SNM vs. HBOT for Refractory IC/BPS

NCT ID: NCT07091266

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-12-31

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.

Conditions

Interstitial Cystitis/Bladder Pain Syndrome; Underactive Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: Sacral Neuromodulation (SNM) Group

Patients were randomized to receive sacral neuromodulation therapy. They were followed up at 1 month and 3 months post-procedure.

Group Type: EXPERIMENTAL

Sacral Neuromodulation (SNM)

Intervention Type: DEVICE

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.

Active Comparator: Hyperbaric Oxygen Therapy (HBOT) Group

Patients were randomized to receive hyperbaric oxygen therapy. They were followed up at 1 month and 3 months post-treatment.

Group Type: ACTIVE_COMPARATOR

Hyperbaric Oxygen Therapy (HBOT)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Adults aged 18 years or older.
• Diagnosis of refractory Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) according to AUA/SUFU guidelines, confirmed by cystoscopy with hydrodistention and glomerulations, and/or Hunner's lesions.
• Failure of at least two prior therapies (e.g., oral medications, intravesical instillations, pelvic floor physical therapy).
• Willingness to provide written informed consent.

Exclusion Criteria

• Presence of urinary tract malignancies, pelvic organ prolapse ≥ stage III, or urethral stricture.
• Low-compliance bladder (<10 mL/cm H₂O), organic bladder outlet obstruction, or active urinary tract infection.
• Contraindications to surgery (e.g., coagulopathy, existing pacemaker) or HBOT (e.g., untreated pneumothorax).
• Pregnancy.
• Presence of psychiatric disorders or inability to comply with follow-up protocols.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shiyan City Renmin Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yan Wen

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Renmin Hospital, Hubei University of Medicine

Shiyan, Hubei, China

Countries

China

Other Identifiers

WDRY2020-K056

Identifier Type: -

Identifier Source: org_study_id