Overactive Bladder (OAB)Phase 2NCT07405554
Zinc Supplementation With Botulinum Toxin for Overactive Bladder
A Phase 2 study testing Zinc Citrate Oral Capsule in people with Overactive Bladder (OAB), run by Endeavor Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 100 years, women only
- Conditions the study is for
- Overactive Bladder (OAB)
- What is being tested?
- Zinc Citrate Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2026to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Subjects taking aminoglycosides.
- Currently pregnant or lactating.
- Allergy to lidocaine or bupivacaine.
- Prior pelvic radiation.
- Uninvestigated hematuria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Endeavor Health
Skokie, Illinois, 60076
Ana Burgos, MD, 847-570-4729, ana.burgos@endeavorhealth.org
Ghazaleh Rostami Nia, MD
About this study
Official title: Effect of Zinc Supplementation on Botulinum Toxin for Overactive Bladder: A Randomized, Double-Blind, Placebo-Controlled Trial
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.
Read the detailed 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 supplementation administered prior to intradetrusor botulinum toxin injection alters clinical response to treatment.
STUDY OBJECTIVES
Primary Objective:
To determine whether oral zinc plus phytase supplementation prior to intradetrusor botulinum toxin injection reduces the proportion of patients requiring repeat intradetrusor botulinum toxin treatment within 6 months.
Secondary Objectives:
- To evaluate whether zinc plus phytase supplementation reduces urgency urinary incontinence episodes compared with placebo.
- To evaluate changes in overactive bladder symptom severity and patient-reported outcomes following treatment.
- To evaluate duration of clinical response following intradetrusor botulinum toxin injection.
- To evaluate safety and tolerability of short-course zinc plus phytase supplementation in this population.
STUDY DESIGN
This is a prospective, randomized, double-blind, placebo-controlled trial.
Participants with overactive bladder who are scheduled to undergo intradetrusor botulinum toxin injection as part of routine clinical care will be enrolled and randomized in a 1:1 ratio to receive either:
- Oral zinc plus phytase supplementation, or
- Matching placebo
Study medication will be administered for five days prior to the scheduled intradetrusor botulinum toxin injection.
Participants, investigators, and study personnel involved in outcome assessment will remain blinded to treatment assignment.
STUDY PROCEDURES
Participants will undergo intradetrusor botulinum toxin injection according to standard clinical practice.
Following injection, participants will complete remote follow-up assessments every four weeks for six months. Assessments will include:
- Bladder diaries
- Urinary symptom questionnaires
- Patient-reported outcome measures
- Assessment of retreatment status
- Conditions
- Overactive Bladder (OAB)
- Being tested
- Zinc Citrate Oral Capsule, Placebo
- Keywords
- overactive bladder, botulinum toxin, zinc
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc Citrate Oral CapsuleDrug
Zinc citrate 50mg combined with 7,500 phytase units in an oral capsule
PlaceboDrug
Placebo oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Zinc + Phytase Group | Experimental | Participants will receive zinc + phytase capsules for five days prior to the scheduled procedure date. Receives: Drug: Zinc Citrate Oral Capsule |
| Placebo Group | Placebo comparator | Participants will receive placebo capsules for five days prior to the scheduled procedure date. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
Urge urinary incontinence episodes assessed by 3-day Bladder Diaries
Mean number of urge urinary incontinence episodes based on 3-day bladder diaries
Measured: 6 months
Urge urinary incontinence episodes assessed by PFDI-20 scores
Mean score on the Pelvic Floor Distress Inventory-20 (PFDI-20), a validated 20-item questionnaire assessing pelvic floor symptom distress. Total scores range from 0 to 300, with higher scores indicating greater symptom burden (worse outcome).
Measured: 6 months
Adverse events
Any adverse events that occur after intervention is administered.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start26 Feb 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder (OAB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghazaleh Rostami Nia, Endeavor Health
- Investigators
- Ghazaleh Rostami Nia, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405554
- Sponsor's protocol ID
- STUDY00000194
- Status last verified
- Jul 2026
- First submitted
- 5 Feb 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Zinc Supplementation on Botulinum Toxin for Overactive Bladder: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07405554
- Acronym / sponsor ID
- STUDY00000194
- Conditions
- Overactive Bladder (OAB)
- Keywords
- overactive bladder, botulinum toxin, zinc
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 supplementation administered prior to intradetrusor botulinum toxin injection alters clinical response to treatment.
STUDY OBJECTIVES
Primary Objective:
To determine whether oral zinc plus phytase supplementation prior to intradetrusor botulinum toxin injection reduces the proportion of patients requiring repeat intradetrusor botulinum toxin treatment within 6 months.
Secondary Objectives:
- To evaluate whether zinc plus phytase supplementation reduces urgency urinary incontinence episodes compared with placebo.
- To evaluate changes in overactive bladder symptom severity and patient-reported outcomes following treatment.
- To evaluate duration of clinical response following intradetrusor botulinum toxin injection.
- To evaluate safety and tolerability of short-course zinc plus phytase supplementation in this population.
STUDY DESIGN
This is a prospective, randomized, double-blind, placebo-controlled trial.
Participants with overactive bladder who are scheduled to undergo intradetrusor botulinum toxin injection as part of routine clinical care will be enrolled and randomized in a 1:1 ratio to receive either:
- Oral zinc plus phytase supplementation, or
- Matching placebo
Study medication will be administered for five days prior to the scheduled intradetrusor botulinum toxin injection.
Participants, investigators, and study personnel involved in outcome assessment will remain blinded to treatment assignment.
STUDY PROCEDURES
Participants will undergo intradetrusor botulinum toxin injection according to standard clinical practice.
Following injection, participants will complete remote follow-up assessments every four weeks for six months. Assessments will include:
- Bladder diaries
- Urinary symptom questionnaires
- Patient-reported outcome measures
- Assessment of retreatment status
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zinc + Phytase Group | Experimental | Drug: Zinc Citrate Oral CapsuleParticipants will receive zinc + phytase capsules for five days prior to the scheduled procedure date. |
| Placebo Group | Placebo comparator | Drug: PlaceboParticipants will receive placebo capsules for five days prior to the scheduled procedure date. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc Citrate Oral CapsuleZinc citrate 50mg combined with 7,500 phytase units in an oral capsule | Drug | Zinc + Phytase Group |
| PlaceboPlacebo oral capsule | Drug | Placebo Group |
Primary outcome
Number of patients needing repeat intradetrusor botulinum toxin injection at 6 months
Time frame: 6 months
Number of patients who subjectively report a need for repeat intradetrusor botulinum toxin injection at 6 months following the index injection.
3 secondary outcomes
Urge urinary incontinence episodes assessed by 3-day Bladder Diaries
Time frame: 6 months
Urge urinary incontinence episodes assessed by PFDI-20 scores
Time frame: 6 months
Adverse events
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ghazaleh Rostami Nia, MD principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zinc Citrate Oral Capsule in people with Overactive Bladder (OAB), run by Endeavor Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Burgos, MD (847-570-4729, ana.burgos@endeavorhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients needing repeat intradetrusor botulinum toxin injection at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026; AzTrials last refreshed its copy on 30 Oct 2026.