Trial Outcomes & Findings for Clinical Trial Comparing Two Bladder Instillations for IC/BPS (NCT NCT03463915)
NCT ID: NCT03463915
Last Updated: 2021-09-01
Results Overview
Total scores range: 0-36 (0= no symptoms to 36= the most severe symptoms)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
90 participants
Primary outcome timeframe
Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
Results posted on
2021-09-01
Participant Flow
Participants were women with IC/BPS who were recruited from January 2019 to October 2020 from the University of Louisville Female Pelvic Medicine \& Reconstructive Surgery clinic in Louisville, KY.
Participant milestones
| Measure |
Bladder Instillation WITH Triamcinolone Acetonide
Six weekly bladder instillations WITH triamcinolone acetonide: mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 mg)/1 mL.
|
Bladder Instillation WITHOUT Triamcinolone Acetonide
Six weekly bladder instillations WITHOUT triamcinolone acetonide: mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
35
|
36
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Bladder Instillation WITH Triamcinolone Acetonide
n=45 Participants
Six weekly bladder instillations WITH triamcinolone acetonide: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 mg/1 mL).
|
Bladder Instillation WITHOUT Triamcinolone Acetonide
n=45 Participants
Six weekly bladder instillations WITHOUT triamcinolone acetonide: mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.3 years
STANDARD_DEVIATION 13.3 • n=45 Participants
|
46.6 years
STANDARD_DEVIATION 14.0 • n=45 Participants
|
42.0 years
STANDARD_DEVIATION 13.7 • n=90 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=45 Participants
|
45 Participants
n=45 Participants
|
90 Participants
n=90 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=45 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=90 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
45 participants
n=45 Participants
|
45 participants
n=45 Participants
|
90 participants
n=90 Participants
|
PRIMARY outcome
Timeframe: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reportedTotal scores range: 0-36 (0= no symptoms to 36= the most severe symptoms)
Outcome measures
| Measure |
Bladder Instillation WITH Triamcinolone Acetonide
n=45 Participants
Six weekly bladder instillations of standard cocktail plus triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL).
Bladder instillation WITH triamcinolone acetonide: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL).
|
Bladder Instillation WITHOUT Triamcinolone Acetonide
n=45 Participants
Six weekly bladder instillations of standard cocktail without triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).
Bladder instillation WITHOUT triamcinolone acetonide: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).
|
|---|---|---|
|
Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire
|
-6.7 scores on a scale
Standard Deviation 7.1
|
-5.8 scores on a scale
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reportedTotal scores range: 0-35 (0= no symptoms to 35= the most severe symptoms)
Outcome measures
| Measure |
Bladder Instillation WITH Triamcinolone Acetonide
n=33 Participants
Six weekly bladder instillations of standard cocktail plus triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL).
Bladder instillation WITH triamcinolone acetonide: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL).
|
Bladder Instillation WITHOUT Triamcinolone Acetonide
n=36 Participants
Six weekly bladder instillations of standard cocktail without triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).
Bladder instillation WITHOUT triamcinolone acetonide: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).
|
|---|---|---|
|
Pelvic Pain and Urgency/Frequency (PUF) Questionnaire
|
-5.3 score on a scale
Standard Deviation 5.1
|
-2.7 score on a scale
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reportedTotal scores range: 0-100 (higher scores on the symptom-severity scale suggestive of greater severity of symptoms and higher scores on the quality-of-life scale suggestive of better quality of life)
Outcome measures
| Measure |
Bladder Instillation WITH Triamcinolone Acetonide
n=34 Participants
Six weekly bladder instillations of standard cocktail plus triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL).
Bladder instillation WITH triamcinolone acetonide: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL).
|
Bladder Instillation WITHOUT Triamcinolone Acetonide
n=34 Participants
Six weekly bladder instillations of standard cocktail without triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).
Bladder instillation WITHOUT triamcinolone acetonide: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).
|
|---|---|---|
|
Overactive Bladder Questionnaire (OAB-q)
|
-24.2 score on a scale
Standard Deviation 19.1
|
-18.8 score on a scale
Standard Deviation 24.6
|
SECONDARY outcome
Timeframe: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported20 question self-administered questionnaire on the presence and absence of pelvic floor symptoms. Score ranges from 0 (least distress) to 300 (most distress).
Outcome measures
| Measure |
Bladder Instillation WITH Triamcinolone Acetonide
n=29 Participants
Six weekly bladder instillations of standard cocktail plus triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL).
Bladder instillation WITH triamcinolone acetonide: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL).
|
Bladder Instillation WITHOUT Triamcinolone Acetonide
n=29 Participants
Six weekly bladder instillations of standard cocktail without triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).
Bladder instillation WITHOUT triamcinolone acetonide: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).
|
|---|---|---|
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Pelvic Floor Distress Inventory (PFDI)
|
-5.3 score on a scale
Standard Deviation 9.5
|
-6.4 score on a scale
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reportedMeasures sexual function in women with pelvic floor disorders. Queries about arousal, orgasm, partner-related issues, sexual quality, and desire. The tool also takes into account those who are not sexually active. The questionnaire was used in the study solely to determine if patients had improved dyspareunia (as a categorical variable).
Outcome measures
| Measure |
Bladder Instillation WITH Triamcinolone Acetonide
n=36 Participants
Six weekly bladder instillations of standard cocktail plus triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL).
Bladder instillation WITH triamcinolone acetonide: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL).
|
Bladder Instillation WITHOUT Triamcinolone Acetonide
n=40 Participants
Six weekly bladder instillations of standard cocktail without triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).
Bladder instillation WITHOUT triamcinolone acetonide: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).
|
|---|---|---|
|
Sexual Function Measured by the Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) Questionnaire
|
4 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reportedVAS is measured on marking on a 10-centimeter (cm) ruler (measured in cm, 0= no pain and 10= most severe pain possible)
Outcome measures
| Measure |
Bladder Instillation WITH Triamcinolone Acetonide
n=35 Participants
Six weekly bladder instillations of standard cocktail plus triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL).
Bladder instillation WITH triamcinolone acetonide: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL).
|
Bladder Instillation WITHOUT Triamcinolone Acetonide
n=36 Participants
Six weekly bladder instillations of standard cocktail without triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).
Bladder instillation WITHOUT triamcinolone acetonide: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).
|
|---|---|---|
|
Change From Baseline in Treatment Response as Measured by the Visual Analogue Scale (VAS) for Pain
|
-1.9 score on a scale
Standard Deviation 2.6
|
-1.8 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: End of study (6 weeks)Adverse events will only be those determined to be related to the study drug
Outcome measures
| Measure |
Bladder Instillation WITH Triamcinolone Acetonide
n=45 Participants
Six weekly bladder instillations of standard cocktail plus triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL).
Bladder instillation WITH triamcinolone acetonide: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL).
|
Bladder Instillation WITHOUT Triamcinolone Acetonide
n=45 Participants
Six weekly bladder instillations of standard cocktail without triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).
Bladder instillation WITHOUT triamcinolone acetonide: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).
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|---|---|---|
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Number of Participants With at Least One Adverse Event
|
1 Participants
|
5 Participants
|
Adverse Events
Bladder Instillation WITH Triamcinolone Acetonide
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Bladder Instillation WITHOUT Triamcinolone Acetonide
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bladder Instillation WITH Triamcinolone Acetonide
n=45 participants at risk
Six weekly bladder instillations of standard cocktail plus triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL).
Bladder instillation WITH triamcinolone acetonide: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL).
|
Bladder Instillation WITHOUT Triamcinolone Acetonide
n=45 participants at risk
Six weekly bladder instillations of standard cocktail without triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).
Bladder instillation WITHOUT triamcinolone acetonide: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).
|
|---|---|---|
|
Renal and urinary disorders
Urethral pain
|
4.4%
2/45 • Number of events 2 • Through study completion, an average of 6 weeks.
The risk for these severe events is low because the risk of the intervention is known to be low.
|
2.2%
1/45 • Number of events 1 • Through study completion, an average of 6 weeks.
The risk for these severe events is low because the risk of the intervention is known to be low.
|
|
Renal and urinary disorders
Urinary tract infection
|
2.2%
1/45 • Number of events 1 • Through study completion, an average of 6 weeks.
The risk for these severe events is low because the risk of the intervention is known to be low.
|
0.00%
0/45 • Through study completion, an average of 6 weeks.
The risk for these severe events is low because the risk of the intervention is known to be low.
|
|
Psychiatric disorders
Anxiety attack
|
2.2%
1/45 • Number of events 1 • Through study completion, an average of 6 weeks.
The risk for these severe events is low because the risk of the intervention is known to be low.
|
0.00%
0/45 • Through study completion, an average of 6 weeks.
The risk for these severe events is low because the risk of the intervention is known to be low.
|
|
Renal and urinary disorders
Strong bladder spasms
|
2.2%
1/45 • Number of events 1 • Through study completion, an average of 6 weeks.
The risk for these severe events is low because the risk of the intervention is known to be low.
|
0.00%
0/45 • Through study completion, an average of 6 weeks.
The risk for these severe events is low because the risk of the intervention is known to be low.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place