Effect of Zinc Supplementation on Botulinum Toxin for Overactive Bladder: A Randomized, Double-Blind, Placebo-Controlled Trial
Endeavor Health
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.
Description
BACKGROUND AND RATIONALE Intradetrusor botulinum toxin injection is an established treatment for overactive bladder (OAB) refractory to behavioral and pharmacologic therapy. However, duration of therapeutic effect varies among patients, and repeat injections are frequently required. Botulinum toxin activity depends on enzymatic cleavage of synaptic proteins involved in acetylcholine release, and zinc is a cofactor that may influence toxin activity. Phytase may enhance zinc bioavailability by improving intestinal absorption. This study evaluates whether short-course oral zinc plus phytase sup…
Eligibility
- Age range
- 21–100 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 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 persis…
Interventions
- DrugZinc Citrate Oral Capsule
Zinc citrate 50mg combined with 7,500 phytase units in an oral capsule
- DrugPlacebo
Placebo oral capsule
Location
- Endeavor HealthSkokie, Illinois