Effects of a Combined Program of Pelvic Floor Muscle Training and Yoga

Effects of a Combined Program of Pelvic Floor Muscle Training and Yoga on Relieving Genitourinary Symptoms, and Improving Sexual Function and Quality of Life in Asian Women With Breast Cancer

This study aims to examine the effects of Pelvic Floor Muscle Training (PFMT) combined with yoga on relieving genitourinary symptoms, symptom-related quality of life, and improving sexual function in women with breast cancer. This study is a parallel randomized study with two groups. Women will be assigned to the experimental or control group by using the block randomization method. The experimental group will receive regular care and a 12-week program of PFMT and yoga. The control group will receive regular care. We collect relevant data from both groups at baseline and 4, 8, 12, and 24 weeks after baseline during the study period.

Study Overview

• Status: Enrolling by invitation
• Conditions: Quality of Life; Genitourinary Symptoms; Sexual Function
• Intervention / Treatment: Behavioral: Pelvic Floor Muscle Training (PFMT) and yoga

Detailed Description

This study will be conducted with the approval obtained from the Institutional Review Board (IRB) of MacKay Memorial Hospital. This parallel-two-group randomized experimental study including an experimental group and a control group examines the effects of pelvic floor muscle training (PFMT) combined with yoga on genitourinary symptoms, symptom-related quality of life, and sexual function. A sample of women with breast cancer experiencing ≥1 genitourinary symptom(s) will be recruited and assigned to an experimental group or a control group by using the block randomization method. The experimental group will receive regular care and a 12-week program of PFMT and yoga. We will provide the experimental group with 12 days of online group practice sections of PFMT and yoga (weekly 60-minute practice incudes yoga 40 minutes, PFMT 15 minutes, and reflection 5 minutes). We expect them to perform 36 days of home-based practice of PFMT and yoga with 3 days/week of yoga for 40 minutes and PFMT for 15 minutes. The control group will receive regular care and relevant educational materials after data collection. Information will be collected at five time points: baseline and 4, 8, 12, and 24 weeks after baseline. Generalized estimating equation procedures will be used to examine the effects of the intervention. We hypothesized that the experimental group will display more significant improvements in genitourinary symptoms, symptom-related influences, and sexual function than those shown in the control group.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei City, Taiwan, 10449
    • Mackay Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women aged 20-60 years
• Women with a confirmed diagnosis of breast cancer (Stages I-III) for ≥3 months
• Women who experience ≥1 genitourinary symptom(s)

Exclusion Criteria:

• Women with other types of cancer diagnoses (e.g., endometrial cancer and ovarian cancer)
• Women with inadequately managed chronic conditions (e.g., an individual with diabetes having HbA1c level >7%)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; The experimental group will receive regular care and a 12-week program of pelvic floor muscle training (PFMT) and yoga	Behavioral: Pelvic Floor Muscle Training (PFMT) and yoga; The experimental group participants will be instructed to perform the practice session four days a week. The four days per week practice times (PFMT 15 minutes/day; yoga 40 minutes/day.) will result in weekly practice times for pelvic floor muscle training (PFMT) of 60 minutes and for yoga of ≥150 minutes.
No Intervention: Control group; The control group will receive regular care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vulvovaginal Symptoms	The 21-item Chinese version of the Vulvovaginal Symptoms Questionnaire (C-VSQ) comprises four subscales to assess vulvovaginal symptoms experienced during the past week (Items 1-7), and symptom-related influences (Emotions Items 8-11; Life-impact Items 12-15, and Sexual-impact Items 16, 18-21). The response options for all items are "Yes" (1 point) and "No" (0 point). Subscale scores are the sum of the scores for the items included in that subscale. The C-VSQ total score is the sum of three subscale scores (0-15 points) or four subscale scores (0-20 points for sexually active women). A higher C-VSQ total score indicates experiencing greater severity of vulvovaginal symptoms and symptom-related influences.	Baseline
Vulvovaginal Symptoms	The 21-item Chinese version of the Vulvovaginal Symptoms Questionnaire (C-VSQ) comprises four subscales to assess vulvovaginal symptoms experienced during the past week (Items 1-7), and symptom-related influences (Emotions Items 8-11; Life-impact Items 12-15, and Sexual-impact Items 16, 18-21). The response options for all items are "Yes" (1 point) and "No" (0 point). Subscale scores are the sum of the scores for the items included in that subscale. The C-VSQ total score is the sum of three subscale scores (0-15 points) or four subscale scores (0-20 points for sexually active women). A higher C-VSQ total score indicates experiencing greater severity of vulvovaginal symptoms and symptom-related influences.	4 weeks after baseline
Vulvovaginal Symptoms	The 21-item Chinese version of the Vulvovaginal Symptoms Questionnaire (C-VSQ) comprises four subscales to assess vulvovaginal symptoms experienced during the past week (Items 1-7), and symptom-related influences (Emotions Items 8-11; Life-impact Items 12-15, and Sexual-impact Items 16, 18-21). The response options for all items are "Yes" (1 point) and "No" (0 point). Subscale scores are the sum of the scores for the items included in that subscale. The C-VSQ total score is the sum of three subscale scores (0-15 points) or four subscale scores (0-20 points for sexually active women). A higher C-VSQ total score indicates experiencing greater severity of vulvovaginal symptoms and symptom-related influences.	8 weeks after baseline
Vulvovaginal Symptoms	The 21-item Chinese version of the Vulvovaginal Symptoms Questionnaire (C-VSQ) comprises four subscales to assess vulvovaginal symptoms experienced during the past week (Items 1-7), and symptom-related influences (Emotions Items 8-11; Life-impact Items 12-15, and Sexual-impact Items 16, 18-21). The response options for all items are "Yes" (1 point) and "No" (0 point). Subscale scores are the sum of the scores for the items included in that subscale. The C-VSQ total score is the sum of three subscale scores (0-15 points) or four subscale scores (0-20 points for sexually active women). A higher C-VSQ total score indicates experiencing greater severity of vulvovaginal symptoms and symptom-related influences.	12 weeks after baseline
Vulvovaginal Symptoms	The 21-item Chinese version of the Vulvovaginal Symptoms Questionnaire (C-VSQ) comprises four subscales to assess vulvovaginal symptoms experienced during the past week (Items 1-7), and symptom-related influences (Emotions Items 8-11; Life-impact Items 12-15, and Sexual-impact Items 16, 18-21). The response options for all items are "Yes" (1 point) and "No" (0 point). Subscale scores are the sum of the scores for the items included in that subscale. The C-VSQ total score is the sum of three subscale scores (0-15 points) or four subscale scores (0-20 points for sexually active women). A higher C-VSQ total score indicates experiencing greater severity of vulvovaginal symptoms and symptom-related influences.	24 weeks after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary symptoms	We investigated eight common urinary symptoms using the lower urinary tract symptoms (LUTS) subscale. The LUTS subscale investigates (a) urinary incontinence, (b) increased daytime urinary frequency, (c) urgency, (d) nocturia, (e) intermittent stream/intermittency, (f) slow stream, (g) hesitancy, and (h) a feeling of incomplete emptying. A higher total LUTS score (Range 0-11) indicates that a woman experiences a greater number of different types of urinary symptoms.	Baseline
Urinary symptoms	We investigated eight common urinary symptoms using the lower urinary tract symptoms (LUTS) subscale. The LUTS subscale investigates (a) urinary incontinence, (b) increased daytime urinary frequency, (c) urgency, (d) nocturia, (e) intermittent stream/intermittency, (f) slow stream, (g) hesitancy, and (h) a feeling of incomplete emptying. A higher total LUTS score (Range 0-11) indicates that a woman experiences a greater number of different types of urinary symptoms.	4 weeks after baseline
Urinary symptoms	We investigated eight common urinary symptoms using the lower urinary tract symptoms (LUTS) subscale. The LUTS subscale investigates (a) urinary incontinence, (b) increased daytime urinary frequency, (c) urgency, (d) nocturia, (e) intermittent stream/intermittency, (f) slow stream, (g) hesitancy, and (h) a feeling of incomplete emptying. A higher total LUTS score (Range 0-11) indicates that a woman experiences a greater number of different types of urinary symptoms.	8 weeks after baseline
Urinary symptoms	We investigated eight common urinary symptoms using the lower urinary tract symptoms (LUTS) subscale. The LUTS subscale investigates (a) urinary incontinence, (b) increased daytime urinary frequency, (c) urgency, (d) nocturia, (e) intermittent stream/intermittency, (f) slow stream, (g) hesitancy, and (h) a feeling of incomplete emptying. A higher total LUTS score (Range 0-11) indicates that a woman experiences a greater number of different types of urinary symptoms.	12 weeks after baseline
Urinary symptoms	We investigated eight common urinary symptoms using the lower urinary tract symptoms (LUTS) subscale. The LUTS subscale investigates (a) urinary incontinence, (b) increased daytime urinary frequency, (c) urgency, (d) nocturia, (e) intermittent stream/intermittency, (f) slow stream, (g) hesitancy, and (h) a feeling of incomplete emptying. A higher total LUTS score (Range 0-11) indicates that a woman experiences a greater number of different types of urinary symptoms.	24 weeks after baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual function	The 19-item Female Sexual Function Index (FSFI) consists of six domains: sexual desire (Items 1-2), subjective arousal (Items 3-6), lubrication (Items 7-10), orgasm (Items 11-13), satisfaction (Items 14-16), and pain (Items 17-19). The total score is the sum of all the item scores. A higher FSFI total score indicates better overall sexual functioning.	Baseline
Sexual function	The 19-item Female Sexual Function Index (FSFI) consists of six domains: sexual desire (Items 1-2), subjective arousal (Items 3-6), lubrication (Items 7-10), orgasm (Items 11-13), satisfaction (Items 14-16), and pain (Items 17-19). The total score is the sum of all the item scores. A higher FSFI total score indicates better overall sexual functioning.	4 weeks after baseline
Sexual function	The 19-item Female Sexual Function Index (FSFI) consists of six domains: sexual desire (Items 1-2), subjective arousal (Items 3-6), lubrication (Items 7-10), orgasm (Items 11-13), satisfaction (Items 14-16), and pain (Items 17-19). The total score is the sum of all the item scores. A higher FSFI total score indicates better overall sexual functioning.	8 weeks after baseline
Sexual function	The 19-item Female Sexual Function Index (FSFI) consists of six domains: sexual desire (Items 1-2), subjective arousal (Items 3-6), lubrication (Items 7-10), orgasm (Items 11-13), satisfaction (Items 14-16), and pain (Items 17-19). The total score is the sum of all the item scores. A higher FSFI total score indicates better overall sexual functioning.	12 weeks after baseline
Sexual function	The 19-item Female Sexual Function Index (FSFI) consists of six domains: sexual desire (Items 1-2), subjective arousal (Items 3-6), lubrication (Items 7-10), orgasm (Items 11-13), satisfaction (Items 14-16), and pain (Items 17-19). The total score is the sum of all the item scores. A higher FSFI total score indicates better overall sexual functioning.	24 weeks after baseline
Quality of life and distress associated with pelvic floor symptoms	The 20-item Pelvic Floor Distress Inventory-20 (PFDI-20) consists of three sections: Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6; Items 1-6), Colorectal-Anal Distress Inventory (CRAD-8; Items 7-14), and Urinary Distress Inventory 6 (UDI-6; Items 15-20). The total score ranges from 0-300, and a higher PFDI-20 total score indicates more severe influences associated with pelvic floor symptoms.	Baseline
Quality of life and distress associated with pelvic floor symptoms	The 20-item Pelvic Floor Distress Inventory-20 (PFDI-20) consists of three sections: Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6; Items 1-6), Colorectal-Anal Distress Inventory (CRAD-8; Items 7-14), and Urinary Distress Inventory 6 (UDI-6; Items 15-20). The total score ranges from 0-300, and a higher PFDI-20 total score indicates more severe influences associated with pelvic floor symptoms.	4 weeks after baseline
Quality of life and distress associated with pelvic floor symptoms	The 20-item Pelvic Floor Distress Inventory-20 (PFDI-20) consists of three sections: Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6; Items 1-6), Colorectal-Anal Distress Inventory (CRAD-8; Items 7-14), and Urinary Distress Inventory 6 (UDI-6; Items 15-20). The total score ranges from 0-300, and a higher PFDI-20 total score indicates more severe influences associated with pelvic floor symptoms.	8 weeks after baseline
Quality of life and distress associated with pelvic floor symptoms	The 20-item Pelvic Floor Distress Inventory-20 (PFDI-20) consists of three sections: Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6; Items 1-6), Colorectal-Anal Distress Inventory (CRAD-8; Items 7-14), and Urinary Distress Inventory 6 (UDI-6; Items 15-20). The total score ranges from 0-300, and a higher PFDI-20 total score indicates more severe influences associated with pelvic floor symptoms.	12 weeks after baseline
Quality of life and distress associated with pelvic floor symptoms	The 20-item Pelvic Floor Distress Inventory-20 (PFDI-20) consists of three sections: Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6; Items 1-6), Colorectal-Anal Distress Inventory (CRAD-8; Items 7-14), and Urinary Distress Inventory 6 (UDI-6; Items 15-20). The total score ranges from 0-300, and a higher PFDI-20 total score indicates more severe influences associated with pelvic floor symptoms.	24 weeks after baseline

Collaborators and Investigators

• Sponsor: National Yang Ming Chiao Tung University
• Investigators: Principal Investigator: Yuan-Mei Liao, PhD, National Yang Ming Chiao Tung University

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 24MMHIS120e

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data are available on request due to privacy and ethical restrictions.
• IPD Sharing Time Frame: Baseline and 4, 8, 12 weeks after baseline
• IPD Sharing Access Criteria: Data are available on request due to privacy and ethical restrictions.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

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