Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-24 @ 1:04 PM
NCT ID:
NCT03104361
Brief Summary:
Interstitial cystitis/painful bladder syndrome (IC/PBS) is a debilitating chronic disease of unknown etiology characterized by urgency frequency and suprapubic pain at full bladder. Current treatments are usually unsuccessful in completely eradicating bladder pain and increasing bladder capacity. Autologous platelet-rich plasma (PRP) is growing in popularity as a therapy to augment wound healing, speed the recovery from muscle and joint injuries, and enhance recovery after surgical repair. PRP is extremely rich in growth factors and cytokines, which regulate tissue reconstruction and has been studied extensively among trauma patients and trauma experimental models. Tissue regeneration can be improved by local application of autologous bone marrow derived progenitor cells and PRP. This clinical trial attempts to use autologous PRP in treatment of interstitial cystitis refractory to currently available medical treatment or intravesical therapy. The results of this study might provide clinical evidence for a novel therapeutic regimen in the treatment of IC/PBS.
Detailed Description:
Background: Interstitial cystitis/painful bladder syndrome (IC/PBS) is a debilitating chronic disease of unknown etiology characterized by urgency frequency and suprapubic pain at full bladder. Current treatments are usually unsuccessful in completely eradicating bladder pain and increasing bladder capacity. Autologous platelet-rich plasma (PRP) is growing in popularity as a therapy to augment wound healing, speed the recovery from muscle and joint injuries, and enhance recovery after surgical repair. PRP is extremely rich in growth factors and cytokines, which regulate tissue reconstruction and has been studied extensively among trauma patients and trauma experimental models. Tissue regeneration can be improved by local application of autologous bone marrow derived progenitor cells and PRP.
Aim: This clinical trial attempts to use autologous PRP in treatment of interstitial cystitis refractory to currently available medical treatment or intravesical therapy. The results of this study might provide clinical evidence for a novel therapeutic regimen in the treatment of IC/PBS.
Setting: Department of Urology, Buddhist Tzu Chi General Hospital.
Materials and Methods: A total of 30 patients with IC/PBS who have failed conventional treatments for at least 6 months will be enrolled in this study. A diagnosis of IC/PBS has been established based on characteristic symptoms and cystoscopic findings of glomerulations, petechia, or mucosal fissures after hydrodistention. All patients have been treated with at least two types of treatment modalities including oral PPS, intravesical instillation of heparin, hyaluronic acid, or tricyclic antidepressant for at least 6 months but the symptoms remained unchanged or relapsed. All patients should have IC symptoms for at least 6 months, and proven to have grade 1 diffused glomerulations after cystoscopic hydrodistention (HD) within recent 1 year without Hunner's lesion. Eligible patients will be admitted for the treatment. The patients will receive intravesical injection of 12ml PRP (extracted from 50ml of patient's own whole blood) followed by cystoscopic hydrodistention under intravenous general anesthesia in the operation room. The procedure will repeat every one month for a total of four treatments. Blood (10ml) and urine samples (30ml) will be collected before intravesical PRP injection and at 4, 12 and 24 weeks after PRP injection.
Assessment: Primary end-point is the change of the O'Leary-Sant symptom score (including ICSI and ICPI) from baseline to 6 months after the first treatment day. Secondary endpoints include VAS, daily frequency, nocturia and FBC as record in 3-day voiding diary, Qmax, vided volume, PVR and global response assessment (GRA). Four visits are required at baseline screening (before first treatment) (V1), 1 month after the first treatment (V2, primary end-point), 4 weeks after the fourth treatment (V3), 24 weeks after the first treatment (V4, secondary end-point).
Urine samples will be collected at each time-point for NGF and cytokines tests. Bladder biopsy will be performed at baseline and 6 months after the first treatment day if possible.
Adverse events including UTI, AUR, large PVR (\>150ml), dysuria and micturition pain will be recorded
Study:
NCT03104361
Study Brief:
Protocol Section:
NCT03104361