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Interstitial CystitisPhase 2NCT04401176

Bladder Instillations Versus Onabotulinumtoxin A for Treatment of Interstitial Cystitis/Bladder Pain Syndrome

A Phase 2 study testing Heparin & Alkalinized Lidocaine Bladder Instillation and Onabotulinum Toxin A in people with Interstitial Cystitis and Bladder Pain Syndrome, run by Walter Reed National Military Medical Center 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
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Trial summary

Recognition of interstitial cystitis (IC)/bladder pain syndrome (BPS) is increasing. There is a dire need to develop effective treatment options for these patients as it manifests as more than a physical disease, affecting general and psychological health as well. Read more about this study

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?
Heparin & Alkalinized Lidocaine Bladder Instillation and Onabotulinum Toxin A
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteUnited States
Study dates
15 Sep 2020to 1 Jun 2023
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Females ≥ 18 years of age
  • O'Leary-Sant questionnaire score ≥ 6
  • Ability to follow study instructions and complete all required follow-up

Who cannot join

  • Contraindications and/or allergies to medications used
  • Known alternative diagnosis explaining bladder pain symptoms
  • Bladder instillation within the past 3 months
  • Intradetrusor onabotulinumtoxinA injection within the past 6 months
  • Use of ≥ 400 units of onabotulinumtoxinA in the last 3 months
  • Inability or unwillingness to self-catheterize
Show all 12Show fewer
  • Post-void residual > 200mL
  • Concurrent procedural treatment (including hydrodistension, sacral neuromodulation)
  • Current use of vaginal pessary/devices
  • Untreated symptomatic prolapse > pelvic organ prolapse quantification system (POP-Q) stage 2
  • Females who are pregnant or planning a pregnancy during the study or who think that they may be pregnant at the start of the study and who are unwilling or unable to use a reliable form of contraception during the study
  • Inability to speak/read English

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889

Other trials in United States

About this study

Official title: A Randomized Trial of Bladder Instillations Versus Onabotulinumtoxin A for Treatment of Interstitial Cystitis/Bladder Pain Syndrome

Recognition of interstitial cystitis (IC)/bladder pain syndrome (BPS) is increasing. There is a dire need to develop effective treatment options for these patients as it manifests as more than a physical disease, affecting general and psychological health as well. Existing trials comparing varying bladder instillation formulations have not identified an optimal bladder instillation therapy, however existing studies support combined heparin and alkalinized lidocaine bladder instillation as an affordable and effective treatment for IC/BPS. Additionally, intradetrusor onabotulinumtoxinA injection has been well established for the treatment of overactive bladder (OAB), a constellation of symptoms similar to that of IC/BPS. OnabotulinumtoxinA has now come into the forefront for treatment of OAB due to its efficacy, safety profile, and absence of cognitive effects related to the previous mainstay anticholinergic treatment. While both bladder instillation and onabotulinumtoxinA therapy have been shown to be effective for treatment of IC/BPS, a direct comparison of these treatments has not been performed. We therefore designed a randomized controlled trial to compare the efficacy of heparin with alkalized local anesthetic bladder instillation versus intradetrusor onabotulinumtoxinA injection in treating IC/BPS symptoms.

Being tested
Heparin & Alkalinized Lidocaine Bladder Instillation, Onabotulinum Toxin A
Medical subject headings
Cystitis, Interstitial

What participants receive

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

  • Heparin & Alkalinized Lidocaine Bladder InstillationDrug

    Bladder instillation instilled via catheter and to dwell for minimum of 30 minutes prior to spontaneous void

  • Onabotulinum Toxin ADrug

    Intradetrusor onabotulinumtoxinA injection (0.5mL x 20 sites)

Study groups in NCT04401176
Study groupRoleWhat they receive
Heparin & Alkalinized Lidocaine Bladder InstillationActive comparatorSix weekly bladder instillations, each instillation consisting of 40,000 IU Heparin, 200mg lidocaine, 2ml 8.4% sodium bicarbonate, sterile water for a total volume 50 milliliters (mL).
Receives: Drug: Heparin & Alkalinized Lidocaine Bladder Instillation
Intradetrusor Onabotulinumtoxin A InjectionActive comparator100 units onabotulinumtoxinA reconstituted in 10mL of injectable saline, injected in 20 sites with 0.5mL per injection along the posterior wall of the bladder above the trigone.
Receives: Drug: Onabotulinum Toxin A

What is being measured

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

  1. Change in O'Leary-Sant questionnaire scores from baseline between bladder instillation and intradetrusor onabotulinumtoxinA injection groups

    Consists of O'Leary-Sant Symptom and Problem Index, total score 0-36.

    Measured: Baseline, 8-10 weeks

Secondary outcomes (9)

  1. Change in O'Leary-Sant questionnaire scores from baseline between bladder instillation and intradetrusor onabotulinumtoxinA injection groups

    Consists of O'Leary-Sant Symptom and Problem Index. Total score 0-36

    Measured: Baseline, 4-6 weeks, 6-9 months

  2. Change in pain scores using the Defense and Veterans Pain Rating Scale (visual analog scale) between bladder instillation and intradetrusor onabotulinumtoxinA injection groups

    Scale of 0-10 (0= no pain, 10 = worst pain)

    Measured: Baseline, 4-6 weeks, 8-10 weeks, 6-9 months

  3. Change in Female Sexual Function Index (FSFI) score between bladder instillation and intradetrusor onabotulinumtoxinA injection groups

    FSFI evaluates 5 domains of female sexual function including desire, arousal, lubrication, orgasm, satisfaction, and pain. Total score 2-36.

    Measured: Baseline, 4-6 weeks, 8-10 weeks

  4. Change in Female Sexual Distress Scale-Revised (FSDS-R) score between bladder instillation and intradetrusor onabotulinumtoxinA injection groups

    FSDS-R evaluates distress associated with inadequate/impaired sexual function. Total score 0-52.

    Measured: Baseline, 4-6 weeks, 8-10 weeks

  5. Change in 12-item Short Form Survey (SF-12) score between bladder instillation and intradetrusor onabotulinumtoxinA injection groups

    SF-12 is a general health questionnaire that evaluates quality of life measures, divided into mental and physical component scores.

    Measured: Baseline, 4-6 weeks, 8-10 weeks

  6. Change in bladder capacity between bladder instillation and intradetrusor onabotulinumtoxinA injection groups

    Bladder capacity via 1-day bladder diary

    Measured: Baseline, 4-6 weeks, 8-10 weeks

  7. Incidence of adverse outcomes between bladder instillation and intradetrusor onabotulinumtoxinA injection groups

    Adverse outcomes to be defined specific to medication administered (urinary tract infection in both bladder instillation and onabotulinumtoxinA injection groups, urinary retention requiring catheterization, systemic effects related to onabotulinumtoxinA group only)

    Measured: 8-10 weeks

  8. Patient perceptions of treatment between bladder instillation and intradetrusor onabotulinumtoxinA injection groups

    "How convenient or inconvenient was it to follow the treatment schedule as instructed?" (Scale 1-5 extremely inconvenient - extremely convenient) "How satisfied or dissatisfied are you in the ability of the treatment to treat your condition?" (Scale 1-5 extremely dissatisfied - extremely satisfied) "Taking all things into account, how satisfied or dissatisfied are you with this treatment?" (Scale 1-5 extremely dissatisfied - extremely satisfied) "How willing would you be to undergo this treatment again?" (Scale 1-5 extremely unwilling - extremely willing).

    Measured: 6-9 months

  9. Incidence of re-treatment between bladder instillation and intradetrusor onabotulinumtoxinA injection groups

    Re-treatment defined as additional course or crossover treatment outside of assigned treatment group

    Measured: 6-9 months

Timeline

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

  1. First posted26 May 2020
  2. Study start15 Sep 2020
  3. Primary completion1 Jun 2023
  4. Study completion1 Jun 2023

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04401176
Sponsor's protocol ID
EKW_01-2020
Status last verified
Oct 2023
First submitted
19 May 2020
Last updated
12 Oct 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Hanno P, Dmochowski R. Status of international consensus on interstitial cystitis/bladder pain syndrome/painful bladder syndrome: 2008 snapshot. Neurourol Urodyn. 2009;28(4):274-86. doi: 10.1002/nau.20687.

    PubMed 19260081

  • Berry SH, Elliott MN, Suttorp M, Bogart LM, Stoto MA, Eggers P, Nyberg L, Clemens JQ. Prevalence of symptoms of bladder pain syndrome/interstitial cystitis among adult females in the United States. J Urol. 2011 Aug;186(2):540-4. doi: 10.1016/j.juro.2011.03.132. Epub 2011 Jun 16.

    PubMed 21683389

  • Clemens JQ, Link CL, Eggers PW, Kusek JW, Nyberg LM Jr, McKinlay JB; BACH Survey Investigators. Prevalence of painful bladder symptoms and effect on quality of life in black, Hispanic and white men and women. J Urol. 2007 Apr;177(4):1390-4. doi: 10.1016/j.juro.2006.11.084.

    PubMed 17382739

  • Rothrock NE, Lutgendorf SK, Hoffman A, Kreder KJ. Depressive symptoms and quality of life in patients with interstitial cystitis. J Urol. 2002 Apr;167(4):1763-7.

    PubMed 11912405

  • Rothrock N, Lutgendorf SK, Kreder KJ. Coping strategies in patients with interstitial cystitis: relationships with quality of life and depression. J Urol. 2003 Jan;169(1):233-6. doi: 10.1016/S0022-5347(05)64075-X.

    PubMed 12478143

  • Nickel JC, Payne CK, Forrest J, Parsons CL, Wan GJ, Xiao X. The relationship among symptoms, sleep disturbances and quality of life in patients with interstitial cystitis. J Urol. 2009 Jun;181(6):2555-61. doi: 10.1016/j.juro.2009.02.030. Epub 2009 Apr 16.

    PubMed 19375108

  • Nickel JC, Tripp DA, Pontari M, Moldwin R, Mayer R, Carr LK, Doggweiler R, Yang CC, Mishra N, Nordling J. Psychosocial phenotyping in women with interstitial cystitis/painful bladder syndrome: a case control study. J Urol. 2010 Jan;183(1):167-72. doi: 10.1016/j.juro.2009.08.133.

    PubMed 19913812

  • Payne CK, Joyce GF, Wise M, Clemens JQ; Urologic Diseases in America Project. Interstitial cystitis and painful bladder syndrome. J Urol. 2007 Jun;177(6):2042-9. doi: 10.1016/j.juro.2007.01.124.

    PubMed 17509284

  • Hurst RE. Structure, function, and pathology of proteoglycans and glycosaminoglycans in the urinary tract. World J Urol. 1994;12(1):3-10. doi: 10.1007/BF00182044.

    PubMed 8012413

  • Parsons CL. The role of the urinary epithelium in the pathogenesis of interstitial cystitis/prostatitis/urethritis. Urology. 2007 Apr;69(4 Suppl):9-16. doi: 10.1016/j.urology.2006.03.084.

    PubMed 17462486

  • 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

  • Basbaum AI, Bautista DM, Scherrer G, Julius D. Cellular and molecular mechanisms of pain. Cell. 2009 Oct 16;139(2):267-84. doi: 10.1016/j.cell.2009.09.028.

    PubMed 19837031

  • Henry RA, Morales A, Cahill CM. Beyond a Simple Anesthetic Effect: Lidocaine in the Diagnosis and Treatment of Interstitial Cystitis/bladder Pain Syndrome. Urology. 2015 May;85(5):1025-1033. doi: 10.1016/j.urology.2015.01.021.

    PubMed 25917728

  • Nickel JC, Stephens A, Landis JR, Mullins C, van Bokhoven A, Lucia MS, Ehrlich GD; MAPP Research Network. Assessment of the Lower Urinary Tract Microbiota during Symptom Flare in Women with Urologic Chronic Pelvic Pain Syndrome: A MAPP Network Study. J Urol. 2016 Feb;195(2):356-62. doi: 10.1016/j.juro.2015.09.075. Epub 2015 Sep 26.

    PubMed 26410734

  • Pearce MM, Zilliox MJ, Rosenfeld AB, Thomas-White KJ, Richter HE, Nager CW, Visco AG, Nygaard IE, Barber MD, Schaffer J, Moalli P, Sung VW, Smith AL, Rogers R, Nolen TL, Wallace D, Meikle SF, Gai X, Wolfe AJ, Brubaker L; Pelvic Floor Disorders Network. The female urinary microbiome in urgency urinary incontinence. Am J Obstet Gynecol. 2015 Sep;213(3):347.e1-11. doi: 10.1016/j.ajog.2015.07.009. Epub 2015 Jul 23.

    PubMed 26210757

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Heparin & Alkalinized Lidocaine Bladder Instillation and Onabotulinum Toxin A in people with Interstitial Cystitis and Bladder Pain Syndrome, run by Walter Reed National Military Medical Center at 1 site in United States.

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 12 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 12 Oct 2023. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 in O'Leary-Sant questionnaire scores from baseline between bladder instillation and intradetrusor onabotulinumtoxinA injection groups (time frame: Baseline, 8-10 weeks). 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 NCT04401176, which also lists 46 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 12 Oct 2023.

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