RecruitingPhase 2NCT07405554

Zinc Supplementation With Botulinum Toxin for Overactive Bladder

Effect of Zinc Supplementation on Botulinum Toxin for Overactive Bladder: A Randomized, Double-Blind, Placebo-Controlled Trial

Sponsor

Endeavor Health

Enrollment

72 participants

Start Date

Feb 26, 2026

Study Type

INTERVENTIONAL

Conditions

Overactive Bladder (OAB)

Summary

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.

Eligibility

Sex: FEMALEMin Age: 21 YearsMax Age: 100 Years

Inclusion Criteria8

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 Criteria11

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.

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