Efficacy of Probiotics for OAB Patients With Anxiety
ConditionOveractive Bladder (OAB)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorQilu Hospital of Shandong University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Multi-strain Probiotic Compound
Dietary supplementThe active intervention consists of a probiotic powder containing Lactobacillus plantarum DY-1, Lactobacillus casei KDB-LC, and Lactobacillus acidophilus KDB-03. The powder is to be dissolved in a glass of water and administered orally once a day for 12 weeks.
Placebo
Other interventionAn inactive placebo powder composed of inert excipients (maltodextrin) containing no active bacteria. It is visually and organoleptically identical to the active probiotic product (matching in color, texture, taste, and solubility). The powder is to be dissolved in a glass of water and administered orally once a day for 12 weeks.
Treatment groups
218 Participants
are divided into 2 treatment groupsGroup A: Probiotics + Standard Behavioral TherapyExperimental treatment 1 intervention
Group B: Placebo + Standard Behavioral TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in the Mean Number of Micturitions per 24 Hours
Assessed using a 3-day voiding diary. Participants record every voiding event over 3 consecutive days. The metric is calculated as the total number of micturitions divided by 3 to determine the mean daily frequency. A negative change (decrease) from baseline indicates an improvement in overactive bladder symptoms.
Time frame
Baseline (Week 0), Week 4, Week 8, and Week 12Secondary outcomes
1
Change in the Mean Number of Urgency Episodes per 24 Hours
Assessed using a 3-day voiding diary, where participants rate urgency for each voiding event on a 0-5 scale (0=no urgency, 5=severe urgency). The metric is calculated as the mean number of urgency episodes per day. A decrease in the number of episodes from baseline indicates symptom improvement.
Time frame
Baseline (Week 0), Week 4, Week 8, and Week 122
Change in the Mean Number of Urgency Urinary Incontinence (UUI) Episodes per 24 Hours
Assessed using a 3-day voiding diary, recording urine leakage (in mL). UUI is defined as the involuntary leakage of urine associated with urgency. The metric is calculated as the mean number of UUI episodes per day. A decrease from baseline indicates symptom improvement.
Time frame
Baseline (Week 0), Week 4, Week 8, and Week 123
Change in Mean Volume Voided per Micturition
Assessed using a 3-day voiding diary. The value is calculated by dividing the total volume of urine voided over the 3-day period by the total number of micturitions during that same period, measured in milliliters (mL). An increase from baseline indicates improved functional bladder capacity.
Time frame
Baseline (Week 0), Week 4, Week 8, and Week 124
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
The GAD-7 is a standardized questionnaire used to measure the severity of anxiety. It consists of 7 items, each scored from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 21. Higher scores indicate greater severity of anxiety symptoms. A decrease in the total score from baseline indicates clinical improvement.
Time frame
Baseline (Week 0), Week 4, Week 8, and Week 12Sponsors and contacts
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Source ClinicalTrials.gov
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