Trial Outcomes & Findings for Lessening Incontinence Through Low-impact Activity (NCT NCT02342678)
NCT ID: NCT02342678
Last Updated: 2018-12-19
Results Overview
Change in the frequency of urinary incontinence episodes of any type. Analysis of covariance models were developed to examine change in incontinence frequency over 3 months. Results were summarized using least square mean estimates of changes in incontinence frequency in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values.
COMPLETED
NA
56 participants
Baseline and 3 months
2018-12-19
Participant Flow
Participant milestones
| Measure |
Yoga Therapy Group
Participants will take part in twice weekly group yoga classes focusing on selected Iyengar-based yoga techniques as well as practice study-specific yoga techniques at home for at least one hour per week for a total of 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing yoga exercises for at least an hour per week.
Yoga Therapy
|
Physical Conditioning Group
Patricipants will take part in twice weekly group physical conditioning classes and practice stretching exercises at least one hour per week at home for 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing stretching exercises for at least an hour per week.
Physical Conditioning
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
|
Overall Study
COMPLETED
|
27
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
| Measure |
Yoga Therapy Group
Participants will take part in twice weekly group yoga classes focusing on selected Iyengar-based yoga techniques as well as practice study-specific yoga techniques at home for at least one hour per week for a total of 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing yoga exercises for at least an hour per week.
Yoga Therapy
|
Physical Conditioning Group
Patricipants will take part in twice weekly group physical conditioning classes and practice stretching exercises at least one hour per week at home for 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing stretching exercises for at least an hour per week.
Physical Conditioning
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Too busy to complete study
|
0
|
2
|
|
Overall Study
Family illness/emergency
|
0
|
1
|
|
Overall Study
Illness/medical reason
|
1
|
1
|
Baseline Characteristics
Lessening Incontinence Through Low-impact Activity
Baseline characteristics by cohort
| Measure |
Yoga Therapy Group
n=28 Participants
Participants will take part in twice weekly group yoga classes focusing on selected Iyengar-based yoga techniques as well as practice study-specific yoga techniques at home for at least one hour per week for a total of 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing yoga exercises for at least an hour per week.
Yoga Therapy
|
Physical Conditioning Group
n=28 Participants
Patricipants will take part in twice weekly group physical conditioning classes and practice stretching exercises at least one hour per week at home for 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing stretching exercises for at least an hour per week.
Physical Conditioning
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Latina White
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latina White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Asian-American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
28 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Incontinence Frequency
Total Incontinence
|
3.8 Episodes per day
STANDARD_DEVIATION 1.6 • n=5 Participants
|
3.1 Episodes per day
STANDARD_DEVIATION 2.3 • n=7 Participants
|
3.5 Episodes per day
STANDARD_DEVIATION 2.0 • n=5 Participants
|
|
Incontinence Frequency
Urgency Incontinence
|
2.1 Episodes per day
STANDARD_DEVIATION 1.8 • n=5 Participants
|
2.3 Episodes per day
STANDARD_DEVIATION 2.3 • n=7 Participants
|
2.2 Episodes per day
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Incontinence Frequency
Stress Incontinence
|
1.4 Episodes per day
STANDARD_DEVIATION 1.5 • n=5 Participants
|
0.7 Episodes per day
STANDARD_DEVIATION 1.1 • n=7 Participants
|
1.0 Episodes per day
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Urinary Symptom Questionnaire Scores
Incontinence Impact Questionnaire
|
117.9 Scores on Scale
STANDARD_DEVIATION 82.1 • n=5 Participants
|
133.9 Scores on Scale
STANDARD_DEVIATION 92.3 • n=7 Participants
|
125.9 Scores on Scale
STANDARD_DEVIATION 87.0 • n=5 Participants
|
|
Urinary Symptom Questionnaire Scores
Urogenital Distress Inventory-6
|
34.5 Scores on Scale
STANDARD_DEVIATION 16.4 • n=5 Participants
|
36.5 Scores on Scale
STANDARD_DEVIATION 19.5 • n=7 Participants
|
35.5 Scores on Scale
STANDARD_DEVIATION 17.8 • n=5 Participants
|
|
Urinary Symptom Questionnaire Scores
Patient Perception of Bladder Condition
|
3.4 Scores on Scale
STANDARD_DEVIATION 1.0 • n=5 Participants
|
3.3 Scores on Scale
STANDARD_DEVIATION 1.1 • n=7 Participants
|
3.4 Scores on Scale
STANDARD_DEVIATION 1.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsChange in the frequency of urinary incontinence episodes of any type. Analysis of covariance models were developed to examine change in incontinence frequency over 3 months. Results were summarized using least square mean estimates of changes in incontinence frequency in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values.
Outcome measures
| Measure |
Yoga Therapy Group
n=28 Participants
Participants will take part in twice weekly group yoga classes focusing on selected Iyengar-based yoga techniques as well as practice study-specific yoga techniques at home for at least one hour per week for a total of 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing yoga exercises for at least an hour per week.
Yoga Therapy
|
Physical Conditioning Group
n=28 Participants
Patricipants will take part in twice weekly group physical conditioning classes and practice stretching exercises at least one hour per week at home for 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing stretching exercises for at least an hour per week.
Physical Conditioning
|
|---|---|---|
|
Total Incontinence Frequency
|
-2.8 episodes per day
Interval -3.6 to -2.0
|
-1.9 episodes per day
Interval -2.8 to -0.9
|
SECONDARY outcome
Timeframe: Baseline and 3 MonthsChange in the frequency of stress-type incontinence episodes Analysis of covariance models were developed to examine change in incontinence frequency over 3 months. Results were summarized using least square mean estimates of changes in incontinence frequency in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values.
Outcome measures
| Measure |
Yoga Therapy Group
n=28 Participants
Participants will take part in twice weekly group yoga classes focusing on selected Iyengar-based yoga techniques as well as practice study-specific yoga techniques at home for at least one hour per week for a total of 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing yoga exercises for at least an hour per week.
Yoga Therapy
|
Physical Conditioning Group
n=28 Participants
Patricipants will take part in twice weekly group physical conditioning classes and practice stretching exercises at least one hour per week at home for 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing stretching exercises for at least an hour per week.
Physical Conditioning
|
|---|---|---|
|
Stress-type Incontinence Frequency
|
-0.8 Episodes per day
Interval -1.2 to -0.4
|
-0.4 Episodes per day
Interval -0.9 to 0.1
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsChange in frequency of urgency-type incontinence Analysis of covariance models were developed to examine change in incontinence frequency over 3 months. Results were summarized using least square mean estimates of changes in incontinence frequency in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values.
Outcome measures
| Measure |
Yoga Therapy Group
n=28 Participants
Participants will take part in twice weekly group yoga classes focusing on selected Iyengar-based yoga techniques as well as practice study-specific yoga techniques at home for at least one hour per week for a total of 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing yoga exercises for at least an hour per week.
Yoga Therapy
|
Physical Conditioning Group
n=28 Participants
Patricipants will take part in twice weekly group physical conditioning classes and practice stretching exercises at least one hour per week at home for 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing stretching exercises for at least an hour per week.
Physical Conditioning
|
|---|---|---|
|
Urgency-type Incontinence
|
-1.7 Episodes per day
Interval -2.6 to -0.91
|
-1.7 Episodes per day
Interval -2.6 to -0.7
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsChange in frequency of total daytime incontinence Analysis of covariance models were developed to examine change in incontinence frequency over 3 months. Results were summarized using least square mean estimates of changes in incontinence frequency in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values.
Outcome measures
| Measure |
Yoga Therapy Group
n=28 Participants
Participants will take part in twice weekly group yoga classes focusing on selected Iyengar-based yoga techniques as well as practice study-specific yoga techniques at home for at least one hour per week for a total of 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing yoga exercises for at least an hour per week.
Yoga Therapy
|
Physical Conditioning Group
n=28 Participants
Patricipants will take part in twice weekly group physical conditioning classes and practice stretching exercises at least one hour per week at home for 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing stretching exercises for at least an hour per week.
Physical Conditioning
|
|---|---|---|
|
Total Daytime Incontinence
|
-2.5 Episodes per day
Interval -3.3 to -1.8
|
-1.6 Episodes per day
Interval -2.5 to -0.8
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsChange in frequency of total nighttime incontinence Analysis of covariance models were developed to examine change in incontinence frequency over 3 months. Results were summarized using least square mean estimates of changes in incontinence frequency in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values.
Outcome measures
| Measure |
Yoga Therapy Group
n=28 Participants
Participants will take part in twice weekly group yoga classes focusing on selected Iyengar-based yoga techniques as well as practice study-specific yoga techniques at home for at least one hour per week for a total of 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing yoga exercises for at least an hour per week.
Yoga Therapy
|
Physical Conditioning Group
n=28 Participants
Patricipants will take part in twice weekly group physical conditioning classes and practice stretching exercises at least one hour per week at home for 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing stretching exercises for at least an hour per week.
Physical Conditioning
|
|---|---|---|
|
Total Nighttime Incontinence
|
-0.3 Episodes per day
Interval -0.5 to -0.1
|
-0.2 Episodes per day
Interval -0.5 to 0.0
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsChange in questionnaire score for Incontinence Impact Questionnaire. Range 0-400, with higher scores mean worse function. Analysis of covariance models were developed to examine change in quality of life outcomes over 3 months. Results were summarized using least square mean estimates of changes in quality of life outcomes in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values.
Outcome measures
| Measure |
Yoga Therapy Group
n=28 Participants
Participants will take part in twice weekly group yoga classes focusing on selected Iyengar-based yoga techniques as well as practice study-specific yoga techniques at home for at least one hour per week for a total of 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing yoga exercises for at least an hour per week.
Yoga Therapy
|
Physical Conditioning Group
n=28 Participants
Patricipants will take part in twice weekly group physical conditioning classes and practice stretching exercises at least one hour per week at home for 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing stretching exercises for at least an hour per week.
Physical Conditioning
|
|---|---|---|
|
Incontinence Impact Questionnaire
|
-74 scores on scale
Interval -103.0 to -45.0
|
-94 scores on scale
Interval -127.0 to -60.0
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsChange in the questionnaire score for Urogenital Distress Inventory-6. Range 0-100, with higher scores mean worse function. Analysis of covariance models were developed to examine change in quality of life outcomes over 3 months. Results were summarized using least square mean estimates of changes in quality of life outcomes in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values.
Outcome measures
| Measure |
Yoga Therapy Group
n=28 Participants
Participants will take part in twice weekly group yoga classes focusing on selected Iyengar-based yoga techniques as well as practice study-specific yoga techniques at home for at least one hour per week for a total of 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing yoga exercises for at least an hour per week.
Yoga Therapy
|
Physical Conditioning Group
n=28 Participants
Patricipants will take part in twice weekly group physical conditioning classes and practice stretching exercises at least one hour per week at home for 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing stretching exercises for at least an hour per week.
Physical Conditioning
|
|---|---|---|
|
Urogenital Distress Inventory-6
|
-21 Scores on scale
Interval -27.0 to -15.0
|
-15 Scores on scale
Interval -23.0 to -8.0
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsChange in questionnaire score for Patient Perception of Bladder Condition. Range 1-6, with higher score mean worse function. Analysis of covariance models were developed to examine change in quality of life outcomes over 3 months. Results were summarized using least square mean estimates of changes in quality of life outcomes in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values.
Outcome measures
| Measure |
Yoga Therapy Group
n=28 Participants
Participants will take part in twice weekly group yoga classes focusing on selected Iyengar-based yoga techniques as well as practice study-specific yoga techniques at home for at least one hour per week for a total of 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing yoga exercises for at least an hour per week.
Yoga Therapy
|
Physical Conditioning Group
n=28 Participants
Patricipants will take part in twice weekly group physical conditioning classes and practice stretching exercises at least one hour per week at home for 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing stretching exercises for at least an hour per week.
Physical Conditioning
|
|---|---|---|
|
Patient Perception of Bladder Condition
|
-1.3 scores on scale
Interval -1.7 to -0.8
|
-1.0 scores on scale
Interval -1.5 to -0.5
|
Adverse Events
Yoga Therapy Group
Physical Conditioning Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Yoga Therapy Group
n=28 participants at risk
Participants will take part in twice weekly group yoga classes focusing on selected Iyengar-based yoga techniques as well as practice study-specific yoga techniques at home for at least one hour per week for a total of 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing yoga exercises for at least an hour per week.
Yoga Therapy
|
Physical Conditioning Group
n=28 participants at risk
Patricipants will take part in twice weekly group physical conditioning classes and practice stretching exercises at least one hour per week at home for 12 weeks. During a 12-week post-treatment follow-up period, participants will also be encouraged to continue practicing stretching exercises for at least an hour per week.
Physical Conditioning
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal Issues
|
0.00%
0/28 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
suspected prolapse
|
3.6%
1/28 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Broken Hand
|
3.6%
1/28 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Psychiatric disorders
Depression
|
7.1%
2/28 • Number of events 2 • 6 months
|
0.00%
0/28 • 6 months
|
|
Eye disorders
Eye soreness/sensitivity
|
0.00%
0/28 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma Attack
|
0.00%
0/28 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Upcoming Endoscopy For Small Hernia
|
0.00%
0/28 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Bursitis of left hip
|
3.6%
1/28 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Carpal Tunnel
|
0.00%
0/28 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Fall, Right arm
|
3.6%
1/28 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Foot sprain at site of old fracture
|
3.6%
1/28 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Musculoskeletal and connective tissue disorders
knee injury
|
0.00%
0/28 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle or joint pain
|
3.6%
1/28 • Number of events 1 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Neck Injury
|
0.00%
0/28 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in right leg/foot
|
0.00%
0/28 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Right knee stiffness
|
0.00%
0/28 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Sciatica
|
3.6%
1/28 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Severe right knee pain from previous injury
|
3.6%
1/28 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Thoracic pain
|
3.6%
1/28 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Toe Fracture
|
3.6%
1/28 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Musculoskeletal and connective tissue disorders
sprained ankle, hurt knee, and cracked patella
|
0.00%
0/28 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
sprained wrist
|
0.00%
0/28 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Nervous system disorders
Headache
|
0.00%
0/28 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Mental Health Issues
|
0.00%
0/28 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Nervous system disorders
Migraine
|
3.6%
1/28 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Nervous system disorders
Concussion
|
0.00%
0/28 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Nervous system disorders
Transient Ischemic Attack
|
3.6%
1/28 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Ear and labyrinth disorders
Burst eardrum
|
0.00%
0/28 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Eye disorders
Macular Degeneration
|
0.00%
0/28 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Eye disorders
Eye infection
|
0.00%
0/28 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Eye disorders
Uveitis
|
3.6%
1/28 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
14.3%
4/28 • Number of events 4 • 6 months
|
14.3%
4/28 • Number of events 4 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Flu
|
10.7%
3/28 • Number of events 3 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Infection
|
0.00%
0/28 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Irritation
|
0.00%
0/28 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Ear and labyrinth disorders
Ear Infection
|
3.6%
1/28 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
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Additional Information
Alison Huang, MD
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place