Effect of Zinc Supplementation on Botulinum Toxin for Overactive Bladder: A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Number of patients needing repeat intradetrusor botulinum toxin injection at 6 months
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Zinc + Phytase Group
Participants will receive zinc + phytase capsules for five days prior to the scheduled procedure date.
干预措施: Zinc Citrate Oral Capsule (Drug)
Placebo Group
Participants will receive placebo capsules for five days prior to the scheduled procedure date.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of patients needing repeat intradetrusor botulinum toxin injection at 6 months
时间窗: 6 months
Number of patients who subjectively report a need for repeat intradetrusor botulinum toxin injection at 6 months following the index injection.
次要结局
- Adverse events(6 months)
- Urge urinary incontinence episodes assessed by 3-day Bladder Diaries(6 months)
- Urge urinary incontinence episodes assessed by PFDI-20 scores(6 months)
研究者
Ghazaleh Rostami Nia
Director of Research Division of Urogynecology, NorthShore University HealthSystem
Endeavor Health