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Nocturia clinical trials

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NCT ID: NCT01681927 Completed - Clinical trials for Idiopathic Edema Nocturia

Study of Idiopathic Edema

Start date: September 2011
Phase: N/A
Study type: Observational

Idiopathic edema (IE) is an ill-defined syndrome of uncertain etiology that occurs virtually exclusively in women. It has also been referred to as cyclical edema, periodic edema, fluid retention syndrome and orthostatic edema. The present studies were designed to 1. Improve our ability to identify patients with idiopathic edema by extending the clinical criteria from an increase in weight of > 1.4 kg between 8 AM to 10 PM to the inclusion of nocturia, a very important component to the history. Additional aims are to: 2. Demonstrate orthostatic weight gain with or without edema in idiopathic edema and autonomic failure that will identify a greater number of patients suffering from variable degrees of weight gain and compare to controls or other conditions associated with edema. The study will focus mainly on subjects with polycystic ovaries and autonomic failure. 3. Provide a reasonable course of therapy that is presently not well defined. 4. Provide evidence that orthostatic edema or weight gain has two common etiologies, a. an increase in vascular membrane as in idiopathic edema and b. pooling of blood in the lower extremities in autonomic failure due to a lack of vascular tone.

NCT ID: NCT01656239 Completed - Nocturia Clinical Trials

Dose Range Finding Study of Fedovapagon in Men With Nocturia

Start date: August 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the dose level(s) of fedovapagon which result in a decrease in the mean nocturnal void frequency.

NCT ID: NCT01576900 Completed - Nocturia Clinical Trials

The Effect of Combined Systematized Behavioural Modification Education Program (SyBeMeP) With DDAVP in Patients With Nocturia

Start date: April 2012
Phase: N/A
Study type: Observational

In patients with nocturia, combinational treatment of DDAVP and SyBeMeP might show better outcomes. Systemic video instruction might prove to be beneficial by helping patients have better understanding on treatment and replacing healthcare personnel.

NCT ID: NCT01552395 Completed - Nocturia Clinical Trials

A Study of Minirin Melt in 24 Months Treatment in Patients With Nocturia

Start date: March 2012
Phase: N/A
Study type: Observational

A Confirmation of the Safety Profile for Minirin Melt in Clinical Practice

NCT ID: NCT01552343 Completed - Nocturia Clinical Trials

Study Investigating the Impact Burden of Nocturia Using the Nocturia Impact Diary

IMPACT
Start date: March 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess psychometric properties (reliability and validity) of the Nocturia Impact (NI) diary. To assess the association between reduction of number of nocturnal voids and the mean changes in NI scores(sensitivity of the NI total score to change in nocturia). To assess which NI diary items account for the main difference in change in total NI score in treatment versus placebo.

NCT ID: NCT01520948 Completed - Clinical trials for Urinary Incontinence

Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease

BETTUR PD
Start date: September 2012
Phase: Phase 3
Study type: Interventional

Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor symptoms of tremor, slowness of movement, and stiffness, leading to progressive disability and loss of independence. Lower urinary tract symptoms (LUTS), including urinary incontinence (UI), urgency, and/or nocturia, are common non-motor symptoms that further diminish the already compromised quality of life for adults living with PD. Behavioral interventions for UI - including pelvic floor muscle exercise (PFME) therapy - have proven efficacy in randomized controlled trials and are free of side effects. Exercise-based behavioral therapy for UI requires individuals to learn a motor skill (PFME) and implement an adaptive behavioral strategy that incorporates the PFME to suppress urinary urgency and prevent UI. We will conduct a two-site, randomized controlled trial to assess the efficacy of PFME-based behavioral therapy to treat urinary symptoms in adults with PD. After stratification by UI severity, PD severity, and gender, a group of 60 subjects (30 in each group) will be randomized to receive behavioral therapy or a behavioral control over 8 weeks in order to achieve a sample size of 50 individuals (25 in each group) who complete the study. A 6-month follow-up is planned in the treatment group. We hypothesize that: 1. PD participants who are randomized to the exercise-based behavioral therapy group (Group A) will report a significant reduction in weekly frequency of UI episodes compared to PD participants in the behavioral control group (Group B). The primary outcome, frequency of UI, will be measured using a seven-day bladder diary. 2. Compared to PD participants in Group B, the reduction in UI frequency in Group A will be clinically meaningful as measured by a corresponding improvement on questionnaires of satisfaction and quality of life as well as a decline in other urinary symptoms including urgency and nocturia.

NCT ID: NCT01486706 Completed - Quality of Life Clinical Trials

Efficacy and Safety of Gabapentin in Treating Overactive Bladder

OAB
Start date: October 2010
Phase: Phase 2/Phase 3
Study type: Interventional

Overactive bladder (OAB) syndrome as defined by International Continence Society is a pathological condition characterized by irritative symptoms: urinary urgency, with or without incontinence, urinary frequency and nocturia. The syndrome often seriously compromises the quality of life of the patients. The etiology of the OAB is considered multifactorial. Neural plasticity of bladder afferent pathways is one of the proposed mechanisms of OAB. The detrusor muscle itself has for many years been the target for drug treatment such as antimuscarinics. However, depression of detrusor contractility, may results in a reduced ability to empty the bladder and lead to some sympathetic adverse effects, which limits the treatment of OAB. Currently the focus of OAB treatment has changed to other bladder structures/mechanisms, such as afferent nerves and urothelial signaling as targets for intervention. C-fiber bladder afferents nerves may be critical for symptom generation in pathologic states such as OAB because these fibers demonstrate remarkable plasticity. Up-regulation of bladder C-fiber afferent nerve function may also play a role in urge incontinence, overactive bladder (OAB) and sensory urgency. The mechanism of Gabapentin's action for neuropathic pain has not been fully elucidated but is appears to have inhibitory activity on afferent C-fibers nerve activity; moreover, several studies had established the safety of Gabapentin in its treatment of different conditions. Due to the proposed mechanism, the investigators suggest that Gabapentin may be a new alternative for treating OAB.

NCT ID: NCT01439997 Completed - Nocturia Clinical Trials

Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study

Start date: March 26, 2012
Phase: Phase 4
Study type: Interventional

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

NCT ID: NCT01435083 Completed - Nocturnal Polyuria Clinical Trials

Desmopressin Melt Therapy in Patients With Nocturnal Polyuria: a Pharmacokinetic/Dynamic Study

Start date: November 2011
Phase: Phase 4
Study type: Interventional

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

NCT ID: NCT01357356 Completed - Nocturia Clinical Trials

Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia

Start date: May 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia for a total duration of 14 weeks.