Clinical trial NCT01729819: Interventional Clinical Trial in Patients in Overactive Bladder With Nocturia in Women
Official title: A Multi-centre, Double-blind, Randomised Trial Investigating the Efficacy and Safety of a Combination Therapy, Desmopressin and Tolterodine, for Treatment of Overactive Bladder With Nocturia in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overactive Bladder
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-11-20
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* Written informed consent prior to performance of any trial-related activity
* Female sex, at least 18 years of age (at the time of written consent)
* Nocturia and overactive bladder symptoms present for ≥6 months prior to trial entry (patient-reported)
* At least 2 nocturnal voids each night as documented in 2 diary periods during the screening. A mean of at least 8 daytime voids per day over 3 days with a minimum of at least 6 daytime voids each day as documented in 2 diary periods during the screening. At least 1 urgency episode each 24 hours as documented in 2 diary periods during the screening. Each diary period consists of 3 consecutive days, with at least 14 days between each period.

Exclusion Criteria:

* Evidence of severe voiding dysfunction defined as:

More than 10 nocturnal voids per 24 hours as documented on any of the days in both diary periods during screening.

More than 20 daytime voids per 24 hours as documented on any of the days in both diary periods during screening.

* Genito-urinary tract pathology that can in the investigator's opinion be responsible for urgency or urinary incontinence e.g., symptomatic or recurrent urinary tract infections, interstitial cystitis, bladder related pain, or stone in the bladder and urethra causing symptoms
* Current or a history within 5 years of lower urologic malignancies (e.g., bladder cancer), lower urinary tract surgery, previous pelvic irradiation, or severe neurological disease affecting bladder function or muscle strength (e.g., multiple sclerosis, Parkinson's disease, spinal cord injury, spina bifida)
* Symptoms of severe stress urinary incontinence in the opinion of the investigator
* Urinary retention or a post void residual volume in excess of 150 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention
* Habitual or psychogenic polydipsia (fluid intake resulting in a urine production exceeding 40 mL/kg/24 hours) or a mean volume voided per void of 350 mL or more during one or more 24-hour periods as assessed by the screening diaries
* Central or nephrogenic diabetes insipidus
* Syndrome of inappropriate antidiuretic hormone (SIADH)
* Gastric retention
* Myasthenia gravis
* Uncontrolled narrow-angle glaucoma
* Suspicion or evidence of cardiac failure
* Uncontrolled and clinically relevant (in the judgement of the investigator) hypertension or diabetes mellitus
* History and/or current treatment of obstructive sleep apnoea
* Hyponatraemia:Serum sodium level must not be below 135 mmol/L
* Evidence of potential renal impairment:Serum creatinine must be within normal laboratory reference intervals AND estimated glomerular filtration rate must be more than or equal to 50 mL/min
* Hepatic and/or biliary diseases: Aspartate aminotransferase and/or alanine aminotransferase levels must not be more than twice the upper limit of normal range. Total bilirubin level must not be more than 1.5 mg/dL
* Pregnancy, breastfeeding, or a plan to become pregnant during the period of the trial. Women of reproductive age must have documentation of a reliable method of contraception. All pre- and perimenopausal women have to perform pregnancy tests. Amenorrhea of more than 12 months duration based on the reported date of the last menstrual period is sufficient documentation of post-menopausal status and does not require a pregnancy test
* Known alcohol or substance abuse; work or lifestyle that may interfere with regular night-time sleep e.g., shift workers; or any other medical condition, laboratory abnormality, psychiatric condition, mental incapacity, illiteracy or language barrier which, in the judgement of the investigator, would impair participation in the trial
* Known or suspected hypersensitivity to any active ingredient or excipients in the investigational medicinal products used in the trial
* Previous participation in any desmopressin trial within the last 5 years
* Use of any prohibited therapy, as defined in the protocol

Primary outcomes:
measure: Change in Mean Number of Nocturnal Voids From Baseline
timeFrame: Baseline to 3 months of treatment
Secondary outcomes:
measure: Change in Mean Time to First Nocturnal Void From Baseline
timeFrame: Baseline to 3 months of treatment
measure: Change in Mean Nocturnal Urine Volume From Baseline
timeFrame: Baseline to 3 months of treatment
measure: Responder Status
timeFrame: Baseline to 3 months of treatment
measure: Onset of Effect as Seen in Change in Mean Number of Nocturnal Voids From Baseline for Each Visit During Three Months of Treatment
timeFrame: Baseline to 3 months of treatment
measure: Change in the Impact on Sleep as Measured by the Sleep Rating Scales From Baseline
timeFrame: Baseline to 3 months of treatment
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: NEA Baptist Clinic
state: Arkansas
city: Little Rock
country: United States
facility: Lynn Institute of The Ozarks
state: Arkansas
city: Los Angeles
country: United States
facility: Moez Khorsandi, DO
state: California
city: Los Angeles
country: United States
facility: Urology Group of Southern California
state: California
city: Edgewater
country: United States
facility: Riverside Clinical Research
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc.
state: Florida
city: Pembroke Pines
country: United States
facility: Pines Clinical Research, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Evanston
country: United States
facility: Northshore Center for Gastroenterology
state: Illinois
city: Rochester
country: United States
facility: Remedica, LLC
state: Michigan
city: Albany
country: United States
facility: The Urological Institute of Northeastern New York
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley, P.C.
state: New York
city: Bethany
country: United States
facility: Parkhurst Research Organization, LLC
state: Oklahoma
city: Philadelphia
country: United States
facility: Philadelphia Clinical Research, LLC
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Houston
country: United States
facility: Advances in Health
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: San Antonio
country: United States
facility: Radiant Research
state: Texas
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater
state: Virginia
city: Seattle
country: United States
facility: Seattle Women's: Health, Research, Gynecology
state: Washington
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: