Trial Outcomes & Findings for A Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women (NCT NCT03672461)

NCT ID: NCT03672461

Last Updated: 2025-03-30

Results Overview

Change was calculated as the followup value minus the baseline value. Values are model-generated Least Square Means for combined 6 and 12 week time points.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

240 participants

Primary outcome timeframe

Repeated change from baseline to 6 and 12 weeks

Results posted on

2025-03-30

Participant Flow

Participant milestones

Participant milestones
Measure
Yoga Practice Program
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Overall Study
STARTED
121
119
Overall Study
COMPLETED
101
109
Overall Study
NOT COMPLETED
20
10

Reasons for withdrawal

Reasons for withdrawal
Measure
Yoga Practice Program
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Overall Study
COVID Related
4
2
Overall Study
Adverse Event
2
0
Overall Study
Serious Adverse Event
0
1
Overall Study
Too Busy
3
1
Overall Study
Lost to Follow-up
1
2
Overall Study
Family
2
2
Overall Study
No remote technology access
0
1
Overall Study
Withdrawal by Subject
1
0
Overall Study
Cannot tolerate intervention
1
0
Overall Study
Incomplete outcome data
6
1

Baseline Characteristics

The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Yoga Practice Program
n=121 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=119 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Total
n=240 Participants
Total of all reporting groups
Age, Continuous
62.7 years
STANDARD_DEVIATION 8.7 • n=121 Participants
61.4 years
STANDARD_DEVIATION 8.8 • n=119 Participants
62.1 years
STANDARD_DEVIATION 8.7 • n=240 Participants
Sex: Female, Male
Female
121 Participants
n=121 Participants
119 Participants
n=119 Participants
240 Participants
n=240 Participants
Sex: Female, Male
Male
0 Participants
n=121 Participants
0 Participants
n=119 Participants
0 Participants
n=240 Participants
Race/Ethnicity, Customized
White
83 Participants
n=121 Participants
77 Participants
n=119 Participants
160 Participants
n=240 Participants
Race/Ethnicity, Customized
Black
7 Participants
n=121 Participants
12 Participants
n=119 Participants
19 Participants
n=240 Participants
Race/Ethnicity, Customized
Hispanic
21 Participants
n=121 Participants
11 Participants
n=119 Participants
32 Participants
n=240 Participants
Race/Ethnicity, Customized
Asian
20 Participants
n=121 Participants
20 Participants
n=119 Participants
40 Participants
n=240 Participants
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
0 Participants
n=121 Participants
0 Participants
n=119 Participants
0 Participants
n=240 Participants
Race/Ethnicity, Customized
American Indian
0 Participants
n=121 Participants
0 Participants
n=119 Participants
0 Participants
n=240 Participants
Race/Ethnicity, Customized
Other
0 Participants
n=121 Participants
1 Participants
n=119 Participants
1 Participants
n=240 Participants
Race/Ethnicity, Customized
More than one race
11 Participants
n=121 Participants
9 Participants
n=119 Participants
20 Participants
n=240 Participants
Region of Enrollment
United States
121 Participants
n=121 Participants
119 Participants
n=119 Participants
240 Participants
n=240 Participants
Total Urinary Incontinence Episodes
3.6 episodes per day
STANDARD_DEVIATION 2.5 • n=121 Participants
3.2 episodes per day
STANDARD_DEVIATION 1.9 • n=119 Participants
3.4 episodes per day
STANDARD_DEVIATION 2.2 • n=240 Participants
Stress-Type Urinary Incontinence Episodes
1.4 episodes per day
STANDARD_DEVIATION 1.8 • n=121 Participants
1.4 episodes per day
STANDARD_DEVIATION 1.5 • n=119 Participants
1.4 episodes per day
STANDARD_DEVIATION 1.6 • n=240 Participants
Urgency-Type Urinary Incontinence Episodes
2.1 episodes per day
STANDARD_DEVIATION 2.2 • n=121 Participants
1.7 episodes per day
STANDARD_DEVIATION 1.4 • n=119 Participants
1.9 episodes per day
STANDARD_DEVIATION 1.9 • n=240 Participants
Incontinence Impact Questionnaire (IIQ)
100.4 units on a scale
STANDARD_DEVIATION 78.9 • n=121 Participants
101.6 units on a scale
STANDARD_DEVIATION 66.4 • n=119 Participants
101.0 units on a scale
STANDARD_DEVIATION 72.7 • n=240 Participants
Urogenital distress inventory-6 score (UDI)
39.1 units on a scale
STANDARD_DEVIATION 19.1 • n=121 Participants
38.5 units on a scale
STANDARD_DEVIATION 19.4 • n=119 Participants
38.8 units on a scale
STANDARD_DEVIATION 19.2 • n=240 Participants
Patient Perception of Bladder Condition (PPBC)
3.3 units on a scale
STANDARD_DEVIATION 1.0 • n=121 Participants
3.4 units on a scale
STANDARD_DEVIATION 1.0 • n=119 Participants
3.4 units on a scale
STANDARD_DEVIATION 1.0 • n=240 Participants
Center for Epidemiologic Studies Depression Scale (CES-D)
10.1 units on a scale
STANDARD_DEVIATION 8.8 • n=121 Participants
10.0 units on a scale
STANDARD_DEVIATION 8.1 • n=119 Participants
10.0 units on a scale
STANDARD_DEVIATION 8.4 • n=240 Participants
State/Trait Anxiety Inventory (STAI)--Trait
36.1 units on a scale
STANDARD_DEVIATION 11.2 • n=121 Participants
36.1 units on a scale
STANDARD_DEVIATION 10.5 • n=119 Participants
36.1 units on a scale
STANDARD_DEVIATION 10.9 • n=240 Participants
Hospital Anxiety & Depression (HADS)--Anxiety score
5.3 units on a scale
STANDARD_DEVIATION 3.8 • n=121 Participants
5.2 units on a scale
STANDARD_DEVIATION 3.7 • n=119 Participants
5.3 units on a scale
STANDARD_DEVIATION 3.8 • n=240 Participants
Perceived Stress Scale (PSS) score
13.0 units on a scale
STANDARD_DEVIATION 7.2 • n=121 Participants
13.3 units on a scale
STANDARD_DEVIATION 6.8 • n=119 Participants
13.2 units on a scale
STANDARD_DEVIATION 7.0 • n=240 Participants
PROMIS Physical 8B, T-Score
51.0 T-Score
STANDARD_DEVIATION 6.2 • n=121 Participants
51.3 T-Score
STANDARD_DEVIATION 6.8 • n=119 Participants
51.2 T-Score
STANDARD_DEVIATION 6.5 • n=240 Participants
One-legged Balance Test
24.4 seconds
STANDARD_DEVIATION 9.9 • n=121 Participants
25.5 seconds
STANDARD_DEVIATION 8.7 • n=119 Participants
24.9 seconds
STANDARD_DEVIATION 9.4 • n=240 Participants
Chair Stands (in 30 seconds)
12.6 chair stands
STANDARD_DEVIATION 3.9 • n=121 Participants
13.1 chair stands
STANDARD_DEVIATION 4.2 • n=119 Participants
12.9 chair stands
STANDARD_DEVIATION 4.1 • n=240 Participants
2-Minute Step Test
85.9 steps
STANDARD_DEVIATION 22.8 • n=121 Participants
88.5 steps
STANDARD_DEVIATION 26.1 • n=119 Participants
87.2 steps
STANDARD_DEVIATION 24.5 • n=240 Participants
Wake after sleep onset
24.4 minutes
STANDARD_DEVIATION 29.2 • n=121 Participants
25.2 minutes
STANDARD_DEVIATION 25.6 • n=119 Participants
24.8 minutes
STANDARD_DEVIATION 27.4 • n=240 Participants
Total sleep time
7.1 Hours
STANDARD_DEVIATION 1.2 • n=121 Participants
7.0 Hours
STANDARD_DEVIATION 1.0 • n=119 Participants
7.0 Hours
STANDARD_DEVIATION 1.1 • n=240 Participants
Pittsburgh Sleep Quality Index (PSQI) total score
6.2 units on a scale
STANDARD_DEVIATION 3.1 • n=121 Participants
6.6 units on a scale
STANDARD_DEVIATION 3.1 • n=119 Participants
6.4 units on a scale
STANDARD_DEVIATION 3.1 • n=240 Participants
Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)
PISQ-IR Sexually Inactive, Condition Impact on Sexual Quality
21.6 units on a scale
STANDARD_DEVIATION 26.9 • n=55 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
13.6 units on a scale
STANDARD_DEVIATION 21.6 • n=50 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
17.8 units on a scale
STANDARD_DEVIATION 24.7 • n=105 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)
PISQ-IR Sexually Inactive, Condition Specific Reason for Not Being Active
24.8 units on a scale
STANDARD_DEVIATION 21.9 • n=54 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
19.6 units on a scale
STANDARD_DEVIATION 22.2 • n=47 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
22.4 units on a scale
STANDARD_DEVIATION 22.1 • n=101 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)
PISQ-IR Sexually Inactive, Global Quality
48.6 units on a scale
STANDARD_DEVIATION 29.6 • n=55 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
49.6 units on a scale
STANDARD_DEVIATION 32.5 • n=50 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
49.1 units on a scale
STANDARD_DEVIATION 30.9 • n=105 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)
PISQ-IR Sexually Inactive, Partner-Related Reasons for Not Being Active
56.8 units on a scale
STANDARD_DEVIATION 26.0 • n=54 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
60.0 units on a scale
STANDARD_DEVIATION 23.6 • n=50 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
58.3 units on a scale
STANDARD_DEVIATION 24.8 • n=104 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)
PISQ-IR Sexually Active, Assessment of Arousal, Orgasm
63.2 units on a scale
STANDARD_DEVIATION 12.8 • n=61 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
63.3 units on a scale
STANDARD_DEVIATION 17.3 • n=68 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
63.3 units on a scale
STANDARD_DEVIATION 15.3 • n=129 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)
PISQ-IR Sexually Active, Condition-specific Impact on Sexual Quality
81.4 units on a scale
STANDARD_DEVIATION 23.4 • n=61 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
79.4 units on a scale
STANDARD_DEVIATION 20.3 • n=68 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
80.4 units on a scale
STANDARD_DEVIATION 21.8 • n=129 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)
PISQ-IR Sexually Active, Condition-specifc Impacts on Activity
86.2 units on a scale
STANDARD_DEVIATION 13.9 • n=61 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
87.0 units on a scale
STANDARD_DEVIATION 12.8 • n=68 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
86.6 units on a scale
STANDARD_DEVIATION 13.3 • n=129 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)
PISQ-IR Sexually Active, Assessment of Desire
48.6 units on a scale
STANDARD_DEVIATION 18.1 • n=61 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
50.1 units on a scale
STANDARD_DEVIATION 18.3 • n=68 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
49.4 units on a scale
STANDARD_DEVIATION 18.2 • n=129 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)
PISQ-IR Sexually Active, Global Quality
62.2 units on a scale
STANDARD_DEVIATION 28.3 • n=61 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
64.0 units on a scale
STANDARD_DEVIATION 28.1 • n=68 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
63.2 units on a scale
STANDARD_DEVIATION 28.1 • n=129 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)
PISQ-IR Sexually Active Interest, Assessment of Partner Related Impacts
77.2 units on a scale
STANDARD_DEVIATION 17.1 • n=54 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
77.0 units on a scale
STANDARD_DEVIATION 19.0 • n=54 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
77.1 units on a scale
STANDARD_DEVIATION 18.0 • n=108 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)
PISQ-IR Sexually Active Interest, Summary Score
68.8 units on a scale
STANDARD_DEVIATION 13.2 • n=61 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
68.9 units on a scale
STANDARD_DEVIATION 13.8 • n=68 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.
68.9 units on a scale
STANDARD_DEVIATION 13.5 • n=129 Participants • The domains are specific to two distinct groups: Sexually active (SA) and Not Sexually Active (NSA). 4 NSA variables: Domains relevant only to participants that are not sexually active. 6 SA variables: Domains relevant only to sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.

PRIMARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Number of participants with outcomes data

Change was calculated as the followup value minus the baseline value. Values are model-generated Least Square Means for combined 6 and 12 week time points.

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=106 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=113 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in Total Urinary Incontinence Episodes
-1.99 episodes per day
Interval -2.21 to -1.77
-1.7 episodes per day
Interval -1.91 to -1.49

SECONDARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Number of participants with outcomes data

Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=106 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=113 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in Stress-Type Urinary Incontinence Episodes
-0.8 episodes per day
Interval -0.93 to -0.67
-0.77 episodes per day
Interval -0.9 to -0.65

SECONDARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Number of participants with outcomes data

Change was calculated as the follow-up value minus the baseline value. Values are model-generated Least Square Means for combined 6 and 12 week time points

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=106 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=113 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in Urgency-Type Urinary Incontinence Episodes
-1.12 episodes per day
Interval -1.28 to -0.96
-0.9 episodes per day
Interval -1.06 to -0.74

SECONDARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Number of participants with outcomes data

Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range 0-400, Higher score indicates lower quality of life

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=107 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=112 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in Incontinence Impact Questionnaire (IIQ)
-31.3 units on a scale
Interval -41.6 to -20.9
-30.4 units on a scale
Interval -40.7 to -20.2

SECONDARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Number of participants with outcomes data

Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range 0-100, Higher score indicates lower quality of life

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=108 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=112 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in Urogenital Distress Inventory-6 Score (UDI)
-14.9 units on a scale
Interval -17.0 to -12.7
-11.7 units on a scale
Interval -13.9 to -9.59

SECONDARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Number of participants with outcomes data

Change was calculated as the follow-up value minus the baseline value. Values are model-generated Least Square Means for combined 6 and 12 week time points Range 1-6, Higher score indicates lower quality of life

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=107 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=112 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in Patient Perception of Bladder Condition (PPBC)
-0.59 units on a scale
Interval -0.75 to -0.42
-0.52 units on a scale
Interval -0.69 to -0.36

SECONDARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Number of participants with outcomes data

Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range 0-60, Higher score indicates lower quality of life

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=107 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=112 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)
-0.82 units on a scale
Interval -2.25 to 0.6
-0.52 units on a scale
Interval -1.93 to 0.9

SECONDARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Number of participants with outcomes data

Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range 20-80, Higher score indicates lower quality of life

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=107 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=112 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in State/Trait Anxiety Inventory (STAI)--Trait
-1.22 units on a scale
Interval -2.41 to -0.03
-1.34 units on a scale
Interval -2.52 to -0.17

SECONDARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Number of participants with outcomes data

Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range 0-21, Higher score indicates lower quality of life

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=107 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=111 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in Hospital Anxiety & Depression (HADS)--Anxiety Score
-0.21 units on a scale
Interval -0.72 to 0.3
-0.33 units on a scale
Interval -0.83 to 0.18

SECONDARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Number of participants with outcomes data

Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range 0-40, Higher score indicates lower quality of life

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=106 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=112 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in Perceived Stress Scale (PSS) Score
-0.44 units on a scale
Interval -1.41 to 0.52
-0.72 units on a scale
Interval -1.68 to 0.24

SECONDARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Number of participants with outcomes data

Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points (Mean 50, Std Dev 10) no widely accepted thresholds have been published. Higher score indicates better quality of life

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=106 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=109 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in PROMIS Physical Function Short Form 8B, T-Score
-0.2 T-score
Interval -1.05 to 0.65
0.04 T-score
Interval -0.81 to 0.89

SECONDARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Number of participants with outcomes data

Change was calculated as the followup value minus the baseline value. Change values were Winsorized at the 1st and 99th percentile. Values are model generated Least Square Means for combined 6 and 12 week time points. Higher score indicates better quality of life.

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=107 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=110 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in One-legged Balance Test (Winsorized)
1.34 seconds
Interval 0.52 to 2.16
1.53 seconds
Interval 0.72 to 2.35

SECONDARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Number of participants with outcomes data

Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Higher score indicates better quality of life

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=105 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=106 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in Chair Stands (in 30 Seconds)
1 chair stands
Interval 0.32 to 1.68
1.98 chair stands
Interval 1.3 to 2.66

SECONDARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Number of participants with outcomes data

Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Higher score indicates better quality of life

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=104 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=109 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in 2-Minute Step Test
8.05 steps
Interval 4.58 to 11.51
9.03 steps
Interval 5.59 to 12.48

SECONDARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Number of participants with outcomes data

Change was calculated as the follow-up value minus the baseline value. Change values were Winsorized at the 1st and 99th percentile. Values are model generated Least Square Means for combined 6 and 12 week time points. Higher score indicates lower quality of life.

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=104 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=108 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in Wake After Sleep Onset (Winsorized)
-3.55 minutes
Interval -7.96 to 0.85
-6.96 minutes
Interval -11.3 to -2.61

SECONDARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Number of participants with outcomes data

Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points. Higher score indicates better quality of life.

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=104 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=109 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in Total Sleep Time
0 hours
Interval -0.18 to 0.17
0.09 hours
Interval -0.08 to 0.27

SECONDARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Number of participants with outcomes data

Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points. Range of 0-21, higher score indicates lower quality of life.

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=108 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=112 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score
-0.37 units on a scale
Interval -0.78 to 0.04
-0.66 units on a scale
Interval -1.07 to -0.25

SECONDARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Domains relevant only to participants that are not sexually active. Additional missingness is due to not having a partner (SA), or to survey or item non-response.

Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=38 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=44 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Condition Impact on Sexual Quality
-5.04 units on a scale
Interval -10.7 to 0.58
-3.83 units on a scale
Interval -8.84 to 1.19

SECONDARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Domains relevant only to participants that are not sexually active. Additional missingness is due to not having a partner (SA), or to survey or item non-response.

Change was calculated as the follow-up value minus the baseline value. Values are model-generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=38 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=40 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Condition Specific Reason for Not Being Active
-1 units on a scale
Interval -6.52 to 4.52
-3.76 units on a scale
Interval -8.86 to 1.35

SECONDARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Domains relevant only to participants that are not sexually active. Additional missingness is due to not having a partner (SA), or to survey or item non-response.

Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=38 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=43 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Global Quality
1.3 units on a scale
Interval -3.67 to 6.27
-0.67 units on a scale
Interval -5.27 to 3.93

SECONDARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Domains relevant only to participants that are not sexually active. Additional missingness is due to not having a partner (SA), or to survey or item non-response.

Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=38 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=43 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Inactive, Partner Related Reasons for Not Being Active
1.73 units on a scale
Interval -5.52 to 8.98
-1.52 units on a scale
Interval -8.52 to 5.47

SECONDARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Domain is relevant only the sexually active participants

Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=57 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=61 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Assessment of Arousal, Orgasm
0.83 units on a scale
Interval -1.54 to 3.2
-1.55 units on a scale
Interval -3.85 to 0.75

SECONDARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Domain is relevant only the sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.

Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=56 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=62 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Condition-specific Impact on Sexual Quality
2.84 units on a scale
Interval -0.74 to 6.42
0.62 units on a scale
Interval -2.81 to 4.04

SECONDARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Domain is relevant only the sexually active participants

Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=57 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=61 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Condition-specifc Impacts on Activity
3.7 units on a scale
Interval 1.36 to 6.05
1.95 units on a scale
Interval 1.95 to 4.22

SECONDARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Domain is relevant only the sexually active participants

Change was calculated as the follow-up value minus the baseline value. Values are model-generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=57 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=61 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active Interest, Summary Score
1.47 units on a scale
Interval -0.12 to 3.07
-0.16 units on a scale
Interval -1.71 to 1.39

SECONDARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Domain is relevant only the sexually active participants

Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=57 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=61 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Assessment of Desire
0.08 units on a scale
Interval -2.79 to 2.95
-1.3 units on a scale
Interval -4.09 to 1.5

SECONDARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Domain is relevant only the sexually active participants

Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=57 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=61 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active, Global Quality
2.75 units on a scale
Interval -1.13 to 6.64
-0.07 units on a scale
Interval -3.84 to 3.71

SECONDARY outcome

Timeframe: Repeated change from baseline to 6 and 12 weeks

Population: Domain is relevant only the sexually active participants. Additional missingness is due to not having a partner (SA), or to survey or item non-response.

Change was calculated as the followup value minus the baseline value. Change values were Winsorized at the 1st and 99th percentile. Values are model generated Least Square Means for combined 6 and 12 week time points Range of 0-100, higher score indicates better quality of life

Outcome measures

Outcome measures
Measure
Yoga Practice Program
n=50 Participants
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=50 Participants
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Change From Baseline in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire IUGA-Revised (PISQ-IR)--Sexually Active Interest, Assessment of Partner Related Impacts (Winsorized)
-2.52 units on a scale
Interval -5.73 to 0.7
0.45 units on a scale
Interval -2.77 to 3.68

Adverse Events

Yoga Practice Program

Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths

Physical Conditioning Program

Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Yoga Practice Program
n=121 participants at risk
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=119 participants at risk
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Cardiac disorders
Atrial Fibrillation
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
High Grade B-Cell Lymphoma Burkitt-Like Lymphoma Nos
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months

Other adverse events

Other adverse events
Measure
Yoga Practice Program
n=121 participants at risk
The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population. The study will feature a therapeutic program based primarily on Iyengar yoga, a form of Hatha yoga that is known for its potential therapeutic applications. Yoga Practice Program: The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
Physical Conditioning Program
n=119 participants at risk
The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants. Similar to postures in the yoga intervention program, the exercises in the stretching/strengthening program have been selected for their potential to be performed safely by women across a range of ages and flexibility levels. Physical Conditioning Program: The 3-month muscle stretching/strengthening intervention program (also referred to as the "physical conditioning" program) has been designed by the study physical therapist consultants.
Cardiac disorders
Recurrent Atrial Fibrillation
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Ear and labyrinth disorders
Vertigo
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Eye disorders
Detached Retina
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Gastrointestinal disorders
Abdominal Cramps
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Gastrointestinal disorders
Dental Discomfort
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Gastrointestinal disorders
Diarrhea
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Gastrointestinal disorders
Epigastric Pain
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Gastrointestinal disorders
Food Poisoning
1.7%
2/121 • Number of events 2 • 9 months
1.7%
2/119 • Number of events 2 • 9 months
Gastrointestinal disorders
Tooth Pain
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
General disorders
Facial Pain
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Immune system disorders
Allergy
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Immune system disorders
Allergy Nos
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Immune system disorders
Hay Fever
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Infections and infestations
Bladder Infection
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Infections and infestations
Bronchitis
0.83%
1/121 • Number of events 1 • 9 months
1.7%
2/119 • Number of events 2 • 9 months
Infections and infestations
Coronavirus Infection
0.83%
1/121 • Number of events 1 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Infections and infestations
Ear Infection
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Infections and infestations
Lower Urinary Tract Infection
0.00%
0/121 • 9 months
1.7%
2/119 • Number of events 2 • 9 months
Infections and infestations
Mumps
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Infections and infestations
Shingles
0.83%
1/121 • Number of events 1 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Infections and infestations
Tooth Infection
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Infections and infestations
Upper Respiratory Infection
3.3%
4/121 • Number of events 4 • 9 months
1.7%
2/119 • Number of events 2 • 9 months
Infections and infestations
Urinary Tract Infection
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Injury, poisoning and procedural complications
Back Sprain
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Injury, poisoning and procedural complications
Epicondylitis
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Injury, poisoning and procedural complications
Fall
0.83%
1/121 • Number of events 1 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Injury, poisoning and procedural complications
Knee Injury
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Injury, poisoning and procedural complications
Lateral Epicondylitis
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Injury, poisoning and procedural complications
Leg Fracture
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Injury, poisoning and procedural complications
Muscle Strain
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Injury, poisoning and procedural complications
Pulled Hamstring
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Injury, poisoning and procedural complications
Rib Fracture
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Injury, poisoning and procedural complications
Shoulder Injury
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Injury, poisoning and procedural complications
Toe Injury
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Injury, poisoning and procedural complications
Vaccination Adverse Reaction
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Investigations
Colonoscopy
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Investigations
Endoscopy
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Musculoskeletal and connective tissue disorders
Back Muscle Spasms
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Musculoskeletal and connective tissue disorders
Back Pain
0.83%
1/121 • Number of events 1 • 9 months
2.5%
3/119 • Number of events 3 • 9 months
Musculoskeletal and connective tissue disorders
Back Pain; Knee Injury
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Musculoskeletal and connective tissue disorders
Foot Pain
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Musculoskeletal and connective tissue disorders
Frozen Shoulder
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Musculoskeletal and connective tissue disorders
Groin Discomfort
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Musculoskeletal and connective tissue disorders
Hand Pain
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Musculoskeletal and connective tissue disorders
Hip Arthrosis
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Musculoskeletal and connective tissue disorders
Hip Discomfort
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Musculoskeletal and connective tissue disorders
Knee Pain
4.1%
5/121 • Number of events 5 • 9 months
2.5%
3/119 • Number of events 3 • 9 months
Musculoskeletal and connective tissue disorders
Knee Swelling
3.3%
4/121 • Number of events 4 • 9 months
0.00%
0/119 • 9 months
Musculoskeletal and connective tissue disorders
Leg Pain
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Musculoskeletal and connective tissue disorders
Low Back Pain
0.83%
1/121 • Number of events 1 • 9 months
1.7%
2/119 • Number of events 2 • 9 months
Musculoskeletal and connective tissue disorders
Lumbar Pain
1.7%
2/121 • Number of events 2 • 9 months
0.00%
0/119 • 9 months
Musculoskeletal and connective tissue disorders
Muscle Soreness
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Musculoskeletal and connective tissue disorders
Neck Pain
0.83%
1/121 • Number of events 1 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Musculoskeletal and connective tissue disorders
Pain Ankle
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Musculoskeletal and connective tissue disorders
Pain In Ankle
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Musculoskeletal and connective tissue disorders
Pain In Elbow
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Musculoskeletal and connective tissue disorders
Pain In Hip
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Musculoskeletal and connective tissue disorders
Patellofemoral Pain Syndrome
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Musculoskeletal and connective tissue disorders
Rotator Cuff Injury
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Musculoskeletal and connective tissue disorders
Shoulder Deformity Nos
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Musculoskeletal and connective tissue disorders
Shoulder Pain
3.3%
4/121 • Number of events 4 • 9 months
3.4%
4/119 • Number of events 4 • 9 months
Musculoskeletal and connective tissue disorders
Shoulder Soreness
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Musculoskeletal and connective tissue disorders
Spinal Disorder Nos
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma In Situ
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Nervous system disorders
Cervical Radiculopathy
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Nervous system disorders
Dizziness
0.83%
1/121 • Number of events 1 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Nervous system disorders
Headache
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Nervous system disorders
Localised Numbness
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Nervous system disorders
Migraine, Unspecified
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Nervous system disorders
Neck Numbness
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Nervous system disorders
Sciatica Aggravated
0.83%
1/121 • Number of events 1 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Psychiatric disorders
Stress
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Respiratory, thoracic and mediastinal disorders
Asthma Aggravated
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Respiratory, thoracic and mediastinal disorders
Asthmatic Attack
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Respiratory, thoracic and mediastinal disorders
Shortness Of Breath
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Skin and subcutaneous tissue disorders
Cyst Epidermal
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Skin and subcutaneous tissue disorders
Neck Rash
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Skin and subcutaneous tissue disorders
Rash
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Surgical and medical procedures
Back Surgery
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Surgical and medical procedures
Bladder Sling Procedure
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Surgical and medical procedures
Bunionectomy
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Surgical and medical procedures
Knee Arthroplasty
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Surgical and medical procedures
Oral Surgery
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months
Surgical and medical procedures
Shoulder Replacement
0.00%
0/121 • 9 months
0.84%
1/119 • Number of events 1 • 9 months
Vascular disorders
Hot Flashes
0.83%
1/121 • Number of events 1 • 9 months
0.00%
0/119 • 9 months

Additional Information

Alison Huang, MD

University of California, San Francisco

Phone: 415-353-7900

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place