Zinc Supplementation With Botulinum Toxin for Overactive Bladder
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Overactive Bladder (OAB)
In brief
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.
Key facts
- Study ID
- NCT07405554
- Run by
- Endeavor Health
- People needed
- 72
- Starts
- 2026-02-26
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-07-02
Who can join
Age: 21 and older, up to 100. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Endeavor Health — Skokie, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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