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

NCT00824200 | Completed Phase 4

• 2 other identifiers: VA RR&D No. D6110RD6110R
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Nocturia

Keywords

Sleep; Quality of life; nocturia

Outcome Measures

Primary Outcomes (1)

• Nocturia episodes (voiding diary)

  Participant recorded bladder diary over 7-day that included nocturia episodes

  12 weeks

Secondary Outcomes (4)

• Sleep quality

  12 weeks

• Bother from nocturia

  12 weeks

• Symptom-specific quality of life measure

  12 weeks

• Nocturia episodes (self report)

  12 weeks

Study Arms (3)

Behavioral and Exercise Therapy (M-BET)

EXPERIMENTAL

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; Drug: placebo

Drug Therapy w/ Behavioral Placebo

ACTIVE COMPARATOR

alpha-adrenergic antagonist medication with a placebo behavioral intervention

Drug: tamsulosin (alpha-adrenergic antagonist medication); Behavioral: placebo

Combination Therapy

ACTIVE COMPARATOR

Combination therapy: MBET and alpha-adrenergic antagonist medication

Behavioral: Behavioral; Drug: tamsulosin (alpha-adrenergic antagonist medication)

Interventions

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.

Also known as: M-BET

Behavioral and Exercise Therapy (M-BET); Combination Therapy

tamsulosin (alpha-adrenergic antagonist medication) DRUG

0.4 mg given daily

Also known as: Drug Group

Combination Therapy; Drug Therapy w/ Behavioral Placebo

placebo DRUG

tamsulosin placebo

Behavioral and Exercise Therapy (M-BET)

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Evidence of overt bladder outlet obstruction: peak uroflow \<4 mL/sec on a void of ≥125 mL, or a PVR of ≥ 300 mL;
• Use of clean intermittent self-catheterization at home or having been instructed by a provider to do so within the last 12 months;
• Genitourinary cancer, including active prostate cancer with ongoing surgical or radiation treatment, or the need of treatment, or bladder cancer, or persistent unexplained hematuria;
• Obstructive sleep apnea with CPAP use, provider diagnosis with symptoms, or strong suspicion of diagnosis during screening;
• Having Parkinson's disease with an uncontrolled tremor (invalidates wrist actigraphy);
• Poorly controlled congestive heart failure as evidenced on physical examination;
• Poorly controlled diabetes mellitus with either hemoglobin A1c of ≥ 7.5 or a random glucose ≥ 200 within last 3 months; or
• Unstable health conditions expected to result in death or hospitalization within 3 months, as assessed by PI or Site PI;
• Previously receiving intensive bladder training;
• Allergic to Tamsulosin;
• Previous spinal cord injury;
• Currently on dialysis or in consideration for dialysis due to end stage renal disease;
• More than 2 urinary tract infections within the last 12 months;
• Not able to transfer independently from a wheelchair to the toilet;
• Unstable dose of diuretic within the past 3 months;

Sponsors & Collaborators

• Atlanta VA Medical Center: lead
• Emory University: collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (2)

Birmingham VA Medical Center

Birmingham, Alabama, 35233, United States

Location

Atlanta VA Medical Center

Atlanta, Georgia, 30033, United States

Location

Related Publications (1)

• Johnson TM 2nd, Vaughan CP, Goode PS, Bliwise DL, Markland AD, Huisingh C, Redden DT, McGwin G, Eisenstein R, Ouslander JG, Issa M, Burgio KL. Pilot Results from a Randomized Trial in Men Comparing Alpha-Adrenergic Antagonist versus Behavior and Exercise for Nocturia and Sleep. Clin Ther. 2016 Oct 28:S0149-2918(16)30742-1. doi: 10.1016/j.clinthera.2016.10.001. Online ahead of print.

  PMID: 28029383 RESULT

MeSH Terms

Conditions

Nocturia

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Theodore Johnson II, MD, MPH

  Atlanta Veteran Affairs Adminstration, Emory University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Main outcome measure was 7-day bladder diary derived count of nocturia episodes. Assessor was blinded to randomization
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Site Director, Birmingham/Atlanta VA GRECC

Model Details: Factorial design with no true placebo arm- drug alone versus behavior alone versus drug + behavior

Study Record Dates

• First Submitted: January 15, 2009
• First Posted: January 16, 2009
• Study Start: July 1, 2008
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

US (2)