Actively Recruiting
Zinc Supplementation With Botulinum Toxin for Overactive Bladder
Led by Endeavor Health · Updated on 2026-02-27
72
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Zinc Supplementation With Botulinum Toxin for Overactive Bladder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, at least 21 years old, not pregnant or planning pregnancy during the trial, with a negative pregnancy test if of child-bearing potential, and using medically acceptable contraception if sexually active
- At least 6 urgency urinary incontinence episodes over a 3-day period, with these episodes being more than 50% of total incontinence episodes
- Willing and able to complete all study-related tasks and interviews
- Persistent urgency urinary incontinence despite one or more conservative treatments such as supervised behavioral or physical therapy
- Symptoms remain despite using at least two anticholinergic medications, or unable to tolerate these medications, or have contraindications to anticholinergic or Beta-3 agonist medications
- Not currently using anticholinergic or antimuscarinic/Beta-3 agonist medications or willing to stop these for 3 weeks before baseline diary and remain off during the study
- Able to perform or have caregiver assist with clean intermittent self-catheterization
- Neurologically normal with no systemic neurologic conditions affecting urinary function
You will not qualify if you...
- Neurologic diseases like multiple sclerosis, Parkinson disease, recent stroke within 6 months, myasthenia gravis, Charcot-Marie-Tooth disease, significant peripheral neuropathy, or complete spinal cord injury
- Untreated urinary tract infection
- Previous treatment with Botox A4 or Interstim4 for urinary urge incontinence
- Post-void residual volume over 150 ml on two occasions within 6 months before enrollment, confirmed by catheterization if ultrasound shows 2150 ml
- Current or past bladder cancer
- Surgically altered detrusor muscle such as augmentation cystoplasty
- Taking aminoglycoside antibiotics
- Currently pregnant or breastfeeding
- Allergy to lidocaine or bupivacaine
- Prior pelvic radiation therapy
- Unexplained blood in urine (hematuria)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Endeavor Health
Skokie, Illinois, United States, 60076
Actively Recruiting
Research Team
A
Ana Burgos, MD
CONTACT
J
Jungeun Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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