Evaluation of a new technology for the treatment of bladder leakage in wome

Not Applicable

Completed

• Conditions: Female urinary incontinence; Urological and Genital Diseases

• Registration Number: ISRCTN13500331
• Lead Sponsor: niversity of Manchester

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34415401/ (added 20/04/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-16
• Study Completion: 2020-06-30
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 86

Inclusion Criteria

1. Women
2. Aged between 18 and 65
3. GP determined urinary incontinence

Exclusion Criteria

Current exclusion criteria as of 01/09/2017:
1. Abnormal abdominal mass
2. Clinical history of urinary retention problems
3. 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
4. Pregnancy or given birth within the last three months
5. Implanted pacemaker
6. Recent pelvic surgery (within the last 12 months)
7. Recent haemorrhage, haematoma and/or tissue damage to the vagina
8. Undergoing any active therapy or review appointments for pelvic malignancy
9. Current urinary tract infection confirmed by urinary dip stick test on initial visit (can be included following a subsequent clear urinary dipstick test)
10. Manual dexterity insufficient to place the Pelviva device in the vagina
11. Presence of a severe neurological conditions such as Multiple Sclerosis, Motor Neuron Disease or Parkinson’s Disease
12. Anticholinergic and/or device treatment in the preceding 4 weeks
13. Multiple co-morbidities to the extent that the activities involved in the pad test (i.e. stair climbing) cannot be completed
14. Insufficient cognitive ability to provide informed consent and/or participate in the study
15. Unwillingness to participate in the study

Previous exclusion criteria:
1. Abnormal abdominal mass
2. Problems with urinary retention
3. 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
4. Pregnancy or given birth within the last three months
5. Implanted pacemaker
6. Recent pelvic surgery (within the last 12 months)
7. Recent haemorrhage, haematoma and/or tissue damage to the vagina
8. Previous or current active treatment for pelvic malignancy
9. Current urinary tract infection confirmed by urinary dip stick test on initial visit
10. Manual dexterity insufficient to place the Pelviva device in the vagina
11. Presence of a severe neurological conditions such as Multiple Sclerosis, Motor Neuron Disease or Parkinson’s Disease
12. No anticholinergic and/or device treatment in the preceding 4 weeks
13. Multiple co-morbidities to the extent that the activities involved in the pad test (i.e. stair climbing) cannot be completed
14. Unwillingness to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of Life is measured using the International Consultation on Incontinence Questionnaire—Urinary Incontinence (ICIQ-UI) at baseline, month one and a half, three, six, 12, 24 and 36.