Electroacupuncture as a Treatment for Refractory Overactive Bladder

Official title

Electroacupuncture as a Treatment for Refractory Overactive Bladder: A Feasibility /Pilot Randomized Controlled Trial

Overview

This study is a single-site feasibility randomised controlled trial evaluating the feasibility and acceptability of electroacupuncture (EA), percutaneous tibial nerve stimulation (PTNS), and sham electroacupuncture 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, blinding credibility, safety, and participant acceptability. Thirty-six participants will be randomly allocated to receive electroacupuncture, PTNS, or sham electroacupuncture 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 three-arm randomised controlled trial comparing electroacupuncture, PTNS, and sham electroacupuncture in women with refractory OAB.

This is a single-centre feasibility randomised controlled trial conducted within a pelvic health physiotherapy service. Thirty-six women with refractory OAB will be randomised in a 1:1:1 ratio to receive:

1. Electroacupuncture (EA) 2. Percutaneous tibial nerve stimulation (PTNS) 3. Sham electroacupuncture

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 * Blinding credibility * Safety and adverse events * Participant acceptability

Exploratory clinical outcomes include:

* International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) * International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)

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

• Device Name: Electroacupuncture (EA) Type: Device-based acupuncture therapy
  Description: Insertion of acupuncture needles at specific points with electrical stimulation (2 Hz) for 30 minutes per session.
• Device Neuromodulation 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.
• Device Sham Acupuncture
  Type: Placebo Description: Non-invasive, non-penetrating placebo needles placed at the same points as in the EA group, without electrical stimulation, for 30 minutes per session.

Primary outcome measures

• Change in Female Lower Urinary Tract Symptoms Measured by ICIQ-FLUTS [Time frame: This questionnaire will be completed at 6 weeks, 12 weeks, 6 months, and 12 months]
• Change in Urinary Symptom-Related Quality of Life Measured by ICIQ-LUTSqol [Time frame: This questionnaire will be completed at 6 weeks, 12 weeks, 6 months, and 12 months]

Secondary outcome measures (3)

• Participant Satisfaction and Treatment Acceptability [Time frame: This questionnaire will be completed at 12 weeks (end of treatment)]
• Frequency and Severity of Adverse Events [Time frame: From beginning of trial to 12 months after the trial]
• Treatment Compliance and Attendance Rates [Time frame: From randomisation to 12 weeks after randomisation]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United Kingdom · 1 center

• Chelsea and Westminster hospital NHS foundation Trust — London

Identifiers

NCT: NCT07124390 · OAB · IRAS No: 354646 · REC reference: 26/LO/0362

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗