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CompletedNCT02202031CUREUpdated Jul 30, 2019Results posted

Controlling Urgency Through Relaxation Exercises

An interventional study of Paced Respiration and Music Therapy in Overactive Bladder, Urgency Urinary Symptoms and Urgency Incontinence, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to female participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-30.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
161
Allocation
Randomized
Ages
21 Years and older
Sex
Female
01

Study summary

We propose to conduct a rigorous, 12-week, randomized controlled trial of two relaxation therapies in 160 ambulatory women who report an average of at least 3 urgency-associated voiding or incontinence episodes per day. Participants will be randomized in a 1:1 ratio to: 1) practice slowing their resting respiratory rate to 5 to 10 breaths per minute for at least 15 minutes/day at home using a portable guided-breathing device; or 2) use an identical-appearing device that plays relaxing music while monitoring their spontaneous breathing pattern. We do not know if either of the two types of relaxation therapies is effective in treating OAB. All women will also receive a usual care pamphlet providing basic information about other traditional self-management strategies for OAB.

02

Conditions studied

  • Overactive Bladder
  • Urgency Urinary Symptoms
  • Urgency Incontinence
03

In context

Urinary Bladder, Overactive

855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.

This study's enrollment of 161 is above the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.

Browse Urinary Bladder, Overactive studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Women aged 21 years or older who are able to walk to the bathroom without assistance
  2. Report recurrent episodes of urgency (sudden or strong urges to urinate) beginning at least 3 months prior to screening
  3. Able to record all voiding and incontinence episodes on a screening 3-day voiding diary29,30 and rate the severity of urgency associated with each episode using a validated urgency severity scale31
  4. Document at least 9 voiding or incontinence episodes on the above 3-day voiding diary that are associated with at least moderate sensation of urgency (using the above validated urgency severity scale) 31
  5. Willing to refrain from initiating other treatments that may affect voiding pattern during the trial period

Exclusion criteria

Exclusion Criteria:

  1. Use of anticholinergic OAB medications or other medications known to affect urinary function (i.e., diuretics, tricyclic antidepressants) within 1 month of screening
  2. Current urinary tract infection (detected via screening dipstick urinalysis or urine culture) or a history more than 3 urinary tract infections in the preceding 1 year
  3. Prior history of lower urinary tract surgery, pelvic cancer, or pelvic irradiation; or other pelvic or abdominal surgery within 6 months of screening
  4. History of interstitial cystitis, fistula in the bladder or rectum, or congenital or childhood defect leading to chronic urinary incontinence, retention, or other chronic urinary symptoms
  5. Known history of major neurologic conditions likely to have major or permanent effects on bladder function such as stroke, multiple sclerosis, spinal cord injury, or Parkinson's disease
  6. Use of bladder botulinum injections, electrostimulation, or other invasive therapies for OAB or incontinence within 3 months of screening
  7. Formal pelvic floor rehabilitation or other formal behavioral therapy for bladder symptoms involving a physical therapist or other certified practitioner within 3 months of screening
  8. Started, stopped, or changed dosage of a psychoactive medication likely to affect anxiety (SSRIs/SNRIs, tricyclics) within 3 months of screening, or plans to start, stop, or change dosage during the trial
  9. Resting blood pressure (average of 2 measures) less than 100/60 at screening (women with baseline low blood pressure may theoretically be at increased risk of hypotension with use of RESPeRATE)
  10. Resting breathing rate already below 10 breaths/minute before treatment (as measured during run-in)
  11. History of chronic pulmonary disease likely to interfere with breathing exercises (e.g., emphysema)
  12. Currently pregnant, gave birth within the past 3 months, or planning pregnancy during the study period
  13. Unable or willing to sign an informed consent, fill out questionnaires, or undergo study procedures
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
161 participants (actual)

Study arms

  • Experimental
    Music Therapy

    Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.

    Behavioral: Music Therapy

  • Experimental
    Paced Respiration

    Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.

    Behavioral: Paced Respiration

Interventions

  • BehavioralPaced Respiration

    Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.

  • BehavioralMusic Therapy

    Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With At Least a Moderate Sensation of Urgency at 12 Weeks.

    Self-reported on voiding diary.

    Time frame: Baseline to 12 weeks

Secondary outcomes

  1. Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With a Severe Sensation of Urgency at 12 Weeks.

    Self-reported on voiding diary

    Time frame: Baseline to 12 weeks

  2. Change From Baseline in Urgency Incontinence Episodes at 12 Weeks.

    Self-reported on voiding diary

    Time frame: Baseline to 12 weeks.

  3. Change From Baseline in Total Voiding Episodes at 12 Weeks.

    Self-reported on voiding diary.

    Time frame: Baseline to 12 weeks

  4. Change From Baseline in Overactive Bladder Questionnaire Score at 12 Weeks

    A 33-item measure of the bothersomness and impact of multiple OAB symptoms (such as urgency, incontinence, nocturia) along a 100-point scale. Higher the score the greater the bothersome.

    Time frame: Baseline to 12 weeks.

  5. Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Severity Subscale at 12 Weeks.

    A 13-item measure of the severity and impact of urgency validated specifically in patients with OAB, range of 0-100. Higher the severity score, the more severe.

    Time frame: Baseline to 12 weeks.

  6. Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Health-Related Quality of Life Subscale at 12 Weeks.

    A 13-item measure of the severity and impact of urgency validated specifically in patients with OAB, range of 0-100. Higher the severity score, the more interference with quality of life.

    Time frame: Baseline to 12 weeks

  7. Change From Baseline in Urogenital Distress Inventory Short Form (UDI-6) Score at 12 Weeks.

    A 6-item measure of the bothersomeness of multiple urinary symptoms, including urgency and incontinence; scores range from 0-100. Higher the score, the more distress.

    Time frame: Baseline to 12 weeks

  8. Change From Baseline on Patient Perception of Bladder Condition (PPBC) Score at 12 Weeks.

    A single-item assessing patient's overall perception of their bladder problems using a 6-point Likert scale, score range 1-6. The higher the score the more severe.

    Time frame: Baseline to 12 weeks

  9. Change From Baseline on Spielberger State Trait Anxiety Inventory (STAI) - Trait Component Score at 12 Weeks.

    A 20-item self-administered measure validated in both clinical and psychiatric populations, including patients with bladder symptoms. Scores range from 20 to 80, with higher scores indicating greater somatic anxiety.

    Time frame: Baseline to 12 Weeks

  10. Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score at 12 Weeks.

    A validated self-administered questionnaire that includes a 7-item Anxiety Subscale shown to be sensitive to change in incontinence trials. Scores range from 0 to 21, with higher scores indicating greater anxiety.

    Time frame: Baseline to 12 Weeks

  11. Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score at 12 Weeks.

    A 20-item measure that has been widely used in clinical trials, including trials of bladder interventions, and is sensitive to change. Total scores range from 0 to 60, with higher scores indicating greater likelihood of depression.

    Time frame: Baseline to 12 weeks

  12. Change From Baseline in Perceived Stress Scale (PSS) Score at 12 Weeks.

    A 10-item self-administered questionnaire assessing subjective feelings and thoughts related to perceived stress in the past month, validated in a probability sample of the United States. Scores range from 0 to 40, with higher scores indicating greater perceived stress.

    Time frame: Baseline to 12 weeks

  13. Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Overall Sleep Quality Score at 12 Weeks.

    An 18-item validated questionnaire evaluating sleep quality, sleep latency, sleep efficiency, and sleep problems over a one-week period. A global sleep quality score ranging from 0 to 21 can be derived from the PSQI, with higher scores reflecting poor sleep quality.

    Time frame: Baseline to 12 weeks

  14. Change From Baseline in Respiratory Sinus Arrhythmia at 12 Weeks.

    Resting (neutral) state

    Time frame: Baseline to 12 weeks

  15. Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Resting (Neutral) State at 12 Weeks.

    Change in autonomic control as assessed by high frequency heart rate variability (RSA)

    Time frame: Baseline to 12 weeks

  16. Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Dot Task at 12 Weeks.

    High frequency heart rate variability

    Time frame: Baseline to 12 weeks

  17. Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Maze Task at 12 Weeks

    high frequency heart rate variability

    Time frame: Baseline to 12 weeks

  18. Change From Baseline in Pre-ejection Period (PEP) Resting (Neutral) State at 12 Weeks.

    PEP is the time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed, is an established measure of sympathetic autonomic activity that can be measured non-invasively using impedance cardiography .

    Time frame: Baseline to 12 weeks

  19. Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Dot Task at 12 Weeks.

    The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed

    Time frame: Baseline to 12 weeks

  20. Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Maze Task at 12 Weeks

    The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed

    Time frame: Baseline to 12 weeks

07

Results

Posted Jul 5, 2019

Participant flow

Participant flow — Overall Study
MilestoneMusic TherapyPaced Respiration
Started8279
Completed7774
Not completed55
Withdrew: Lost to follow-up10
Withdrew: Too busy13
Withdrew: Illness/medical reason02
Withdrew: Intolerance/lack of improvement30

Outcome measures

PrimaryChange From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With At Least a Moderate Sensation of Urgency at 12 Weeks.

Self-reported on voiding diary.

Time frame:
Baseline to 12 weeks
Reported as:
Least squares mean · episodes
Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With At Least a Moderate Sensation of Urgency at 12 Weeks.
episodesMusic TherapyPaced Respiration
Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With At Least a Moderate Sensation of Urgency at 12 Weeks.-1.06 (-1.74 to -0.37)-0.86 (-1.50 to -0.13)
Statistical analysis
  • Music Therapy vs Paced Respiration · ANCOVA · p = 0.6222 · Mean difference (final values): 0.24 · 95% CI -0.73 to 1.21change from baseline, adjusted for baseline value
SecondaryChange From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With a Severe Sensation of Urgency at 12 Weeks.

Self-reported on voiding diary

Time frame:
Baseline to 12 weeks
Reported as:
Least squares mean · episodes
Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With a Severe Sensation of Urgency at 12 Weeks.
episodesMusic TherapyPaced Respiration
Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With a Severe Sensation of Urgency at 12 Weeks.-0.85 (-1.24 to -0.46)-0.94 (-1.32 to -0.55)
Statistical analysis
  • Music Therapy vs Paced Respiration · ANCOVA · p = 0.7695 · Mean difference (final values): -0.08 · 95% CI -0.64 to 0.47change from baseline, adjusted for baseline value
SecondaryChange From Baseline in Urgency Incontinence Episodes at 12 Weeks.

Self-reported on voiding diary

Time frame:
Baseline to 12 weeks.
Reported as:
Least squares mean · episodes
Change From Baseline in Urgency Incontinence Episodes at 12 Weeks.
episodesMusic TherapyPaced Respiration
Change From Baseline in Urgency Incontinence Episodes at 12 Weeks.-0.63 (-0.85 to -0.40)-0.55 (-0.77 to -0.33)
Statistical analysis
  • Music Therapy vs Paced Respiration · ANCOVA · p = 0.6456 · Mean difference (final values): 0.07 · 95% CI -0.24 to 0.39change from baseline value, adjusted for baseline value
SecondaryChange From Baseline in Total Voiding Episodes at 12 Weeks.

Self-reported on voiding diary.

Time frame:
Baseline to 12 weeks
Reported as:
Least squares mean · episodes
Change From Baseline in Total Voiding Episodes at 12 Weeks.
episodesMusic TherapyPaced Respiration
Change From Baseline in Total Voiding Episodes at 12 Weeks.-1.04 (-1.49 to -0.60)-1.08 (-1.52 to -0.63)
Statistical analysis
  • Music Therapy vs Paced Respiration · ANCOVA · p = 0.9190 · Mean difference (final values): -0.03 · 95% CI -0.66 to 0.60change from baseline, adjusted for baseline value
SecondaryChange From Baseline in Overactive Bladder Questionnaire Score at 12 Weeks

A 33-item measure of the bothersomness and impact of multiple OAB symptoms (such as urgency, incontinence, nocturia) along a 100-point scale. Higher the score the greater the bothersome.

Time frame:
Baseline to 12 weeks.
Reported as:
Least squares mean · score on a scale
Change From Baseline in Overactive Bladder Questionnaire Score at 12 Weeks
score on a scaleMusic TherapyPaced Respiration
Change From Baseline in Overactive Bladder Questionnaire Score at 12 Weeks-15.45 (-18.03 to -12.87)-14.29 (-16.91 to -11.68)
Statistical analysis
  • Music Therapy vs Paced Respiration · ANCOVA · p = 0.5358 · Mean difference (final values): 1.16 · 95% CI -2.51 to 4.84change from baseline, adjusted for baseline value.
SecondaryChange From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Severity Subscale at 12 Weeks.

A 13-item measure of the severity and impact of urgency validated specifically in patients with OAB, range of 0-100. Higher the severity score, the more severe.

Time frame:
Baseline to 12 weeks.
Reported as:
Least squares mean · score on a scale
Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Severity Subscale at 12 Weeks.
score on a scaleMusic TherapyPaced Respiration
Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Severity Subscale at 12 Weeks.-15.56 (-18.81 to -12.32)-13.85 (-17.13 to -10.56)
Statistical analysis
  • Music Therapy vs Paced Respiration · ANCOVA · p = 0.4663 · Mean difference (final values): 1.72 · 95% CI -2.90 to 6.34change from baseline, adjusted for baseline value
SecondaryChange From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Health-Related Quality of Life Subscale at 12 Weeks.

A 13-item measure of the severity and impact of urgency validated specifically in patients with OAB, range of 0-100. Higher the severity score, the more interference with quality of life.

Time frame:
Baseline to 12 weeks
Reported as:
Least squares mean · score on a scale
Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Health-Related Quality of Life Subscale at 12 Weeks.
score on a scaleMusic TherapyPaced Respiration
Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Health-Related Quality of Life Subscale at 12 Weeks.-12.35 (-15.30 to -9.39)-10.18 (-13.17 to -7.18)
Statistical analysis
  • Music Therapy vs Paced Respiration · ANCOVA · p = 0.3134 · Mean difference (final values): 2.17 · 95% CI -2.05 to 6.38change from baseline, adjusted for baseline value
SecondaryChange From Baseline in Urogenital Distress Inventory Short Form (UDI-6) Score at 12 Weeks.

A 6-item measure of the bothersomeness of multiple urinary symptoms, including urgency and incontinence; scores range from 0-100. Higher the score, the more distress.

Time frame:
Baseline to 12 weeks
Reported as:
Least squares mean · score on a scale
Change From Baseline in Urogenital Distress Inventory Short Form (UDI-6) Score at 12 Weeks.
score on a scaleMusic TherapyPaced Respiration
Change From Baseline in Urogenital Distress Inventory Short Form (UDI-6) Score at 12 Weeks.-15.35 (-19.07 to -11.64)-17.11 (-20.88 to -13.35)
Statistical analysis
  • Music Therapy vs Paced Respiration · ANCOVA · p = 0.5146 · Mean difference (final values): -1.76 · 95% CI -7.05 to 3.53change from baseline, adjusted for baseline value
SecondaryChange From Baseline on Patient Perception of Bladder Condition (PPBC) Score at 12 Weeks.

A single-item assessing patient's overall perception of their bladder problems using a 6-point Likert scale, score range 1-6. The higher the score the more severe.

Time frame:
Baseline to 12 weeks
Reported as:
Least squares mean · score on a scale
Change From Baseline on Patient Perception of Bladder Condition (PPBC) Score at 12 Weeks.
score on a scaleMusic TherapyPaced Respiration
Change From Baseline on Patient Perception of Bladder Condition (PPBC) Score at 12 Weeks.-0.74 (-0.95 to -0.53)-0.88 (-1.09 to -0.66)
Statistical analysis
  • Music Therapy vs Paced Respiration · ANCOVA · p = 0.3611 · Mean difference (final values): -0.14 · 95% CI -0.44 to 0.16change from baseline, adjusted for baseline value
SecondaryChange From Baseline on Spielberger State Trait Anxiety Inventory (STAI) - Trait Component Score at 12 Weeks.

A 20-item self-administered measure validated in both clinical and psychiatric populations, including patients with bladder symptoms. Scores range from 20 to 80, with higher scores indicating greater somatic anxiety.

Time frame:
Baseline to 12 Weeks
Reported as:
Least squares mean · score on a scale
Change From Baseline on Spielberger State Trait Anxiety Inventory (STAI) - Trait Component Score at 12 Weeks.
score on a scaleMusic TherapyPaced Respiration
Change From Baseline on Spielberger State Trait Anxiety Inventory (STAI) - Trait Component Score at 12 Weeks.-2.42 (-3.82 to -1.02)-2.85 (-4.27 to -1.43)
Statistical analysis
  • Music Therapy vs Paced Respiration · ANCOVA · p = 0.6722 · Mean difference (final values): -0.43 · 95% CI -2.43 to 1.57change from baseline, adjusted for baseline value
SecondaryChange From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score at 12 Weeks.

A validated self-administered questionnaire that includes a 7-item Anxiety Subscale shown to be sensitive to change in incontinence trials. Scores range from 0 to 21, with higher scores indicating greater anxiety.

Time frame:
Baseline to 12 Weeks
Reported as:
Least squares mean · score on a scale
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score at 12 Weeks.
score on a scaleMusic TherapyPaced Respiration
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score at 12 Weeks.-0.71 (-1.23 to -0.19)-1.38 (-1.90 to -0.86)
Statistical analysis
  • Music Therapy vs Paced Respiration · ANCOVA · p = 0.0786 · Mean difference (final values): -0.67 · 95% CI -1.4 to 0.07change from baseline, adjusted for baseline value
SecondaryChange From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score at 12 Weeks.

A 20-item measure that has been widely used in clinical trials, including trials of bladder interventions, and is sensitive to change. Total scores range from 0 to 60, with higher scores indicating greater likelihood of depression.

Time frame:
Baseline to 12 weeks
Reported as:
Least squares mean · score on a scale
Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score at 12 Weeks.
score on a scaleMusic TherapyPaced Respiration
Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score at 12 Weeks.-1.97 (-3.25 to -0.69)-3.01 (-4.31 to -1.72)
Statistical analysis
  • Music Therapy vs Paced Respiration · ANCOVA · p = 0.2284 · Mean difference (final values): -1.04 · 95% CI -2.87 to 0.79change from baseline, adjusted for baseline value
SecondaryChange From Baseline in Perceived Stress Scale (PSS) Score at 12 Weeks.

A 10-item self-administered questionnaire assessing subjective feelings and thoughts related to perceived stress in the past month, validated in a probability sample of the United States. Scores range from 0 to 40, with higher scores indicating greater perceived stress.

Time frame:
Baseline to 12 weeks
Reported as:
Least squares mean · score on a scale
Change From Baseline in Perceived Stress Scale (PSS) Score at 12 Weeks.
score on a scaleMusic TherapyPaced Respiration
Change From Baseline in Perceived Stress Scale (PSS) Score at 12 Weeks.-1.12 (-2.23 to -0.02)-2.83 (-3.95 to -1.71)
Statistical analysis
  • Music Therapy vs Paced Respiration · ANCOVA · p = 0.0335 · Mean difference (final values): -1.71 · 95% CI -3.28 to -0.13change from baseline, adjusted for baseline value
SecondaryChange From Baseline in Pittsburgh Sleep Quality Index (PSQI) Overall Sleep Quality Score at 12 Weeks.

An 18-item validated questionnaire evaluating sleep quality, sleep latency, sleep efficiency, and sleep problems over a one-week period. A global sleep quality score ranging from 0 to 21 can be derived from the PSQI, with higher scores reflecting poor sleep quality.

Time frame:
Baseline to 12 weeks
Reported as:
Least squares mean · score on a scale
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Overall Sleep Quality Score at 12 Weeks.
score on a scaleMusic TherapyPaced Respiration
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Overall Sleep Quality Score at 12 Weeks.-1.22 (-1.74 to -0.70)-1.14 (-1.67 to -0.62)
Statistical analysis
  • Music Therapy vs Paced Respiration · ANCOVA · p = 0.8408 · Mean difference (final values): 0.08 · 95% CI -0.66 to 0.81change from baseline, adjusted for baseline value
SecondaryChange From Baseline in Respiratory Sinus Arrhythmia at 12 Weeks.

Resting (neutral) state

Time frame:
Baseline to 12 weeks
Reported as:
Least squares mean · msec^2
Change From Baseline in Respiratory Sinus Arrhythmia at 12 Weeks.
msec^2Music TherapyPaced Respiration
Change From Baseline in Respiratory Sinus Arrhythmia at 12 Weeks.-0.40 (-1.13 to 0.32)-0.27 (-1.09 to 0.55)
Statistical analysis
  • Music Therapy vs Paced Respiration · ANCOVA · p = 0.5578 · Mean difference (final values): 0.14 · 95% CI -0.32 to 0.60
SecondaryChange From Baseline in Respiratory Sinus Arrhythmia (RSA) Resting (Neutral) State at 12 Weeks.

Change in autonomic control as assessed by high frequency heart rate variability (RSA)

Time frame:
Baseline to 12 weeks
Reported as:
Least squares mean · msec^2
Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Resting (Neutral) State at 12 Weeks.
msec^2Music TherapyPaced Respiration
Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Resting (Neutral) State at 12 Weeks.-0.40 (-1.13 to 0.32)-0.27 (-1.09 to 0.55)
Statistical analysis
  • Music Therapy vs Paced Respiration · ANCOVA · p = 0.5578Adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.
SecondaryChange From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Dot Task at 12 Weeks.

High frequency heart rate variability

Time frame:
Baseline to 12 weeks
Reported as:
Least squares mean · msec2
Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Dot Task at 12 Weeks.
msec2Music TherapyPaced Respiration
Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Dot Task at 12 Weeks.0.58 (-0.28 to 1.43)0.33 (-0.66 to 1.32)
Statistical analysis
  • Music Therapy vs Paced Respiration · ANCOVA · p = 0.7301 · Mean difference (final values): -0.24 · 95% CI -0.79 to 0.31adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.
SecondaryChange From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Maze Task at 12 Weeks

high frequency heart rate variability

Time frame:
Baseline to 12 weeks
Reported as:
Least squares mean · msec^2
Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Maze Task at 12 Weeks
msec^2Music TherapyPaced Respiration
Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Maze Task at 12 Weeks0.69 (-0.09 to 1.47)0.26 (-0.61 to 1.13)
Statistical analysis
  • Music Therapy vs Paced Respiration · ANCOVA · p = 0.6646 · Mean difference (final values): -0.43 · 95% CI -0.89 to 0.04adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic
SecondaryChange From Baseline in Pre-ejection Period (PEP) Resting (Neutral) State at 12 Weeks.

PEP is the time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed, is an established measure of sympathetic autonomic activity that can be measured non-invasively using impedance cardiography .

Time frame:
Baseline to 12 weeks
Reported as:
Least squares mean · msec
Change From Baseline in Pre-ejection Period (PEP) Resting (Neutral) State at 12 Weeks.
msecMusic TherapyPaced Respiration
Change From Baseline in Pre-ejection Period (PEP) Resting (Neutral) State at 12 Weeks.-3.41 (-21.94 to 15.12)0.34 (-20.19 to 20.86)
Statistical analysis
  • Music Therapy vs Paced Respiration · ANCOVA · p = 0.4993Adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.
SecondaryChange From Baseline in Pre-ejection Period (PEP) Change From Rest to Dot Task at 12 Weeks.

The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed

Time frame:
Baseline to 12 weeks
Reported as:
Least squares mean · msec
Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Dot Task at 12 Weeks.
msecMusic TherapyPaced Respiration
Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Dot Task at 12 Weeks.1.28 (-5.12 to 7.69)1.87 (-4.85 to 8.60)
Statistical analysis
  • Music Therapy vs Paced Respiration · ANCOVA · p = 0.7506 · Mean difference (final values): 0.59 · 95% CI -3.05 to 4.23adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.
SecondaryChange From Baseline in Pre-ejection Period (PEP) Change From Rest to Maze Task at 12 Weeks

The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed

Time frame:
Baseline to 12 weeks
Reported as:
Least squares mean · msec
Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Maze Task at 12 Weeks
msecMusic TherapyPaced Respiration
Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Maze Task at 12 Weeks-4.79 (-14.07 to 4.49)-6.35 (-16.56 to 3.87)
Statistical analysis
  • Music Therapy vs Paced Respiration · ANCOVA · p = 0.6268 · Mean difference (final values): -1.55 · 95% CI -6.98 to 3.87adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.

Adverse events

Collected over Baseline to 12 weeks.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Music Therapy0/82 (0%)0/82 (0%)12/82 (14.6%)
Paced Respiration0/79 (0%)0/79 (0%)10/79 (12.7%)
Most frequent other events
Most frequent other events
EventMusic TherapyPaced Respiration
Cold/FluRespiratory, thoracic and mediastinal disorders12/8210/79

Baseline characteristics

Age, Continuous
Age, Continuous(years)Music TherapyPaced RespirationTotal
Mean61.67 ± 10.960.35 ± 11.461.02 ± 11.1
Sex: Female, Male
Sex: Female, Male(Participants)Music TherapyPaced RespirationTotal
Female8279161
Male000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Music TherapyPaced RespirationTotal
Asian/Asian-American6713
Latina61218
Mixed7310
Non-Latina African-American121224
Non-Latina White494089
Unknown257
Region of Enrollment
Region of Enrollment(participants)Music TherapyPaced RespirationTotal
United States8279161
Incontinence Frequency
Incontinence Frequency(Episodes per day)Music TherapyPaced RespirationTotal
Urgency Incontinence1.19 ± 1.61.37 ± 2.01.28 ± 1.8
Moderate Sensation of Urgency Incontinence or Void6.77 ± 3.87.10 ± 2.96.93 ± 3.4
Severe Sensation of Urgency Incontinence or Void2.42 ± 2.33.01 ± 2.62.71 ± 2.4
Daytime voiding9.70 ± 3.89.81 ± 2.89.76 ± 3.3
Nighttime voiding1.42 ± 1.01.25 ± 1.01.34 ± 1.0
Total voiding11.12 ± 3.911.06 ± 2.911.09 ± 3.4
Overactive Bladder Questionnaire
Overactive Bladder Questionnaire(score on a scale)Music TherapyPaced RespirationTotal
Mean27.59 ± 11.429.12 ± 9.928.35 ± 10.7
Urgency Severity and Impact Questionnaire
Urgency Severity and Impact Questionnaire(score on scale)Music TherapyPaced RespirationTotal
Severity Subscale58.51 ± 11.758.45 ± 14.558.48 ± 13.1
Health-Related Quality of Life Subscale21.94 ± 15.424.57 ± 19.423.23 ± 17.5
Urogenital Distress Inventory Short Form (UDI-6)
Urogenital Distress Inventory Short Form (UDI-6)(score on scale)Music TherapyPaced RespirationTotal
Mean45.19 ± 17.345.57 ± 19.645.38 ± 18.4

8 further baseline measures are reported on the registry.

08

Study locations

1 site
  • University of California, San Francisco
    San Francisco, California 94115, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 4, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02202031
Lead sponsor
University of California, San Francisco
Collaborators
National Institute on Aging (NIA)
Responsible party
Alison Huang, MD (Assistant Professor, University of California, San Francisco) — Principal investigator
First posted
Jul 28, 2014
Start date
Sep 2014
Primary completion
Dec 2017
Completion
Mar 2018
Results posted
Jul 5, 2019
Last update
Jul 30, 2019

Study contacts

Alison Huang, MD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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