A Telehealth-delivered Physical Therapy Program for Postmenopausal Women With Urinary Incontinence

Urinary Incontinence Clinical Trial

Official title:

The Feasibility and Effects of a Telehealth-delivered Physical Therapy Program for Postmenopausal Women With Urinary Incontinence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05970796
• Other study ID #: NSTC 112-2314-B-002-315-
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: February 2024
• Source: National Taiwan University
• Contact: Kuan-Yin Lin, Ph.D.
• Phone: 0965581178
• Email: idoruyin0808[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postmenopausal women frequently report physical (hot flushes, night sweat, insomnia, vaginal dryness, sexual dysfunction, urinary incontinence, reduced fitness level, osteoporotic symptoms, sarcopenia, decreased fat free mass, etc.) and psychological (depression, anxiety, cognitive decline, etc.) symptoms. Among these symptoms, urinary incontinence is one of the most common manifestations of pelvic floor dysfunction and may significantly impact on women's quality of life. Urinary incontinence is highly prevalent (30%) in postmenopausal women and is primarily attributed to the decreased level of estrogen. Other potential risk factors for urinary incontinence after menopause include age, parity, genetic factors, pregnancy, overweight/obesity, low physical activity levels, diabetes, urinary tract infection, etc. International guidelines recommend lifestyle and behavioral change, pelvic floor muscle training and bladder training as first-line treatments for urinary incontinence in postmenopausal women. During the COVID-19 pandemic, access to and utilization of healthcare services is reduced. As travel distance has been reported as one of the strong barriers to healthcare among patients with incontinence, research has been conducted to investigate the applications and effects of telehealth. While telehealth rehabilitation may improve urinary incontinence symptoms, the field is still emerging and more studies are needed to elucidate how physical therapists can perform telehealth pelvic floor muscle training for urinary incontinence.

The objectives of this three-year study are:

1. to investigate the feasibility of a telehealth-delivered physical therapy program for postmenopausal women with urinary incontinence

2. to explore the effects of a telehealth-delivered physical therapy program on urinary incontinence symptoms, pelvic floor muscle function and quality of life in postmenopausal women with urinary incontinence

3. to compare the effectiveness of telehealth physical therapy program with face-to-face physical therapy in this population

4. to compare body composition, physical activity levels, functional capacity, grip strength, urinary incontinence symptoms, and pelvic floor muscles function in women at early versus late stage of post-menopause

5. to evaluate the relationships between duration after menopause and body composition, physical activity levels, functional capacity, grip strength, urinary incontinence symptoms, and pelvic floor muscles function

Description:

This is a non-inferiority randomized controlled trial with a nested cross-sectional study and a nested qualitative interview study. Sixty community-dwelling postmenopausal women with urinary incontinence, aged >40 years, will be recruited and randomly allocated to two groups, telehealth group or face-to-face group. All groups will receive a 12-week pelvic floor muscle training. The face-to-face group will be supervised by a female physical therapist who will provide pelvic floor muscle training twice a week. The training will be adjusted according to the performance of the participant. The telehealth group will receive eight sessions of individualized pelvic floor muscle training provided by a physical therapist via telehealth in addition to a weekly telephone coaching. The baseline, post-intervention, and 3-month follow-up assessments will include feasibility outcomes, measurements of anthropometry, body composition (body composition monitor), hand grip strength (dynamometer), functional exercise capacity (six minute walk test), and pelvic floor muscle function (vaginal manometry, transperineal ultrasound and digital palpation) and two questionnaires about symptom severity of urinary incontinence and physical activity levels. This study will provide evidence of effectiveness of different delivery modes of physical therapy program for postmenopausal women with urinary incontinence and health-care professionals working with this population in clinical practice.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 30, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

1. women aged over 40 years

2. postmenopausal women: amenorrhea for longer than 12 months

3. having symptomatic UI (defined as having the Questionnaire for Urinary Incontinence Diagnosis score > 0 point)

4. being able to answer the questionnaire correctly (no language barrier or cognitive problems)

5. having no other physical or psychological problem that would interfere participation in the study

6. having access to a mobile video conference device with internet access

Exclusion Criteria:

1. women aged over 85 years old

2. receiving hormone therapy

3. having neurological conditions, malignancy for pelvic organ, overflow incontinence or voiding dysfunction

4. had received radical surgery for pelvis, sling or prolapse surgery

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Behavioral:
• Pelvic floor muscle training
The pelvic floor muscle training program will be provided via an intra-vaginal biofeedback device - Smart Kegel Trainer, which will be connected to the product application installed on the mobile phone or tablet so the participants can monitor their pelvic floor contractions in real time and directly in the application. Participants will be asked to complete three sets of 8 to 12 maximal pelvic floor muscle contractions and three to ten fast contractions per training session. The home program will be tailored to each participant and include "pelvic floor safe" exercises recommended by the Continence Foundation of Australia.

Locations

Country	Name	City	State
Taiwan	National Taiwan University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants consented to participate	Consent rate: number of participants enrolled will be divided by number of eligible patients approached	absolute values at baseline
Primary	Number of intervention sessions attended	Attendance rate: number of sessions attended will be divided by the total number of expected sessions within each treatment arm	absolute values at 12 weeks
Primary	Number of participants who remain in the study 3 months after baseline assessment	Retention rate: number of participants who remain in the study at 3-month follow-up as a proportion of the total number of participants recruited at the baseline assessment	absolute values at 3 months
Primary	Number of participants who withdrew from the trial	Withdrawal rate: number of participants who withdraw from the trial after consenting divided by the number of participants who initially consent to the trial	absolute values at 12 weeks and 3 months
Primary	Number of completed training sessions in relation to the scheduled sessions	Adherence rate: the total number of exercise sessions completed as a proportion of that prescribed each week from baseline to 12 week.	absolute values at 12 weeks
Primary	Number of participants with intervention-related adverse events as assessed by CTCAE v4.0	Adverse events: the number of adverse or serious adverse events throughout the 12-week intervention period. Participants will be asked about any symptoms (such as pain, bleeding or itching) at each training session.	absolute values at 12 weeks
Primary	Satisfaction scale	Satisfaction will be was assessed using a five-point Likert-scale ranging from '1 = very dissatisfied' to '5 = very satisfied'.	absolute values at 12 weeks
Primary	Acceptability scale	Acceptability will be was assessed using a five-point Likert-scale ranging from '1 = very dissatisfied' to '5 = very satisfied'.	absolute values at 12 weeks
Secondary	Weight	Weight in kilograms will be measured using a Full Body Sensor Body Composition Monitor.	absolute values at 12 weeks and 3 months
Secondary	Height	Height in meters will be measured using a measuring tape.	absolute values at 12 weeks and 3 months
Secondary	Body mass index	Weight and height will be combined to report body mass index in kg/m^2	absolute values at 12 weeks and 3 months
Secondary	Body fat percentage	Body fat percentage will be measured using a Full Body Sensor Body Composition Monitor. Body fat percentage will be classified as 5.0 to 19.9% (low), 20.0 to 29.9% (normal), 30.0 to 34.9% (high), and 35.0% and above (very high).	absolute values at 12 weeks and 3 months
Secondary	Visceral fat level	Visceral fat level will be measured using a Full Body Sensor Body Composition Monitor. Visceral fat level will be classified as 1 to 9 (normal), 10 to 14 (high), and 15 to 30 (very high).	absolute values at 12 weeks and 3 months
Secondary	Skeletal muscle percentage	Skeletal muscle percentage will be measured using a Full Body Sensor Body Composition Monitor. Skeletal muscle percentage will be classified as 5.0 to 25.8% (low), 25.9 to 37.9% (normal), 28.0 to 29.0% (high), and 29.1 to 60.0% (very high).	absolute values at 12 weeks and 3 months
Secondary	Handgrip strength	The grip strength of dominant hand will be measured in kilograms using a Jamar Plus+ Dynamometer.	absolute values at 12 weeks and 3 months
Secondary	Functional exercise capacity	Functional exercise capacity will be assessed using six-minute walk test. The distance covered over a time of 6 minutes will be recorded in meters.	absolute values at 12 weeks and 3 months
Secondary	Pelvic floor muscle strength	Pelvic floor muscle strength will be measured using digital palpation. The results will be recorded using the modified Oxford Grading scale, which quantifies pelvic floor muscle strength as: 0, no contraction; 1, flicker; 2, weak; 3, moderate; 4, good; and 5, strong.	absolute values at 12 weeks and 3 months
Secondary	Bladder neck descent	Bladder neck descent will be measured in centimeters using a transperineal ultrasound at rest and during maximal voluntary contraction.	absolute values at 12 weeks and 3 months
Secondary	Anteroposterior diameter of the urogenital levator hiatus	Anteroposterior diameter of the urogenital levator hiatus will be measured in centimeters using a transperineal ultrasound at rest and during maximal voluntary contraction.	absolute values at 12 weeks and 3 months
Secondary	Anorectal angle	Anorectal angle will be measured using a transperineal ultrasound. The anorectal angle between the anal canal longitudinal axis and the posterior rectal line will be measured in degrees at rest and during maximal voluntary contraction.	absolute values at 12 weeks and 3 months
Secondary	Severity of urinary incontinence	The severity of urinary incontinence will be measured using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form. The total score ranges from 0-21 with a higher score indicating greater severity of symptoms.	absolute values at 12 weeks and 3 months
Secondary	Physical activity levels	The International Physical Activity Questionnaire - Short Form will be used to measure total physical activity levels in MET minutes a week with a higher score corresponding to a higher physical activity level.	absolute values at 12 weeks and 3 months