Zinc Supplementation With Botulinum Toxin for Overactive Bladder

NCT07405554 | Recruiting Phase 2 FDA Drug

• 1 other identifier: STUDY00000194
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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)

Keywords

overactive bladder; botulinum toxin; zinc

Outcome Measures

Primary Outcomes (1)

• Number of patients needing repeat intradetrusor botulinum toxin injection at 6 months

  Number of patients who subjectively report a need for repeat intradetrusor botulinum toxin injection at 6 months following the index injection.

  6 months

Secondary Outcomes (3)

• Urge urinary incontinence episodes assessed by 3-day Bladder Diaries

  6 months

• Urge urinary incontinence episodes assessed by PFDI-20 scores

  6 months

• Adverse events

  6 months

Study Arms (2)

Zinc + Phytase Group

EXPERIMENTAL

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

Drug: Zinc Citrate Oral Capsule

Placebo Group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Zinc Citrate Oral Capsule DRUG

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

Zinc + Phytase Group

Placebo DRUG

Placebo oral capsule

Placebo Group

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

Endeavor Health

Skokie, Illinois, 60076, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ghazaleh Rostami Nia, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Burgos, MD

CONTACT

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

Jungeun Lee

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research Division of Urogynecology, NorthShore University HealthSystem

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 12, 2026
• Study Start: February 26, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)