Clinical trial NCT05970796: A Telehealth-delivered Physical Therapy Program for Postmenopausal Women with Urinary Incontinence
Official title: The Feasibility and Effects of a Telehealth-delivered Physical Therapy Program for Postmenopausal Women with Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: National Taiwan University
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 22
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants consented to participate
timeFrame: absolute values at baseline
measure: Number of intervention sessions attended
timeFrame: absolute values at 12 weeks
measure: Number of participants who remain in the study 3 months after baseline assessment
timeFrame: absolute values at 3 months
measure: Number of participants who withdrew from the trial
timeFrame: absolute values at 12 weeks and 3 months
measure: Number of completed training sessions in relation to the scheduled sessions
timeFrame: absolute values at 12 weeks
measure: Number of participants with intervention-related adverse events as assessed by CTCAE v4.0
timeFrame: absolute values at 12 weeks
measure: Satisfaction scale
timeFrame: absolute values at 12 weeks
measure: Acceptability scale
timeFrame: absolute values at 12 weeks
Secondary outcomes:
measure: Weight
timeFrame: absolute values at 12 weeks and 3 months
measure: Height
timeFrame: absolute values at 12 weeks and 3 months
measure: Body mass index
timeFrame: absolute values at 12 weeks and 3 months
measure: Body fat percentage
timeFrame: absolute values at 12 weeks and 3 months
measure: Visceral fat level
timeFrame: absolute values at 12 weeks and 3 months
measure: Skeletal muscle percentage
timeFrame: absolute values at 12 weeks and 3 months
measure: Handgrip strength
timeFrame: absolute values at 12 weeks and 3 months
measure: Functional exercise capacity
timeFrame: absolute values at 12 weeks and 3 months
measure: Pelvic floor muscle strength
timeFrame: absolute values at 12 weeks and 3 months
measure: Bladder neck descent
timeFrame: absolute values at 12 weeks and 3 months
measure: Anteroposterior diameter of the urogenital levator hiatus
timeFrame: absolute values at 12 weeks and 3 months
measure: Anorectal angle
timeFrame: absolute values at 12 weeks and 3 months
measure: Severity of urinary incontinence
timeFrame: absolute values at 12 weeks and 3 months
measure: Physical activity levels
timeFrame: absolute values at 12 weeks and 3 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University
Study officials:
affiliation: National Taiwan University
name: Kuan-Yin Lin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: