NCT07091266

SNM vs. HBOT for Refractory IC/BPS

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Shiyan City Renmin Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Interstitial Cystitis/Bladder Pain Syndrome
• Underactive Bladder

Interventions

Type	Name	Description
DEVICE	Sacral Neuromodulation (SNM)	A standardized two-stage implantation protocol was used. In Stage 1, a temporary lead (InterStim 3093, Medtronic) was implanted at the S3 sacral foramen under fluoroscopic guidance. Patients with ≥50% improvement in urinary symptoms over a 7-day test period proceeded to Stage 2, where a permanent neurostimulator (InterStim 3058, Medtronic) was implanted subcutaneously. Stimulation parameters were adjusted (amplitude: 0.5-10 V; frequency: 14 Hz; pulse width: 210 μs) to optimize symptom control.
PROCEDURE	Hyperbaric Oxygen Therapy (HBOT)	Patients received two 20-session courses (5 sessions/week) in a hyperbaric chamber at 2.0 atmospheres absolute (ATA). Each session consisted of 60 minutes of 100% oxygen inhalation, bracketed by compression and decompression periods.

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2025-07-29
• Last updated: 2025-07-29

Locations

1 site across 1 country: China