Efficacy of Probiotics for OAB Patients With Anxiety (NCT07635212) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy of Probiotics for OAB Patients With Anxiety
China218 participantsStarted 2026-07-01
Plain-language summary
The goal of this clinical trial is to learn if probiotics can help improve symptoms in adults with overactive bladder (OAB) and anxiety. The main questions it aims to answer are:
1. Does taking probiotics lower the number of times participants need to urinate in a 24-hour period?
2. Does taking probiotics lower participants' anxiety levels?
Researchers will compare probiotics to a placebo (a look-alike powder that contains no active bacteria) to see if the probiotics work better to treat OAB and anxiety when both groups also use standard behavioral therapy (like bladder training).
Participants will:
1. Take probiotics or a placebo twice a day for 12 weeks.
2. Learn and practice bladder training using a manual and educational videos.
3. Keep a 3-day diary of when they urinate and what they drink at the beginning, middle, and end of the study.
4. Answer survey questions about their anxiety and quality of life during clinic visits.
5. Provide urine samples for routine checkups to ensure they do not have infections.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged between 18 and 80 years old (inclusive).
. Able to understand study-related instructions and independently complete the required questionnaires.
. Able to provide written informed consent and willing to comply with all study requirements, including completing diaries/questionnaires and refraining from taking any other probiotic or prebiotic supplements during the 3-month study period.
. Meet the diagnostic criteria for Overactive Bladder (OAB) as defined by the International Continence Society (ICS) (urgency as the core symptom, with or without urgency urinary incontinence, frequency, and nocturia); have an Overactive Bladder Symptom Score (OABSS) ≥ 6; and have a daytime voiding frequency of ≥ 8 times.
. Have a preliminary diagnosis of "Generalized Anxiety Disorder" or "Anxiety state" assessed by a psychiatrist or trained investigator according to DSM-5 or ICD-10 criteria, or have a Generalized Anxiety Disorder-7 (GAD-7) scale score ≥ 5.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the Mean Number of Micturitions per 24 Hours
. If previously using any over-the-counter medications or other products for anxiety relief (e.g., magnesium, melatonin, anticholinergic drugs) or receiving psychotherapy, these must have been discontinued for at least 4 weeks prior to randomization and must remain completely discontinued throughout the entire study period.
Exclusion criteria
. Presence of organic diseases of the urinary system (e.g., urinary tract obstruction, tumors, stones, acute infection, interstitial cystitis, stress urinary incontinence).
. Neurogenic bladder caused by neurological diseases or a history of pelvic surgery.
. Use of antibiotics, probiotics, or prebiotics within the past 1 month prior to screening.
. Any adjustment to medications used for treating OAB or anxiety within the past 2 weeks prior to screening.
. Pregnant or lactating women, or individuals with a known allergy to any components of the study preparation.
. Suffering from other severe psychiatric/psychological disorders or severe systemic diseases (e.g., uncontrolled diabetes mellitus, severe obesity).