Clinical trial NCT01530451: Clinical Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients
Official title: Prospective, Randomized, Double-blind Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Nocturia
Obstructive Sleep Apnoea
Keywords: Nocturia
Obstructive sleep Apnoea
Desmopressin
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2012-02-10
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy of desmopressin on symptoms of nocturia in patients with Obstructive Sleep Apnoea (OSA). The improvement of sleep quality and the quality of life will be measured.

Detailed description: Nocturia is one of the commonest urinary symptoms in elderly and in patients with obstructive sleep apnoea (OSA). According to the International Continence Society (ICS) definition, nocturia is defined as "the complaint that the individual has to wake at night one or more times to void" . It implies a continuum beginning from what might be considered normal, to a bothersome state. Bothersome nocturia is a common and age-dependent condition. A prevalence ranging from 48.6% to 77% were reported in the literature. Pathogenesis of nocturia is multi-factorial, and has closely related to OSA. OSA patients generate negative intrathoracic pressure during sleep, this leads to increased venous return and distension of the right atrium. This leads to an increase of hormone secretion, namely Atrial Natriuretic Peptide (ANP). ANP causes increased sodium and water excretion, and inhibits the secretion of antidiuretic hormone. All of the above factors results in an increased nocturnal urine production and nocturia.

Middle-aged men with OSA always present to urology clinic with lower urinary tract symptoms with predominant nocturia. Many a time they were treated as benign prostatic hyperplasia with multiple medications with suboptimal response. The underlying genuine pathology of OSA-related nocturia is overlooked.

Desmopressin is an analogue of antidiuretic hormone, it is the pharmacological therapy of choice for patients with nocturia where night-time polyuria is present.

In this study, the investigators would like to evaluate the efficacy of desmopressin on symptoms of nocturia in patients with Obstructive Sleep Apnoea (OSA). The improvement of sleep quality and the quality of life will be measured.

Eligibility criteria: Inclusion Criteria:

* Adult male or female patient (aged\</=65 years old)
* Obstructive sleep apnoea diagnosed by sleep study
* Stable treatment on obstructive sleep apnoea and / or LUTS
* Nocturia on average more than once per night
* Having the ability to communicate and comply with the requirements of the study

Exclusion Criteria:

* Presence of urethral strictures and neurogenic bladder dysfunction
* Clinical evidence of bladder stones, bladder tumor or an active urinary tract infection
* History of prostate cancer or prostate specific antigen (PSA) level \> 10ng/ml or suspicious of prostate cancer on digital rectal examination (DRE), unless a transrectal biopsy of prostate has been performed and the presence of prostate cancer has been excluded.
* Patient on intermittent self-catheterisation
* Recent start or change of treatment on obstructive sleep apnoea and / or nocturia
* Uncontrolled medical problems: e.g. Diabetes Mellitus or Diabetes insipidus
* Hyponatraemia
* Pregnancy

Primary outcomes:
measure: Change in no. of nocturia
timeFrame: Week 4 and Week 13
Secondary outcomes:
measure: Side effects related to desmopressin
timeFrame: up to Week 13
measure: Change in quality of Life - NQOL
timeFrame: Week 4 and Week 13
measure: Change of quality of Sleep - PSQI
timeFrame: Week 4 and Week 13
measure: Change in lower urinary tract symptoms - OABSS
timeFrame: Week 4 and Week 13
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Eddie SY Chan
role: PRINCIPAL_INVESTIGATOR
References: