Interstitial Cystitis/Bladder Pain SyndromeNCT07091266
SNM vs. HBOT for Refractory IC/BPS
A study testing Sacral Neuromodulation (SNM) and Hyperbaric Oxygen Therapy (HBOT) in people with Interstitial Cystitis/Bladder Pain Syndrome and Underactive Bladder, run by Shiyan City Renmin Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Cystitis/Bladder Pain Syndrome, Underactive Bladder
- What is being tested?
- Sacral Neuromodulation (SNM) and Hyperbaric Oxygen Therapy (HBOT)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed 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.
- Being tested
- Sacral Neuromodulation (SNM), Hyperbaric Oxygen Therapy (HBOT)
- Medical subject headings
- Cystitis, Interstitial, Urinary Bladder, Underactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Hyperbaric Oxygen Therapy (HBOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 Months
Change in Pain Severity
Measured using a Visual Analog Scale (VAS) from 0 (no pain) to 10 (worst imaginable pain).
Measured: Baseline, 1 Month, 3 Months
Secondary outcomes (7)
Change in Post-void Residual (PVR) Volume
Measured by ultrasound in milliliters (mL).
Measured: Baseline, 1 Month, 3 Months
Change in Maximum Voided Volume (MVV)
Measured by a 3-day bladder diary in milliliters (mL).
Measured: Baseline, 1 Month, 3 Months
Change in Average Voided Volume (AVV)
Measured by a 3-day bladder diary in milliliters (mL).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Feb 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Cystitis/Bladder Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiyan City Renmin Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yan Wen, Shiyan City Renmin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091266
- Sponsor's protocol ID
- WDRY2020-K056
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07091266
- Acronym / sponsor ID
- WDRY2020-K056
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Shiyan City Renmin HospitalOther government
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Sacral Neuromodulation (SNM) Group | Experimental | Device: Sacral Neuromodulation (SNM)Patients were randomized to receive sacral neuromodulation therapy. They were followed up at 1 month and 3 months post-procedure. |
| Active Comparator: Hyperbaric Oxygen Therapy (HBOT) Group | Active comparator | Procedure: Hyperbaric Oxygen Therapy (HBOT)Patients were randomized to receive hyperbaric oxygen therapy. They were followed up at 1 month and 3 months post-treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacral Neuromodulation (SNM)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. | Device | Experimental: Sacral Neuromodulation (SNM) Group |
| Hyperbaric Oxygen Therapy (HBOT)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. | Procedure or surgery | Active Comparator: Hyperbaric Oxygen Therapy (HBOT) Group |
Primary outcome
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.
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.
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.
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).
7 secondary outcomes
Change in Post-void Residual (PVR) Volume
Time frame: Baseline, 1 Month, 3 Months
Change in Maximum Voided Volume (MVV)
Time frame: Baseline, 1 Month, 3 Months
Change in Average Voided Volume (AVV)
Time frame: Baseline, 1 Month, 3 Months
Change in Bladder Compliance (BC)
Time frame: Baseline, 1 Month, 3 Months
Change in Maximum Urethral Closure Pressure (MUCP)
Time frame: Baseline, 1 Month, 3 Months
Change in Abdominal Leak Point Pressure (ALPP)
Time frame: Baseline, 1 Month, 3 Months
Incidence of Adverse Events
Time frame: Up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacral Neuromodulation (SNM) and Hyperbaric Oxygen Therapy (HBOT) in people with Interstitial Cystitis/Bladder Pain Syndrome and Underactive Bladder, run by Shiyan City Renmin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Daily Urination Frequency (time frame: Baseline, 1 Month, 3 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025; AzTrials last refreshed its copy on 27 Oct 2026.