Bladder Pain Syndrome, Interstitial Cystitis
Conditions
Keywords
Interstitial cystitis, Bladder pain syndrome, IC/BPS, Women, Pelvic pain, Urologic pain, Bladder instillation, Kenalog, Steroid
Brief summary
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.
Detailed description
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.
Interventions
DRUGBladder 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).
DRUGBladder 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).
Sponsors
Olivia Cardenas-Trowers, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women 18 years and older * Women with IC/BPS who have a score of ≥ 6 on either index (problem or symptom index) of the O'Leary-Sant questionnaire who have selected bladder instillations as part of their IC/BPS treatment * Suitability for follow-up
Exclusion criteria
* Contraindications and/or allergies to the ingredients used in the bladder instillations * Diagnosis of idiopathic thrombocytopenic purpura * Does not desire to undergo bladder instillation therapy or unwilling to undergo bladder instillation therapy on schedule mandated by study * Have a known alternative diagnosis explaining bladder pain symptoms that would preclude the diagnosis of IC/BPS (e.g. radiation cystitis, active urinary tract infection with bacteria or fungus treated within last 2 weeks or diagnosed at index visit, bladder injury or trauma within the last 30 days) * Inability to speak or read English * Bladder instillation within the past 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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). |
| 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) |
| 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) |
| 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 |
| 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). |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Bladder Instillation WITH Triamcinolone Acetonide 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). | 45 |
| 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). | 45 |
| Total | 90 |
Baseline characteristics
| Characteristic | Bladder Instillation WITH Triamcinolone Acetonide | Bladder Instillation WITHOUT Triamcinolone Acetonide | Total |
|---|---|---|---|
| Age, Continuous | 37.3 years STANDARD_DEVIATION 13.3 | 46.6 years STANDARD_DEVIATION 14 | 42.0 years STANDARD_DEVIATION 13.7 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 45 participants | 45 participants | 90 participants |
| Sex: Female, Male Female | 45 Participants | 45 Participants | 90 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 45 |
| other Total, other adverse events | 5 / 45 | 1 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bladder Instillation WITH Triamcinolone Acetonide | 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 |
| Bladder Instillation WITHOUT Triamcinolone Acetonide | Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire | -5.8 scores on a scale | Standard Deviation 8 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bladder Instillation WITH Triamcinolone Acetonide | 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 |
| Bladder Instillation WITHOUT Triamcinolone Acetonide | Change From Baseline in Treatment Response as Measured by the Visual Analogue Scale (VAS) for Pain | -1.8 score on a scale | Standard Deviation 2.4 |
Secondary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bladder Instillation WITH Triamcinolone Acetonide | Number of Participants With at Least One Adverse Event | 1 Participants |
| Bladder Instillation WITHOUT Triamcinolone Acetonide | Number of Participants With at Least One Adverse Event | 5 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bladder Instillation WITH Triamcinolone Acetonide | Overactive Bladder Questionnaire (OAB-q) | -24.2 score on a scale | Standard Deviation 19.1 |
| Bladder Instillation WITHOUT Triamcinolone Acetonide | Overactive Bladder Questionnaire (OAB-q) | -18.8 score on a scale | Standard Deviation 24.6 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bladder Instillation WITH Triamcinolone Acetonide | Pelvic Floor Distress Inventory (PFDI) | -5.3 score on a scale | Standard Deviation 9.5 |
| Bladder Instillation WITHOUT Triamcinolone Acetonide | Pelvic Floor Distress Inventory (PFDI) | -6.4 score on a scale | Standard Deviation 9.7 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bladder Instillation WITH Triamcinolone Acetonide | Pelvic Pain and Urgency/Frequency (PUF) Questionnaire | -5.3 score on a scale | Standard Deviation 5.1 |
| Bladder Instillation WITHOUT Triamcinolone Acetonide | Pelvic Pain and Urgency/Frequency (PUF) Questionnaire | -2.7 score on a scale | Standard Deviation 5.5 |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bladder Instillation WITH Triamcinolone Acetonide | Sexual Function Measured by the Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) Questionnaire | 4 participants |
| Bladder Instillation WITHOUT Triamcinolone Acetonide | Sexual Function Measured by the Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) Questionnaire | 4 participants |