Tele-rehabilitation Group Program for Urinary Incontinence in Older Women

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Urinary Incontinence; Urinary Stress Incontinence
• Intervention / Treatment: Behavioral: Group pelvic floor telerehabilitation

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chantale Dumoulin, PhD; Phone Number: 4153 514 340-3540; Email: chantal.dumoulin@umontreal.ca
• Study Contact Backup: Name: Mélanie Le Berre, MSc; Phone Number: 4825 514 340-3540; Email: melanie.le.berre@umontreal.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3W 1W4
      • Centre de recherche de l'Institut universitaire de gériatrie de Montréal (CRIUGM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group pelvic floor tele-rehabilitation; 12 weekly treatment online sessions + daily home exercise program	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of UI episodes	number of UI episodes, evaluated with a 7-day bladder diary	at recruitment (PRE1)
number of UI episodes	number of UI episodes, evaluated with a 7-day bladder diary	just before the intervention (PRE2)
number of UI episodes	number of UI episodes, evaluated with a 7-day bladder diary	immediately after the 12-week intervention (POST)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
UI-associated costs	UI-associated costs, using the adapted Dowell-Bryant Incontinence Cost Index (DBICI) questionnaire	at recruitment (PRE1)
UI-associated costs	UI-associated costs, using the adapted Dowell-Bryant Incontinence Cost Index (DBICI) questionnaire	immediately after the 12-week intervention (POST)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Feasibility/Acceptability (reach)	Reach aspect of feasibility/acceptability, evaluated using attendance to weekly sessions	through intervention completion, for 12 weeks
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
Feasibility/Acceptability (dose)	Dose aspect feasibility/acceptability, evaluated using adherence to home exercises (exercises journal)	through intervention completion, for 12 weeks
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)
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Université de Montréal
• Collaborators: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal; Réseau québécois de recherche sur le vieillissement (RQRV)
• Investigators: Principal Investigator: Chantale Dumoulin, PhD, Université de Montréal

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2021
• Primary Completion (Actual): April 6, 2022
• Study Completion (Estimated): March 6, 2025

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: December 21, 2021
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: rehabilitation; aging; physiotherapy; physical therapy; female; telerehabilitation; pelvic floor
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: CER VN 20-21-33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Data will be available on request to Prof Dumoulin for researchers whose proposed use of the data has been approved by ethics committee.

Email: chantal.dumoulin@umontreal.ca

• IPD Sharing Time Frame: Available from 1 year after the publication of the main findings until five years after that publication
• IPD Sharing Access Criteria: If proposed use of the data has been approved by ethics committee
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No