An interventional study of Sacral Neuromodulation (SNM) and Hyperbaric Oxygen Therapy (HBOT) in Interstitial Cystitis/Bladder Pain Syndrome and Underactive Bladder, sponsored by Shiyan City Renmin Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-29.
Sponsored by Shiyan City Renmin Hospital · Not applicable, Interventional, and Treatment
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.
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.
236 studies on the registry are indexed under Cystitis, Interstitial; 35 are open to participants now.
This study's enrollment of 88 is above the median of 51 across 158 interventional studies indexed under Cystitis, Interstitial.
Browse Cystitis, Interstitial studies →Shiyan City Renmin Hospital is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients were randomized to receive sacral neuromodulation therapy. They were followed up at 1 month and 3 months post-procedure.
Device: Sacral Neuromodulation (SNM)
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)
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 3 Months
Change in Pain Severity
Measured using a Visual Analog Scale (VAS) from 0 (no pain) to 10 (worst imaginable pain).
Time frame: Baseline, 1 Month, 3 Months
Change in Post-void Residual (PVR) Volume
Measured by ultrasound in milliliters (mL).
Time frame: Baseline, 1 Month, 3 Months
Change in Maximum Voided Volume (MVV)
Measured by a 3-day bladder diary in milliliters (mL).
Time frame: Baseline, 1 Month, 3 Months
Change in Average Voided Volume (AVV)
Measured by a 3-day bladder diary in milliliters (mL).
Time frame: Baseline, 1 Month, 3 Months
Change in Bladder Compliance (BC)
Measured via urodynamic studies as the change in bladder volume per unit change in pressure. Unit: milliliters per centimeter of water (mL/cm H₂O).
Time frame: Baseline, 1 Month, 3 Months
Change in Maximum Urethral Closure Pressure (MUCP)
Measured via urodynamic studies to assess urethral sphincter function. Unit: centimeters of water (cm H₂O).
Time frame: Baseline, 1 Month, 3 Months
Change in Abdominal Leak Point Pressure (ALPP)
Measured via urodynamic studies as the intravesical pressure at which urine leakage occurs during a cough or strain. Unit: centimeters of water (cm H₂O).
Time frame: Baseline, 1 Month, 3 Months
Incidence of Adverse Events
Number of participants experiencing adverse events, such as pain at the implantation site, symptom recurrence, electrode displacement, urinary tract infection, dizziness, or vomiting.
Time frame: Up to 3 months
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Shiyan City Renmin Hospital