Recruiting
Phase 2

Zinc & Phytase

Sponsor:

Endeavor Health

Code:

NCT07405554

Conditions

Overactive Bladder (OAB)

Eligibility Criteria

Sex: Female

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Zinc Citrate Oral Capsule

Placebo

Study Details

Brief 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.

Conditions

Overactive Bladder (OAB)

Study ID

NCT07405554

Start date

Feb 26, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Zinc + Phytase Group

Participants will receive zinc + phytase capsules for five days prior to the scheduled procedure date.

placebo comparator: Placebo Group

Participants will receive placebo capsules for five days prior to the scheduled procedure date.

Interventions

Zinc Citrate Oral Capsule

Zinc citrate 50mg combined with 7,500 phytase units in an oral capsule

Placebo

Placebo oral capsule

Primary outcome measure

  • Number of patients needing repeat intradetrusor botulinum toxin injection at 6 months [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Ana Burgos, MD

847-570-4729ana.burgos@endeavorhealth.org

Jungeun Lee

847-570-4729jungeun.lee@endeavorhealth.org

Locations

Endeavor Health

Recruiting

Skokie, Illinois, United States, 60076

Contacts

Ana Burgos, MD

847-570-4729ana.burgos@endeavorhealth.org

Principal Investigator:

Ghazaleh Rostami Nia, MD

More Information

Sponsor

Endeavor Health

Last update posted

Jul 2, 2026

Last verified

Jul, 2026

Keywords

  • overactive bladder
  • botulinum toxin
  • zinc

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Endeavor Health on 2026-07-02.