Treatment Trials

56 Clinical Trials for Various Conditions

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Multi-center Trial to Improve Nocturia and Sleep in Older Adults
Description

The Multi-center Trial to Improve Nocturia and Sleep in Older Adults (MINT) study is a randomized trial to determine and assess the efficacy of integrated treatment of coexisting nocturia and insomnia, as well as explore the effects of this treatment on quality of life.

Conditions

Nocturia, Insomnia

A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia
Description

A study to find out if daridorexant is safe and efficacious in patients with insomnia and comorbid nocturia

Conditions

Insomnia Disorder, Nocturia

Mandibular Advancement Device and Changes in Nocturia
Description

The main purpose of this study is to test is mandibular advacenment device (MAD) use is associated with reductions in nocturia.

Conditions

Obstructive Sleep Apnea, Nocturia, OSA

Sleep, Hypertension, and Nocturia: a Multicomponent Approach for Comorbid Illnesses
Description

In this study the investigators target three common and comorbid illnesses among older adults namely nocturia or waking at night to void, poor sleep and hypertension. The aim of this proposal is to test behavioral sleep intervention to improve sleep and nocturia vs switching the time of antihypertensive administration to improve nighttime and in turn daytime blood pressure control.

Conditions

Nocturia, Hypertension, Sleep Disturbance

Pathophysiologic Study to Understand and Possibly Treat Nocturia
Description

This study will mainly look at how well compression stockings decrease body weight between morning and night and the number of nocturia events, by preventing blood from pooling in your legs. Also, this research study is being done to collect the thoughts/reactions/opinions on how nocturia affects the life of one who suffers from nocturia.

Conditions

Nocturia

A Pilot Study to Evaluate PureWick for Nocturia
Description

This is a single-center prospective pilot study of PureWick used as a management for nocturia and reduction of nighttime falls associated with going to the bathroom. Subjects are followed up to 3 months after the intervention. As a pilot study, it is expected that a 3-month follow-up will adequately capture urinary and sleep outcomes data and any adverse events related or unrelated to the study device.

Conditions

Nocturia

A Trial to Investigate Efficacy, Safety and Tolerability of FE 201836 for Nocturia Due to Nocturnal Polyuria in Adults
Description

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

Conditions

Nocturia

Paxerol™ for Treatment of Nocturia - A Phase II Placebo-Controlled Trial
Description

This is a multi-center, double-blind, placebo-controlled study with two weeks of daily oral administration of one of three dose levels of Paxerol or placebo in subjects with nocturia. Eligible study subjects will be identified according to inclusion/exclusion criteria (see below), and baseline assessments will be recorded. Due to small sample size of 25 patients per group in this proof-of-principle dosing-finding trial, stratification according to gender and BMI will be difficult. However, similar distribution of patient types to the four treatment groups will be attempted by evenly assigning patients to the four treatment groups according to genders and body mass index (BMI) of \<25, 25-30 and 30-40. Paxerol or placebo will be taken 30 minutes before bedtime daily for two weeks. Nocturia frequency, Nocturia Quality of Life (NQOL), Duration of First Undisturbed Sleep (DFUS), total hours of nightly sleep, safety and tolerability will be monitored before and after a two-week treatment period. Results from subjects treated with different doses of Paxerol and placebo will be assessed and compared. Baseline urinary Prostaglandin E2 (PGE2) production will also be assayed to assess potential correlation between baseline urinary PGE2 production and responsiveness to Paxerol treatment.

Conditions

Nocturia

Efficacy Study of Fedovapagon for Nocturia in Men With Benign Prostatic Hyperplasia (BPH)
Description

This study will investigate the efficacy and safety of fedovapagon in the treatment of nocturia in men with BPH.

Conditions

Nocturia

Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
Description

The objective of the study is to evaluate armodafinil as a wakefulness-promoting therapy as a means of improving residual daytime sleepiness in patients with treated nocturia.

Conditions

Nocturia, Daytime Sleepiness

Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia - DB4
Description

To investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia

Conditions

Nocturia

Dose Range Finding Study of Fedovapagon in Men With Nocturia
Description

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.

Conditions

Nocturia

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

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.

Conditions

Nocturia

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

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.

Conditions

Nocturia

Investigation of the Superiority Effect of Orally Disintegrating Desmopressin Tablets to Placebo in Terms of Night Voids Reduction in Nocturia Adult Male Patients
Description

The purpose of this trial was to confirm/establish long-term safety and efficacy of desmopressin orally disintegrating tablets at dose levels of 50 μg and 75 μg and to further evaluate the safety of an efficacious higher dose level of 100 μg in males with nocturia.

Conditions

Nocturia

Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray in Elderly Patients With Nocturia
Description

The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75 years or older nocturic patients.

Conditions

Nocturia

Investigation of the Superiority Effect of Desmopressin to Placebo in Terms of Night Voids Reduction in Nocturia Adult Female Patients
Description

A multicenter, randomized, double-blind, placebo-controlled, parallel-group trial to investigate the safety and efficacy of desmopressin oral melt tablets against placebo during 3 months of treatment in adult females with nocturia.

Conditions

Nocturia

Efficacy Study of VA106483 in Males With Nocturia.
Description

To investigate the effect of VA106483 on nocturia related clinical outcomes compared to placebo.

Conditions

Nocturia

Long Term Safety Assessment of SER120 in Patients With Nocturia
Description

The hypothesis of this study is that SER120 is safe and well tolerated for use in nocturic patients.

Conditions

Nocturia

Treatment of Patients With Nocturia
Description

The purpose of this study is to evaluate a treatment of nocturia. The hypothesis is that SER120 will decrease the number of nocturic episodes compared to placebo.

Conditions

Nocturia

Treatment of Patients With Nocturia (Non-PK Study)
Description

The purpose of this study is to evaluate a treatment of nocturia. The hypothesis is that SER120 will decrease the number of nocturic episodes compared to placebo.

Conditions

Nocturia

Behavior and Exercise Versus Drug Treatment in Men With Nocturia (BEDTiMe)
Description

Nocturia, waking at night from sleep to void, is a prevalent and troublesome symptom. Treatment with an alpha-adrenergic antagonist medication (α-blockers) is a standard therapy for LUTS in men, but α-blockers offer only limited reductions in nocturia. While combinations of multiple drugs could be used, many individuals wish to take fewer medications. Participants in the BEDTiMe Nocturia Study will undergo a series of visits during which they will receive a combination of either standard drug therapy (or placebo) and a behavioral intervention tailored to help with nocturia or problems with nocturia. Participants will be evaluated for outcomes at 12 weeks and followed for six months. This study will yield important information related to alternative treatments of nocturia in men, as well as novel information regarding the clinical importance of these nocturia reductions. This study has the potential to alter standards of care.

Conditions

Nocturia

A Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia
Description

Silodosin is compared to placebo to determine if it is safe and effective for the treatment of nighttime urination (nocturia) in men with BPH

Conditions

Nocturia, Prostatic Hyperplasia

An Extension Study Investigating the Efficacy and Safety of a Fast-Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults
Description

The purpose of this study was to investigate the long term efficacy and safety of several doses of the Melt formulation of desmopressin in a broad population of adult patients with nocturia.

Conditions

Nocturia

Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia
Description

The purpose of this study is to investigate the efficacy and safety of several doses of the melt formulation of desmopressin in a broad population of adult patients with nocturia.

Conditions

Nocturia

A Cross-Functional, Population-Representative, Web-Based, Epidemiologic Study to Estimate the Prevalence and Burden of Nocturia Due to Nocturnal Polyuria in the US
Description

To estimate the prevalence of nocturia due to nocturnal polyuria (NP) in the US and describe the demographic and clinical characteristics as well as the burden of illness in participants with nocturia due to NP.

Conditions

Nocturnal Polyuria

Treating Nocturnal Hypertension and Nocturia in African American Men
Description

This is a protocol to obtain pilot data to submit a new NIH grant on Nocturnal Hypertension and Nocturia. In the diversity supplement to Dr. Victor's current NIH grant (Cut Your Pressure Too: The Los Angeles Barbershop Blood Pressure Study) the results show that uncontrolled systolic hypertension is an independent determinant of nocturia in African American men. the investigators now want to pursue this correlation by designing a new NIH grant proposal to determine whether replacing short acting with long acting drugs and dosing them at bedtime rather than in the morning will: A. Lower systolic blood pressure during sleep B. Improve nocturia and result in better sleep quality

Conditions

High Blood Pressure

Interventional Clinical Trial in Patients in Overactive Bladder With Nocturia in Women
Description

The purpose of the trial is to investigate the efficacy of combining tolterodine and desmopressin compared with tolterodine monotherapy in the treatment of women with overactive bladder with nocturia in terms of reduction of nocturnal voids during 3 months of treatment

Conditions

Overactive Bladder

Severe Pelvic Organ Prolapse and Post-Obstructive Diuresis (SOPPO) Pilot Study
Description

In our experience, women with severe pelvic organ prolapse (POP) frequently have bothersome nocturia. The International Continence Society (ICS) defines nocturia as "having to wake at night one or more times to void." Though some of this nocturia may be secondary to obstructed bladder emptying, the investigators hypothesize that in some women compression of the bilateral ureters due to prolapsed pelvic organs during the day and subsequent relief of that prolapse while the patient lays supine overnight results in nighttime post-obstructive diuresis (inability to concentrate urine) and resultant large nighttime urine volumes and nocturia. Previous case reports have proposed that vaginal and uterine vault prolapse causes obstruction due to descent of the bladder floor which leads to compression of the bilateral ureters between the uterus and the borders of the genital opening. No large prospective studies, however, have evaluated the possible impact of this phenomenon on patients or the possible post-operative changes following surgical correction of POP. Using the Nocturnal Enuresis, and Sleep interruption Questionnaire (NNES-Q), voiding diaries, and urine studies, the investigators aim to evaluate the pre-operative and post-operative voiding habits and urinary parameters of women with severe pelvic organ prolapse and bothersome nocturia who undergo colpocleisis. Colpocleisis is a procedure which surgically obliterates the vaginal lumen to treat severe POP in properly counseled patients with \>90% satisfaction rates. Other treatments offered to women, such as the laparoscopic or open sacrocolpopexy, uterosacral ligament suspension, and sacrospinous ligament suspension, also offer high rates of success. The investigators aim to determine whether surgical correction of severe pelvic organ prolapse, to be defined as either with colpocleisis, laparoscopic or open sacrocolpopexy, uterosacral ligament suspension, or sacrospinous ligament suspension, results in improvement and/or resolution of nocturia and post-obstructive diuresis.

Conditions

Nocturia, Pelvic Organ Prolapse

VA106483 Dose Response in Females
Description

The purpose of this study is to describe the pharmacokinetics and pharmacodynamics of VA106483 in female subjects.

Conditions

Nocturia