Interventional Clinical Trial in Patients in Overactive Bladder With Nocturia in Women
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
1 other identifier
interventional
106
1 country
24
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2013
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2012
CompletedFirst Posted
Study publicly available on registry
November 20, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedResults Posted
Study results publicly available
August 14, 2018
CompletedSeptember 12, 2018
August 1, 2018
1.8 years
November 15, 2012
July 20, 2018
August 16, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Mean Number of Nocturnal Voids From Baseline
A nocturnal void was defined as a void occurring at least 5 minutes after going to bed, but before getting up the next morning. The mean estimate was the average over 3 consecutive 24-hour periods prior to the respective visit as captured in the voiding and sleep diary.
Baseline to 3 months of treatment
Secondary Outcomes (5)
Change in Mean Time to First Nocturnal Void From Baseline
Baseline to 3 months of treatment
Change in Mean Nocturnal Urine Volume From Baseline
Baseline to 3 months of treatment
Responder Status
Baseline to 3 months of treatment
Onset of Effect as Seen in Change in Mean Number of Nocturnal Voids From Baseline for Each Visit During Three Months of Treatment
Baseline to 3 months of treatment
Change in the Impact on Sleep as Measured by the Sleep Rating Scales From Baseline
Baseline to 3 months of treatment
Study Arms (2)
Combination
EXPERIMENTALTolterodine tartrate extended release capsules + Desmopressin orally disintegrating tablets
Tolterodine
ACTIVE COMPARATORTolterodine tartrate extended release capsules + Placebo orally disintegrating tablets
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
NEA Baptist Clinic
Jonesboro, Arkansas, United States
Lynn Institute of The Ozarks
Little Rock, Arkansas, United States
Moez Khorsandi, DO
Los Angeles, California, United States
Urology Group of Southern California
Los Angeles, California, United States
Riverside Clinical Research
Edgewater, Florida, United States
Health Awareness, Inc.
Jupiter, Florida, United States
Pines Clinical Research, Inc.
Pembroke Pines, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Northshore Center for Gastroenterology
Evanston, Illinois, United States
Remedica, LLC
Rochester, Michigan, United States
The Urological Institute of Northeastern New York
Albany, New York, United States
Premier Medical Group of the Hudson Valley, P.C.
Poughkeepsie, New York, United States
Parkhurst Research Organization, LLC
Bethany, Oklahoma, United States
Philadelphia Clinical Research, LLC
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Research Across America
Dallas, Texas, United States
Advances in Health
Houston, Texas, United States
Pioneer Research Solutions, Inc.
Houston, Texas, United States
Radiant Research
San Antonio, Texas, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States
Seattle Women's: Health, Research, Gynecology
Seattle, Washington, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Development Support
- Organization
- Ferring Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2012
First Posted
November 20, 2012
Study Start
January 1, 2013
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
September 12, 2018
Results First Posted
August 14, 2018
Record last verified: 2018-08