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Heparin & Alkalinized Lidocaine Bladder Instillation for Interstitial Cystitis

Phase 2
Waitlist Available
Research Sponsored by Walter Reed National Military Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4-6 weeks, 8-10 weeks, 6-9 months
Awards & highlights

Study Summary

This trial is testing whether heparin with alkalized local anesthetic bladder instillation is more effective than intradetrusor onabotulinumtoxinA injection in treating IC/BPS symptoms.

Eligible Conditions
  • Interstitial Cystitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4-6 weeks, 8-10 weeks, 6-9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4-6 weeks, 8-10 weeks, 6-9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in 12-item Short Form Survey (SF-12) score between bladder instillation and intradetrusor onabotulinumtoxinA injection groups
Change in Female Sexual Distress Scale-Revised (FSDS-R) score between bladder instillation and intradetrusor onabotulinumtoxinA injection groups
Change in Female Sexual Function Index (FSFI) score between bladder instillation and intradetrusor onabotulinumtoxinA injection groups
+6 more

Trial Design

2Treatment groups
Active Control
Group I: Heparin & Alkalinized Lidocaine Bladder InstillationActive Control1 Intervention
Six 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).
Group II: Intradetrusor Onabotulinumtoxin A InjectionActive Control1 Intervention
100 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.

Find a Location

Who is running the clinical trial?

Walter Reed National Military Medical CenterLead Sponsor
137 Previous Clinical Trials
34,430 Total Patients Enrolled
1 Trials studying Interstitial Cystitis
29 Patients Enrolled for Interstitial Cystitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the bladder instillation of Heparin & Alkalinized Lidocaine a safe medical procedure for patients?

"While Phase 2 trials don't yet have data supporting efficacy, there is evidence that Heparin & Alkalinized Lidocaine Bladder Instillation is safe. Therefore, our team gave it a score of 2."

Answered by AI

What is the nature of this clinical test?

"Currently, there are 180 ongoing studies for Heparin & Alkalinized Lidocaine Bladder Instillation in 37 countries and 615 cities. The first study was conducted in 2006 by Ash Access Technology. That initial415-patient study completed Phase 3 drug approval in 2006. In the years since, 931 similar studies have been completed"

Answered by AI

How many research subjects are you looking for in total?

"Unfortunately, this study is not presently enrolling patients. The clinical trial was initially posted on September 15th 2020 and has since been updated on June 17th 2022. There are presently 1483 other trials actively admitting patients with bladder pain syndrome and 180 trials for Heparin & Alkalinized Lidocaine Bladder Instillation that are seeking participants."

Answered by AI

Are there any other scientific papers which mention using Heparin & Alkalinized Lidocaine Bladder Instillation?

"There are a total of 50 Phase 3 clinical trials for Heparin & Alkalinized Lidocaine Bladder Instillation with 180 being active as of now. Although many trials are based in Duarte, California, there are 1,499 locations running studies on this topic."

Answered by AI

What is the usual purpose for prescribing Heparin & Alkalinized Lidocaine Bladder Instillation?

"While commonly used to treat cervical syndrome, Heparin & Alkalinized Lidocaine Bladder Instillation is also effective for prophylaxis of peripheral arterial embolism, minor burns, and medical devices."

Answered by AI

Are there any patients needed to complete this testing phase of the treatment?

"The research project is not presently recruiting patients, as per information available on clinicaltrials.gov. The trial was initially advertised on September 15th 2020 and last updated June 17th 2022. There are 1663 other ongoing studies that are actively looking for participants."

Answered by AI
Recent research and studies
~13 spots leftby Apr 2025