Zinc plus phytase given before botulinum toxin injections for overactive bladder

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

This trial will test whether a short course of oral zinc plus phytase before botulinum toxin bladder injections helps adult women with overactive bladder go longer without needing another injection over six months.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 21 Years to 100 Years
• Sex: Female
• Sponsor: Endeavor Health (other)
• Drugs / interventions: radiation
• Locations: 1 site (Skokie, Illinois)
• Trial ID: NCT07405554 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 2 trial in which eligible adult female patients receive either oral zinc plus phytase or matching placebo for five days before intradetrusor botulinum toxin injection. Participants are followed for six months to record need for repeat injections, urinary symptom diaries, and patient-reported outcomes. The primary outcome is the proportion of patients requiring repeat botulinum toxin treatment within six months; secondary outcomes include changes in urgency urinary incontinence episodes, symptom severity scores, duration of response, and safety/tolerability. The rationale is that zinc is a cofactor for botulinum toxin activity and phytase may improve zinc absorption, so short-course supplementation might modify clinical response.

Who should consider this trial

Good fit: Adult non-pregnant women (≥21 years) with refractory urgency urinary incontinence who have at least six urgency incontinence episodes over a 3-day baseline diary and meet the trial's contraception and medication criteria are ideal candidates.

Not a fit: People who are male, pregnant, have fewer than the required baseline incontinence episodes, or whose symptoms are already well controlled are unlikely to benefit from this intervention as studied.

Why it matters

Potential benefit: If successful, supplementation could extend the time between botulinum toxin injections and reduce urinary symptoms for patients with refractory overactive bladder.

How similar studies have performed: Botulinum toxin for overactive bladder is an established therapy, but the use of zinc plus phytase as a pre-treatment to modify toxin response is novel with limited prior clinical data.

Eligibility criteria

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 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 Criteria:

* 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 this trial is running

Skokie, Illinois

• Endeavor Health — Skokie, Illinois, United States (RECRUITING)

Study contacts

• Principal investigator: Ghazaleh Rostami Nia, MD — Endeavor Health
• Study coordinator: Ana Burgos, MD

Conditions: Overactive Bladder, overactive bladder, botulinum toxin, zinc