[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07405554":3,"trial-entities:NCT07405554":116,"trial-summary:NCT07405554":120},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":43,"secondary_outcomes":48,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":15,"eligibility_criteria":61,"std_ages":84,"locations":87,"central_contacts":107,"overall_officials":112,"references":114,"see_also_links":115},"NCT07405554","STUDY00000194","Zinc Supplementation With Botulinum Toxin for Overactive Bladder","Effect of Zinc Supplementation on Botulinum Toxin for Overactive Bladder: A Randomized, Double-Blind, Placebo-Controlled Trial","RECRUITING","2026-12","2026-07","2026-07-02","2026-02-26","Endeavor Health","OTHER",false,"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.","BACKGROUND AND RATIONALE\n\nIntradetrusor 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.\n\nThis study evaluates whether short-course oral zinc plus phytase supplementation administered prior to intradetrusor botulinum toxin injection alters clinical response to treatment.\n\nSTUDY OBJECTIVES\n\nPrimary Objective:\n\nTo 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.\n\nSecondary Objectives:\n\n* To evaluate whether zinc plus phytase supplementation reduces urgency urinary incontinence episodes compared with placebo.\n* To evaluate changes in overactive bladder symptom severity and patient-reported outcomes following treatment.\n* To evaluate duration of clinical response following intradetrusor botulinum toxin injection.\n* To evaluate safety and tolerability of short-course zinc plus phytase supplementation in this population.\n\nSTUDY DESIGN\n\nThis is a prospective, randomized, double-blind, placebo-controlled trial.\n\nParticipants 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:\n\n* Oral zinc plus phytase supplementation, or\n* Matching placebo\n\nStudy medication will be administered for five days prior to the scheduled intradetrusor botulinum toxin injection.\n\nParticipants, investigators, and study personnel involved in outcome assessment will remain blinded to treatment assignment.\n\nSTUDY PROCEDURES\n\nParticipants will undergo intradetrusor botulinum toxin injection according to standard clinical practice.\n\nFollowing injection, participants will complete remote follow-up assessments every four weeks for six months. Assessments will include:\n\n* Bladder diaries\n* Urinary symptom questionnaires\n* Patient-reported outcome measures\n* Assessment of retreatment status",[19],"Overactive Bladder (OAB)",[21,22,23],"overactive bladder","botulinum toxin","zinc","INTERVENTIONAL","TREATMENT",[27],"PHASE2",{"count":29,"type":30},72,"ESTIMATED",[32,38],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","Zinc Citrate Oral Capsule","Zinc citrate 50mg combined with 7,500 phytase units in an oral capsule",[37],"Zinc + Phytase Group",{"type":33,"name":39,"description":40,"armGroupLabels":41},"Placebo","Placebo oral capsule",[42],"Placebo Group",[44],{"measure":45,"description":46,"timeFrame":47},"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.","6 months",[49,52,55],{"measure":50,"description":51,"timeFrame":47},"Urge urinary incontinence episodes assessed by 3-day Bladder Diaries","Mean number of urge urinary incontinence episodes based on 3-day bladder diaries",{"measure":53,"description":54,"timeFrame":47},"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).",{"measure":56,"description":57,"timeFrame":47},"Adverse events","Any adverse events that occur after intervention is administered.","FEMALE","21 Years","100 Years",{"inclusion":62,"exclusion":71,"raw_text":83},[63,64,65,66,67,68,69,70],"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\u002FBeta 3 agonist medication.","Currently not on an anticholinergic or antimuscarinic\u002FBeta 3 agonist medication (e.g. oxybutynin, tolterodine, darifenacin, trospium chloride, solifenacin-succinate, fesoterodine and\u002For 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.",[72,73,74,75,76,77,78,79,80,81,82],"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.","Inclusion Criteria:\n\n* 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.\n* ≥ 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.\n* Willing and able to complete all study related items and interviews.\n* Refractory urgency urinary incontinence: defined as persistent symptoms despite at least one or more conservative treatments (e.g. supervised behavioral therapy, supervised physical therapy)\n* 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\u002FBeta 3 agonist medication.\n* Currently not on an anticholinergic or antimuscarinic\u002FBeta 3 agonist medication (e.g. oxybutynin, tolterodine, darifenacin, trospium chloride, solifenacin-succinate, fesoterodine and\u002For 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.\n* Demonstrates ability (or have caregiver demonstrate ability) to perform clean intermittent self-catheterization.\n* Grossly neurologically normal on exam and no gross systemic neurologic conditions believed to affect urinary function.\n\nExclusion Criteria:\n\n* 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.\n* Untreated urinary tract infection (UTI).\n* Any prior use of either study therapy for treatment of urinary urge incontinence (Botox A® or Interstim®).\n* 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).\n* Current or prior bladder malignancy.\n* Surgically altered detrusor muscle, such as augmentation cystoplasty.\n* Subjects taking aminoglycosides.\n* Currently pregnant or lactating.\n* Allergy to lidocaine or bupivacaine.\n* Prior pelvic radiation.\n* Uninvestigated hematuria.",[85,86],"ADULT","OLDER_ADULT",[88],{"facility":13,"status":8,"city":89,"state":90,"zip":91,"country":92,"contacts":93,"geoPoint":104},"Skokie","Illinois","60076","United States",[94,99,102],{"name":95,"role":96,"phone":97,"email":98},"Ana Burgos, MD","CONTACT","847-570-4729","ana.burgos@endeavorhealth.org",{"name":100,"role":101},"Ghazaleh Rostami Nia, MD","PRINCIPAL_INVESTIGATOR",{"name":95,"role":103},"SUB_INVESTIGATOR",{"lat":105,"lon":106},42.03336,-87.73339,[108,109],{"name":95,"role":96,"phone":97,"email":98},{"name":110,"role":96,"phone":97,"email":111},"Jungeun Lee","jungeun.lee@endeavorhealth.org",[113],{"name":100,"affiliation":13,"role":101},[],[],{"nct_id":4,"conditions":117,"biomarkers":119},[118],"Overactive Bladder",[],{"nct_id":4,"found":121,"summary":122,"prompt_version":132},true,{"design":123,"status":124,"heading":125,"summary":126,"follow_up":127,"word_count":128,"commitments":129,"compensation":130,"drugs_mentioned":131},"This is a randomized, double-blind, placebo-controlled study with 72 participants. This means participants are randomly assigned to receive either the active treatment or a placebo, and neither you nor your doctors will know which you are receiving.","completed","Zinc Supplementation for Overactive Bladder","This study is looking at whether adding an oral zinc supplement (Zinc Citrate Oral Capsule) can help people with overactive bladder (OAB) who are also getting botulinum toxin injections. You would receive either the zinc supplement or a placebo (an inactive pill) for five days before your botulinum toxin injection. Researchers want to see if the zinc helps the botulinum toxin work better or last longer, meaning you might not need another injection as soon. They will also track your urinary symptoms and how you feel about your OAB. This study is for women aged 21 to 100 who have at least 6 urgency urinary incontinence episodes over three days.","Participants will be followed for six months after treatment.",110,"You would take an oral capsule for five days before your botulinum toxin injection. You will then be followed for six months after the injection to assess your need for repeat treatment and your symptoms.","Not stated in the trial record.",[34,39],"v2"]