SNM vs. HBOT for Refractory IC/BPS

Shiyan City Renmin Hospital

Status: Completed

Conditions: Interstitial Cystitis/Bladder Pain Syndrome; Underactive Bladder

Treatments: Procedure: Hyperbaric Oxygen Therapy (HBOT); Device: Sacral Neuromodulation (SNM)

Study type: Interventional

Funder types: Other

Identifiers

NCT07091266

WDRY2020-K056

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Experimental: Sacral Neuromodulation (SNM) Group

Experimental group

Description:

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

Treatment:

Device: Sacral Neuromodulation (SNM)

Active Comparator: Hyperbaric Oxygen Therapy (HBOT) Group

Active Comparator group

Description:

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

Treatment:

Procedure: Hyperbaric Oxygen Therapy (HBOT)