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

No Placebo-Only Group

Summary

This trial compares two treatments for chronic bladder pain: a mixture of heparin and a numbing medicine put directly into the bladder, and Botox injections into the bladder muscle. The goal is to find out which treatment works better for people with interstitial cystitis or bladder pain syndrome, conditions that cause ongoing bladder pain and discomfort. Another treatment being studied is Prolotherapy, which involves injecting solutions like dextrose to reduce pain and promote tissue growth.

Eligible Conditions

Interstitial Cystitis
Painful Bladder Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4-6 weeks, 8-10 weeks, 6-9 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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