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

University of Manchester

Status

Terminated

Conditions

Urinary Incontinence, Stress

Urinary Incontinence, Urge

Urinary Incontinence

Treatments

Device: Electrical stimulation

Other: Treatment as usual

Study type

Interventional

Funder types

Other

Identifiers

NCT04059653

223014 (Other Identifier)

R123366

Details and patient eligibility

About

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.

Full 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.

Enrollment

86 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Women
Aged between 18 and 65
GP determined urinary incontinence

Exclusion criteria

Abnormal abdominal mass
Clinical history of urinary retention problems
Severe atrophic vaginitis, vaginal infection, vaginal lesion, severe urogenital prolapse at the level of the vaginal introitus or any other pathology of the vagina or labia
Pregnancy or given birth within the last three months
Implanted pacemaker
Recent pelvic surgery (within the last 12 months)
Recent haemorrhage, haematoma and/or tissue damage to the vagina
Undergoing any active therapy or review appointments for pelvic malignancy
Current urinary tract infection confirmed by urinary dip stick test on initial visit (can be included following a subsequent clear urinary dipstick test)
Manual dexterity insufficient to place the electrical stimulation device in the vagina
Presence of a severe neurological conditions such as Multiple Sclerosis, Motor Neuron Disease or Parkinson's Disease
Multiple co-morbidities to the extent that the activities involved in the pad test (i.e. stair climbing) cannot be completed
Insufficient cognitive ability to provide informed consent and/or participate in the study
Unwillingness to participate in the study