SNM vs. HBOT for Refractory IC/BPS

NCT07091266 | Completed

• 1 other identifier: WDRY2020-K056
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Cystitis/Bladder Pain Syndrome; Underactive Bladder

Outcome Measures

Primary Outcomes (4)

• Change in Daily Urination Frequency

  Measured by a 3-day bladder diary as the average number of voids per 24 hours. A lower value indicates better outcome.

  Baseline, 1 Month, 3 Months

• Change in Nocturia Frequency

  Measured by a 3-day bladder diary as the average number of nighttime voids. A lower value indicates better outcome.

  Baseline, 1 Month, 3 Months

• Change from Baseline in Quality of Life Score at 3 Months

  Measured using the Incontinence Quality of Life Questionnaire-Short Form (ICI-Q-SF). A lower score indicates better quality of life.

  Baseline, 3 Months

• Change in Pain Severity

  Measured using a Visual Analog Scale (VAS) from 0 (no pain) to 10 (worst imaginable pain).

  Baseline, 1 Month, 3 Months

Secondary Outcomes (7)

• Change in Post-void Residual (PVR) Volume

  Baseline, 1 Month, 3 Months

• Change in Maximum Voided Volume (MVV)

  Baseline, 1 Month, 3 Months

• Change in Average Voided Volume (AVV)

  Baseline, 1 Month, 3 Months

• Change in Bladder Compliance (BC)

  Baseline, 1 Month, 3 Months

• Change in Maximum Urethral Closure Pressure (MUCP)

  Baseline, 1 Month, 3 Months

Study Arms (2)

Experimental: Sacral Neuromodulation (SNM) Group

EXPERIMENTAL

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

Device: Sacral Neuromodulation (SNM)

Active Comparator: Hyperbaric Oxygen Therapy (HBOT) Group

ACTIVE COMPARATOR

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

Procedure: Hyperbaric Oxygen Therapy (HBOT)

Interventions

Sacral Neuromodulation (SNM) 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.

Experimental: Sacral Neuromodulation (SNM) Group

Hyperbaric Oxygen Therapy (HBOT) 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.

Active Comparator: Hyperbaric Oxygen Therapy (HBOT) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shiyan City Renmin Hospital: lead

Study Sites (1)

Renmin Hospital, Hubei University of Medicine

Shiyan, Hubei, 442000, China

Location

MeSH Terms

Conditions

Cystitis, Interstitial; Urinary Bladder, Underactive

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 29, 2025
• Study Start: February 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

CN (1)