Zinc + Botulinum Toxin for Overactive Bladder

AB
JL
Overseen ByJungeun Lee
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether taking zinc (specifically zinc citrate) and phytase supplements before a botulinum toxin injection can benefit individuals with overactive bladder. The goal is to determine if these supplements affect the injection's effectiveness in reducing symptoms like frequent urgent bathroom trips. Participants will receive either the supplements or a placebo (a pill with no active ingredients) for five days before the injection. Women who have tried other treatments without success and experience frequent urgent incontinence episodes may be suitable for this trial. Researchers will monitor participants for six months to observe symptom changes and assess the need for another injection. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

Yes, if you are currently taking anticholinergic or antimuscarinic/Beta 3 agonist medications, you will need to stop them for 3 weeks before starting the trial and remain off them during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining zinc with phytase improves zinc absorption. While specific research on zinc and phytase for overactive bladder is lacking, zinc supplements are generally safe and rarely cause major side effects when taken in normal amounts.

Botulinum toxin, another component of the trial, is already used safely for various health issues, including overactive bladder. It is generally safe, though some individuals may experience mild side effects such as urinary tract infections or temporary difficulty emptying the bladder.

This is a Phase 2 trial, indicating that earlier studies have suggested the treatment is likely safe and worth testing in more people. Participants will be closely monitored to quickly manage any side effects.12345

Why do researchers think this study treatment might be promising for overactive bladder?

Researchers are excited about the zinc plus botulinum toxin approach for overactive bladder because it offers a new way to enhance the effectiveness of botulinum toxin, a common treatment for this condition. Unlike standard treatments like anticholinergics, which focus on blocking nerve signals, this combination uses zinc citrate alongside botulinum toxin to potentially improve its uptake and duration of effect. This novel mechanism could lead to faster relief and longer-lasting benefits, making it a promising option for those who don’t respond well to existing therapies.

What evidence suggests that this trial's treatments could be effective for overactive bladder?

This trial will compare the effects of zinc with phytase to a placebo in enhancing the effectiveness of botulinum toxin injections for treating an overactive bladder. Research has shown that taking zinc with phytase might improve the efficacy of botulinum toxin injections. Studies have found that adding zinc to this treatment could help reduce sudden urges to urinate. Zinc might boost the effects of the botulinum toxin, possibly leading to fewer bladder control problems. Earlier findings suggest that this combination might provide better relief from symptoms than using botulinum toxin alone. Overall, these early results offer hope for people seeking more effective solutions for overactive bladder issues.16789

Who Is on the Research Team?

GR

Ghazaleh Rostami Nia, MD

Principal Investigator

Endeavor Health

Are You a Good Fit for This Trial?

This trial is for non-pregnant adult women at least 21 years old with overactive bladder who've tried at least one conservative treatment without success. They must be able to self-catheterize, not currently pregnant or breastfeeding, and willing to stop certain bladder medications before the study.

Inclusion Criteria

≥ 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
My urgent urinary incontinence hasn't improved despite trying at least one conservative treatment.
I am a woman over 21, not pregnant, not planning to become pregnant, and using birth control if needed.
See 5 more

Exclusion Criteria

Uninvestigated hematuria
I have or had bladder cancer.
I have had surgery to modify the bladder muscle.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment

Participants receive oral zinc plus phytase supplementation or placebo for five days prior to intradetrusor botulinum toxin injection

1 week
1 visit (in-person)

Treatment

Participants undergo intradetrusor botulinum toxin injection

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with remote follow-up assessments every four weeks for six months

6 months
6 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Zinc Citrate

Trial Overview

The trial tests if taking oral zinc plus phytase supplements improves the effect of botulinum toxin injections in treating overactive bladder. Participants will either receive these supplements or a placebo for five days before their injection and will be monitored for six months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Zinc + Phytase GroupExperimental Treatment1 Intervention
Group II: Placebo GroupPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Endeavor Health

Lead Sponsor

Trials
135
Recruited
742,000+

Citations

Zinc Supplementation With Botulinum Toxin for Overactive ...

Secondary Objectives: To evaluate whether zinc plus phytase supplementation reduces urgency urinary incontinence episodes compared with placebo.

Effectiveness of Combined Behavioral and Drug Therapy for ...

This randomized clinical trial evaluates whether combining behavioral and drug therapies improves outcomes compared with each therapy alone for overactive ...

Comparison of Different Treatment Outcomes for Refractory ...

The current meta-analysis revealed clinically important differences between intradetrusor BoNT-A injections and SNM for refractory overactive bladder in adult ...

Comparison of Different Treatments for Overactive Bladder ...

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers ...

:: International Neurourology Journal

Combining silodosin with solifenacin significantly improved OAB symptoms and QoL in females. This combination therapy was particularly effective in reducing ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31416636/

Efficacy and Safety of Combination Pharmacotherapy for ...

Conclusions: Mirabegron plus solifenacin provides effective, well-tolerated treatment for patients with OAB. Limited data for dual antimuscarinic therapy ...

Botulinum Toxin Effects and Its Association with Vitamin ...

Consequently, the co-administration of phytase with zinc supplements could enhance zinc bioavailability. However, independent scientific critique of the ...

Current pharmacotherapy of overactive bladder - PMC - NIH

In long term administration (52 weeks), the combination remained effective and safe (111). When mirabegron is the first drug to be introduced and patients ...

a new solution for an old problem?

Combination pharmacotherapy for the treatment of the overactive bladder syndrome: a new solution for an old problem? November 2019 ...