Efficacy and Safety of SER120 Nasal Spray in Patients with Nocturia: Pooled Analysis of 2 Randomized, Double-Blind, Placebo Controlled, Phase 3 Trials

Kaminetsky, Jed; Fein, Seymour; Dmochowski, Roger R.; MacDiarmid, Scott; Abrams, Steven A.; Cheng, Maria; Wein, Alan J.

doi:10.1016/j.juro.2018.04.050

Cited by 19 publications

(24 citation statements)

References 27 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The problem with trying to draw conclusions from the OAB literature regarding the effects on nocturia of either antimuscarinics or a β3 agonist is that the baseline number of nocturic episodes rarely exceeds two or slightly above, making it very difficult to show statistical significance over placebo with either conscious or unconscious behavioral modification. Trials with a nasally administered emulsified microdose of desmopressin in patients with NP seem to show a similar reduction in nocturic episodes whether or not OAB is present …”

Section: Resultsmentioning

confidence: 86%

“…Trials with a nasally administered emulsified microdose of desmopressin in patients with NP seem to show a similar reduction in nocturic episodes whether or not OAB is present. 29 In men, small micturitions and difficulties to pass urine during the night may also be related to nocturnal erections. The "Piss proud" phenomenon may explain increased residual urine at night, or male patients voiding less well at night, as it is difficult to pass urine with an erected penis, which may take a prolonged time to detumesce.…”

Section: Polyuria and Bladder Capacity In Patients With Nocturiamentioning

confidence: 99%

See 1 more Smart Citation

Is our current understanding and management of nocturia allowing improved care? International Consultation on Incontinence‐Research Society 2018

Hervé

Abrams

Bower

et al. 2019

Neurourology and Urodynamics

Self Cite

View full text Add to dashboard Cite

Aims: Nocturia or waking at night, to urinate is a common cause of awakenings and may lead to sleep disturbance, impaired somatic health, impaired quality of life, and increased mortality.The aim of this report is to point out and discuss the aspects and issues that need to be addressed to improve the care of nocturia. Methods: This paper is a report of the presentations and subsequent discussion of a Think Tank session at the annual International Consultation on Incontinence-Research Society (ICI-RS) in June 2018 in Bristol.Results and conclusion: Nocturia is a known risk factor for in-hospital falls. Unfortunately, its assessment in acutely hospitalized (older) people is not the current practice and ward-based care plans are not tailored to this symptom. A new care pathway for hospitalized patients who have nocturia should be considered.

show abstract

Section: Resultsmentioning

confidence: 86%

Section: Polyuria and Bladder Capacity In Patients With Nocturiamentioning

confidence: 99%

Is our current understanding and management of nocturia allowing improved care? International Consultation on Incontinence‐Research Society 2018

Hervé

Abrams

Bower

et al. 2019

Neurourology and Urodynamics

Self Cite

View full text Add to dashboard Cite

show abstract

“…Two formulations, an orally disintegrating tablet and a low-dose intranasal spray, showed treatment effects corresponded with significant improvements in patient QoL based on the Nocturia QoL questionnaire scores for bother/concern and sleep/energy; P <.05 31 and the Impact of Nighttime Urination QoL questionnaire scores for overall impact and the nighttime domain; P ≤.0255. 32…”

Section: Nocturia Np and Potential Health Impactsmentioning

confidence: 99%

Nocturia: A Highly Prevalent Disorder With Multifaceted Consequences

Bliwise

Wagg

Sand

2019

Urology

View full text Add to dashboard Cite

“…Patients with nocturia have to face many hurdles before being diagnosed properly and treated with desmopressin, instead of OAB/BPO medication . Potential reasons for this, besides side effects, are the limited knowledge of clinicians regarding the drug and how to use it, and anxiety about safety, regardless of the evidence that with the available low‐dose formulations, hyponatremia is extremely rare, even in older patients . There is a clear need for a summary of the available information and a simple algorithm on how desmopressin should be used in adults with nocturia.…”

Section: Introductionmentioning

confidence: 99%

International Continence Society consensus on the diagnosis and treatment of nocturia

Everaert

Hervé

Bosch

et al. 2019

Neurourology and Urodynamics

Self Cite

109

104

View full text Add to dashboard Cite

Introduction Patients with nocturia have to face many hurdles before being diagnosed and treated properly. The aim of this paper is to: summarize the nocturia patient pathway, explore how nocturia is diagnosed and treated in the real world and use the Delphi method to develop a practical algorithm with a focus on what steps need to be taken before prescribing desmopressin. Methods Evidence comes from existing guidelines (Google, PubMed), International Consultation on Incontinence‐Research Society (ICI‐RS) 2017, prescribing information and a Delphi panel (3 rounds). The International Continence Society initiated this study, the authors represent the ICI‐RS, European Association of Urology, and Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU). Results Diagnostic packages: consensus on, history taking for all causalities, intake diary (fluid, food) and bladder diary, not for its duration. Pelvic (women) or rectal (men) examination, prostate‐specific antigen, serum sodium check (SSC), renal function, endocrine screening: when judged necessary. Timing or empty stomach when SSC is not important. Therapeutic packages: the safe candidates for desmopressin can be phenotyped as no polydipsia, heart/kidney failure, severe leg edema or obstructive sleep apnea syndrome. Lifestyle interventions may be useful. Initiating desmopressin: risk management consensus on three clinical pictures. Follow‐up of desmopressin therapy: there was consensus on SSC day 3 to 7, and at 1 month. Stop therapy if SSC is <130 mmol/L regardless of symptoms. Stop if SSC is 130 to 135 mmol/L with symptoms of hyponatremia. Conclusion A summary of the nocturia patient pathway across different medical specialists is useful in the visualization and phenotyping of patients for diagnosis and therapy. By summarizing basic knowledge of desmopressin, we aim to ease its initiation and shorten the patient journey for nocturia.

show abstract

Efficacy and Safety of SER120 Nasal Spray in Patients with Nocturia: Pooled Analysis of 2 Randomized, Double-Blind, Placebo Controlled, Phase 3 Trials

Abstract: SER120 demonstrated significant improvements over placebo for co-primary and secondary efficacy end points that corresponded with quality of life improvements. SER120 at each dose had an acceptable safety profile.

Cited by 19 publications

References 27 publications

Is our current understanding and management of nocturia allowing improved care? International Consultation on Incontinence‐Research Society 2018

Is our current understanding and management of nocturia allowing improved care? International Consultation on Incontinence‐Research Society 2018

Nocturia: A Highly Prevalent Disorder With Multifaceted Consequences

International Continence Society consensus on the diagnosis and treatment of nocturia

Contact Info

Product

Resources

About