Using bedside transperineal ultrasound to give visual feedback during pelvic floor exercises after childbirth

Transperineal Ultrasound as a Biofeedback Tool for Pelvic Floor Muscle Therapy in Postpartum Patients

This trial will test whether showing postpartum women live ultrasound images of their pelvic floor helps them do pelvic floor exercises more correctly and stay more engaged after a vaginal birth.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 94 (estimated)
• Ages: 21 Years to 45 Years
• Sex: Female
• Sponsor: Singapore General Hospital (Academic / other)
• Locations: 1 site (Singapore)
• Trial ID: NCT07065708 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized controlled study that assigns postpartum women to one of two arms: transperineal ultrasound with real-time visual biofeedback or transperineal ultrasound without visual biofeedback. Participants are recruited within four months of a singleton vaginal delivery and undergo baseline assessment, supervised physiotherapy sessions, and follow-up assessments to compare pelvic floor contraction performance and engagement. Randomization is computer-generated to ensure equal group sizes, and assessments include clinical measures and patient questionnaires. The study includes interim analysis and a final analysis stage.

Who should consider this trial

Good fit: Women aged 21–45 within four months of a singleton vaginal delivery, not currently pregnant and without prior pelvic floor surgery or neurological disorders affecting muscle control, are ideal candidates.

Not a fit: Women who had a caesarean delivery, prior pelvic floor surgery, neurological conditions affecting muscle contraction, are more than four months postpartum, or cannot attend in-person clinic visits are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, this approach could help women learn to contract their pelvic floor muscles more accurately and improve engagement with exercises, potentially reducing future pelvic floor problems.

How similar studies have performed: Smaller prior studies using ultrasound or other biofeedback methods for pelvic floor training have reported improvements in muscle control and adherence, but larger randomized trials are still limited.

Eligibility criteria

Inclusion Criteria:

* Female participants
* Aged 21 - 45 years old.
* Within 4 months of a singleton, vaginal delivery

Exclusion Criteria:

* Currently pregnant
* Over 4 months since vaginal birth.
* Previous caesarean delivery.
* Previous pelvic floor surgery (eg. pelvic floor repair, continence surgery, cervicetomy,cosmetic pelvic floor procedures)
* Neurological disorder affecting muscle contraction (eg. Guillan-Barre syndrome, motorneuron disease, multiple sclerosis)

Where this trial is running

Singapore

• Division of Obstetrics and Gynaecology — Singapore, Singapore (Recruiting)

Study contacts

• Study coordinator: Asad A Rahim, MB BS BMedSci MRCOG

Conditions Pelvic Floor Muscle Training; Transperineal Ultrasound; Biofeedback Therapy; Postpartum; Pelvic Floor Disorder; Pelvic Floor Muscle Exercise; Pelvic Floor, Obstetric; Pelvic Floor Dysfunction