Behavior and Exercise Versus Drug Treatment in Men With Nocturia (BEDTiMe)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Emory University
University of Alabama at Birmingham
Information provided by (Responsible Party):
Theodore Johnson II, M.D., M.P.H., Atlanta VA Medical Center
ClinicalTrials.gov Identifier:
NCT00824200
First received: January 15, 2009
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

Nocturia, waking at night from sleep to void, is a prevalent and troublesome symptom. Treatment with an alpha-adrenergic antagonist medication (α-blockers) is a standard therapy for LUTS in men, but α-blockers offer only limited reductions in nocturia. While combinations of multiple drugs could be used, many individuals wish to take fewer medications.

Participants in the BEDTiMe Nocturia Study will undergo a series of visits during which they will receive a combination of either standard drug therapy (or placebo) and a behavioral intervention tailored to help with nocturia or problems with nocturia. Participants will be evaluated for outcomes at 12 weeks and followed for six months.

This study will yield important information related to alternative treatments of nocturia in men, as well as novel information regarding the clinical importance of these nocturia reductions. This study has the potential to alter standards of care.


Condition Intervention Phase
Nocturia
Behavioral: Behavioral
Drug: tamsulosin (alpha-adrenergic antagonist medication)
Drug: placebo
Behavioral: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavior and Exercise Versus Drug Treatment in Men With Nocturia

Resource links provided by NLM:


Further study details as provided by Atlanta VA Medical Center:

Primary Outcome Measures:
  • Nocturia episodes (voiding diary) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sleep quality [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Bother from nocturia [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Nocturia episodes (self report) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2008
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Behavioral and Exercise Therapy (M-BET)
Multicomponent behavior and exercise therapy program (M-BET) - pelvic floor muscle exercises, urge suppression strategies, fluid strategies, sleep hygiene & non-pharmacological management of peripheral edema. M-BET alone will be given with placebo capsules.
Behavioral: Behavioral
Multicomponent Behavioral and Exercise Therapy (M-BET) - pelvic floor muscle exercises, urge suppression strategies, fluid strategies, sleep hygiene & non-pharmacological management of peripheral edema.
Other Name: M-BET
Drug: placebo
tamsulosin placebo
Other Name: placebo
Active Comparator: Drug Therapy w/ Behavioral Placebo
alpha-adrenergic antagonist medication with a placebo behavioral intervention
Drug: tamsulosin (alpha-adrenergic antagonist medication)
0.4 mg given daily
Other Name: Drug Group
Behavioral: placebo
placebo behavioral intervention
Other Name: Face Recognition Behavioral placebo
Active Comparator: Combination Therapy
Combination therapy: MBET and alpha-adrenergic antagonist medication
Behavioral: Behavioral
Multicomponent Behavioral and Exercise Therapy (M-BET) - pelvic floor muscle exercises, urge suppression strategies, fluid strategies, sleep hygiene & non-pharmacological management of peripheral edema.
Other Name: M-BET
Drug: tamsulosin (alpha-adrenergic antagonist medication)
0.4 mg given daily
Other Name: Drug Group

Detailed Description:

Nocturia, waking at night from sleep to void, is a prevalent and troublesome symptom. While other lower urinary tract symptoms (LUTS)-- including poor urinary stream, urgency, frequency, and straining to void-- are also common, nocturia is one of the most bothersome LUTS. Nocturia causes sleep disruption and is associated with accidental falls and higher utilization of sick days from work. Conditions that result in low volume urinary voids, high urine production at night, and/or primary sleep disturbances will cause nocturia. Overactive bladder (OAB), benign prostatic hyperplasia (BPH), congestive heart failure (CHF), poorly controlled diabetes mellitus (DM), peripheral edema, and obstructive sleep apnea all cause nocturia. Individual patients frequently have multiple conditions potentially related to nocturia, which highlights the need for strategies that are broad-based interventions. Treatment with an alpha-adrenergic antagonist medication (α-blockers) is a standard therapy for LUTS in men, but α-blockers offer only limited reductions in nocturia. While combinations of multiple drugs could also be employed to more successfully treat nocturia, non-drug treatments are an important option for those unwilling or unable to take additional medications.

The BEDTiMe Nocturia Study (Behavior and Exercise or Drug Trial in Men with Nocturia), is a two-site (Atlanta and Birmingham), randomized, clinical trial. The 200 male participants will be stratified by degree of nocturia and urinary flow rate and randomized to three treatment arms: 1) α-blocker therapy alone; versus 2) a standardized, multicomponent behavioral and exercise therapy (M-BET), given with placebo tablets; versus 3) combination therapy (M-BET and α-blockers). The M-BET intervention includes: training in pelvic floor muscle rehabilitation, self monitoring with bladder diaries, and teaching urge suppression and other skills to inhibit detrusor contractions; fluid management strategies; sleep hygiene strategies; and non-pharmacological management of lower extremity edema. Interventions similar to M-BET have shown reductions in nocturia in women with urge urinary incontinence (UI) that exceeded benefit from anticholinergic drug therapy. The use of this intervention in men builds upon strong pilot data from the MINIM trial (Multicomponent Interventions for Nocturia in Men; VA GRECC Pilot, VA Medical Research Services) and the ongoing study Behavioral Treatment For Overactive Bladder In Men (VA RR&D B02-2489R, Burgio, PI).

The study design allows 3 main research questions to be addressed: 1) Does M-BET reduce nocturia more than α-blockers?; 2) Does M-BET improve sleep more than α-blockers?; and 3) Will combination therapy be more effective than either treatment alone? The main outcomes will be nocturia reduction and sleep improvement at 12 weeks. Nocturia reduction will be assessed by participant completed bladder diaries and sleep improvement will be assessed by wrist-actigraph determined sleep efficiency, total sleep time, and wake time after sleep onset.

This study will yield important information related to alternative treatments of nocturia in male veterans, as well as novel information regarding the clinical importance of these nocturia reductions. Though many clinicians employ single-agent α-blockers routinely for the treatment of nocturia, few utilize multicomponent behavioral interventions or use behavioral therapy. Thus, this study has the potential to alter standards of care.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Nocturia ≥2 episodes / night average on the screening diary;
  2. Willingness and appropriateness to receive an α- blocker;
  3. Willingness to keep a bladder and sleep diary;
  4. Willingness to wear a wrist actigraph; and
  5. Willingness to make study visits

Exclusion Criteria:

  1. Evidence of overt bladder outlet obstruction: peak uroflow <4 mL/sec on a void of ≥125 mL, or a PVR of ≥ 300 mL;
  2. Use of clean intermittent self-catheterization at home or having been instructed by a provider to do so within the last 12 months;
  3. Genitourinary cancer, including active prostate cancer with ongoing surgical or radiation treatment, or the need of treatment, or bladder cancer, or persistent unexplained hematuria;
  4. Obstructive sleep apnea with CPAP use, provider diagnosis with symptoms, or strong suspicion of diagnosis during screening;
  5. Having Parkinson's disease with an uncontrolled tremor (invalidates wrist actigraphy);
  6. Poorly controlled congestive heart failure as evidenced on physical examination;
  7. Poorly controlled diabetes mellitus with either hemoglobin A1c of ≥ 7.5 or a random glucose ≥ 200 within last 3 months; or
  8. Unstable health conditions expected to result in death or hospitalization within 3 months, as assessed by PI or Site PI;
  9. Previously receiving intensive bladder training;
  10. Allergic to Tamsulosin;
  11. Previous spinal cord injury;
  12. Currently on dialysis or in consideration for dialysis due to end stage renal disease;
  13. More than 2 urinary tract infections within the last 12 months;
  14. Not able to transfer independently from a wheelchair to the toilet;
  15. Unstable dose of diuretic within the past 3 months;
  16. Has an artificial urinary sphincter;
  17. Impaired mental status;
  18. TURP or other urologic surgery within the last 6 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824200

Locations
United States, Alabama
Birmingham VA Medical Center
Birmingham, Alabama, United States, 35233
United States, Georgia
Atlanta VA Medical Center
Atlanta, Georgia, United States, 30033
Sponsors and Collaborators
Atlanta VA Medical Center
Emory University
University of Alabama at Birmingham
Investigators
Principal Investigator: Theodore Johnson II, MD, MPH Atlanta Veteran Affairs Adminstration, Emory University School of Medicine
  More Information

No publications provided

Responsible Party: Theodore Johnson II, M.D., M.P.H., Site Director, Birmingham/Atlanta VA GRECC, Atlanta VA Medical Center
ClinicalTrials.gov Identifier: NCT00824200     History of Changes
Other Study ID Numbers: VA RR&D No. D6110R, D6110R
Study First Received: January 15, 2009
Last Updated: January 6, 2014
Health Authority: United States: Federal Government

Keywords provided by Atlanta VA Medical Center:
Sleep
Quality of life
nocturia

Additional relevant MeSH terms:
Nocturia
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Tamsulosin
Adrenergic Agents
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic alpha-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014