SNM vs. HBOT for Refractory IC/BPS

NACompletedINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

February 1, 2021

Primary Completion Date

December 31, 2022

Study Completion Date

December 31, 2022

Conditions
Interstitial Cystitis/Bladder Pain SyndromeUnderactive Bladder
Interventions
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.

Trial Locations (1)

442000

Renmin Hospital, Hubei University of Medicine, Shiyan

All Listed Sponsors
lead

Shiyan City Renmin Hospital

OTHER_GOV

NCT07091266 - SNM vs. HBOT for Refractory IC/BPS | Biotech Hunter | Biotech Hunter