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The efficacy and safety of PRP bladder submucosal injection in the treatment of chronic cystitis: a multicenter prospective clinical study

The efficacy and safety of PRP bladder submucosal injection in the treatment of chronic cystitis: a multicenter prospective clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123702
Enrollment
Unknown
Registered
2026-04-29
Start date
2026-02-02
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic cystitis/interstitial cystitis

Interventions

PRP Group:Autologous platelet-rich plasma (PRP) submucosal injection into the bladder: 50 mL autologous whole blood was collected and processed to prepare PRP (10 mL injection solution), injected at 2
Botulinum Toxin Group:Multisite bladder wall injection of botulinum toxin type A: 100 U botulinum toxin dissolved in 10 mL normal saline, injected at 20 sites identical to those used in the PRP group.

Sponsors

Gongli Hospital, Shanghai
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age range of 45-65 years old, male or female not limited; 2. Meets the clinical diagnostic criteria for chronic cystitis (persistent lower urinary tract symptoms>6 weeks, excluding infection/tumor); 3. The patient's last water dilation treatment has been more than 3 months, and the last water dilation indicates a bladder capacity between 100-350ml; 4. Pain score>4 points; 5. Willing to participate in this study and sign an informed consent form

Exclusion criteria

Exclusion criteria: 1. Serious underlying diseases, including: (1) hypertension with systolic blood pressure >= 160 mmHg or systolic blood pressure >= 110 mmHg; (2) Diabetes (fasting blood glucose >= 10 mmol/L) or poor blood glucose control; (3) Respiratory system disorders, with normal oxygen saturation below 95% or moderate to severe ventilation/diffusion dysfunction; (4) T-cell lymphoma leading to systemic immune disorders; (5) Currently using anticoagulants or antiplatelet drugs; (6) There are other serious illnesses that result in insufficient physical strength to climb three floors on their own. 2. Urinary system diseases, including: (1) bladder or ureteral stones; (2) Recent (within 3 months) urinary tract infections; (3) Other pathological changes in the bladder, such as benign or malignant tumors of the bladder, urethral diverticulum, etc. 3. Other treatment influencing factors: (1) Platelet count < 100 × 10^9/L, hemoglobin < 100 g/L; (2) History of allergies to bladder injection therapy; (3) Received bladder botulinum toxin injection treatment within the past 6 months. 4. Pregnant or lactating women 5. Patients with mental illness, cognitive impairment, or inability to understand and comply with research requirements. 6. Other diseases that cannot accept platelet apheresis. 7. It is expected that data collection will not be completed during the follow-up period.

Design outcomes

Primary

MeasureTime frame
PUF(Pelvic Pain and Urgency/Frequency Symptom Scale);

Secondary

MeasureTime frame
VAS(Visual Analogue Scale for Pain);Functional bladder capacity(FBC);Average number of urinations per 24 hours;GRA(Interstitial Cystitis Problem Index Score);SAS(Self-Rating Anxiety Scale);

Countries

China

Contacts

Public ContactLü Jianwei

Gongli Hospital, Shanghai

ljwass@126.com+86 138 1669 4688

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026