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Clinical Trial Comparing Two Bladder Instillations for IC/BPS
Phase 3 trial testing Bladder instillation WITH triamcinolone acetonide in Interstitial Cystitis in 90 participants. Completed in 23 October 2020.
| Lead sponsor | Olivia Cardenas-Trowers, M.D. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 25 January 2019 |
| Primary completion | 23 October 2020 |
| Estimated completion | 23 October 2020 |
| Sites | 1 location across United States |
Olivia Cardenas-Trowers, M.D. — full company profile →
18 and older, female only, with Interstitial Cystitis or Bladder Pain Syndrome. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Total scores range: 0-36 (0= no symptoms to 36= the most severe symptoms)
| Group | Value | 95% CI |
|---|---|---|
| Bladder Instillation WITH Triamcinolone Acetonide | -6.7 | ± 7.1 |
| Bladder Instillation WITHOUT Triamcinolone Acetonide | -5.8 | ± 8.0 |
Total scores range: 0-35 (0= no symptoms to 35= the most severe symptoms)
| Group | Value | 95% CI |
|---|---|---|
| Bladder Instillation WITH Triamcinolone Acetonide | -5.3 | ± 5.1 |
| Bladder Instillation WITHOUT Triamcinolone Acetonide | -2.7 | ± 5.5 |
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)
| Group | Value | 95% CI |
|---|---|---|
| Bladder Instillation WITH Triamcinolone Acetonide | -24.2 | ± 19.1 |
| Bladder Instillation WITHOUT Triamcinolone Acetonide | -18.8 | ± 24.6 |
20 question self-administered questionnaire on the presence and absence of pelvic floor symptoms. Score ranges from 0 (least distress) to 300 (most distress).
| Group | Value | 95% CI |
|---|---|---|
| Bladder Instillation WITH Triamcinolone Acetonide | -5.3 | ± 9.5 |
| Bladder Instillation WITHOUT Triamcinolone Acetonide | -6.4 | ± 9.7 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Bladder Instillation WITH Triamcinolone Acetonide | 4 | |
| Bladder Instillation WITHOUT Triamcinolone Acetonide | 4 |
VAS is measured on marking on a 10-centimeter (cm) ruler (measured in cm, 0= no pain and 10= most severe pain possible)
| Group | Value | 95% CI |
|---|---|---|
| Bladder Instillation WITH Triamcinolone Acetonide | -1.9 | ± 2.6 |
| Bladder Instillation WITHOUT Triamcinolone Acetonide | -1.8 | ± 2.4 |
Adverse events will only be those determined to be related to the study drug
| Group | Value | 95% CI |
|---|---|---|
| Bladder Instillation WITH Triamcinolone Acetonide | 1 | |
| Bladder Instillation WITHOUT Triamcinolone Acetonide | 5 |
Time frame: Through study completion, an average of 6 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Bladder Instillation WITH … | Bladder Instillation WITHO… |
|---|---|---|---|
| Urethral pain | Renal and urinary disorders | — | — |
| Urinary tract infection | Renal and urinary disorders | — | — |
| Anxiety attack | Psychiatric disorders | — | — |
| Strong bladder spasms | Renal and urinary disorders | — | — |
Data from ClinicalTrials.gov NCT03463915 adverse events section.
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a condition that results in long-term bladder and pelvic pain. IC/BPS affects women more often than men. How the disorder develops is not completely known. Bladder instillation is a commonly used treatment in which a mixture of different ingredients are passed into the bladder to help IC/BPS symptoms. There is room to learn more about bladder instillations and which ingredients in them work best. The purpose of this study is to compare the effectiveness of a bladder instillation that contains a steroid (triamcinolone acetonide) to a bladder instillation that does not contain a steroid to treat IC/BPS in women. The study hypothesis is that women with IC/BPS treated with bladder instillations that contain a steroid will have improved outcomes compared to women treated with bladder instillations that do not contain a steroid.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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