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NCT Number: NCT07091266

SNM vs. HBOT for Refractory IC/BPS

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.

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Key information

Conditions

Interstitial Cystitis/Bladder Pain Syndrome Cystitis Cystitis, Interstitial Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Underactive Bladder Urinary Bladder Diseases Urinary Bladder, Underactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renmin Hospital, Hubei University of Medicine

Shiyan, Hubei, 442000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Daily Urination Frequency

    Time frame: Baseline, 1 Month, 3 Months

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

  2. Change in Nocturia Frequency

    Time frame: Baseline, 1 Month, 3 Months

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

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

    Time frame: Baseline, 3 Months

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

  4. Change in Pain Severity

    Time frame: Baseline, 1 Month, 3 Months

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

Secondary outcomes

  1. Change in Post-void Residual (PVR) Volume

    Time frame: Baseline, 1 Month, 3 Months

    Measured by ultrasound in milliliters (mL).

  2. Change in Maximum Voided Volume (MVV)

    Time frame: Baseline, 1 Month, 3 Months

    Measured by a 3-day bladder diary in milliliters (mL).

  3. Change in Average Voided Volume (AVV)

    Time frame: Baseline, 1 Month, 3 Months

    Measured by a 3-day bladder diary in milliliters (mL).

  4. Change in Bladder Compliance (BC)

    Time frame: Baseline, 1 Month, 3 Months

    Measured via urodynamic studies as the change in bladder volume per unit change in pressure. Unit: milliliters per centimeter of water (mL/cm H₂O).

  5. Change in Maximum Urethral Closure Pressure (MUCP)

    Time frame: Baseline, 1 Month, 3 Months

    Measured via urodynamic studies to assess urethral sphincter function. Unit: centimeters of water (cm H₂O).

  6. Change in Abdominal Leak Point Pressure (ALPP)

    Time frame: Baseline, 1 Month, 3 Months

    Measured via urodynamic studies as the intravesical pressure at which urine leakage occurs during a cough or strain. Unit: centimeters of water (cm H₂O).

  7. Incidence of Adverse Events

    Time frame: Up to 3 months

    Number of participants experiencing adverse events, such as pain at the implantation site, symptom recurrence, electrode displacement, urinary tract infection, dizziness, or vomiting.

Sponsors and collaborators

Lead sponsor

Shiyan City Renmin Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 29, 2025
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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