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

Interstitial Cystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04401176
• Other study ID #: EKW_01-2020
• Status: Completed
• Phase: Phase 2
• Start date: September 15, 2020
• Est. completion date: June 1, 2023

Study information

• Verified date: October 2023
• Source: Walter Reed National Military Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Females = 18 years of age

• O'Leary-Sant questionnaire score = 6

• Ability to follow study instructions and complete all required follow-up

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Bladder Pain Syndrome
• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Somatoform Disorders
• Syndrome

Intervention

Drug:
• Heparin & Alkalinized Lidocaine Bladder Instillation
Bladder instillation instilled via catheter and to dwell for minimum of 30 minutes prior to spontaneous void
• Onabotulinum Toxin A
Intradetrusor onabotulinumtoxinA injection (0.5mL x 20 sites)

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Walter Reed National Military Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (45)

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* Note: There are 45 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 8-10 weeks
Secondary	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	Baseline, 4-6 weeks, 6-9 months
Secondary	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)	Baseline, 4-6 weeks, 8-10 weeks, 6-9 months
Secondary	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.	Baseline, 4-6 weeks, 8-10 weeks
Secondary	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.	Baseline, 4-6 weeks, 8-10 weeks
Secondary	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.	Baseline, 4-6 weeks, 8-10 weeks
Secondary	Change in bladder capacity between bladder instillation and intradetrusor onabotulinumtoxinA injection groups	Bladder capacity via 1-day bladder diary	Baseline, 4-6 weeks, 8-10 weeks
Secondary	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)	8-10 weeks
Secondary	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).	6-9 months
Secondary	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	6-9 months

External Links

•   American Urological Association Interstitial Cystitis Guidelines