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The efficacy and safety of PRP submucosal injection in the treatment of interstitial cystitis

The efficacy and safety of PRP submucosal injection in the treatment of interstitial cystitis

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084009
Enrollment
Unknown
Registered
2024-05-09
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

interstitial cystitis

Interventions

The experimental group:10 mL PRP (extracted from 50 mL of patients own whole blood) is injected into the bladder submucosa, and this process is repeated every 1 month for a total of 4 treatments

Sponsors

Gongli Hospital, Shanghai
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 65 Years

Inclusion criteria

Inclusion criteria: ?Refer to ‘the IC diagnostic criteria developed by the Guidelines for the Diagnosis and Treatment of Andrology Diseases in Urology in China’;? Age 18~85 years old (inclusive), female;? In the awake state, the bladder capacity is > 150 mL (there is no urgency to urinate when the bladder is filled with 150ml of liquid);? The previous drug treatment or physical therapy effect was not good, and the drug has been stopped for 2 weeks;? The 24-hour average pain score was greater than 4 points and less than 8 points.? Able to comply with study and follow-up procedures;? Voluntarily participate in this clinical trial and sign the informed consent form of the subject;

Exclusion criteria

Exclusion criteria: ? Other patients with chemical cystitis or tuberculous cystitis; ? People with urinary tract infection; ? Bladder tumors; ? In the awake state, the bladder capacity < 150 mL;? Pregnant women;? Allergic constitution,G6PD deficiency(favism)and hyperthyroidism are contraindications to ozone therapy; ? Patients treated with intravenous copper or iron are contraindicated to ozone therapy; ? Those with major diseases of the heart, liver and other systems are excluded;? Exclusion of those with poor compliance;? Those who have participated in other clinical trials within 1 month before the start of this trial

Design outcomes

Primary

MeasureTime frame
ICSI(Interstitial Cystitis Symptom Index Score);SAS(Self-Rating Anxiety Scale);Average urination volume per session;Maximum urination volume;

Secondary

MeasureTime frame
ICPI(Interstitial Cystitis Problem Index Score);GRA(Interstitial Cystitis Problem Index Score);VAS(Visual Analogue Scale for Pain);PUF(Pelvic Pain and Urgency/Frequency Symptom Scale);Average number of urinations per 24 hours;

Countries

China

Contacts

Public ContactJianwei Lyv

Gongli Hospital, Shanghai

ljwass@126.com+86 138 1669 4688

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026