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Zinc Supplementation for Overactive Bladder

This study is looking at whether adding an oral zinc supplement (Zinc Citrate Oral Capsule) can help people with overactive bladder (OAB) who are also getting botulinum toxin injections. You would receive either the zinc supplement or a placebo (an inactive pill) for five days before your botulinum toxin injection. Researchers want to see if the zinc helps the botulinum toxin work better or last longer, meaning you might not need another injection as soon. They will also track your urinary symptoms and how you feel about your OAB. This study is for women aged 21 to 100 who have at least 6 urgency urinary incontinence episodes over three days.

Study design
This is a randomized, double-blind, placebo-controlled study with 72 participants. This means participants are randomly assigned to receive either the active treatment or a placebo, and neither you nor your doctors will know which you are receiving.
What's involved
You would take an oral capsule for five days before your botulinum toxin injection. You will then be followed for six months after the injection to assess your need for repeat treatment and your symptoms.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for six months after treatment.

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NCT07405554

Zinc Supplementation With Botulinum Toxin for Overactive Bladder

Recruiting
PHASE2Ages 21+InterventionalTreatment
Endeavor Health
~72 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:Zinc Citrate Oral CapsulePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients needing repeat intradetrusor botulinum toxin injection at 6 months
Measured over 6 months

Conditions

Overactive Bladder (OAB)

Explore related trials

Overactive Bladder

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Ghazaleh Rostami Nia, MD · PRINCIPAL_INVESTIGATOR · Endeavor Health

Who to contact

Ana Burgos, MD
[email protected]
847-570-4729
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Non-pregnant adult female at least 21 years old, with no plans to become pregnant during the course of the trial) and if of child-bearing potential, with a negative pregnancy test, and if sexually active, must be using medically acceptable contraception.
≥ 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.
Willing and able to complete all study related items and interviews.
Refractory urgency urinary incontinence: defined as persistent symptoms despite at least one or more conservative treatments (e.g. supervised behavioral therapy, supervised physical therapy)
Persistent symptoms despite the use of a minimum of two anticholinergics, or unable to tolerate medication due to side effects, or has a contraindication to taking anticholinergic/Beta 3 agonist medication.
Currently not on an anticholinergic or antimuscarinic/Beta 3 agonist medication (e.g. oxybutynin, tolterodine, darifenacin, trospium chloride, solifenacin-succinate, fesoterodine and/or mirabegron) or be willing to stop medication for 3 weeks prior to completing baseline bladder diary and expected to remain off medications through duration of study.
Demonstrates ability (or have caregiver demonstrate ability) to perform clean intermittent self-catheterization.
Grossly neurologically normal on exam and no gross systemic neurologic conditions believed to affect urinary function.

Exclusion

Neurologic diseases such as multiple sclerosis, Parkinson Disease, CVA within 6 months prior to enrollment, myasthenia gravis, Charcot-Marie-Tooth disease, clinically significant peripheral neuropathy, and complete spinal cord injury.
Untreated urinary tract infection (UTI).
Any prior use of either study therapy for treatment of urinary urge incontinence (Botox A® or Interstim®).
PVR \>150 ml on 2 occasions within 6 months prior to enrollment (If the PVR value was obtained by ultrasound and was ≥150 ml, the PVR will be confirmed by catheterization which will be the gold standard).
Current or prior bladder malignancy.
Surgically altered detrusor muscle, such as augmentation cystoplasty.
Subjects taking aminoglycosides.
Currently pregnant or lactating.
Allergy to lidocaine or bupivacaine.
Prior pelvic radiation.
Uninvestigated hematuria.

What this trial measures

  • Number of patients needing repeat intradetrusor botulinum toxin injection at 6 months6 months

    Number of patients who subjectively report a need for repeat intradetrusor botulinum toxin injection at 6 months following the index injection.