Health TrialsbyHealthPanel

Zinc Supplementation With Botulinum Toxin for Overactive Bladder

ConditionOveractive Bladder (OAB)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age21-100
SponsorEndeavor Health

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Zinc Citrate Oral Capsule

    Drug

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

  • Placebo

    Drug

    Placebo oral capsule

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Zinc + Phytase GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
6 months

Secondary outcomes

1

Urge urinary incontinence episodes assessed by 3-day Bladder Diaries

Mean number of urge urinary incontinence episodes based on 3-day bladder diaries

Time frame
6 months
2

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).

Time frame
6 months
3

Adverse events

Any adverse events that occur after intervention is administered.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Endeavor Health

Lead sponsor

Source ClinicalTrials.gov
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