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

N

National Yang Ming Chiao Tung University

Status

Invitation-only

Conditions

Quality of Life
Sexual Function
Genitourinary Symptoms

Treatments

Behavioral: Pelvic Floor Muscle Training (PFMT) and yoga

Study type

Interventional

Funder types

Other

Identifiers

NCT06411041
24MMHIS120e

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

Female

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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%)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

90 participants in 2 patient groups

Intervention group
Experimental group
Description:
The experimental group will receive regular care and a 12-week program of pelvic floor muscle training (PFMT) and yoga
Treatment:
Behavioral: Pelvic Floor Muscle Training (PFMT) and yoga
Control group
No Intervention group
Description:
The control group will receive regular care

Trial contacts and locations

1

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Central trial contact

Yuan-Mei Liao, PhD; Yueh-Ching Lee, MSN

Data sourced from clinicaltrials.gov

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