Electroacupuncture as a Treatment for Refractory Overactive Bladder: A Feasibility /Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Change in Female Lower Urinary Tract Symptoms Measured by ICIQ-FLUTS
研究概览
简要总结
This study is a single-site feasibility randomised controlled trial evaluating the feasibility and acceptability of electroacupuncture (EA), and percutaneous tibial nerve stimulation (PTNS), in women with refractory overactive bladder (OAB) who have not achieved satisfactory improvement following standard pelvic health physiotherapy.
The primary aim is to determine whether a larger definitive trial is feasible by assessing recruitment, consent, retention, treatment adherence, data completeness, intervention delivery, safety, and participant acceptability.
Twenty-four participants will be randomly allocated to receive electroacupuncture or PTNS, over a 12-week treatment period. Outcome assessments will be completed at baseline, 6 weeks, 12 weeks, 6 months, and 12 months.
The findings will inform the design of a future definitive randomised controlled trial and contribute to the evidence base for non-pharmacological treatment options for overactive bladder.
详细描述
Overactive bladder (OAB) is a common and distressing condition characterised by urinary urgency, frequency, nocturia, and, in some cases, urgency urinary incontinence. OAB can substantially affect quality of life, psychological wellbeing, social participation, and healthcare utilisation. Although first-line management includes behavioural interventions and pelvic floor physiotherapy, a proportion of women continue to experience bothersome symptoms despite these treatments and require additional therapeutic options.
Electroacupuncture (EA) has emerged as a potential treatment for lower urinary tract symptoms and overactive bladder. Previous studies suggest that EA may improve urinary symptoms through neuromodulatory mechanisms; however, the quality, consistency, and applicability of the evidence remain uncertain. Percutaneous tibial nerve stimulation (PTNS) is an established neuromodulation treatment used within clinical practice and is recommended for selected patients with refractory OAB. To date, there is limited evidence directly comparing EA with PTNS, and uncertainty remains regarding the feasibility of conducting a definitive comparative trial.
The purpose of this study is to evaluate the feasibility and acceptability of a two-arm randomised controlled trial comparing electroacupuncture and PTNS in women with refractory OAB.
This is a single-centre feasibility randomised controlled trial conducted within a pelvic health physiotherapy service. Twent-four women with refractory OAB will be randomised in a 1:1 ratio to receive:
- Electroacupuncture (EA)
- Percutaneous tibial nerve stimulation (PTNS)
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
- Single (Participant)
盲法说明
Participants allocated to the electroacupuncture and sham electroacupuncture groups will be blinded to treatment allocation. Due to the nature of the interventions, treatment providers cannot be blinded. Blinding credibility will be assessed at the end of treatment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the following criteria:
- •Female adults aged 18 years or older.
- •Diagnosed with overactive bladder syndrome (ICIQ-OAB score ≥10).
- •Symptoms present for at least three months and refractory to first-line treatments.
- •Willing to refrain from starting new bladder-related treatments during the study period.
- •Able and willing to provide written informed consent.
排除标准
- •Participants meeting any of the following criteria will be excluded:
- •Pregnant or planning pregnancy during the study period.
- •Bleeding disorders.
- •Severe needle phobia.
- •Presence of a pacemaker.
- •Active cancer diagnosis.
- •Active urinary tract infections or other urological conditions requiring urgent intervention.
- •Participation in another clinical trial for bladder dysfunction within the past six months.
- •Neurological conditions affecting continence (e.g., diabetic neuropathy, multiple sclerosis, Parkinson's disease).
- •Life-threatening infections.
- •Severe cognitive deficits, unconsciousness, dementia (e.g., Alzheimer's or other neurodegenerative diseases).
- •History of incontinence surgery.
- •Previous acupuncture for OAB within the past two months.
- •History of thromboses.
- •Recovering from or suffering from a serious illness or major surgery.
研究组 & 干预措施
Arm 1: Electroacupuncture (EA) Group Experimental
Arm 1: Electroacupuncture (EA) Group Arm Type: Experimental Description: Participants in this group will receive electroacupuncture treatment targeting sacral and lower abdominal acupuncture points traditionally used for overactive bladder (OAB). Sterile, single-use acupuncture needles will be inserted and connected to an electroacupuncture device that delivers a low-frequency electrical current.
Duration: 12 weekly sessions over 12 weeks Setting: Delivered by trained pelvic health physiotherapists in an outpatient hospital setting.
Intervention:
干预措施: Name: Electroacupuncture (EA) Type: Device-based acupuncture therapy (Device)
Arm 2: Percutaneous Tibial Nerve Stimulation (PTNS) Group
Arm Type: Active Comparator Description: Participants in this group will receive percutaneous tibial nerve stimulation, a standard treatment for OAB. A fine needle electrode is inserted near the ankle to stimulate the tibial nerve, transmitting signals to the sacral nerve plexus that controls bladder function.
Duration: 12 weekly sessions over 12 weeks Setting: Delivered by trained clinicians in an outpatient setting.
干预措施: Neuromodulation therapy (Device)
结局指标
主要结局
Change in Female Lower Urinary Tract Symptoms Measured by ICIQ-FLUTS
时间窗: This questionnaire will be completed at 6 weeks, 12 weeks, 6 months, and 12 months
Participants will complete the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) at baseline, 6 weeks, 12 weeks, 6 months, and 12 months. The questionnaire assesses the severity and impact of female lower urinary tract symptoms, including urinary urgency, frequency, nocturia, and urinary incontinence. Changes in questionnaire scores over time will be explored to assess symptom progression and response to treatment.
Change in Urinary Symptom-Related Quality of Life Measured by ICIQ-LUTSqol
时间窗: This questionnaire will be completed at 6 weeks, 12 weeks, 6 months, and 12 months
Participants will complete the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) questionnaire at baseline, 6 weeks, 12 weeks, 6 months, and 12 months. The questionnaire assesses the impact of lower urinary tract symptoms on quality of life, including physical, social, emotional, and daily activities. Changes in questionnaire scores over time will be explored to assess the impact of treatment on symptom-related quality of life.
Change in Functional Activity Measured by Patient-Specific Functional Scale (PSFS)
时间窗: This questionnaire will be completed at 6 weeks, 12 weeks, 6 months, and 12 months
Participants will identify up to three daily activities affected by overactive bladder (OAB) and rate their ability to perform each activity on a scale from 0 to 10, using the Patient-Specific Functional Scale (PSFS). A score of 0 indicates they are unable to perform the activity at all, while a score of 10 reflects their prior or normal level of function before symptoms began. The PSFS is a patient-centred, valid, and responsive measure that allows individuals to report the specific functional limitations that matter most to them. This personalised approach ensures relevance and sensitivity to change, as it captures the real-life impact of OAB on daily functioning. An increase in scores over time will indicate an improvement in function and reduced symptom interference, while stable or declining scores may suggest limited benefit or worsening symptoms. This tool complements symptom-based questionnaires by focusing on individual goals and quality of life.
Improvement in Overactive Bladder Symptoms Using the International Consultation on Incontinence Questionnaire - Overactive Bladder Module (ICIQ-OAB)
时间窗: This questionnaire will be completed at 6 weeks, 12 weeks, 6 months, and 12 months
Participants will complete the validated International Consultation on Incontinence Questionnaire - Overactive Bladder (ICIQ-OAB) at baseline, 6 weeks, 12 weeks, 6 months, and 12 months to assess changes in urinary symptoms, including urgency, frequency, nocturia (waking up to urinate), and incontinence. The ICIQ-OAB is a standardised, reliable, and responsive patient-reported outcome measure commonly used to monitor the severity and impact of overactive bladder symptoms. It consists of four symptom-specific questions, each scored from 0 to 4 or 0 to 5, resulting in a total score range from 0 to 16, where higher scores indicate more severe symptoms. A decrease in total score over time will indicate an improvement in OAB symptoms. The measure is sensitive to change, making it appropriate for tracking the effectiveness of interventions over multiple time points.
Change in Urinary Frequency and Incontinence Episodes via 3-Day Bladder Diary
时间窗: This questionnaire will be completed at 6 weeks, 12 weeks, 6 months, and 12 months
Participants will complete a bladder diary for 3 consecutive days at baseline, 6 weeks, 12 weeks, 6 months, and 12 months. This diary captures frequency of voids, incontinence episodes, urgency, and fluid intake. Bladder diaries are a gold standard for tracking urinary behaviour and treatment response in OAB management. Less visit to toilet will show positive outcome
Frequency and Severity of Adverse Events
时间窗: Baseline, during each treatment session, 6 weeks, 12 weeks, and throughout study participation up to 12 weeks after randomisation.
All adverse events related to EA or PTNS will be recorded and categorised by severity and causality. Monitoring will follow ICH Good Clinical Practice (E6\[R2\]) standards to ensure participant safety.
Recruitment Rate
时间窗: At completion of recruitment (anticipated recruitment period: Sept 2026 to March 2027.
Recruitment feasibility will be assessed as the number and proportion of eligible patients who consent to participate in the study. The number of patients approached, assessed for eligibility, eligible, and recruited will be recorded. Reasons for declining participation will also be recorded where available.
Participant Retention and Follow-up Completion Rate.
时间窗: 6 weeks, 12 weeks, 6 months, and 12 months after randomisation.
Retention will be assessed as the number and proportion of randomised participants who remain in the study and complete the scheduled follow-up assessments. Participant withdrawals and losses to follow-up will be recorded, including reasons where available.
Treatment Compliance and Attendance Rates
时间窗: During each treatment session and at 12 weeks after randomisation.
Participant adherence will be tracked through a treatment log. Missed sessions and reasons for non-attendance will be recorded to assess treatment feasibility and refine delivery strategies for future implementation.
Outcome Data Completeness
时间窗: Baseline, 6 weeks, 12 weeks, 6 months and 12 months
Feasibility of outcome data collection will be assessed as the number and proportion of participants providing complete outcome measure data at each scheduled assessment. Missing questionnaires, questionnaire items, bladder diary data and other missing outcome data will be recorded.
次要结局
- Participant Satisfaction and Treatment Acceptability(This questionnaire will be completed at 12 weeks (end of treatment))
- Patient Satisfaction Assessed by Likert-Scale Questionnaire(This questionnaire will be completed at 12 weeks)
- The International Consultation on Incontinence Questionnaire - Overactive Bladder Quality of Life (ICIQ-OABqol) will be used to assess the impact of overactive bladder (OAB) symptoms on participants' quality of life.(This questionnaire will be completed at 6 weeks, 12 weeks, 6 months, and 12 months)
- Pain Intensity Measured by Visual Analogue Scale (VAS)(This questionnaire will be completed at 6 weeks, 12 weeks, 6 months, and 12 months)
- Incremental Cost-Effectiveness Ratio (ICER) of EA vs. PTNS(This questionnaire will be completed at 12 months)
- Frequency and Severity of Adverse Events(From beginning of trial to 12 months after the trial)
- Treatment Compliance and Attendance Rates(From randomisation to 12 weeks after randomisation)
- Long-Term Symptom and Functional Outcomes at 6 and 12 Months(will be completed at, 6 months, and 12 months)
- Participant Satisfaction and Treatment Acceptability(At the end of 12 weeks post treatment)
- Change in Overactive Bladder Symptoms Measured by ICIQ-OAB(Baseline, 6 weeks, 12 weeks, 6 months and 12 months)
- Change in Urinary Symptom-Related Quality of Life Measured by ICIQ-LUTSqol(This questionnaire will be completed at Baseline 6 weeks, 12 weeks, 6 months, and 12 months)
- Change in Overactive Bladder Symptoms Measured Using a 3-Day Bladder Diary(This questionnaire will be completed at Baseline, 6 weeks, 12 weeks, 6 months, and 12 months)
研究者
Elmas
Pelvic Health Physiotherapist
Chelsea and Westminster NHS Foundation Trust