Status:
TERMINATED
Evaluation of a New Technology for the Treatment of Bladder Leakage in Women
Lead Sponsor:
University of Manchester
Conditions:
Urinary Incontinence
Urinary Incontinence, Stress
Eligibility:
FEMALE
18-65 years
Phase:
NA
Brief 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 Gen...
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 determin...
Eligibility Criteria
Inclusion
- Women
- Aged between 18 and 65
- GP determined urinary incontinence
Exclusion
- 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
Key Trial Info
Start Date :
January 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT04059653
Start Date
January 6 2020
End Date
June 30 2020
Last Update
July 23 2020
Active Locations (1)
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1
South Manchester GP Federation
Manchester, Greater Manchester, United Kingdom, M20 2RN