Overactive Bladder (OAB)NCT07635212
Efficacy of Probiotics for OAB Patients With Anxiety
A study testing Multi-strain Probiotic Compound in people with Overactive Bladder (OAB), run by Qilu Hospital of Shandong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Overactive Bladder (OAB)
- What is being tested?
- Multi-strain Probiotic Compound
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Qilu Hospital of Shandong University
Jinan, Shandong
Yan Li, doctor, +86 18560089113, yanli@sdu.edu.cn
About this study
Official title: Evaluating the Efficacy of Probiotics as an Adjunct to Behavioral Therapy in Patients With Overactive Bladder (OAB) and Anxiety Symptoms: A Randomized, Double-Blind, Placebo-Controlled 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:
- Does taking probiotics lower the number of times participants need to urinate in a 24-hour period?
- Does taking probiotics lower participants' anxiety levels?
Read more
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:
- Take probiotics or a placebo twice a day for 12 weeks.
- Learn and practice bladder training using a manual and educational videos.
- Keep a 3-day diary of when they urinate and what they drink at the beginning, middle, and end of the study.
- Answer survey questions about their anxiety and quality of life during clinic visits.
- Provide urine samples for routine checkups to ensure they do not have infections.
Read the detailed description
Background and Scientific Rationale Overactive bladder (OAB) is a prevalent chronic condition that severely impairs patients' quality of life. Accumulating epidemiological evidence highlights a high comorbidity rate between OAB and psychological disorders, particularly anxiety. These two conditions often exacerbate each other, forming a vicious pathological cycle: anxiety heightens central sensitivity to bladder fullness, while unpredictable urinary urgency worsens psychosocial stress. Current pharmacological mainstays, such as antimuscarinics and β3-adrenoceptor agonists, primarily target local bladder smooth muscle. They often fail to address the underlying psychological comorbidities and are frequently associated with intolerable adverse effects (e.g., dry mouth, constipation), leading to high discontinuation rates. There is an urgent clinical need for systemic, well-tolerated therapeutic strategies that address both physical and emotional symptoms.
Theoretical Framework: The Brain-Gut-Bladder Axis This trial is grounded in the emerging "Brain-Gut-Bladder Axis" model. Chronic stress and anxiety can trigger systemic low-grade inflammation and alter the gut microbiome, which in turn influences peripheral neural pathways and bladder afferent signaling. We hypothesize that targeted microecological interventions using specific "psychobiotics" can modulate this axis. Scientific literature suggests that select probiotic strains can communicate with the central nervous system via the vagus nerve and systemic metabolites. By doing so, they may downregulate the hypothalamic-pituitary-adrenal (HPA) axis, optimize the levels of inhibitory neurotransmitters (such as GABA and Serotonin), and suppress neurogenic inflammation.
Intervention Strategy To test this hypothesis, this study employs an "add-on" clinical trial design. All enrolled participants will receive standardized behavioral therapy, which remains the fundamental first-line treatment for OAB, consisting of bladder training and lifestyle modification instructions. On top of this standard of care, participants will be randomized to receive either a multi-strain probiotic compound or a visually and organoleptically matched placebo.
The active intervention utilizes a compound of food-grade, widely recognized safe bacterial strains: Lactobacillus plantarum, Bacillus coagulans, Lactobacillus casei, and Lactobacillus acidophilus. These specific strains were selected for their documented potential in immune regulation, anti-inflammatory properties, and central nervous system modulation.
Study Execution and Clinical Significance Throughout the 12-week intervention period, the study avoids invasive procedures or the collection of extensive biological samples for complex genomic sequencing. Instead, it relies on validated clinical instruments, patient diaries, and standard routine urinalysis (strictly for safety monitoring and infection exclusion) to track treatment trajectories.
By bridging urology and neurogastroenterology, this study seeks to provide high-quality, evidence-based data for a paradigm shift in OAB management. If proven effective, this probiotic-assisted approach will offer a safe, non-pharmacological "mind-body" co-treatment option, potentially breaking the anxiety-urgency cycle and significantly improving the comprehensive well-being of a difficult-to-treat patient population.
- Conditions
- Overactive Bladder (OAB)
- Being tested
- Multi-strain Probiotic Compound, Placebo
- Keywords
- probiotics, OAB, overactive bladder
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-strain Probiotic CompoundDietary supplement
Also called Lactobacillus plantarum, Lactobacillus casei, Lactobacillus acidophilus
The 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.
PlaceboOther
Also called Maltodextrin powder
An 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.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics + Standard Behavioral Therapy | Experimental | Participants assigned to this arm will receive a probiotic powder compound containing Lactobacillus plantarum, Lactobacillus casei, and Lactobacillus acidophilus. The probiotic powder will be dissolved in a glass of water and taken orally once a day for 12 weeks. In addition to the probiotic, participants will receive standard behavioral therapy for overactive bladder (OAB) administered by trained clinical staff. This comprehensive, individualized therapy includes six core modules: bowel management (e.g., dietary fiber intake), fluid and diet modification (e.g., limiting caffeine and other bladder irritants), weight and smoking management, bladder training (including voiding diaries, delayed voiding, and urge suppression techniques), pelvic floor muscle training (PFMT), and personalized follow-up adjustments. Receives: Dietary Supplement: Multi-strain Probiotic Compound |
| Placebo + Standard Behavioral Therapy | Experimental | Participants assigned to this arm will receive a placebo powder dissolved in a glass of water, taken orally once a day for 12 weeks. The placebo is composed of inert excipients (such as maltodextrin) and contains no active bacteria, but is identical to the active probiotic product in color, texture, taste, and solubility. In addition to the placebo, participants will receive the exact same standard behavioral therapy for OAB as the experimental group. This comprehensive, individualized therapy includes six core modules: bowel management, fluid and diet modification (e.g., limiting bladder irritants), weight and smoking management, bladder training (including voiding diaries, delayed voiding, and urge suppression techniques), pelvic floor muscle training (PFMT), and personalized follow-up adjustments. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0), Week 4, Week 8, and Week 12
Secondary outcomes (8)
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.
Measured: Baseline (Week 0), Week 4, Week 8, and Week 12
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.
Measured: Baseline (Week 0), Week 4, Week 8, and Week 12
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.
Measured: Baseline (Week 0), Week 4, Week 8, and Week 12
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.
Measured: Baseline (Week 0), Week 4, Week 8, and Week 12
Change in Overactive Bladder Symptom Score (OABSS)
The OABSS is a validated 4-item questionnaire assessing daytime frequency, nighttime frequency, urgency, and urgency urinary incontinence. The total score ranges from 0 to 15, derived from the sum of the four symptom scores. A higher score indicates more severe OAB symptoms. A decrease from baseline reflects clinical improvement.
Measured: Baseline (Week 0), Week 4, Week 8, and Week 12
Change in Overactive Bladder Questionnaire (OAB-q) Score
Assessed using a 13-item health-related quality of life and symptom bother questionnaire (OAB-q). Each item is rated on a 6-point Likert scale from 1 (never) to 6 (all the time). The total score ranges from 13 to 78. A higher score indicates worse symptom bother and a greater negative impact on the patient's quality of life. A decrease in score indicates improvement.
Measured: Baseline (Week 0) and Week 12
Patient Global Impression of Improvement (PGI-I) Score
The PGI-I is a single-item questionnaire assessing the patient's overall perception of their OAB symptom condition compared to baseline. Participants rate their condition on a 7-point scale ranging from 1 ("very much better") to 7 ("very much worse"). A lower score indicates a better treatment outcome.
Measured: Week 12
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Safety and tolerability will be evaluated by monitoring the frequency, severity, and relatedness of adverse events (AEs) and serious adverse events (SAEs) reported by participants throughout the study period.
Measured: From Baseline (Week 0) up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder (OAB)Studies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuchao Sun, Bachelor, Study chair, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635212
- Sponsor's protocol ID
- KYLL-2026-03-006-1
- Status last verified
- May 2026
- First submitted
- 3 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lai HH, Rawal A, Shen B, Vetter J. The Relationship Between Anxiety and Overactive Bladder or Urinary Incontinence Symptoms in the Clinical Population. Urology. 2016 Dec;98:50-57. doi: 10.1016/j.urology.2016.07.013. Epub 2016 Jul 19.
PubMed 27450939Chapple CR, Kaplan SA, Mitcheson D, Klecka J, Cummings J, Drogendijk T, Dorrepaal C, Martin N. Randomized double-blind, active-controlled phase 3 study to assess 12-month safety and efficacy of mirabegron, a beta(3)-adrenoceptor agonist, in overactive bladder. Eur Urol. 2013 Feb;63(2):296-305. doi: 10.1016/j.eururo.2012.10.048. Epub 2012 Nov 6.
PubMed 23195283Zhao W, Peng C, Sakandar HA, Kwok LY, Zhang W. Meta-Analysis: Randomized Trials of Lactobacillus plantarum on Immune Regulation Over the Last Decades. Front Immunol. 2021 Mar 22;12:643420. doi: 10.3389/fimmu.2021.643420. eCollection 2021.
PubMed 33828554Smith AL, Berry A, Brubaker L, Cunningham SD, Gahagan S, Kane Low L, Mueller M, Sutcliffe S, Williams BR, Brady SS; the Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium. The brain, gut, and bladder health nexus: A conceptual model linking stress and mental health disorders to overactive bladder in women. Neurourol Urodyn. 2024 Feb;43(2):424-436. doi: 10.1002/nau.25356. Epub 2023 Dec 11.
PubMed 38078701Bradley CS, Nygaard IE, Torner JC, Hillis SL, Johnson S, Sadler AG. Overactive bladder and mental health symptoms in recently deployed female veterans. J Urol. 2014 May;191(5):1327-32. doi: 10.1016/j.juro.2013.11.100. Epub 2013 Dec 6.
PubMed 24316095Chung E, Lee D, Gani J, Gillman M, Maher C, Brennan J, Johns Putra L, Ahmad L, Chan LL. Position statement: a clinical approach to the management of adult non-neurogenic overactive bladder. Med J Aust. 2018 Jan 15;208(1):41-45. doi: 10.5694/mja16.01097.
PubMed 29320672Lightner DJ, Gomelsky A, Souter L, Vasavada SP. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019 Sep;202(3):558-563. doi: 10.1097/JU.0000000000000309. Epub 2019 Aug 8.
PubMed 31039103
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Probiotics as an Adjunct to Behavioral Therapy in Patients With Overactive Bladder (OAB) and Anxiety Symptoms: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07635212
- Acronym / sponsor ID
- KYLL-2026-03-006-1
- Conditions
- Overactive Bladder (OAB)
- Keywords
- probiotics, OAB, overactive bladder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does taking probiotics lower the number of times participants need to urinate in a 24-hour period?
- 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:
- Take probiotics or a placebo twice a day for 12 weeks.
- Learn and practice bladder training using a manual and educational videos.
- Keep a 3-day diary of when they urinate and what they drink at the beginning, middle, and end of the study.
- Answer survey questions about their anxiety and quality of life during clinic visits.
- Provide urine samples for routine checkups to ensure they do not have infections.
Detailed description
Background and Scientific Rationale Overactive bladder (OAB) is a prevalent chronic condition that severely impairs patients' quality of life. Accumulating epidemiological evidence highlights a high comorbidity rate between OAB and psychological disorders, particularly anxiety. These two conditions often exacerbate each other, forming a vicious pathological cycle: anxiety heightens central sensitivity to bladder fullness, while unpredictable urinary urgency worsens psychosocial stress. Current pharmacological mainstays, such as antimuscarinics and β3-adrenoceptor agonists, primarily target local bladder smooth muscle. They often fail to address the underlying psychological comorbidities and are frequently associated with intolerable adverse effects (e.g., dry mouth, constipation), leading to high discontinuation rates. There is an urgent clinical need for systemic, well-tolerated therapeutic strategies that address both physical and emotional symptoms.
Theoretical Framework: The Brain-Gut-Bladder Axis This trial is grounded in the emerging "Brain-Gut-Bladder Axis" model. Chronic stress and anxiety can trigger systemic low-grade inflammation and alter the gut microbiome, which in turn influences peripheral neural pathways and bladder afferent signaling. We hypothesize that targeted microecological interventions using specific "psychobiotics" can modulate this axis. Scientific literature suggests that select probiotic strains can communicate with the central nervous system via the vagus nerve and systemic metabolites. By doing so, they may downregulate the hypothalamic-pituitary-adrenal (HPA) axis, optimize the levels of inhibitory neurotransmitters (such as GABA and Serotonin), and suppress neurogenic inflammation.
Intervention Strategy To test this hypothesis, this study employs an "add-on" clinical trial design. All enrolled participants will receive standardized behavioral therapy, which remains the fundamental first-line treatment for OAB, consisting of bladder training and lifestyle modification instructions. On top of this standard of care, participants will be randomized to receive either a multi-strain probiotic compound or a visually and organoleptically matched placebo.
The active intervention utilizes a compound of food-grade, widely recognized safe bacterial strains: Lactobacillus plantarum, Bacillus coagulans, Lactobacillus casei, and Lactobacillus acidophilus. These specific strains were selected for their documented potential in immune regulation, anti-inflammatory properties, and central nervous system modulation.
Study Execution and Clinical Significance Throughout the 12-week intervention period, the study avoids invasive procedures or the collection of extensive biological samples for complex genomic sequencing. Instead, it relies on validated clinical instruments, patient diaries, and standard routine urinalysis (strictly for safety monitoring and infection exclusion) to track treatment trajectories.
By bridging urology and neurogastroenterology, this study seeks to provide high-quality, evidence-based data for a paradigm shift in OAB management. If proven effective, this probiotic-assisted approach will offer a safe, non-pharmacological "mind-body" co-treatment option, potentially breaking the anxiety-urgency cycle and significantly improving the comprehensive well-being of a difficult-to-treat patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics + Standard Behavioral Therapy | Experimental | Dietary Supplement: Multi-strain Probiotic CompoundParticipants assigned to this arm will receive a probiotic powder compound containing Lactobacillus plantarum, Lactobacillus casei, and Lactobacillus acidophilus. The probiotic powder will be dissolved in a glass of water and taken orally once a day for 12 weeks. In addition to the probiotic, participants will receive standard behavioral therapy for overactive bladder (OAB) administered by trained clinical staff. This comprehensive, individualized therapy includes six core modules: bowel management (e.g., dietary fiber intake), fluid and diet modification (e.g., limiting caffeine and other bladder irritants), weight and smoking management, bladder training (including voiding diaries, delayed voiding, and urge suppression techniques), pelvic floor muscle training (PFMT), and personalized follow-up adjustments. |
| Placebo + Standard Behavioral Therapy | Experimental | Other: PlaceboParticipants assigned to this arm will receive a placebo powder dissolved in a glass of water, taken orally once a day for 12 weeks. The placebo is composed of inert excipients (such as maltodextrin) and contains no active bacteria, but is identical to the active probiotic product in color, texture, taste, and solubility. In addition to the placebo, participants will receive the exact same standard behavioral therapy for OAB as the experimental group. This comprehensive, individualized therapy includes six core modules: bowel management, fluid and diet modification (e.g., limiting bladder irritants), weight and smoking management, bladder training (including voiding diaries, delayed voiding, and urge suppression techniques), pelvic floor muscle training (PFMT), and personalized follow-up adjustments. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-strain Probiotic CompoundAlso: Lactobacillus plantarum, Lactobacillus casei, Lactobacillus acidophilusThe 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. | Dietary supplement | Probiotics + Standard Behavioral Therapy |
| PlaceboAlso: Maltodextrin powderAn 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. | Other | Placebo + Standard Behavioral Therapy |
Primary outcome
Change in the Mean Number of Micturitions per 24 Hours
Time frame: Baseline (Week 0), Week 4, Week 8, and Week 12
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.
8 secondary outcomes
Change in the Mean Number of Urgency Episodes per 24 Hours
Time frame: Baseline (Week 0), Week 4, Week 8, and Week 12
Change in the Mean Number of Urgency Urinary Incontinence (UUI) Episodes per 24 Hours
Time frame: Baseline (Week 0), Week 4, Week 8, and Week 12
Change in Mean Volume Voided per Micturition
Time frame: Baseline (Week 0), Week 4, Week 8, and Week 12
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
Time frame: Baseline (Week 0), Week 4, Week 8, and Week 12
Change in Overactive Bladder Symptom Score (OABSS)
Time frame: Baseline (Week 0), Week 4, Week 8, and Week 12
Change in Overactive Bladder Questionnaire (OAB-q) Score
Time frame: Baseline (Week 0) and Week 12
Patient Global Impression of Improvement (PGI-I) Score
Time frame: Week 12
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From Baseline (Week 0) up to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Background: PubMed 27450939Lai HH, Rawal A, Shen B, Vetter J. The Relationship Between Anxiety and Overactive Bladder or Urinary Incontinence Symptoms in the Clinical Population. Urology. 2016 Dec;98:50-57. doi: 10.1016/j.urology.2016.07.013. Epub 2016 Jul 19.
- Background: PubMed 23195283Chapple CR, Kaplan SA, Mitcheson D, Klecka J, Cummings J, Drogendijk T, Dorrepaal C, Martin N. Randomized double-blind, active-controlled phase 3 study to assess 12-month safety and efficacy of mirabegron, a beta(3)-adrenoceptor agonist, in overactive bladder. Eur Urol. 2013 Feb;63(2):296-305. doi: 10.1016/j.eururo.2012.10.048. Epub 2012 Nov 6.
- Background: PubMed 33828554Zhao W, Peng C, Sakandar HA, Kwok LY, Zhang W. Meta-Analysis: Randomized Trials of Lactobacillus plantarum on Immune Regulation Over the Last Decades. Front Immunol. 2021 Mar 22;12:643420. doi: 10.3389/fimmu.2021.643420. eCollection 2021.
- Background: PubMed 38078701Smith AL, Berry A, Brubaker L, Cunningham SD, Gahagan S, Kane Low L, Mueller M, Sutcliffe S, Williams BR, Brady SS; the Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium. The brain, gut, and bladder health nexus: A conceptual model linking stress and mental health disorders to overactive bladder in women. Neurourol Urodyn. 2024 Feb;43(2):424-436. doi: 10.1002/nau.25356. Epub 2023 Dec 11.
- Background: PubMed 24316095Bradley CS, Nygaard IE, Torner JC, Hillis SL, Johnson S, Sadler AG. Overactive bladder and mental health symptoms in recently deployed female veterans. J Urol. 2014 May;191(5):1327-32. doi: 10.1016/j.juro.2013.11.100. Epub 2013 Dec 6.
- Background: PubMed 29320672Chung E, Lee D, Gani J, Gillman M, Maher C, Brennan J, Johns Putra L, Ahmad L, Chan LL. Position statement: a clinical approach to the management of adult non-neurogenic overactive bladder. Med J Aust. 2018 Jan 15;208(1):41-45. doi: 10.5694/mja16.01097.
- Background: PubMed 31039103Lightner DJ, Gomelsky A, Souter L, Vasavada SP. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019 Sep;202(3):558-563. doi: 10.1097/JU.0000000000000309. Epub 2019 Aug 8.
- Individual participant dataSharing planned: Undecided
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Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuchao Sun, Bachelor study chair
Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-strain Probiotic Compound in people with Overactive Bladder (OAB), run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Li, doctor (+86 18560089113, yanli@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Mean Number of Micturitions per 24 Hours (time frame: Baseline (Week 0), Week 4, Week 8, and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07635212, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.