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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124448
Enrollment
Unknown
Registered
2026-05-12
Start date
2025-03-03
Completion date
Unknown
Last updated
2026-05-18

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

Conditions

refractory interstitial cystitis

Interventions

The experimental group:Perform submucosal injection of 10 mL PRP (extracted from 50 mL of the patient's own whole blood) into the bladder, with a 2-week interval between the first and second injection
The control group:Receive a single injection of botulinum toxin into the bladder (dose 100u), with only one injection and no repeated injections

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. Patients who meet all diagnostic criteria for NIDDK interstitial cystitis (except for condition 2) are classified as non Hunner's type; 3. 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 >= 160mmHg or systolic blood pressure >= 110mmHg; (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 lymphocyte tumors that cause systemic immune diseases; (5) Currently using anticoagulants or antiplatelet drugs; (6) Other serious illnesses that result in insufficient physical strength to climb three floors on their own. 2. Diseases of the urinary system, 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<100g/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. There are 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
ICSI(Interstitial Cystitis Symptom Index Score);

Secondary

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

Countries

China

Contacts

Public ContactLv Jianwei

Gongli Hospital, Shanghai

ljwass@126.com+86 138 1669 4688

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026