Interstitial CystitisPhase 3NCT03463915

Clinical Trial Comparing Two Bladder Instillations for IC/BPS

A Phase 3 study testing Bladder instillation WITH triamcinolone acetonide and Bladder instillation WITHOUT triamcinolone acetonide in people with Interstitial Cystitis and Bladder Pain Syndrome, run by Olivia Cardenas-Trowers, M.D. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Interstitial Cystitis, Bladder Pain Syndrome
What is being tested?: Bladder instillation WITH triamcinolone acetonide and Bladder instillation WITHOUT triamcinolone acetonide
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: 1 siteUnited States
Study dates: 25 Jan 2019to 23 Oct 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Louisville Urogynecology at Springs Medical Center
Louisville, Kentucky, 40205

Other trials in United States

About this study

Official title: Randomized Controlled Trial Comparing Two Different Bladder Instillation Treatments for Interstitial Cystitis/Bladder Pain Syndrome

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.

Read the 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.

Conditions: Interstitial Cystitis, Bladder Pain Syndrome
Being tested: Bladder instillation WITH triamcinolone acetonide, Bladder instillation WITHOUT triamcinolone acetonide
Keywords: Interstitial cystitis, Bladder pain syndrome, IC/BPS, Women, Pelvic pain, Urologic pain, Bladder instillation, Kenalog, Steroid
Medical subject headings: Cystitis, Interstitial, Pelvic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bladder instillation WITH triamcinolone acetonideDrug
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 acetonideDrug
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).

Study groups in NCT03463915
Study group	Role	What they receive
Bladder instillation WITH triamcinolone acetonide	Active comparator	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). Receives: Drug: Bladder instillation WITH triamcinolone acetonide
Bladder instillation WITHOUT triamcinolone acetonide	Placebo comparator	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). Receives: Drug: Bladder instillation WITHOUT triamcinolone acetonide

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported

Secondary outcomes (6)

Pelvic Pain and Urgency/Frequency (PUF) Questionnaire
Total scores range: 0-35 (0= no symptoms to 35= the most severe symptoms)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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
Measured: End of study (6 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jan 201923 Oct 2020

First posted13 Mar 2018
Study start25 Jan 2019
Primary completion23 Oct 2020
Study completion23 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Interstitial CystitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03463915
Sponsor's protocol ID: 18.0209
Status last verified: Aug 2021
First submitted: 28 Feb 2018
Last updated: 1 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: De-identified raw data and other supporting materials will be made available to approved investigators. Email requests to olivia.cardenas-trowers@louisville.edu.

Publications

Clemens JQ, Meenan RT, Rosetti MC, Gao SY, Calhoun EA. Prevalence and incidence of interstitial cystitis in a managed care population. J Urol. 2005 Jan;173(1):98-102; discussion 102. doi: 10.1097/01.ju.0000146114.53828.82.
PubMed 15592041
Nickel JC. Interstitial cystitis: a chronic pelvic pain syndrome. Med Clin North Am. 2004 Mar;88(2):467-81, xii. doi: 10.1016/S0025-7125(03)00151-2.
PubMed 15049588
Aaron LA, Buchwald D. A review of the evidence for overlap among unexplained clinical conditions. Ann Intern Med. 2001 May 1;134(9 Pt 2):868-81. doi: 10.7326/0003-4819-134-9_part_2-200105011-00011.
PubMed 11346323
Alagiri M, Chottiner S, Ratner V, Slade D, Hanno PM. Interstitial cystitis: unexplained associations with other chronic disease and pain syndromes. Urology. 1997 May;49(5A Suppl):52-7. doi: 10.1016/s0090-4295(99)80332-x.
PubMed 9146002
Bullones Rodriguez MA, Afari N, Buchwald DS; National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Urological Chronic Pelvic Pain. Evidence for overlap between urological and nonurological unexplained clinical conditions. J Urol. 2013 Jan;189(1 Suppl):S66-74. doi: 10.1016/j.juro.2012.11.019.
PubMed 23234637
Clauw DJ, Schmidt M, Radulovic D, Singer A, Katz P, Bresette J. The relationship between fibromyalgia and interstitial cystitis. J Psychiatr Res. 1997 Jan-Feb;31(1):125-31. doi: 10.1016/s0022-3956(96)00051-9.
PubMed 9201654
Dawson TE, Jamison J. Intravesical treatments for painful bladder syndrome/ interstitial cystitis. Cochrane Database Syst Rev. 2007 Oct 17;2007(4):CD006113. doi: 10.1002/14651858.CD006113.pub2.
PubMed 17943887
Pazin C, de Souza Mitidieri AM, Silva AP, Gurian MB, Poli-Neto OB, Rosa-E-Silva JC. Treatment of bladder pain syndrome and interstitial cystitis: a systematic review. Int Urogynecol J. 2016 May;27(5):697-708. doi: 10.1007/s00192-015-2815-5. Epub 2015 Aug 14.
PubMed 26272202
Chaparro LE, Wiffen PJ, Moore RA, Gilron I. Combination pharmacotherapy for the treatment of neuropathic pain in adults. Cochrane Database Syst Rev. 2012 Jul 11;2012(7):CD008943. doi: 10.1002/14651858.CD008943.pub2.
PubMed 22786518
Cvach K, Rosamilia A. Review of intravesical therapies for bladder pain syndrome/interstitial cystitis. Transl Androl Urol. 2015 Dec;4(6):629-37. doi: 10.3978/j.issn.2223-4683.2015.10.07.
PubMed 26816864
Barua JM, Arance I, Angulo JC, Riedl CR. A systematic review and meta-analysis on the efficacy of intravesical therapy for bladder pain syndrome/interstitial cystitis. Int Urogynecol J. 2016 Aug;27(8):1137-47. doi: 10.1007/s00192-015-2890-7. Epub 2015 Nov 20.
PubMed 26590137
Soucy F, Gregoire M. Efficacy of prednisone for severe refractory ulcerative interstitial cystitis. J Urol. 2005 Mar;173(3):841-3; discussion 843. doi: 10.1097/01.ju.0000153612.14639.19.
PubMed 15711286
Cox M, Klutke JJ, Klutke CG. Assessment of patient outcomes following submucosal injection of triamcinolone for treatment of Hunner's ulcer subtype interstitial cystitis. Can J Urol. 2009 Apr;16(2):4536-40.
PubMed 19364425
Cardenas-Trowers OO, Abraham AG, Dotson TK, Houlette BA, Gaskins JT, Francis SL. Bladder Instillations With Triamcinolone Acetonide for Interstitial Cystitis-Bladder Pain Syndrome: A Randomized Controlled Trial. Obstet Gynecol. 2021 May 1;137(5):810-819. doi: 10.1097/AOG.0000000000004348.
PubMed 33831942
Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
PubMed 32734597

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder Syndrome
RecruitingPhase 2/3
Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome
Interstitial Cystitis, Painful Bladder Syndrome

All Interstitial Cystitis trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Trial Comparing Two Different Bladder Instillation Treatments for Interstitial Cystitis/Bladder Pain Syndrome
ClinicalTrials.gov ID: NCT03463915
Acronym / sponsor ID: 18.0209
Conditions: Interstitial Cystitis, Bladder Pain Syndrome
Keywords: Interstitial cystitis, Bladder pain syndrome, IC/BPS, Women, Pelvic pain, Urologic pain, Bladder instillation, Kenalog
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Olivia Cardenas-Trowers, M.D.University, hospital or other
Study start: 25 Jan 2019 (actual)
Primary completion: 23 Oct 2020 (actual)
Study completion: 23 Oct 2020 (actual)
First posted: 13 Mar 2018 (actual)
Results: Posted 1 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Bladder instillation WITH triamcinolone acetonide	Active comparator	Drug: Bladder instillation WITH triamcinolone acetonideSix 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 WITHOUT triamcinolone acetonide	Placebo comparator	Drug: Bladder instillation WITHOUT triamcinolone acetonideSix 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).

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bladder instillation WITH triamcinolone acetonideBladder 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).	Drug	Bladder instillation WITH triamcinolone acetonide
Bladder instillation WITHOUT triamcinolone acetonideBladder 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).	Drug	Bladder instillation WITHOUT triamcinolone acetonide

Primary outcome

Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire
Time frame: 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)

6 secondary outcomes

Pelvic Pain and Urgency/Frequency (PUF) Questionnaire
Time frame: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
Overactive Bladder Questionnaire (OAB-q)
Time frame: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
Pelvic Floor Distress Inventory (PFDI)
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
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
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
Time frame: End of study (6 weeks)

Results and safety

Results posted to the registry on 1 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bladder Instillation WITH Triamcinolone Acetonide	45	35
Bladder Instillation WITHOUT Triamcinolone Acetonide	45	36

Primary outcome: Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire

Time frame: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported. Mean (Standard Deviation). Unit: scores on a scale

Measure	Bladder Instillation WITH Triamcinolone Acetonide n = 45	Bladder Instillation WITHOUT Triamcinolone Acetonide n = 45
Value	-6.7 (7.1)	-5.8 (8.0)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through study completion, an average of 6 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bladder Instillation WITH Triamcinolone Acetonide	0 of 45 (0%)	5 of 45 (11.1%)	0 of 45
Bladder Instillation WITHOUT Triamcinolone Acetonide	0 of 45 (0%)	1 of 45 (2.2%)	0 of 45

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15592041Clemens JQ, Meenan RT, Rosetti MC, Gao SY, Calhoun EA. Prevalence and incidence of interstitial cystitis in a managed care population. J Urol. 2005 Jan;173(1):98-102; discussion 102. doi: 10.1097/01.ju.0000146114.53828.82.
Background: PubMed 15049588Nickel JC. Interstitial cystitis: a chronic pelvic pain syndrome. Med Clin North Am. 2004 Mar;88(2):467-81, xii. doi: 10.1016/S0025-7125(03)00151-2.
Background: PubMed 11346323Aaron LA, Buchwald D. A review of the evidence for overlap among unexplained clinical conditions. Ann Intern Med. 2001 May 1;134(9 Pt 2):868-81. doi: 10.7326/0003-4819-134-9_part_2-200105011-00011.
Background: PubMed 9146002Alagiri M, Chottiner S, Ratner V, Slade D, Hanno PM. Interstitial cystitis: unexplained associations with other chronic disease and pain syndromes. Urology. 1997 May;49(5A Suppl):52-7. doi: 10.1016/s0090-4295(99)80332-x.
Background: PubMed 23234637Bullones Rodriguez MA, Afari N, Buchwald DS; National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Urological Chronic Pelvic Pain. Evidence for overlap between urological and nonurological unexplained clinical conditions. J Urol. 2013 Jan;189(1 Suppl):S66-74. doi: 10.1016/j.juro.2012.11.019.
Background: PubMed 9201654Clauw DJ, Schmidt M, Radulovic D, Singer A, Katz P, Bresette J. The relationship between fibromyalgia and interstitial cystitis. J Psychiatr Res. 1997 Jan-Feb;31(1):125-31. doi: 10.1016/s0022-3956(96)00051-9.
Background: PubMed 17943887Dawson TE, Jamison J. Intravesical treatments for painful bladder syndrome/ interstitial cystitis. Cochrane Database Syst Rev. 2007 Oct 17;2007(4):CD006113. doi: 10.1002/14651858.CD006113.pub2.
Background: PubMed 26272202Pazin C, de Souza Mitidieri AM, Silva AP, Gurian MB, Poli-Neto OB, Rosa-E-Silva JC. Treatment of bladder pain syndrome and interstitial cystitis: a systematic review. Int Urogynecol J. 2016 May;27(5):697-708. doi: 10.1007/s00192-015-2815-5. Epub 2015 Aug 14.
Background: PubMed 22786518Chaparro LE, Wiffen PJ, Moore RA, Gilron I. Combination pharmacotherapy for the treatment of neuropathic pain in adults. Cochrane Database Syst Rev. 2012 Jul 11;2012(7):CD008943. doi: 10.1002/14651858.CD008943.pub2.
Background: PubMed 26816864Cvach K, Rosamilia A. Review of intravesical therapies for bladder pain syndrome/interstitial cystitis. Transl Androl Urol. 2015 Dec;4(6):629-37. doi: 10.3978/j.issn.2223-4683.2015.10.07.
Background: PubMed 26590137Barua JM, Arance I, Angulo JC, Riedl CR. A systematic review and meta-analysis on the efficacy of intravesical therapy for bladder pain syndrome/interstitial cystitis. Int Urogynecol J. 2016 Aug;27(8):1137-47. doi: 10.1007/s00192-015-2890-7. Epub 2015 Nov 20.
Background: PubMed 15711286Soucy F, Gregoire M. Efficacy of prednisone for severe refractory ulcerative interstitial cystitis. J Urol. 2005 Mar;173(3):841-3; discussion 843. doi: 10.1097/01.ju.0000153612.14639.19.
Individual participant dataSharing planned: Yes. De-identified raw data and other supporting materials will be made available to approved investigators. Email requests to olivia.cardenas-trowers@louisville.edu.

Related trials for Interstitial Cystitis

Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
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Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Olivia Cardenas-Trowers, M.D. principal investigator

University of Louisville

Sean Francis, M.D. principal investigator

University of Louisville

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire (time frame: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03463915, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.