Intravesical Platelet-rich Plasma Injection in Patients With Interstitial Cystitis/Bladder-A Retrospective Study

NCT06339645 | Not Yet Recruiting

• 1 other identifier: P00003121
• Study Type: observational
• Target: 658
• Locations: 1 country
• Sites: 1

Brief Summary

The correlation of safety and effectiveness between intravesical platelet-rich plasma injection in patients with interstitial cystitis/bladder-A retrospective study to evaluate the correlation of safety and effectiveness between intravesical platelet-rich plasma injection of IC/BPS, with age of at least 20-84 years old in Taiwan of either sex with IC/BPS symptoms and proven of IC by cystoscopic hydrodistention. Patients who meet all eligibility requirements for entry into the study of intravesical PRP injection.

Conditions

Safety and Effectiveness Between Intravesical Platelet-rich Plasma Injection in Patients With Interstitial Cystitis/Bladder

Outcome Measures

Primary Outcomes (1)

• Global response assessment (GRA)

  satisfaction by the patient (categorized into -3, -2,-1, 0, +1, +2, +3, indicating markedly worse to markedly improved ) after the treatment day

  6 months

Interventions

PRP PROCEDURE

Patients who meet all eligibility requirements for entry into the study of intravesical PRP injection

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with age of at least 20-84 years old in Taiwan of either sex with IC/BPS symptoms and proven of IC by cystoscopic hydrodistention

You may qualify if:

• NIDDK criteria diagnostic IC/BPS, and received the intravesical PRP injection before

You may not qualify if:

• non-IC/BPS patients
• psychological disease was diagnosed
• non-NIDDK criteria (Hunner's ulcer type)
• Under-primary or illiterate respondents
• patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow up
• Patients with bladder outlet obstruction on enrollment
• Patients with post-void residual \> 150ml
• Patients with an uncontrolled confirmed diagnosis of acute urinary tract infection
• Patients have laboratory abnormalities at screening
• Patients who cannot used urinary catheter to treat.
• Female patients who are pregnant, lactating, or childbearing potential without contraception.
• Patients with any other serious disease considered by the investigator not in the condition to enter the trial
• Patients cannot record the voiding diary

Sponsors & Collaborators

• Hualien Tzu Chi General Hospital: lead

Study Sites (1)

Wan Ru Yu

Hualien City, Outside U.S./Taiwan, 970, Taiwan

Location

Related Publications (1)

• Yu WR, Kuo HC. Functional bladder capacity can reflect the bladder condition and treatment outcome in patients with interstitial cystitis/bladder pain syndrome. World J Urol. 2026 Jan 17;44(1):101. doi: 10.1007/s00345-025-05937-2. No abstract available.

  PMID: 41546691 DERIVED

Study Officials

• Wan Ru Yu

  Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan,

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wan Ru Yu

CONTACT

0925051013; wanzu666@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: April 1, 2024
• Primary Completion: May 22, 2024
• Study Completion: December 31, 2024
• Last Updated: April 1, 2024

Record last verified: 2024-03

Locations

TW (1)