Trial Outcomes & Findings for Bacterial Genomic Sequencing in Overactive Bladder (NCT NCT01642277)
NCT ID: NCT01642277
Last Updated: 2015-12-07
Results Overview
Participants were classified into Low Biomass, Lactobacillus, Gardnerella, Diverse, and Other urotypes based on the bacterial DNA at baseline.
COMPLETED
PHASE2
134 participants
12 weeks
2015-12-07
Participant Flow
Recruitment began on July 16th, 2012 and ended on May 22nd, 2014 (i.e., 22.2 months). Participants were recruited during their outpatient appointments to the Urogynecology Clinic at Loyola University Medical Center (Maywood, IL) by a member of the research team.
This was a 12-week open label study with no randomization scheme. Following diagnosis, patients were administered 5 mg daily solifenacin. At the 4-week visit, if a participant's symptoms were adequately controlled (response), she continued at dose for the study duration. If a participant reported no improvement, the dose was increased to 10 mg.
Participant milestones
| Measure |
Urinary Urge Incontinence
Seventy-four (n = 74) women received 5-10mg daily solifenacin for the treatment of urinary urge incontinence (UUI).
|
Non-Urinary Urge Incontinence
Sixty (n = 60) women without UUI were evaluated at baseline only (week 0) in order to serve as a control cohort. These women never received study therapy (i.e., 5-10mg daily solifenacin).
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
60
|
|
Overall Study
COMPLETED
|
50
|
60
|
|
Overall Study
NOT COMPLETED
|
24
|
0
|
Reasons for withdrawal
| Measure |
Urinary Urge Incontinence
Seventy-four (n = 74) women received 5-10mg daily solifenacin for the treatment of urinary urge incontinence (UUI).
|
Non-Urinary Urge Incontinence
Sixty (n = 60) women without UUI were evaluated at baseline only (week 0) in order to serve as a control cohort. These women never received study therapy (i.e., 5-10mg daily solifenacin).
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
11
|
0
|
Baseline Characteristics
Bacterial Genomic Sequencing in Overactive Bladder
Baseline characteristics by cohort
| Measure |
Urinary Urge Incontinence
n=74 Participants
Seventy-four (n = 74) women received 5mg daily solifenacin (with an option to increase to 10mg daily solifenacin at 4 weeks) for the treatment of urinary urge incontinence (UUI).
|
Non-Urinary Urge Incontinence
n=60 Participants
Sixty (n = 60) women without UUI were evaluated at baseline only (week 0) in order to serve as a control cohort. These women never received study therapy (i.e., 5-10mg daily solifenacin).
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
49 years
STANDARD_DEVIATION 14.7 • n=7 Participants
|
56.04 years
STANDARD_DEVIATION 14.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
56 participants
n=5 Participants
|
43 participants
n=7 Participants
|
99 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
74 participants
n=5 Participants
|
60 participants
n=7 Participants
|
134 participants
n=5 Participants
|
|
Body Mass Index
|
32.7 kg/m2
STANDARD_DEVIATION 8.4 • n=5 Participants
|
27.9 kg/m2
STANDARD_DEVIATION 5.5 • n=7 Participants
|
30.59 kg/m2
STANDARD_DEVIATION 7.61 • n=5 Participants
|
|
Vaginal Parity
|
2.00 Births
n=5 Participants
|
2.00 Births
n=7 Participants
|
2.00 Births
n=5 Participants
|
|
Estrogen Status
Negative
|
7 participants
n=5 Participants
|
32 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Estrogen Status
Positive
|
65 participants
n=5 Participants
|
26 participants
n=7 Participants
|
91 participants
n=5 Participants
|
|
Estrogen Status
Unknown
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Diabetes
No
|
67 participants
n=5 Participants
|
58 participants
n=7 Participants
|
125 participants
n=5 Participants
|
|
Diabetes
Yes
|
7 participants
n=5 Participants
|
2 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Hypertension
No
|
48 participants
n=5 Participants
|
49 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Hypertension
Yes
|
26 participants
n=5 Participants
|
11 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Coronary Artery Disease
No
|
65 participants
n=5 Participants
|
59 participants
n=7 Participants
|
124 participants
n=5 Participants
|
|
Coronary Artery Disease
Yes
|
9 participants
n=5 Participants
|
1 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Smoking
Non-Smoker
|
68 participants
n=5 Participants
|
56 participants
n=7 Participants
|
124 participants
n=5 Participants
|
|
Smoking
Smoker
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Marital Status
Married
|
38 participants
n=5 Participants
|
37 participants
n=7 Participants
|
75 participants
n=5 Participants
|
|
Marital Status
Separated
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Marital Status
Divorced
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Marital Status
Widowed
|
14 participants
n=5 Participants
|
1 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Marital Status
Single
|
10 participants
n=5 Participants
|
15 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Prior Treatment for OAB
Prior Treatment
|
37 participants
n=5 Participants
|
0 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Prior Treatment for OAB
No prior treatment
|
37 participants
n=5 Participants
|
60 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Sequencing Urotypes at Baseline
Low biomass
|
37 participants
n=5 Participants
|
34 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Sequencing Urotypes at Baseline
Lactobacillus urotype
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Sequencing Urotypes at Baseline
Diverse urotype
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Sequencing Urotypes at Baseline
Gardnerella urotype
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Sequencing Urotypes at Baseline
Other urotypes
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: This was a completer analysis comprising participants who completed 12 weeks of treatment (n = 50).
Participants were classified into Low Biomass, Lactobacillus, Gardnerella, Diverse, and Other urotypes based on the bacterial DNA at baseline.
Outcome measures
| Measure |
Urinary Urge Incontinence
n=50 Participants
Women who received 5-10mg daily solifenacin for the treatment of urinary urge incontinence (UUI).
|
Solifenacin Non-Responder
Individuals with urinary urge incontinence who did not respond to solifenacin at 12 weeks
|
|---|---|---|
|
Bacterial Genomic Sequencing
Low biomass
|
25 participants
|
—
|
|
Bacterial Genomic Sequencing
Lactobacillus urotype
|
11 participants
|
—
|
|
Bacterial Genomic Sequencing
Diverse urotype
|
3 participants
|
—
|
|
Bacterial Genomic Sequencing
Gardnerella urotype
|
6 participants
|
—
|
|
Bacterial Genomic Sequencing
Other urotypes
|
3 participants
|
—
|
SECONDARY outcome
Timeframe: End of study (Week 12)Population: Participants who received solifenacin were asked to complete the OABQ at 12 weeks in order to assess overactive bladder symptoms.
The Overactive Bladder Questionnaire (OAB-q) was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL). The instrument comprises 33 items. Response options for the symptom frequency and HRQL items are presented as 6-point Likert scales ranging from 'none of the time' to 'all of the time' for symptom frequency (and 'not at all' to 'a very great deal' for symptom bother). From these 33 items, six sub-scales are assessed separately: (1) OAB symptom severity, (2) Coping with OAB symptoms, (3) Concern for OAB symptoms, (4) Sleep as a function of OAB symptoms, (5) Social functioning as a consequence of OAB symptoms, and (6) Health related quality of life (HRQL) as a function of OAB symptoms. Each sub-scale score ranges from 0 to 100 (where higher scores indicate more severe OAB symptoms and lower scores indicate minimal symptom severity).
Outcome measures
| Measure |
Urinary Urge Incontinence
n=37 Participants
Women who received 5-10mg daily solifenacin for the treatment of urinary urge incontinence (UUI).
|
Solifenacin Non-Responder
n=13 Participants
Individuals with urinary urge incontinence who did not respond to solifenacin at 12 weeks
|
|---|---|---|
|
Assessment of Overactive Bladder Questionnaire (OABQ)
Symptom Severity Score
|
17.50 units on a scale
Interval 7.5 to 32.5
|
37.50 units on a scale
Interval 15.0 to 61.25
|
|
Assessment of Overactive Bladder Questionnaire (OABQ)
Coping Score
|
92.50 units on a scale
Interval 85.0 to 100.0
|
80.00 units on a scale
Interval 46.25 to 95.0
|
|
Assessment of Overactive Bladder Questionnaire (OABQ)
Concern Score
|
97.14 units on a scale
Interval 85.71 to 100.0
|
82.86 units on a scale
Interval 41.43 to 95.71
|
|
Assessment of Overactive Bladder Questionnaire (OABQ)
Sleep Score
|
92.00 units on a scale
Interval 76.0 to 100.0
|
84.00 units on a scale
Interval 50.0 to 96.0
|
|
Assessment of Overactive Bladder Questionnaire (OABQ)
Social Score
|
100.00 units on a scale
Interval 98.0 to 100.0
|
96.00 units on a scale
Interval 80.0 to 100.0
|
|
Assessment of Overactive Bladder Questionnaire (OABQ)
Health Related Quality of Life (HRQL)
|
92.80 units on a scale
Interval 86.0 to 99.2
|
76.00 units on a scale
Interval 63.2 to 95.2
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Participants who received solifenacin were asked to complete the PFDI questionnaire at 12 weeks in order to assess certain bowel, bladder, and pelvic symptoms.
The PFDI comprises 46 items on a 4-point symptom severity scale ranging from 1 = "Not at all" to 4 = "Quite a bit". From these items, 13 separate sub-scales are reported: (1) Obstructive discomfort, (2) Irritation, (3) Stress resulting from urinal distress, (4) A general sub-scale for pelvic organ prolapse distress, (5) An anterior sub-scale for pelvic organ prolapse distress, (6) A posterior sub-scale for pelvic organ prolapse distress, (7) An obstructive sub-scale for colorectal anal distress, (8) Incontinence, (9) Pain, and (10) A rectal prolapse sub-scale for colorectal anal distress. For each of these sub-scales, scores from from 0 to 100 (where higher scores indicate greater symptom severity). There are three additional sub-scales: (11) The urinary distress inventory, (12) The pelvic organ distress inventory, and (13) The colorectal distress inventory. Each of these ranges from 0 to 400 (with higher scores indicating greater symptom severity).
Outcome measures
| Measure |
Urinary Urge Incontinence
n=37 Participants
Women who received 5-10mg daily solifenacin for the treatment of urinary urge incontinence (UUI).
|
Solifenacin Non-Responder
n=13 Participants
Individuals with urinary urge incontinence who did not respond to solifenacin at 12 weeks
|
|---|---|---|
|
Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire
Obstructive Discomfort Score
|
5.77 units on a scale
Interval 0.0 to 17.31
|
7.69 units on a scale
Interval 1.92 to 26.92
|
|
Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire
Irritative Score
|
12.50 units on a scale
Interval 5.0 to 30.0
|
32.50 units on a scale
Interval 7.5 to 52.5
|
|
Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire
Stress Score
|
8.33 units on a scale
Interval 0.0 to 27.08
|
16.67 units on a scale
Interval 6.25 to 50.0
|
|
Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire
Urinary Distress Inventory Score
|
40.19 units on a scale
Interval 12.86 to 63.37
|
60.26 units on a scale
Interval 23.37 to 110.87
|
|
Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire
General Score
|
7.14 units on a scale
Interval 0.0 to 16.07
|
14.29 units on a scale
Interval 8.93 to 25.0
|
|
Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire
Anterior Score
|
8.33 units on a scale
Interval 0.0 to 18.75
|
8.33 units on a scale
Interval 0.0 to 31.25
|
|
Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire
Posterior Score
|
0 units on a scale
Interval 0.0 to 33.33
|
16.67 units on a scale
Interval 8.33 to 33.33
|
|
Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire
Pelvic Organ Prolapse Distress Inventory Score
|
20.83 units on a scale
Interval 12.2 to 58.33
|
47.62 units on a scale
Interval 31.85 to 85.12
|
|
Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire
Obstructive Score
|
0 units on a scale
Interval 0.0 to 33.33
|
16.67 units on a scale
Interval 8.33 to 33.33
|
|
Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire
Pain Irritation Score
|
10.71 units on a scale
Interval 0.0 to 26.79
|
10.71 units on a scale
Interval 0.0 to 26.79
|
|
Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire
Rectal Prolapse
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire
Colo-Rectal-Anal Distress Inventory Score
|
17.86 units on a scale
Interval 7.14 to 75.48
|
42.86 units on a scale
Interval 29.52 to 66.25
|
|
Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire
Incontinence Score
|
0 units on a scale
Interval 0.0 to 20.0
|
10.00 units on a scale
Interval 0.0 to 22.5
|
Adverse Events
Urinary Urge Incontinence
Non-Urinary Urge Incontinence
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Urinary Urge Incontinence
n=74 participants at risk
Seventy-four (n = 74) women received 5-10mg daily solifenacin for the treatment of urinary urge incontinence (UUI).
|
Non-Urinary Urge Incontinence
Sixty (n = 60) women without UUI were evaluated at baseline only (week 0) in order to serve as a control cohort. These women never received study therapy (i.e., 5-10mg daily solifenacin).
|
|---|---|---|
|
General disorders
Dry Mouth
|
4.1%
3/74 • Number of events 3 • Participants who received solifenacin were assessed for adverse events over 12 weeks. Control participants who did not receive solifenacin, however, were only seen at baseline (0 weeks).
|
—
0/0 • Participants who received solifenacin were assessed for adverse events over 12 weeks. Control participants who did not receive solifenacin, however, were only seen at baseline (0 weeks).
|
|
Gastrointestinal disorders
Constipation
|
5.4%
4/74 • Number of events 4 • Participants who received solifenacin were assessed for adverse events over 12 weeks. Control participants who did not receive solifenacin, however, were only seen at baseline (0 weeks).
|
—
0/0 • Participants who received solifenacin were assessed for adverse events over 12 weeks. Control participants who did not receive solifenacin, however, were only seen at baseline (0 weeks).
|
|
General disorders
Elevated Blood Pressure
|
1.4%
1/74 • Number of events 1 • Participants who received solifenacin were assessed for adverse events over 12 weeks. Control participants who did not receive solifenacin, however, were only seen at baseline (0 weeks).
|
—
0/0 • Participants who received solifenacin were assessed for adverse events over 12 weeks. Control participants who did not receive solifenacin, however, were only seen at baseline (0 weeks).
|
|
Immune system disorders
Hives
|
1.4%
1/74 • Number of events 1 • Participants who received solifenacin were assessed for adverse events over 12 weeks. Control participants who did not receive solifenacin, however, were only seen at baseline (0 weeks).
|
—
0/0 • Participants who received solifenacin were assessed for adverse events over 12 weeks. Control participants who did not receive solifenacin, however, were only seen at baseline (0 weeks).
|
|
General disorders
Dizziness
|
1.4%
1/74 • Number of events 1 • Participants who received solifenacin were assessed for adverse events over 12 weeks. Control participants who did not receive solifenacin, however, were only seen at baseline (0 weeks).
|
—
0/0 • Participants who received solifenacin were assessed for adverse events over 12 weeks. Control participants who did not receive solifenacin, however, were only seen at baseline (0 weeks).
|
Additional Information
Dr. Alan J. Wolfe
Loyola University Chicago, Microbiology and Immunology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place