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

NCT ID: NCT05970796

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-10-31

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.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Telehealth group

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

Group Type: EXPERIMENTAL

Pelvic floor muscle training

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Pelvic floor muscle training

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University

OTHER

Sponsor Role: lead

Responsible Party

Kuan-Yin Lin

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kuan-Yin Lin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University

Locations

National Taiwan University

Taipei, Taipei, Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 40286562 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39704322 (View on PubMed)

Other Identifiers

NSTC 112-2314-B-002-315-

Identifier Type: -

Identifier Source: org_study_id