Trial Outcomes & Findings for Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics (NCT NCT04090190)
NCT ID: NCT04090190
Last Updated: 2022-11-15
Results Overview
Statistical testing was used to determine if there was a difference in inflammatory markers in the urine of patients between baseline visit and 6 week visit. 7 markers were chosen and compared, all inflammatory markers present in urine.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
Baseline and 6 weeks
Results posted on
2022-11-15
Participant Flow
Participant milestones
| Measure |
Standard of Care Anticholinergic Treatment
Women presenting to the Urogynecology clinic with urgency urinary incontinence symptoms will receive standard of care anticholinergic treatment and will have their urinary microbiome evaluated before and after treatment
Oxybutynin, Solifenacin, Tolterodine, Sanctura or Toviaz: Study participants will be evaluated for urgency urinary incontinence and will be offered treatment with a standard of care anticholinergic medication for 6 weeks. All study participants will fill out the UDI-6 and two day bladder diary at baseline before starting anticholinergic medication treatment. Participants will then provide a urine sample and blood draw to be assessed for urinary microbiome and inflammation. Anticholinergic medication will be taken daily for 6 weeks and the same procedures (UDI-6 questionnaire, bladder diary, urine sample except the blood draw for assessment) will be performed at the 6-week time period.
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|---|---|
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Overall Study
STARTED
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20
|
|
Overall Study
COMPLETED
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20
|
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Overall Study
NOT COMPLETED
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0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics
Baseline characteristics by cohort
| Measure |
Standard of Care Anticholinergic Treatment
n=20 Participants
Women presenting to the Urogynecology clinic with urgency urinary incontinence symptoms will receive standard of care anticholinergic treatment and will have their urinary microbiome evaluated before and after treatment
Oxybutynin, Solifenacin, Tolterodine, Sanctura or Toviaz: Study participants will be evaluated for urgency urinary incontinence and will be offered treatment with a standard of care anticholinergic medication for 6 weeks. All study participants will fill out the UDI-6 and two day bladder diary at baseline before starting anticholinergic medication treatment. Participants will then provide a urine sample and blood draw to be assessed for urinary microbiome and inflammation. Anticholinergic medication will be taken daily for 6 weeks and the same procedures (UDI-6 questionnaire, bladder diary, urine sample except the blood draw for assessment) will be performed at the 6-week time period.
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|---|---|
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Age, Continuous
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64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
|
Menopausal Status
Post-menopausal
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17 Participants
n=5 Participants
|
|
Menopausal Status
Pre-menopausal
|
3 Participants
n=5 Participants
|
|
Smoking Status
Current smoker
|
0 Participants
n=5 Participants
|
|
Smoking Status
Past-smoker
|
8 Participants
n=5 Participants
|
|
Smoking Status
Never-smoker
|
12 Participants
n=5 Participants
|
|
Alcohol Use
Alcohol use
|
11 Participants
n=5 Participants
|
|
Alcohol Use
No alcohol use
|
9 Participants
n=5 Participants
|
|
Caffeine Use
Caffeine use
|
17 Participants
n=5 Participants
|
|
Caffeine Use
No caffeine use
|
3 Participants
n=5 Participants
|
|
HRT/Vaginal Estrogen Use
Hormone Replacement Therapy (HRT)/Vaginal Estrogen Use
|
4 Participants
n=5 Participants
|
|
HRT/Vaginal Estrogen Use
No HRT/Vaginal Estrogen Use
|
16 Participants
n=5 Participants
|
|
Contraceptive Use
Current contraceptive use
|
2 Participants
n=5 Participants
|
|
Contraceptive Use
No contraceptive use
|
18 Participants
n=5 Participants
|
|
Comorbidities
None
|
11 Participants
n=5 Participants
|
|
Comorbidities
Diabetes
|
4 Participants
n=5 Participants
|
|
Comorbidities
Heart disease
|
1 Participants
n=5 Participants
|
|
Comorbidities
Hypertension
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8 Participants
n=5 Participants
|
|
Comorbidities
Stroke
|
1 Participants
n=5 Participants
|
|
Comorbidities
Asthma/COPD
|
4 Participants
n=5 Participants
|
|
Comorbidities
Depression/anxiety
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6 Participants
n=5 Participants
|
|
Comorbidities
Arthritis
|
3 Participants
n=5 Participants
|
|
Comorbidities
Thyroid Disease
|
2 Participants
n=5 Participants
|
|
Comorbidities
Liver Disease
|
0 Participants
n=5 Participants
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Comorbidities
Renal Disease
|
0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline and 6 weeksPopulation: 20 patients were involved in the study, however only 13 returned for follow-up, hence 13 patients involved in "follow-up" group.
Statistical testing was used to determine if there was a difference in inflammatory markers in the urine of patients between baseline visit and 6 week visit. 7 markers were chosen and compared, all inflammatory markers present in urine.
Outcome measures
| Measure |
Standard of Care Anticholinergic Treatment
n=20 Participants
Women presenting to the Urogynecology clinic with urgency urinary incontinence symptoms will receive standard of care anticholinergic treatment and will have their urinary microbiome evaluated before and after treatment
Oxybutynin, Solifenacin, Tolterodine, Sanctura or Toviaz: Study participants will be evaluated for urgency urinary incontinence and will be offered treatment with a standard of care anticholinergic medication for 6 weeks. All study participants will fill out the UDI-6 and two day bladder diary at baseline before starting anticholinergic medication treatment. Participants will then provide a urine sample and blood draw to be assessed for urinary microbiome and inflammation. Anticholinergic medication will be taken daily for 6 weeks and the same procedures (UDI-6 questionnaire, bladder diary, urine sample except the blood draw for assessment) will be performed at the 6-week time period.
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|---|---|
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Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu.
Baseline CRP
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2.192 pg/mL
Interval 1.902 to 2.867
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Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu.
Follow-up CRP
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2.565 pg/mL
Interval 1.9 to 3.758
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Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu.
Baseline IL-12/IL-23p40
|
2.192 pg/mL
Interval 1.902 to 2.867
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|
Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu.
Follow-up IL-12/IL-23p40
|
2.565 pg/mL
Interval 1.9 to 3.758
|
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Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu.
Baseline MCP-1
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75.49 pg/mL
Interval 55.69 to 117.85
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|
Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu.
Follow-up MCP-1
|
65.02 pg/mL
Interval 37.0 to 109.79
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Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu.
Baseline GM-CSF
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0.102 pg/mL
Interval 0.06 to 0.122
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Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu.
Follow-up GM CSF
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0.203 pg/mL
Interval 0.092 to 0.272
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Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu.
Baseline IL-1B
|
0.203 pg/mL
Interval 0.106 to 0.542
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Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu.
Follow-up IL-1B
|
0.415 pg/mL
Interval 0.13 to 42.11
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Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu.
Baseline IL-6
|
0.667 pg/mL
Interval 0.502 to 1.641
|
|
Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu.
Follow-up IL-6
|
0.967 pg/mL
Interval 0.749 to 2.951
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|
Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu.
Baseline IL-8
|
7.211 pg/mL
Interval 4.85 to 23.044
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|
Inflammatory Markers in Urine Will be Measured Using Immunoenzyme Assays to Measure the Interaction of Anticholinergic Treatment and the Inflammatory Milieu.
Follow-up IL-8
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6.116 pg/mL
Interval 3.363 to 24.11
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SECONDARY outcome
Timeframe: At the 6 week markPopulation: The median change in g\_lactobacillus for patients who had both baseline and follow-up samples analyzed.
The change in g\_lactobacillus from Baseline to Follow-up (6 weeks), which corresponds to before and after anticholinergic treatment.
Outcome measures
| Measure |
Standard of Care Anticholinergic Treatment
n=13 Participants
Women presenting to the Urogynecology clinic with urgency urinary incontinence symptoms will receive standard of care anticholinergic treatment and will have their urinary microbiome evaluated before and after treatment
Oxybutynin, Solifenacin, Tolterodine, Sanctura or Toviaz: Study participants will be evaluated for urgency urinary incontinence and will be offered treatment with a standard of care anticholinergic medication for 6 weeks. All study participants will fill out the UDI-6 and two day bladder diary at baseline before starting anticholinergic medication treatment. Participants will then provide a urine sample and blood draw to be assessed for urinary microbiome and inflammation. Anticholinergic medication will be taken daily for 6 weeks and the same procedures (UDI-6 questionnaire, bladder diary, urine sample except the blood draw for assessment) will be performed at the 6-week time period.
|
|---|---|
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The Effectiveness of Anticholinergic Treatment in Relation to the Urinary Microbiome. Culture to Standard Culture Media Will Pickup Aerobic Bacteria and Yeasts After DNA Extraction and End Point PCR for 16S rDNA Genes.
|
0.001131599 pg/mL
Interval -0.020078049 to 0.102829877
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SECONDARY outcome
Timeframe: Baseline visit (0 weeks)Symptoms taken from the UDI-6, a validated questionnaire for urogynecologic symptoms, were gathered at baseline for all patients. Duration of Urinary Incontinence symptoms is presented.
Outcome measures
| Measure |
Standard of Care Anticholinergic Treatment
n=20 Participants
Women presenting to the Urogynecology clinic with urgency urinary incontinence symptoms will receive standard of care anticholinergic treatment and will have their urinary microbiome evaluated before and after treatment
Oxybutynin, Solifenacin, Tolterodine, Sanctura or Toviaz: Study participants will be evaluated for urgency urinary incontinence and will be offered treatment with a standard of care anticholinergic medication for 6 weeks. All study participants will fill out the UDI-6 and two day bladder diary at baseline before starting anticholinergic medication treatment. Participants will then provide a urine sample and blood draw to be assessed for urinary microbiome and inflammation. Anticholinergic medication will be taken daily for 6 weeks and the same procedures (UDI-6 questionnaire, bladder diary, urine sample except the blood draw for assessment) will be performed at the 6-week time period.
|
|---|---|
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The Urogenital Distress Inventory (UDI-6) Questionnaire Will be Used to Assess Baseline Urinary Symptoms Prior to Anticholinergic Treatment. Participants Indicate How Long They Have Had These Symptoms.
<6 months
|
8 Participants
|
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The Urogenital Distress Inventory (UDI-6) Questionnaire Will be Used to Assess Baseline Urinary Symptoms Prior to Anticholinergic Treatment. Participants Indicate How Long They Have Had These Symptoms.
6-23 monts
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7 Participants
|
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The Urogenital Distress Inventory (UDI-6) Questionnaire Will be Used to Assess Baseline Urinary Symptoms Prior to Anticholinergic Treatment. Participants Indicate How Long They Have Had These Symptoms.
2-4 years
|
4 Participants
|
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The Urogenital Distress Inventory (UDI-6) Questionnaire Will be Used to Assess Baseline Urinary Symptoms Prior to Anticholinergic Treatment. Participants Indicate How Long They Have Had These Symptoms.
5-10 years
|
0 Participants
|
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The Urogenital Distress Inventory (UDI-6) Questionnaire Will be Used to Assess Baseline Urinary Symptoms Prior to Anticholinergic Treatment. Participants Indicate How Long They Have Had These Symptoms.
>10 years
|
1 Participants
|
Adverse Events
Standard of Care Anticholinergic Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place