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New treatment option for Overactive Bladder (OAB)
Official title Zinc Supplementation With Botulinum Toxin for Overactive Bladder
ClinicalTrials.gov ID: NCT07405554
What this study is testing
What is Zinc Citrate Oral Capsule?
Zinc Citrate Oral Capsule is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for overactive bladder (oab).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 100, women only
You may be able to join 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...
- ≥ 6 urgency urinary incontinence episodes on a 3-day baseline bladder diary, with these urge incontinence episodes representing greater than 50% of...
- 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...
- Persistent symptoms despite the use of a minimum of two anticholinergics, or unable to tolerate medication due to side effects, or has a...
You likely can't join if
- Neurologic diseases such as multiple sclerosis, Parkinson Disease, CVA within 6 months prior to enrollment, myasthenia gravis, Charcot-Marie-Tooth...
- 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...
- Current or prior bladder malignancy.
- Surgically altered detrusor muscle, such as augmentation cystoplasty.
See the full eligibility 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...
- ≥ 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...
- 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.
- 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...
- 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.
- people taking aminoglycosides.
- Currently pregnant or lactating.
- Allergy to lidocaine or bupivacaine.
- Prior pelvic radiation.
- Uninvestigated hematuria.
The study team makes the final eligibility decision.
Where it's taking place
- Skokie, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 21 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Skokie, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.