can the investigators individualize treatment and reduce risk for hyponatraemia? The patient will be given a prescription to buy Minirin Melt 60µg at the local pharmacy. During 30 days, the patient has to take Minirin Melt 60µg in the evening before going to bed. There are two groups of patients: Group A: Patients that still have to undergo an evaluation phase, according to standard procedures (e.g. osmolality test, blood sample). This procedure is not a part of this study. The study starts when the 1st Minirin Melt tablet has been taken (= day 1). Group B: This group already went through the evaluation phase (by participation to study 1 or study 3 as mentioned above) and they have been prescribed Minirin Melt 60 µg ambulatory. The study starts when the patients takes his first prescribed Minirin Melt tablet: On day 3 and day 7 a blood sample will be taken at the UZ Ghent for safety control (Na+, K+, creatinin, osmolality = good clinical practice guideline). These first 2 visits (day 3 and day 7) are standard procedure. If the patient is at high risk for side effects, blood has to be taken during the first 7 days. On day 3 the patient has to give a urine sample. Patients have to fill out a frequency/volume chart during the first 14 days. On day 30, a 3rd blood sample will be taken

Demonstrate the safety and tolerability of desmopressin ODT during long-term treatment of subjects with nocturia due to nocturnal polyuria, for up to 1 year

The purpose of this trial is to demonstrate efficacy of SK-1404 against placebo for the treatment of subjects with nocturia due to nocturnal polyuria, during 4 weeks of treatment.

The purpose of this trial was to investigate the efficacy, safety and tolerability of different oral doses of FE 201836, with desmopressin as a benchmark, during 12 weeks of treatment for nocturia due to nocturnal polyuria in adults