Autologous Platelet Concentrate Bladder Injection for Refractory Overactive Bladder

NCT07797647 | Enrolling By Invitation

• 1 other identifier: KX2026-KYC571-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Overactive bladder (OAB) is a common lower urinary tract disorder characterized by urinary urgency, usually accompanied by urinary frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious local pathologic, metabolic, or neurologic causes. A subset of patients continue to have bothersome symptoms despite behavioral therapy and oral pharmacologic treatment, or are unable to tolerate medication-related adverse effects. Third-line treatments, including intradetrusor botulinum toxin injection and sacral neuromodulation, may be limited by invasiveness, potential adverse events, cost, or patient preference. Autologous platelet concentrate, commonly referred to as platelet-rich plasma (PRP), is prepared from the participant's own peripheral blood and contains concentrated platelets, growth factors, and cytokines. PRP has potential roles in tissue repair, inflammation modulation, and local neural regulation. This investigator-initiated, prospective, single-center observational clinical study will evaluate the efficacy and safety of bladder injection of autologous platelet concentrate in adults with refractory OAB. Approximately 50 participants will be recruited from the Department of Urology at The First Affiliated Hospital of Chongqing Medical University. Participants will be followed for approximately 24 weeks, with assessments before treatment and at 1, 3, and 6 months after treatment. Outcomes include OAB symptom scores, bladder diary measures, quality-of-life questionnaires, and adverse events.

Conditions

Over Active Bladder

Outcome Measures

Primary Outcomes (2)

• Change from baseline in Overactive Bladder Symptom Score (OABSS)

  escription: Change in the total Overactive Bladder Symptom Score (OABSS) from baseline to each follow-up assessment. The OABSS has a minimum score of 0 and a maximum score of 15. Higher scores indicate worse overactive bladder symptom severity.

  Baseline (pre-procedure), 1 month after procedure, 3 months after procedure, and 6 months after procedure

• Incidence of adverse events and procedure-related complications

  Incidence and type of adverse events and procedure-related complications, including blood-draw complications, PRP preparation failure, pain or discomfort, hematuria, urinary tract infection, bladder injury, bladder spasm, dysuria, urinary retention, allergic reaction, and other clinically significant events.

  From the start of the bladder injection procedure through 24 weeks after the procedure

Secondary Outcomes (6)

• Change from baseline in 24-hour micturition frequency

  Baseline (pre-procedure), 1 month after procedure, 3 months after procedure, and 6 months after procedure

• Change from baseline in urgency urinary incontinence episodes

  Baseline (pre-procedure), 1 month after procedure, 3 months after procedure, and 6 months after procedure

• Change from baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) scores

  Baseline (pre-procedure), 1 month after procedure, 3 months after procedure, and 6 months after procedure

• Change from baseline in International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) score

  Baseline (pre-procedure), 1 month after procedure, 3 months after procedure, and 6 months after procedure, when applicable

• Change from baseline in urodynamic parameters

  Baseline (pre-procedure) and 6 months after procedure, when clinically indicated

Study Arms (1)

PRP therapy group

Intravesical injection of autologous plasma-enriched platelets (PRP)

Eligibility Criteria

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

Study Population

The study will not enroll minors, pregnant women, prisoners, illiterate individuals, or persons without full capacity for civil conduct.

You may qualify if:

• Adult participant aged 18 years or older with full capacity to understand the study and provide written informed consent.
• Diagnosis of overactive bladder according to International Continence Society criteria: urinary urgency, usually with frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or another obvious local, metabolic, or neurologic cause.
• Refractory OAB, defined as persistent bothersome OAB symptoms after standard first-line behavioral therapy for at least 3 to 6 months, and inadequate response or intolerance to at least two oral medications with different mechanisms, such as antimuscarinic agents and beta-3 adrenergic agonists, after adequate treatment duration.
• Other possible causes of OAB-like symptoms have been excluded by appropriate clinical evaluation, such as urinalysis, urine culture, ultrasound, urodynamic testing, and cystoscopy when clinically indicated.
• Participant is unwilling, unsuitable, contraindicated, or has inadequate response to existing third-line treatments such as intradetrusor botulinum toxin injection or sacral neuromodulation.
• General condition allows local anesthesia and cystoscopic bladder injection.
• No absolute contraindication to autologous platelet concentrate / PRP treatment.
• Willing to comply with study visits and follow-up assessments.

You may not qualify if:

• Platelet dysfunction syndrome or platelet count less than 50 x 10\^9/L.
• Coagulation disorder or current anticoagulant therapy that may increase bleeding risk.
• Active systemic infection or local infection at the injection site.
• Active malignancy or history of malignancy within the past 5 years, especially urinary tract malignancy, or hematologic malignancy such as leukemia or lymphoma.
• Active autoimmune disease judged by the investigator to increase risk or affect interpretation of results.
• Pregnancy or lactation.
• Known allergy to any component used in PRP preparation.
• Untreated urinary tract infection.
• Bladder stone, bladder tumor, bladder outlet obstruction, neurogenic bladder, interstitial cystitis / bladder pain syndrome, or another organic disease that explains OAB-like symptoms.
• Prior intradetrusor botulinum toxin injection or sacral neuromodulation if excluded by the final protocol.
• Severe cardiac, hepatic, or renal insufficiency; uncontrolled diabetes; severe anemia; or other systemic disease that may affect safety or wound healing.
• Psychiatric illness, cognitive impairment, or other condition that prevents understanding of informed consent or reliable follow-up.
• Recent use of nonsteroidal anti-inflammatory drugs or corticosteroids when judged by the investigator to interfere with PRP effect, unless discontinued for an appropriate washout period.
• Expected survival shorter than the study period.
• Refusal to sign informed consent or inability/unwillingness to comply with follow-up.

Sponsors & Collaborators

• Gang Chen: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Location

Related Publications (3)

• Lu JH, Chueh KS, Juan TJ, Mao JW, Lin RJ, Lee YC, Shen MC, Sun TW, Lin HY, Juan YS. Effects of Therapeutic Platelet-Rich Plasma on Overactive Bladder via Modulating Hyaluronan Synthesis in Ovariectomized Rat. Int J Mol Sci. 2023 May 4;24(9):8242. doi: 10.3390/ijms24098242.

  PMID: 37175945 BACKGROUND

• Peyronnet B, Mironska E, Chapple C, Cardozo L, Oelke M, Dmochowski R, Amarenco G, Game X, Kirby R, Van Der Aa F, Cornu JN. A Comprehensive Review of Overactive Bladder Pathophysiology: On the Way to Tailored Treatment. Eur Urol. 2019 Jun;75(6):988-1000. doi: 10.1016/j.eururo.2019.02.038. Epub 2019 Mar 26.

  PMID: 30922690 BACKGROUND

• Jiang YH, Jhang JF, Lin TY, Ho HC, Hsu YH, Kuo HC. Therapeutic Efficacy of Intravesical Platelet-Rich Plasma Injections for Interstitial Cystitis/Bladder Pain Syndrome-A Comparative Study of Different Injection Number, Additives and Concentrations. Front Pharmacol. 2022 Mar 22;13:853776. doi: 10.3389/fphar.2022.853776. eCollection 2022.

  PMID: 35392571 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 1, 2026
• Study Start: April 8, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 1, 2026

Record last verified: 2026-06

Locations

CN (1)