Clinical trial NCT04059653: Evaluation of a New Technology for the Treatment of Bladder Leakage in Women
Official title: Primary Care Evaluation of A Novel Disposable Neuromuscular Electrical Stimulation Treatment For Female Urinary Incontinence: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urinary Incontinence
Urinary Incontinence, Stress
Urinary Incontinence, Urge
Keywords: neuromuscular electrical stimulation
incontinence
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2019-08-16
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Condition specific quality of life
timeFrame: 12 weeks
Secondary outcomes:
measure: Female Sexual Function Index (FSFI)
timeFrame: 12 weeks
measure: Sexual dysfunction questionnaire
timeFrame: 12 weeks
measure: Patient Global Impression of Severity and of Improvement
timeFrame: 12 weeks
measure: 1-hour in-clinic provocative pad weight test
timeFrame: 12 weeks
measure: User experience Diaries
timeFrame: 12 weeks
Other outcomes:
measure: Health economics
timeFrame: 12 weeks
Locations:
city: Manchester
country: United Kingdom
facility: South Manchester GP Federation
state: Greater Manchester
Study officials:
affiliation: Univeristy of Manchester
name: Jackie Oldham, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manchester
name: Sheila McCorkindale, MBChB FRCGP
role: STUDY_CHAIR
References:
citation: Oldham J, Herbert J, McBride K. Evaluation of a new disposable "tampon like" electrostimulation technology (Pelviva(R)) for the treatment of urinary incontinence in women: a 12-week single blind randomized controlled trial. Neurourol Urodyn. 2013 Jun;32(5):460-6. doi: 10.1002/nau.22326. Epub 2012 Sep 28.