Ultrasound assessment of pelvic floor muscle contraction: reliability and development of an ultrasound-based contraction scale.
M Ø Nyhus, S H Oversand, Ø Salvesen...
https://pubmed.ncbi.nlm.nih.gov/31237722Actively Recruiting
Phase Not Applicable
Age: 21Years - 45Years
FEMALE
Healthy Volunteers
ID07065708
Transperineal Ultrasound as a Biofeedback Tool for Pelvic Floor Muscle Therapy in Postpartum Patients
Led by Singapore General Hospital · Updated on 2025-07-15
94
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether using transperineal ultrasound as a visual biofeedback tool can improve the effectiveness of pelvic floor muscle therapy in women after vaginal birth. Pelvic floor muscle exercises are important to reduce the risk of pelvic floor disorders postpartum, but it can be hard for patients to know if they are performing these exercises correctly. The study explores if seeing real-time ultrasound images during exercises helps patients perform better and stay engaged in therapy. Participants are randomly assigned to one of two groups: one group receives transperineal ultrasound without visual biofeedback, meaning they cannot see ultrasound images while performing muscle contractions; the other group receives ultrasound with visual biofeedback, allowing them to watch real-time images and adjust their technique. The study includes five stages: recruitment and randomization, initial assessment with ultrasound and questionnaires, preliminary data analysis, a follow-up assessment three months later, and a final analysis. During assessments, participants undergo clinical exams and ultrasound scans of their pelvic floor muscles, with different feedback depending on their group. Participants will complete questionnaires and clinical assessments at the start and again three months later, including pelvic floor muscle strength tests and ultrasound measurements. The study team measures how well patients perform pelvic floor exercises and whether visual biofeedback helps them maintain effective exercises over time. Safety is monitored throughout, and participants can view images after the study if they wish. The total participation time spans from recruitment through a three-month follow-up assessment.
CONDITIONS
Brief Title
Transperineal Ultrasound as a Biofeedback Tool for Pelvic Floor Muscle Therapy in Postpartum Patients
Who Can Participate
Age: 21Years - 45Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Female participants
- Aged 21 - 45 years old
- Within 4 months of a singleton, vaginal delivery
You will not qualify if you...
- Currently pregnant
- More than 4 months since vaginal birth
- Previous caesarean delivery
- Previous pelvic floor surgery such as pelvic floor repair, continence surgery, cervicetomy, or cosmetic pelvic floor procedures
- Neurological disorders affecting muscle contraction, including Guillan-Barre syndrome, motor neuron disease, or multiple sclerosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Assessment
Duration - 1 day
Participants undergo clinical assessments including a physical examination and transperineal ultrasound. Those in the study arm receive visual biofeedback during ultrasound, while control arm participants do not see the ultrasound images. Participants complete questionnaires and are encouraged to perform pelvic floor muscle therapy.
1 visit (in-person)
Treatment
Duration - 3 months
Participants continue pelvic floor muscle therapy using techniques learned during assessment. Those in the study arm use visual biofeedback to improve muscle contraction technique, while the control arm does not receive visual feedback.
Participants perform therapy at home; no in-person visits scheduled during this period
Follow-up
Duration - 1 day
Participants return for a follow-up assessment including physical examination and repeat transperineal ultrasound without visual biofeedback. Adherence to therapy and any difficulties are reviewed. Participants complete a final questionnaire and may view their ultrasound images if desired.
1 visit (in-person) approximately 3 months after assessment
Trial Site Locations
Total: 1 location
1
Division of Obstetrics and Gynaecology
Singapore, Singapore, 169608
Actively Recruiting
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Research Team
A
Asad A Rahim, MB BS BMedSci MRCOG
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Biofeedback in medicine: who, when, why and how?
Dana L Frank, Lamees Khorshid, Jerome F Kiffer...
https://pubmed.ncbi.nlm.nih.gov/22477926Which women do pelvic floor muscle exercises six months' postpartum?
Kari Bø, Katrine Mari Owe, Wenche Nystad
https://pubmed.ncbi.nlm.nih.gov/17618754Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women.
Stephanie J Woodley, Peter Lawrenson, Rhianon Boyle...
https://pubmed.ncbi.nlm.nih.gov/32378735