Urinary Incontinence, Urinary Stress Incontinence
Conditions
Keywords
female, aging, physiotherapy, physical therapy, pelvic floor, rehabilitation, telerehabilitation
Brief summary
The recommended treatment for urinary incontinence (UI) in women is individualized pelvic floor muscle training (PFMT), a costly and resource-intensive approach; one Canada is currently unable to meet. A recent non-inferiority randomized controlled trial just confirmed that group-based PFMT is equally effective but less resource-intensive (more cost-effective) than individual PFMT to treat UI in older women (ClinicalTrials.gov Identifier: NCT02039830). In times of COVID-19 however, with the Quebec, Canada's public health authorities preventing gatherings to stop the virus' spread, the potential of in-person group approaches is temporarily limited. It is thus important to develop innovative ways to deliver this first-line treatment remotely, particularly for those confined at home for whom UI can have a detrimental impact on physical health and quality of life. Ensuring an online option for group-based PFMT would also allow to increase the accessibility of UI treatment for women living in rural or remote areas in Canada, where pelvic floor rehabilitation services are not available or scarce. To this end, this study will assess the feasibility, acceptability and effects of a tele-rehabilitation PFMT group program for UI in older women.
Interventions
BEHAVIORALGroup pelvic floor telerehabilitation
Multimodal group physiotherapy: 12 weeks of weekly group physiotherapy treatments including education and pelvic floor muscle exercises delivered online + home exercise program
Sponsors
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Réseau québécois de recherche sur le vieillissement (RQRV)
Université de Montréal
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
N/A (single-arm study)
Intervention model description
Feasibility pilot study
Eligibility
Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 65 or older, as older women will show a particular genitourinary profile compared with younger women, notably due to menopause. This age cut-off was used in other studies in UI; 2. Ambulatory (able to walk, move about safely and autonomously without any mobility device); 3. Describe a pattern of stress/mixed UI, confirmed using the Questionnaire for Incontinence Diagnosis (QUID); 4. Have at least three urinary leakage per week, persisting for 3 months or more; 5. Understand French or English instructions; 6. Report no important cognitive deficit (determined with a Mini-Mental State Evaluation (MMSE) score of 24/30 or more); 7. Have an internet access; and 8. Able to give informed consent and complete a gynecological examination and fill 7-day bladder diaries and questionnaires.
Exclusion criteria
1. Present risk factors known to interfere with the effects of PFMT or with the PFM evaluation, including chronic constipation (as defined by the International Working Committee for Chronic Constipation), important pelvic organ prolapse (Baden-Walker score \> stage 2), or any other comorbidities with a potential impact on the treatment (i.e. cognitive impairment, diabetes, active cancer, respiratory or cardiovascular conditions, etc); 2. Currently taking medication for UI or medications affecting skeletal muscles; 3. Considered obese with a body mass index (BMI) over 35; 4. Had an active urinary or vaginal infection in the past 3 months; 5. Underwent a change in hormonal replacement therapy in the past 6 months; 6. Received pelvic floor physiotherapy treatment or surgery for UI or pelvic organ prolapse in the past year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of UI episodes | at recruitment (PRE1) | number of UI episodes, evaluated with a 7-day bladder diary |
| percentage reduction (%) in the number of UI episodes | at recruitment (PRE1), just before the intervention (PRE2), immediately after the 12-week intervention (POST), 6 months after the end of the 12-week intervention (FOLLOW-UP) | percentage reduction (%) in the number of UI episodes, evaluated with a 7-day bladder diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| technology self-efficacy | at recruitment (PRE1) | technology self-efficacy, evaluated using the Online Technologies Self-efficacy Scale (OTSES) questionnaire (30-120 overall score, with higher scores indicating lower level of technology self-efficacy) |
| Feasibility/Acceptability (reach) | through intervention completion, for 12 weeks | Reach aspect of feasibility/acceptability, evaluated using attendance to weekly sessions |
| Feasibility/Acceptability (fidelity) | through intervention completion, for 12 weeks | Fidelity aspect of feasibility/acceptability, evaluated using the integrity of the GROUP program elements delivered by the physiotherapist during each session (checklist) |
| Feasibility/Acceptability (dose) | through intervention completion, for 12 weeks | Dose aspect feasibility/acceptability, evaluated using adherence to home exercises (exercises journal) |
| Feasibility/Acceptability (perceived usability of the technology) | immediately after the 12-week intervention (POST) | Perceived usability of the technology from the patients' experience as an aspect of feasibility/acceptability, evaluated using the System Usability Scale (SUS) (0-100 overall score, with higher scores indicating a higher usability) |
| Potential challenges and satisfaction with the program from the patients' perspective | immediately after the intervention (POST) | Potential challenges and satisfaction with the program from the patients' perspective, evaluated during focus groups or interviews using an interview guide developed from the seven dimensions of the Theoretical Framework of Acceptability (TFA), three of the five Consolidated Framework for Implementation Research (CFIR) domains and additional open-ended questions on satisfaction |
| urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome | at recruitment (PRE1) | urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome, evaluated using the International Consultation on Incontinence Questionnaire module on UI symptoms (ICIQ-UI) short form (0-21 overall score, with higher scores indicating more sever symptoms) |
| Changes in urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome | at recruitment (PRE1), just before the intervention (PRE2), immediately after the 12-week intervention (POST), 6 months after the end of the 12-week intervention (FOLLOW-UP) | urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome, evaluated using the International Consultation on Incontinence Questionnaire module on UI symptoms (ICIQ-UI) short form (0-21 overall score, with higher scores indicating more sever symptoms) |
| bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome | at recruitment (PRE1) | bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome, evaluated using the Australian Pelvic Floor Questionnaire (APFQ) (0-45 score for bladder symptoms, 0-34 score for bowel symptoms, 0-15 score for pelvic organ prolapse symptoms, and 0-21 score for sexual function symptoms, with higher scores indicating more severe symptoms) |
| Changes in bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome | at recruitment (PRE1), just before the intervention (PRE2), immediately after the 12-week intervention (POST), 6 months after the end of the 12-week intervention (FOLLOW-UP) | bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome, evaluated using the Australian Pelvic Floor Questionnaire (APFQ) (0-45 score for bladder symptoms, 0-34 score for bowel symptoms, 0-15 score for pelvic organ prolapse symptoms, and 0-21 score for sexual function symptoms, with higher scores indicating more severe symptoms) |
| UI-related quality of life | at recruitment (PRE1) | UI-related quality of life, evaluated using the International Consultation on Incontinence Questionnaire module on Lower Urinary Tract Symptoms quality of life (ICIQ-LUTS QoL) (19-76 overall score with greater values indicating increased impact on quality of life) |
| Changes in UI-related quality of life | at recruitment (PRE1), just before the intervention (PRE2), immediately after the 12-week intervention (POST), 6 months after the end of the 12-week intervention (FOLLOW-UP) | UI-related quality of life, evaluated using the International Consultation on Incontinence Questionnaire module on Lower Urinary Tract Symptoms quality of life (ICIQ-LUTS QoL) (19-76 overall score with greater values indicating increased impact on quality of life) |
| UI-associated costs | at recruitment (PRE1) | UI-associated costs, using the adapted Dowell-Bryant Incontinence Cost Index (DBICI) questionnaire |
| UI related self-efficacy | at recruitment (PRE1) | UI related self-efficacy, evaluated using the geriatric self-efficacy scale (GES) (0-120 overall score, with higher scores indicating higher level of self-efficacy related to urinary incontinence) |
| Pelvic floor muscles related self-efficacy | at recruitment (PRE1) | Pelvic floor muscles related self-efficacy, evaluated using the Broome's self-efficacy scale (14 items with responses ranging 0-100 for part A and 9 items with responses ranging 0-100 for part B; an overall mean self-efficacy score is calculated, also ranging 0-100) |
| Vaginal atrophy symptoms | at recruitment (PRE1) | Vaginal atrophy symptoms, evaluated using the Atrophy Symptom Questionnaire (ASQ) (0-15 overall score, with higher scores indicating higher severity of vaginal atrophy symptoms) |
| Patient reported improvement and satisfaction | immediately after the 12-week intervention (POST) | Patient reported improvement and satisfaction, evaluated using the patient global impression of improvement (PGI-I) index, a single-item tool to capture perceived satisfaction with treatment: satisfied (does not need other treatments); unsatisfied (would like another treatment for UI) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pelvic floor muscle function | at recruitment (PRE1) | Gynecological evaluation of pelvic floor muscle function, using the Laycock's PERFECT score (PERFECT is an acronym with P = power of the pelvic floor muscle contraction, measured with the modified Oxford 6-point scale: 0=no contraction, 1=flicker, 2=weak, 3=moderate, 4=good, and 5=strong; E = endurance of the pelvic floor muscle contraction, measured from 0 to 10 seconds, R = repetitions, measured from 0 to 10 contractions, F = fast contractions, measured as the number of fast maximal contractions over a period of 10 seconds, E = elevation of the posterior vaginal wall during the pelvic floor muscle contraction (yes/no), C = co-contraction of the lower abdominal muscles during the pelvic floor muscle contraction (yes/no), T = timing, with the presence of synchronous involuntary contraction of pelvic floor muscles on coughing (yes/no)) |
| Signs and severity of pelvic prolapse | at recruitment (PRE1) | Signs and severity of pelvic prolapse, observed during a gynecological evaluation, using the Baden-Walker prolapsus score (0-4 overall score, with higher scores indicating a higher severity) |
| Signs of vaginal atrophy | at recruitment (PRE1) | Signs of vaginal atrophy, observed during a gynecological evaluation, using the vaginal atrophy index (VAI) (6-15 overall score, with lower scores indicating more severe symptoms of vaginal atrophy) |
| Cognitive function | at recruitment (PRE1) | Cognitive function, evaluated using the Mini-Mental State Examination (MMSE) (0-30 overall score, with scores of 24 and over indicating a normal cognitive function) |
| Sociodemographic characteristics | at recruitment (PRE1) | Sociodemographic characteristics, evaluated using a home-made questionnaire recording age, weight, height, living situation, marital status, education, annual income, gynecological and medical history, medication and hormones prescriptions, smoking status, along with the Questionnaire for female Urinary Incontinence Diagnosis (QUID) to determine UI type |
Countries
Canada
Outcome results
None listed