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

NCT05970796 | Completed

• 1 other identifier: NSTC 112-2314-B-002-315-
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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. 1.to investigate the feasibility of a telehealth-delivered physical therapy program for postmenopausal women with urinary incontinence
2. 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. 3.to compare the effectiveness of telehealth physical therapy program with face-to-face physical therapy in this population
4. 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. 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

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (14)

• Weight

  absolute values at 12 weeks and 3 months

• Height

  absolute values at 12 weeks and 3 months

• Body mass index

  absolute values at 12 weeks and 3 months

• Body fat percentage

  absolute values at 12 weeks and 3 months

• Visceral fat level

  absolute values at 12 weeks and 3 months

Study Arms (2)

Telehealth group

EXPERIMENTAL

The telehealth group will receive eight sessions of individualized pelvic floor muscle training provided by a physical therapist via telehealth in 12 weeks.

Behavioral: Pelvic floor muscle training

Face-to-face group

ACTIVE COMPARATOR

The face-to-face group will be supervised by a female physical therapist who will provide pelvic floor muscle training twice a week for 12 weeks.

Behavioral: Pelvic floor muscle training

Interventions

Pelvic floor muscle training BEHAVIORAL

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.

Face-to-face group; Telehealth group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women aged over 40 years
• postmenopausal women: amenorrhea for longer than 12 months
• having symptomatic UI (defined as having the Questionnaire for Urinary Incontinence Diagnosis score \> 0 point)
• being able to answer the questionnaire correctly (no language barrier or cognitive problems)
• having no other physical or psychological problem that would interfere participation in the study
• having access to a mobile video conference device with internet access

You may not qualify if:

• women aged over 85 years old
• receiving hormone therapy
• having neurological conditions, malignancy for pelvic organ, overflow incontinence or voiding dysfunction
• had received radical surgery for pelvis, sling or prolapse surgery

Sponsors & Collaborators

• National Taiwan University: lead

Study Sites (1)

National Taiwan University

Taipei, Taipei, 100, Taiwan

Location

Related Publications (2)

• Lin KY, Chen CY, Wu PC, Huang MH, Ou YC, Kao YL, Lin KH. The feasibility and effects of a telehealth-delivered physical therapy program for postmenopausal women with urinary incontinence: A pilot mixed-methods study. Maturitas. 2025 Jun;197:108376. doi: 10.1016/j.maturitas.2025.108376. Epub 2025 Apr 23.

  PMID: 40286562 DERIVED

• Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.

  PMID: 39704322 DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kuan-Yin Lin, Ph.D.

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 1, 2023
• Study Start: December 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

TW (1)