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

NCT04059653 | Terminated DMC

• 2 other identifiers: R123366223014
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence; Urinary Incontinence, Stress; Urinary Incontinence, Urge

Keywords

neuromuscular electrical stimulation; incontinence

Outcome Measures

Primary Outcomes (1)

• Condition specific quality of life

  The primary outcome measure is Quality of Life measured through self-completion of the short form version of the International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI). The Short Form is a brief and psychometrically robust patient-completed questionnaire for evaluating the frequency, severity, and impact on urinary incontinence in research and clinical practice across the world. Scoring \& analysis: Question items include: frequency of urinary incontinence, amount of leakage and leak interference. The overall score is calculated from the sum of: Leak frequency (minimum 0, maximum 5) Leak amount (minimum 0, maximum 6) Leak interference (minimum 0, maximum 10) Overall score is therefore between 0-21 - the higher the score the worse the outcome

  12 weeks

Secondary Outcomes (5)

• Female Sexual Function Index (FSFI)

  12 weeks

• Sexual dysfunction questionnaire

  12 weeks

• Patient Global Impression of Severity and of Improvement

  12 weeks

• 1-hour in-clinic provocative pad weight test

  12 weeks

• User experience Diaries

  12 weeks

Other Outcomes (1)

• Health economics

  12 weeks

Study Arms (2)

Electrical stimulation

EXPERIMENTAL

Neuromuscular electrical stimulation treatment

Device: Electrical stimulation

Treatment As Usual

ACTIVE COMPARATOR

Usual GP treatment

Other: Treatment as usual

Interventions

Electrical stimulation DEVICE

Electrical stimulation device

Electrical stimulation

Treatment as usual OTHER

GP treatment as usual

Treatment As Usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women
• Aged between 18 and 65
• GP determined urinary incontinence

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

South Manchester GP Federation

Manchester, Greater Manchester, M20 2RN, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 23023996 BACKGROUND

Related Links

• Improving quality of life for women. Providing groundbreaking technology for the treatment of urinary incontinence

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Stress; Urinary Incontinence, Urge

Interventions

Electric Stimulation; Therapeutics

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Jackie Oldham, PhD

  Univeristy of Manchester

  PRINCIPAL INVESTIGATOR

• Sheila McCorkindale, MBChB FRCGP

  University of Manchester

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Jackie Oldham

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 16, 2019
• Study Start: January 6, 2020
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: July 23, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)