Zinc + Botulinum Toxin for Overactive Bladder

Overseen By Jungeun Lee

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Endeavor Health

Must not be taking: Aminoglycosides

Disqualifiers: Neurologic diseases, Bladder malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This randomized, double-blind, placebo-controlled trial evaluates whether oral zinc plus phytase supplementation modifies clinical response to intradetrusor botulinum toxin injection in patients with overactive bladder. Participants will receive either zinc plus phytase supplementation or matching placebo for five days prior to intradetrusor botulinum toxin injection. Participants will be followed for six months after treatment to assess need for repeat botulinum toxin injection, urinary symptoms, and patient-reported outcomes related to overactive bladder.

Who Is on the Research Team?

Ghazaleh Rostami Nia, MD

Principal Investigator

Endeavor Health

Are You a Good Fit for This Trial?

Inclusion Criteria

≥ 6 urgency urinary incontinence episodes on a 3-day baseline bladder diary, with these urge incontinence episodes representing greater than 50% of the total incontinent episodes recorded

My urgent urinary incontinence hasn't improved despite trying at least one conservative treatment.

I am a woman over 21, not pregnant, not planning to become pregnant, and using birth control if needed.

Exclusion Criteria

Uninvestigated hematuria

I have or had bladder cancer.

I have had surgery to modify the bladder muscle.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment

Participants receive oral zinc plus phytase supplementation or placebo for five days prior to intradetrusor botulinum toxin injection

1 week

1 visit (in-person)

Treatment

Participants undergo intradetrusor botulinum toxin injection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with remote follow-up assessments every four weeks for six months

6 months

6 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Zinc Citrate

How Is the Trial Designed?

Group I: Zinc + Phytase Group Experimental Treatment 1 Intervention

Participants will receive zinc + phytase capsules for five days prior to the scheduled procedure date.

Group II: Placebo Group Placebo Group 1 Intervention

Participants will receive placebo capsules for five days prior to the scheduled procedure date.

Who Is Running the Clinical Trial?

Endeavor Health

Lead Sponsor

Trials

135

Recruited

742,000+