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

August 16, 2018 updated by: Ferring Pharmaceuticals

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
106

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States
        • NEA Baptist Clinic
      • Little Rock, Arkansas, United States
        • Lynn Institute of the Ozarks
    • California
      • Los Angeles, California, United States
        • Moez Khorsandi, DO
      • Los Angeles, California, United States
        • Urology Group of Southern California
    • Florida
      • Edgewater, Florida, United States
        • Riverside Clinical Research
      • Jupiter, Florida, United States
        • Health Awareness, Inc.
      • Pembroke Pines, Florida, United States
        • Pines Clinical Research, Inc.
      • West Palm Beach, Florida, United States
        • Palm Beach Research Center
    • Georgia
      • Stockbridge, Georgia, United States
        • Clinical Research Atlanta
    • Illinois
      • Evanston, Illinois, United States
        • Northshore Center for Gastroenterology
    • Michigan
      • Rochester, Michigan, United States
        • Remedica, LLC
    • New York
      • Albany, New York, United States
        • The Urological Institute of Northeastern New York
      • Poughkeepsie, New York, United States
        • Premier Medical Group of the Hudson Valley, P.C.
    • Oklahoma
      • Bethany, Oklahoma, United States
        • Parkhurst Research Organization, LLC
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Philadelphia Clinical Research, LLC
    • South Carolina
      • Charleston, South Carolina, United States
        • Medical University of South Carolina
      • Mount Pleasant, South Carolina, United States
        • Coastal Carolina Research Center
    • Tennessee
      • Nashville, Tennessee, United States
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States
        • Research Across America
      • Houston, Texas, United States
        • Pioneer Research Solutions, Inc.
      • Houston, Texas, United States
        • Advances in Health
      • San Antonio, Texas, United States
        • Radiant Research
    • Virginia
      • Norfolk, Virginia, United States
        • Clinical Research Associates of Tidewater
    • Washington
      • Seattle, Washington, United States
        • Seattle Women's: Health, Research, Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Combination
Tolterodine tartrate extended release capsules + Desmopressin orally disintegrating tablets
Drug: Tolterodine tartrate extended release capsules
Drug: Desmopressin orally disintegrating tablets
Active Comparator: Tolterodine
Tolterodine tartrate extended release capsules + Placebo orally disintegrating tablets
Drug: Tolterodine tartrate extended release capsules
Drug: Placebo orally disintegrating tablets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Mean Number of Nocturnal Voids From Baseline
Time Frame: Baseline to 3 months of treatment
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Mean Time to First Nocturnal Void From Baseline
Time Frame: Baseline to 3 months of treatment
The time to first nocturnal void was defined as the time from going to bed with the intention of sleeping until first nocturnal void or until waking in the morning in the case there is no nocturnal void. The time to first void was calculated as the average over three consecutive 24-hour periods prior to the respective visits.
Baseline to 3 months of treatment
Change in Mean Nocturnal Urine Volume From Baseline
Time Frame: Baseline to 3 months of treatment
The mean nocturnal urine volume was derived from the three-day urine volume diary. The nocturnal volume was defined as the sum of the volumes for all nocturnal voids including the volume of the first morning void within 30 min of waking up in the morning.
Baseline to 3 months of treatment
Responder Status
Time Frame: Baseline to 3 months of treatment
Responder status was defined as ≥33% decrease in the mean number of nocturnal void and at least one night with no voids out of the 3-day diary period.
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
Time Frame: Baseline to 3 months of treatment
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
Change in the Impact on Sleep as Measured by the Sleep Rating Scales From Baseline
Time Frame: Baseline to 3 months of treatment
An electronic diary was used in the trial to document the impact on sleep quality (sleep rating scales). The sleep rating scales included three questions that ranged from 0 (poor) to 10 (good). The average of each question for each visit was summarised and the change from baseline was analysed longitudinally during the three months of treatment.
Baseline to 3 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 000085

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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