Nocturia, Over Active Bladder, Urinary Incontinence (UI)
Conditions
Keywords
Electric-Acupuncture, Acupuncture, PTNS, Neuromodulation
Brief summary
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.
Detailed description
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: 1. Electroacupuncture (EA) 2. Percutaneous tibial nerve stimulation (PTNS) Participants will receive weekly treatment sessions for 12 weeks and will be followed up at baseline, 6 weeks, 12 weeks, 6 months, and 12 months. The primary outcomes are feasibility outcomes, including: * Recruitment rate * Consent rate * Retention rate * Treatment adherence * Data completeness * Intervention delivery and fidelity * Safety and adverse events * Participant acceptability Exploratory clinical outcomes include: * International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-OAB) * International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) International Consultation on Incontinence Questionnaire 3 day bladder diary (ICIQ BD) Short health economics questioner The study is not powered to detect treatment effectiveness. Findings will be used to estimate key feasibility parameters and inform the design, conduct, and sample size calculation of a future definitive randomised controlled trial. The study has received favourable ethical approval from a UK Research Ethics Committee and NHS Research & Development approval. The study is sponsored by Chelsea and Westminster Hospital NHS Foundation Trust and forms part of a PhD programme at Imperial College London.
Interventions
DEVICEName: Electroacupuncture (EA) Type: Device-based acupuncture therapy
Description: Insertion of acupuncture needles at specific points with electrical stimulation (20 Hz) for 30 minutes per session.
DEVICENeuromodulation therapy
Type: Neuromodulation therapy Description: Insertion of a needle electrode near the medial malleolus with low-voltage electrical stimulation (20 Hz) applied for 30 minutes per session.
Sponsors
Chelsea and Westminster NHS Foundation Trust
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
2 arm parallel Pilot-RCT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and Severity of Adverse Events | 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 | 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. | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Satisfaction and Treatment Acceptability | At the end of 12 weeks post treatment | Participants will complete a study-specific Likert-scale questionnaire at 12 weeks to assess satisfaction, perceived benefit, treatment burden, and overall acceptability of the intervention. The questionnaire will explore participants' experiences of treatment, including ease of participation, perceived symptom improvement, and willingness to recommend the intervention to others. Results will be used to evaluate the acceptability and feasibility of the interventions and trial procedures. |
| Change in Overactive Bladder Symptoms Measured by ICIQ-OAB | Baseline, 6 weeks, 12 weeks, 6 months and 12 months | change in overactive bladder symptoms as assessed by the International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB). The questionnaire evaluates urinary frequency, urgency, nocturia, and urge urinary incontinence. Changes in total and individual symptom scores from baseline to the end of treatment will be compared between study groups, with lower scores indicating an improvement in symptom severity. |
| 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 | 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 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 | Participants will complete a 3-day bladder diary at baseline, 6 weeks, 12 weeks, 6 months and 12 months. Diary measures will include daytime urinary frequency, nocturia, urgency episodes, urgency urinary incontinence episodes, voided volume, fluid intake and pad use. Changes in bladder diary outcomes over time will be explored within and between the treatment groups. |
Countries
United Kingdom
Contacts
CONTACTElmas Court
STUDY_CHAIRLeila Janani, PhD
Imperial College London-Advanced Research Fellow / Senior Clinical Trials Statistician Deputy Head of Trial Methodology
STUDY_CHAIRDeepa Dr Abichandani
Senior Lecturer in Physiotherapy Employability Lead for School of Allied and Community Health London South Bank Universit
STUDY_CHAIRMark Pro. Johnson
Senior Lecturer, Consultant in Obstetrics and Obstetric Medicine Charing Cross Hospital. And Chelsea and Westminster NHS Trust Imperial College London Clinical Chair in Obstetrics Department of Metabolism, Digestion an
STUDY_DIRECTORRufus Mr. Cartwright
Uro-gynaecologist consultant and Honorary Clinical Senior Lecturer institute of Reproductive and Developmental Biology, Hammersmith Campus and Celsea and Westminster NHS Trust Gynaecology and Departm
PRINCIPAL_INVESTIGATORElmas X Court
Chelsea and Westminster Hospital and Imperial College London
Outcome results
None listed