| City: |
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Birmingham |
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State:
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AL |
| Zip Code: |
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35233 |
| Conditions: |
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Nocturia |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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. |
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| Study is available at: |
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Birmingham VA Medical Center
Birmingham, AL 35233
United States
Primary Contact:
Susan Barnacastle
Email: Susan.Barnacastle@va.gov
Phone: 205-933-8101
Secondary Contact:
Sabrina Ward, MPH
Email: Sabrina.Ward2@va.gov
Phone: 404-321-6111 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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