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
Qualifiers
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
Treatments tested in this trial
- Multi-strain Probiotic Compound
- Placebo
Treatment groups
218 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov