Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-29 @ 6:20 AM
Study NCT ID:
NCT07091266
Status:
COMPLETED
Last Update Posted:
2025-07-29
First Post:
2025-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SNM vs. HBOT for Refractory IC/BPS
Sponsor:
Shiyan City Renmin Hospital
Organization:
Study Overview
Official Title:
A Prospective Randomized Controlled Trial Comparing the Therapeutic Efficacy of Sacral Neuromodulation Versus Hyperbaric Oxygen Therapy in Patients With Refractory Interstitial Cystitis and Bladder Pain Syndrome
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is for people with long-term bladder pain and urinary problems (known as Interstitial Cystitis/Bladder Pain Syndrome or IC/BPS) that have not improved with other treatments. The study compares two different treatments: Sacral Neuromodulation (SNM), which uses an implanted device to send gentle electrical pulses to nerves controlling the bladder, and Hyperbaric Oxygen Therapy (HBOT), where patients breathe pure oxygen in a special chamber. Participants were randomly assigned to one of the two groups to help doctors understand which treatment works better to reduce symptoms and improve quality of life.
Detailed Description:
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic, debilitating condition that is often refractory to conventional treatments. Sacral neuromodulation (SNM) is a third-line therapy recognized by AUA/EAU guidelines, while hyperbaric oxygen therapy (HBOT) is an emerging treatment with potential anti-inflammatory benefits. There is a lack of direct comparative evidence between these two modalities. This study prospectively enrolled and randomized 88 patients with refractory IC/BPS to receive either SNM (study group) or HBOT (control group). The primary objective is to compare changes in urinary symptoms, urodynamic parameters, and quality of life scores between the two groups at baseline, 1-month, and 3-month follow-ups. The study aims to provide robust evidence to guide treatment selection for refractory IC/BPS patients who have failed at least two prior therapies.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: