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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Change in Pain Severity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Pain Severity
时间窗: Baseline, 1 Month, 3 Months
Measured using a Visual Analog Scale (VAS) from 0 (no pain) to 10 (worst imaginable pain).
Change in Daily Urination Frequency
时间窗: 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
时间窗: 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
时间窗: Baseline, 3 Months
Measured using the Incontinence Quality of Life Questionnaire-Short Form (ICI-Q-SF). A lower score indicates better quality of life.
次要结局
- 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)
- Change in Abdominal Leak Point Pressure (ALPP)(Baseline, 1 Month, 3 Months)
- Incidence of Adverse Events(Up to 3 months)
研究者
Yan Wen
Principal investigator
Shiyan City Renmin Hospital