Efficacy of Probiotics for OAB Patients With Anxiety

NCT07635212 | Not Yet Recruiting DMC

• 1 other identifier: KYLL-2026-03-006-1
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does taking probiotics lower the number of times participants need to urinate in a 24-hour period?
2. 2.Does taking probiotics lower participants' anxiety levels?
3. 3.Take probiotics or a placebo twice a day for 12 weeks.
4. 4.Learn and practice bladder training using a manual and educational videos.
5. 5.Keep a 3-day diary of when they urinate and what they drink at the beginning, middle, and end of the study.
6. 6.Answer survey questions about their anxiety and quality of life during clinic visits.
7. 7.Provide urine samples for routine checkups to ensure they do not have infections.

Conditions

Overactive Bladder (OAB)

Keywords

probiotics; OAB; overactive bladder

Outcome Measures

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.

  Baseline (Week 0), Week 4, Week 8, and Week 12

Secondary Outcomes (8)

• Change in the Mean Number of Urgency Episodes per 24 Hours

  Baseline (Week 0), Week 4, Week 8, and Week 12

• Change in the Mean Number of Urgency Urinary Incontinence (UUI) Episodes per 24 Hours

  Baseline (Week 0), Week 4, Week 8, and Week 12

• Change in Mean Volume Voided per Micturition

  Baseline (Week 0), Week 4, Week 8, and Week 12

• Change in Generalized Anxiety Disorder-7 (GAD-7) Score

  Baseline (Week 0), Week 4, Week 8, and Week 12

• Change in Overactive Bladder Symptom Score (OABSS)

  Baseline (Week 0), Week 4, Week 8, and Week 12

Study Arms (2)

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.

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.

Other: Placebo

Interventions

Multi-strain Probiotic Compound DIETARY_SUPPLEMENT

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.

Also known as: Lactobacillus plantarum, Lactobacillus casei, Lactobacillus acidophilus

Probiotics + Standard Behavioral Therapy

Placebo OTHER

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.

Also known as: Maltodextrin powder

Placebo + Standard Behavioral Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

Location

Related Publications (7)

• 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.

  PMID: 27450939 BACKGROUND

• Chapple 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.

  PMID: 23195283 BACKGROUND

• Zhao 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.

  PMID: 33828554 BACKGROUND

• Smith 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.

  PMID: 38078701 BACKGROUND

• Bradley 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.

  PMID: 24316095 BACKGROUND

• Chung 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.

  PMID: 29320672 BACKGROUND

• Lightner 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.

  PMID: 31039103 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Lacteol

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yuchao Sun, Bachelor

  Shandong University

  STUDY CHAIR

Central Study Contacts

Yan Li, doctor

CONTACT

+86 18560089113; yanli@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-05

Locations

CN (1)