CompletedNot Applicable

SNM vs. HBOT for Refractory IC/BPS

China88 participantsStarted 2021-02-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in Daily Urination Frequency

Timeframe: Baseline, 1 Month, 3 Months

Change in Nocturia Frequency

Timeframe: Baseline, 1 Month, 3 Months

Change from Baseline in Quality of Life Score at 3 Months

Timeframe: Baseline, 3 Months

Change in Pain Severity

Timeframe: Baseline, 1 Month, 3 Months

Trial details

NCT IDNCT07091266

SponsorShiyan City Renmin Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More Interstitial Cystitis/Bladder Pain Syndrome trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.