A Phase 3 interventional study of Bladder instillation WITH triamcinolone acetonide and Bladder instillation WITHOUT triamcinolone acetonide in Interstitial Cystitis and Bladder Pain Syndrome, sponsored by Olivia Cardenas-Trowers, M.D.. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-01.
Sponsored by Olivia Cardenas-Trowers, M.D. · Phase 3, Interventional, and Treatment
Among 139 studies in Cystitis, Interstitial with a site in United States — 17 open to participants now, 21 under way, 1 of them phase 3. Cystitis, Interstitial · United States.
Among the 139 studies in Cystitis, Interstitial with a site in United States, this one is the 31st largest by enrollment of the 101 interventional ones that give a count, is one of 5 that started in 2019, is one of 9 in phase 3, and was the 95th registered.
236 studies on the registry are indexed under Cystitis, Interstitial; 35 are open to participants now.
Browse Cystitis, Interstitial studies →17 of the 139 studies in Cystitis, Interstitial with a site in United States are open now. Recruiting first, the newest first:
Wake Forest University Health Sciences · Sites in United States
Ages 18–80
University Hospitals Cleveland Medical Center · Sites in United States
Ages 18–89
Vaneltix Pharma, Inc. · Sites in United States
Ages 18+
Walter Reed National Military Medical Center · Sites in United States
Ages 18–99 · Women only · Healthy volunteers
David Sheyn · Sites in United States
Ages 18+ · Women only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 25 Cystitis, Interstitial studies recruiting now, 15 (60%) set no upper age limit and 5 (20%) stop at 75 or younger; 2 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
139 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 12 · Phase 2 35 · Phase 3 10 · Phase 4 13
First in 1995; this study’s year is marked. 5 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 90 is above the median of 51 across 158 interventional studies indexed under Cystitis, Interstitial.
Median enrollment 46 across the 101 interventional studies, 160 across the 37 observational. Of the 105 that completed or were terminated, 46 (44%) have results posted.
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36 of 139 have an industry lead sponsor. The 10 most frequent:
Olivia Cardenas-Trowers, M.D. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Olivia Cardenas-Trowers, M.D. has 1 study filed under Cystitis, Interstitial — fewer than ten, so there is no comparison to draw.
8 of the studies in Cystitis, Interstitial with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06096597Phase 3David SheynAmniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome | 2027-05-01 |
| NCT06204874Walter Reed National Military Medical CenterNew Approaches to Nerve Stimulation Therapy for Bladder Pain Syndrome | 2026-12 |
| NCT05149573Wake Forest University Health SciencesInvestigation of PEMF Therapy for Female Patients With IC/BPS | 2027-01 |
| NCT04734106Wake Forest University Health SciencesSafety and Efficacy of Aloe Vera in the Management of the Symptoms of Interstitial Cystitis | 2027-04 |
| NCT06299683Vanderbilt University Medical CenterPain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment | 2027-04-05 |
Add all 8 to your calendar (.ics) → With an account.
Among the 139 studies in Cystitis, Interstitial with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic pain disorder involving the genitourinary tract. IC/BPS disproportionately affects women with over 80% of patients with IC/BPS as female. Like other chronic pain conditions, IC/BPS is physically and emotionally taxing on patients. IC/BPS costs the United States over $100 million annually due to direct healthcare costs and loss of worker productivity. The exact pathophysiology of the disease is unknown, leading to a limitation in our ability to treat the disorder effectively. The current leading etiologic theory is that IC/BPS is a neurologically-derived chronic systemic pain syndrome due to its association with musculoskeletal pelvic pain, irritable bowel syndrome, chronic fatigue syndrome, fibromyalgia, and vulvodynia. Although several options exist to treat IC/BPS, therapeutic effects are often transient. Previous studies in chronic pain disorders have shown that multimodal treatment is more effective than single-agent treatment, so future therapy should aim to augment rather than replace current treatments. Bladder instillation is a commonly used treatment in which a mixture of different agents is instilled into the bladder to improve IC/BPS symptoms. The data on the efficacy of bladder instillations, as well as which ingredients in the mixture are effective, are limited. Small studies have shown the potential of steroids in decreasing IC/BPS; the mechanism of action is hypothesized to be due to decrease inflammation in the bladders of these patients. The knowledge gap that exists is the necessity of a steroid in the bladder instillation treatment for IC/BPS symptoms especially since this tends to be the most expensive ingredient.
To evaluate the utility of a steroid in the bladder instillation treatment of IC/BPS, we propose a randomized, double-blind, controlled trial that will compare the efficacy of bladder instillations with and without triamcinolone acetonide on IC/BPS symptoms in women. We hypothesize that the addition of triamcinolone acetonide in bladder instillation therapy will result in a more robust treatment response than bladder instillations without triamcinolone acetonide. Our rationale is based on 1) the results of small studies that showed improvement of IC/BPS symptoms with use of a steroid and 2) the hypothesized mechanism of action of steroids decreasing inflammation in the bladder.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Drug: Bladder instillation WITH triamcinolone acetonide
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).
Drug: 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), 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL).
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
Total scores range: 0-36 (0= no symptoms to 36= the most severe symptoms)
Time frame: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
Pelvic Pain and Urgency/Frequency (PUF) Questionnaire
Total scores range: 0-35 (0= no symptoms to 35= the most severe symptoms)
Time frame: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
Overactive Bladder Questionnaire (OAB-q)
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)
Time frame: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
Pelvic Floor Distress Inventory (PFDI)
20 question self-administered questionnaire on the presence and absence of pelvic floor symptoms. Score ranges from 0 (least distress) to 300 (most distress).
Time frame: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
Sexual Function Measured by the Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) Questionnaire
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).
Time frame: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
Change From Baseline in Treatment Response as Measured by the Visual Analogue Scale (VAS) for Pain
VAS is measured on marking on a 10-centimeter (cm) ruler (measured in cm, 0= no pain and 10= most severe pain possible)
Time frame: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
Number of Participants With at Least One Adverse Event
Adverse events will only be those determined to be related to the study drug
Time frame: End of study (6 weeks)
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.
| Milestone | Bladder Instillation WITH Triamcinolone Acetonide | Bladder Instillation WITHOUT Triamcinolone Acetonide |
|---|---|---|
| Started | 45 | 45 |
| Completed | 35 | 36 |
| Not completed | 10 | 9 |
Total scores range: 0-36 (0= no symptoms to 36= the most severe symptoms)
| scores on a scale | Bladder Instillation WITH Triamcinolone Acetonide | Bladder Instillation WITHOUT Triamcinolone Acetonide |
|---|---|---|
| Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire | -6.7 ± 7.1 | -5.8 ± 8.0 |
Total scores range: 0-35 (0= no symptoms to 35= the most severe symptoms)
| score on a scale | Bladder Instillation WITH Triamcinolone Acetonide | Bladder Instillation WITHOUT Triamcinolone Acetonide |
|---|---|---|
| Pelvic Pain and Urgency/Frequency (PUF) Questionnaire | -5.3 ± 5.1 | -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)
| score on a scale | Bladder Instillation WITH Triamcinolone Acetonide | Bladder Instillation WITHOUT Triamcinolone Acetonide |
|---|---|---|
| Overactive Bladder Questionnaire (OAB-q) | -24.2 ± 19.1 | -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).
| score on a scale | Bladder Instillation WITH Triamcinolone Acetonide | Bladder Instillation WITHOUT Triamcinolone Acetonide |
|---|---|---|
| Pelvic Floor Distress Inventory (PFDI) | -5.3 ± 9.5 | -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).
| participants | Bladder Instillation WITH Triamcinolone Acetonide | Bladder Instillation WITHOUT Triamcinolone Acetonide |
|---|---|---|
| Sexual Function Measured by the Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) Questionnaire | 4 | 4 |
VAS is measured on marking on a 10-centimeter (cm) ruler (measured in cm, 0= no pain and 10= most severe pain possible)
| score on a scale | Bladder Instillation WITH Triamcinolone Acetonide | Bladder Instillation WITHOUT Triamcinolone Acetonide |
|---|---|---|
| Change From Baseline in Treatment Response as Measured by the Visual Analogue Scale (VAS) for Pain | -1.9 ± 2.6 | -1.8 ± 2.4 |
Adverse events will only be those determined to be related to the study drug
| Participants | Bladder Instillation WITH Triamcinolone Acetonide | Bladder Instillation WITHOUT Triamcinolone Acetonide |
|---|---|---|
| Number of Participants With at Least One Adverse Event | 1 | 5 |
Collected over Through study completion, an average of 6 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bladder Instillation WITH Triamcinolone Acetonide | 0/45 (0%) | 0/45 (0%) | 5/45 (11.1%) |
| Bladder Instillation WITHOUT Triamcinolone Acetonide | 0/45 (0%) | 0/45 (0%) | 1/45 (2.2%) |
| Event | Bladder Instillation WITH Triamcinolone Acetonide | Bladder Instillation WITHOUT Triamcinolone Acetonide |
|---|---|---|
| Urethral painRenal and urinary disorders | 2/45 | 1/45 |
| Urinary tract infectionRenal and urinary disorders | 1/45 | 0/45 |
| Anxiety attackPsychiatric disorders | 1/45 | 0/45 |
| Strong bladder spasmsRenal and urinary disorders | 1/45 | 0/45 |
| Age, Continuous(years) | Bladder Instillation WITH Triamcinolone Acetonide | Bladder Instillation WITHOUT Triamcinolone Acetonide | Total |
|---|---|---|---|
| Mean | 37.3 ± 13.3 | 46.6 ± 14.0 | 42.0 ± 13.7 |
| Sex: Female, Male(Participants) | Bladder Instillation WITH Triamcinolone Acetonide | Bladder Instillation WITHOUT Triamcinolone Acetonide | Total |
|---|---|---|---|
| Female | 45 | 45 | 90 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Bladder Instillation WITH Triamcinolone Acetonide | Bladder Instillation WITHOUT Triamcinolone Acetonide | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Bladder Instillation WITH Triamcinolone Acetonide | Bladder Instillation WITHOUT Triamcinolone Acetonide | Total |
|---|---|---|---|
| United States | 45 | 45 | 90 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified raw data and other supporting materials will be made available to approved investigators. Email requests to olivia.cardenas-trowers@louisville.edu.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will be available beginning 1 month and ending 24 months following article publication.
Access criteria: Available to investigators whose proposed use of the data is for individual participant data meta-analysis and has been approved by an independent review committee for this purpose. To gain access, data requestors will need to sign a data access agreement.
Ran from Jan 2019 to primary completion in Oct 2020, 20 months.
Results were first posted in Sep 2021, 10 months after primary completion.
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Olivia Cardenas-Trowers, M.D.