Trial · NCT03463915
Clinical Trial Comparing Two Bladder Instillations for IC/BPS
NCT03463915, Phase 3, Completed, Olivia Cardenas-Trowers, M.D.; results first posted 2021-09-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clinical Trial Comparing Two Bladder Instillations for IC/BPS. Trials, record NCT03463915. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03463915
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trial Comparing Two Bladder Instillations for IC/BPS
- NCT number
- NCT03463915
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 90 participants, actual
- Lead sponsor
- Olivia Cardenas-Trowers, M.D.
- Conditions
- Interstitial Cystitis, Bladder Pain Syndrome
- Interventions
- Bladder instillation WITH triamcinolone acetonide, Bladder instillation WITHOUT triamcinolone acetonide
- First posted
- 2018-03-13
- Last updated
- 2021-09-01
- Results first posted
- 2021-09-01
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire | Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported | Total scores range: 0-36 (0= no symptoms to 36= the most severe symptoms) |
| Secondary | Pelvic Pain and Urgency/Frequency (PUF) Questionnaire | Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported | Total scores range: 0-35 (0= no symptoms to 35= the most severe symptoms) |
| Secondary | Overactive Bladder Questionnaire (OAB-q) | Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported | Total 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) |
| Secondary | Pelvic Floor Distress Inventory (PFDI) | Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported | 20 question self-administered questionnaire on the presence and absence of pelvic floor symptoms. Score ranges from 0 (least distress) to 300 (most distress). |
| Secondary | Sexual Function Measured by the Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) Questionnaire | Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported | Measures 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). |
| Secondary | Change From Baseline in Treatment Response as Measured by the Visual Analogue Scale (VAS) for Pain | Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported | VAS is measured on marking on a 10-centimeter (cm) ruler (measured in cm, 0= no pain and 10= most severe pain possible) |
| Secondary | Number of Participants With at Least One Adverse Event | End of study (6 weeks) | Adverse events will only be those determined to be related to the study drug |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire | Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported | scores on a scale | MEAN | |
| SECONDARY | Pelvic Pain and Urgency/Frequency (PUF) Questionnaire | Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported | score on a scale | MEAN | |
| SECONDARY | Overactive Bladder Questionnaire (OAB-q) | Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported | score on a scale | MEAN | |
| SECONDARY | Pelvic Floor Distress Inventory (PFDI) | Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported | score on a scale | MEAN | |
| SECONDARY | Sexual Function Measured by the Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) Questionnaire | Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported | participants | NUMBER | |
| SECONDARY | Change From Baseline in Treatment Response as Measured by the Visual Analogue Scale (VAS) for Pain | Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported | score on a scale | MEAN | |
| SECONDARY | Number of Participants With at Least One Adverse Event | End of study (6 weeks) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire | Bladder Instillation WITH Triamcinolone Acetonide | -6.7 | Standard Deviation 7.1 | scores on a scale | |
| Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire | Bladder Instillation WITHOUT Triamcinolone Acetonide | -5.8 | Standard Deviation 8.0 | scores on a scale | |
| Pelvic Pain and Urgency/Frequency (PUF) Questionnaire | Bladder Instillation WITH Triamcinolone Acetonide | -5.3 | Standard Deviation 5.1 | score on a scale | |
| Pelvic Pain and Urgency/Frequency (PUF) Questionnaire | Bladder Instillation WITHOUT Triamcinolone Acetonide | -2.7 | Standard Deviation 5.5 | score on a scale | |
| Overactive Bladder Questionnaire (OAB-q) | Bladder Instillation WITH Triamcinolone Acetonide | -24.2 | Standard Deviation 19.1 | score on a scale | |
| Overactive Bladder Questionnaire (OAB-q) | Bladder Instillation WITHOUT Triamcinolone Acetonide | -18.8 | Standard Deviation 24.6 | score on a scale | |
| Pelvic Floor Distress Inventory (PFDI) | Bladder Instillation WITH Triamcinolone Acetonide | -5.3 | Standard Deviation 9.5 | score on a scale | |
| Pelvic Floor Distress Inventory (PFDI) | Bladder Instillation WITHOUT Triamcinolone Acetonide | -6.4 | Standard Deviation 9.7 | score on a scale | |
| Sexual Function Measured by the Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) Questionnaire | Bladder Instillation WITH Triamcinolone Acetonide | 4 | participants | ||
| Sexual Function Measured by the Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) Questionnaire | Bladder Instillation WITHOUT Triamcinolone Acetonide | 4 | participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bladder Instillation WITH Triamcinolone Acetonide | 45 | |
| Overall Study | STARTED | Bladder Instillation WITHOUT Triamcinolone Acetonide | 45 | |
| Overall Study | COMPLETED | Bladder Instillation WITH Triamcinolone Acetonide | 35 | |
| Overall Study | COMPLETED | Bladder Instillation WITHOUT Triamcinolone Acetonide | 36 | |
| Overall Study | NOT COMPLETED | Bladder Instillation WITH Triamcinolone Acetonide | 10 | |
| Overall Study | NOT COMPLETED | Bladder Instillation WITHOUT Triamcinolone Acetonide | 9 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Urethral pain | Renal and urinary disorders | Bladder Instillation WITH Triamcinolone Acetonide | 2 | 45 | 2 |
| other | Urethral pain | Renal and urinary disorders | Bladder Instillation WITHOUT Triamcinolone Acetonide | 1 | 45 | 1 |
| other | Urinary tract infection | Renal and urinary disorders | Bladder Instillation WITH Triamcinolone Acetonide | 1 | 45 | 1 |
| other | Urinary tract infection | Renal and urinary disorders | Bladder Instillation WITHOUT Triamcinolone Acetonide | 0 | 45 | 0 |
| other | Anxiety attack | Psychiatric disorders | Bladder Instillation WITH Triamcinolone Acetonide | 1 | 45 | 1 |
| other | Anxiety attack | Psychiatric disorders | Bladder Instillation WITHOUT Triamcinolone Acetonide | 0 | 45 | 0 |
| other | Strong bladder spasms | Renal and urinary disorders | Bladder Instillation WITH Triamcinolone Acetonide | 1 | 45 | 1 |
| other | Strong bladder spasms | Renal and urinary disorders | Bladder Instillation WITHOUT Triamcinolone Acetonide | 0 | 45 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bladder Instillation WITH Triamcinolone Acetonide | 0 | 45 |
| Total, all-cause mortality | Bladder Instillation WITHOUT Triamcinolone Acetonide | 0 | 45 |
| Total, other adverse events | Bladder Instillation WITH Triamcinolone Acetonide | 5 | 45 |
| Total, other adverse events | Bladder Instillation WITHOUT Triamcinolone Acetonide | 1 | 45 |
| Total, serious adverse events | Bladder Instillation WITH Triamcinolone Acetonide | 0 | 45 |
| Total, serious adverse events | Bladder Instillation WITHOUT Triamcinolone Acetonide | 0 | 45 |
Source ClinicalTrials.gov
Papers15
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Bladder Instillation WITH Triamcinolone Acetonide vs Bladder Instillation WITHOUT Triamcinolone Acetonide: Number of Participants With at Least One Adverse Event | Trial comparisons |
Bladder Instillation WITH Triamcinolone Acetonide vs Bladder Instillation WITHOUT Triamcinolone Acetonide: Sexual Function Measured by the Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) Questionnaire | Trial comparisons |
| Bladder Instillation WITH Triamcinolone Acetonide vs Bladder Instillation WITHOUT Triamcinolone Acetonide: deaths from any cause | Trial comparisons |
| Bladder Instillation WITH Triamcinolone Acetonide vs Bladder Instillation WITHOUT Triamcinolone Acetonide: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03463915
GET https://conductscience.org/api/trials/v1/NCT03463915/registered