NCT04059653

Evaluation of a New Technology for the Treatment of Bladder Leakage in Women

Primary Care Evaluation of A Novel Disposable Neuromuscular Electrical Stimulation Treatment For Female Urinary Incontinence: A Randomised Controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: University of Manchester · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Evaluation of a new technology for the treatment of bladder leakage in women. The objective is to compare quality of life and other incontinence associated outcomes between women receiving routine General Practitioner (GP) prescribed care for urinary incontinence compared with those prescribed the electrical stimulation device.

Detailed description

This United Kingdom study will comprise a single blind, primary care, post-market evaluation of a novel neuromuscular electrical stimulation treatment for urinary incontinence . Women with GP determined urinary incontinence (urgency, stress or mixed) will be randomised into one of two groups (intervention or control). The control group will receive routine care via their GP practice. The intervention group will receive the electrical stimulation device. Treatment will last for 12 weeks with a Quality of Life (QoL) primary end point immediately post treatment with a second phase to explore the impact of a further 12 weeks maintenance programme in the intervention group compared to routine care. There will be a further two year follow-up assessment.

Conditions

• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Incontinence, Urge

Interventions

Type	Name	Description
DEVICE	Electrical stimulation	Electrical stimulation device
OTHER	Treatment as usual	GP treatment as usual

Timeline

• Start date: 2020-01-06
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2019-08-16
• Last updated: 2020-07-23

Locations

1 site across 1 country: United Kingdom