Tele-rehabilitation Group Program for Urinary Incontinence in Older Women

Urinary Incontinence Clinical Trial

Official title:

Feasibility, Acceptability and Effects of a Tele-rehabilitation Pelvic Floor Muscle Training Group Program for Urinary Incontinence in Older Women

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05182632
• Other study ID #: CER VN 20-21-33
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 6, 2021
• Est. completion date: March 6, 2025

Study information

• Verified date: November 2022
• Source: Université de Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: March 6, 2025
• Est. primary completion date: April 6, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Stress Incontinence

Intervention

Behavioral:
• Group 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

Locations

Country	Name	City	State
Canada	Centre de recherche de l'Institut universitaire de gériatrie de Montréal (CRIUGM)	Montréal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Université de Montréal	Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal, Réseau québécois de recherche sur le vieillissement (RQRV)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognitive function	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)	at recruitment (PRE1)
Other	Cognitive function	Cognitive function, evaluated using the Montreal Cognitive Assessment (MoCA) (0-30 overall score, with scores of 26 and over indicating a normal cognitive function)	at recruitment (PRE1)
Other	Sociodemographic characteristics	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	at recruitment (PRE1)
Other	Signs of vaginal atrophy	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)	at recruitment (PRE1)
Other	Pelvic floor muscle function	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))	at recruitment (PRE1)
Other	Signs and severity of pelvic prolapse	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)	at recruitment (PRE1)
Primary	number of UI episodes	number of UI episodes, evaluated with a 7-day bladder diary	at recruitment (PRE1)
Primary	number of UI episodes	number of UI episodes, evaluated with a 7-day bladder diary	just before the intervention (PRE2)
Primary	number of UI episodes	number of UI episodes, evaluated with a 7-day bladder diary	immediately after the 12-week intervention (POST)
Primary	number of UI episodes	number of UI episodes, evaluated with a 7-day bladder diary	6 months after the end of the 12-week intervention (FOLLOW-UP)
Primary	percentage reduction (%) in the number of UI episodes	percentage reduction (%) in the number of UI episodes, evaluated with a 7-day bladder diary	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)
Secondary	urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome	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)	at recruitment (PRE1)
Secondary	urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome	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)	just before the intervention (PRE2)
Secondary	urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome	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)	immediately after the 12-week intervention (POST)
Secondary	urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome	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)	6 months after the end of the 12-week intervention (FOLLOW-UP)
Secondary	Changes in urinary symptoms and degree to which UI-associated symptoms are troubling or bothersome	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)	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)
Secondary	bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome	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)	at recruitment (PRE1)
Secondary	bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome	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)	just before the intervention (PRE2)
Secondary	bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome	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)	immediately after the 12-week intervention (POST)
Secondary	bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome	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)	6 months after the end of the 12-week intervention (FOLLOW-UP)
Secondary	Changes in bladder, bowel, pelvic organ prolapse and sexual function symptoms and degree to which these symptoms are troubling or bothersome	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)	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)
Secondary	UI-related quality of life	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)	at recruitment (PRE1)
Secondary	UI-related quality of life	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)	just before the intervention (PRE2)
Secondary	UI-related quality of life	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)	immediately after the 12-week intervention (POST)
Secondary	UI-related quality of life	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)	6 months after the end of the 12-week intervention (FOLLOW-UP)
Secondary	Changes in UI-related quality of life	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)	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)
Secondary	UI-associated costs	UI-associated costs, using the adapted Dowell-Bryant Incontinence Cost Index (DBICI) questionnaire	at recruitment (PRE1)
Secondary	UI-associated costs	UI-associated costs, using the adapted Dowell-Bryant Incontinence Cost Index (DBICI) questionnaire	immediately after the 12-week intervention (POST)
Secondary	UI-associated costs	UI-associated costs, using the adapted Dowell-Bryant Incontinence Cost Index (DBICI) questionnaire	6 months after the end of the 12-week intervention (FOLLOW-UP)
Secondary	technology self-efficacy	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)	at recruitment (PRE1)
Secondary	technology self-efficacy	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)	immediately after the 12-week intervention (POST)
Secondary	technology self-efficacy	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)	6 months after the end of the 12-week intervention (FOLLOW-UP)
Secondary	UI related self-efficacy	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)	at recruitment (PRE1)
Secondary	UI related self-efficacy	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)	immediately after the 12-week intervention (POST)
Secondary	UI related self-efficacy	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)	6 months after the end of the 12-week intervention (FOLLOW-UP)
Secondary	Pelvic floor muscles related self-efficacy	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)	at recruitment (PRE1)
Secondary	Pelvic floor muscles related self-efficacy	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)	immediately after the 12-week intervention (POST)
Secondary	Pelvic floor muscles related self-efficacy	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)	6 months after the end of the 12-week intervention (FOLLOW-UP)
Secondary	Vaginal atrophy symptoms	Vaginal atrophy symptoms, evaluated using the Atrophy Symptom Questionnaire (ASQ) (0-15 overall score, with higher scores indicating higher severity of vaginal atrophy symptoms)	at recruitment (PRE1)
Secondary	Vaginal atrophy symptoms	Vaginal atrophy symptoms, evaluated using the Atrophy Symptom Questionnaire (ASQ) (0-15 overall score, with higher scores indicating higher severity of vaginal atrophy symptoms)	immediately after the 12-week intervention (POST)
Secondary	Vaginal atrophy symptoms	Vaginal atrophy symptoms, evaluated using the Atrophy Symptom Questionnaire (ASQ) (0-15 overall score, with higher scores indicating higher severity of vaginal atrophy symptoms)	6 months after the end of the 12-week intervention (FOLLOW-UP)
Secondary	Patient reported improvement and satisfaction	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)	immediately after the 12-week intervention (POST)
Secondary	Patient reported improvement and satisfaction	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)	6 months after the end of the 12-week intervention (FOLLOW-UP)
Secondary	Feasibility/Acceptability (reach)	Reach aspect of feasibility/acceptability, evaluated using attendance to weekly sessions	through intervention completion, for 12 weeks
Secondary	Feasibility/Acceptability (fidelity)	Fidelity aspect of feasibility/acceptability, evaluated using the integrity of the GROUP program elements delivered by the physiotherapist during each session (checklist)	through intervention completion, for 12 weeks
Secondary	Feasibility/Acceptability (dose)	Dose aspect feasibility/acceptability, evaluated using adherence to home exercises (exercises journal)	through intervention completion, for 12 weeks
Secondary	Feasibility/Acceptability (perceived usability of the technology)	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)	immediately after the 12-week intervention (POST)
Secondary	Feasibility/Acceptability (perceived usability of the technology)	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)	6 months after the end of the 12-week intervention (FOLLOW-UP)
Secondary	Potential challenges and satisfaction with the program from the patients' perspective	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	immediately after the intervention (POST)