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

NCT07065708 | Recruiting

• 1 other identifier: 2024-4537
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Regular and effective pelvic floor muscle exercises after vaginal birth are crucial in reducing the risk of pelvic floor disorders in women. Pelvic floor muscle exercises are generally encouraged by healthcare providers to their patients after birth. However, it is often difficult to confirm whether a patient is performing pelvic floor muscle contractions correctly. A supervised pelvic floor physiotherapy session allows a professional to assess the pelvic floor and give their verbal feedback to patients. However even in this setting, patient's are reliant on the physiotherapist and have no way to assess their own performance. The 'biofeedback approach' allows for the clinician and patient to visually assess and modify their performance and can potentially allow for more effective therapy and better engagement. Transperineal ultrasonography is a widely available, safe and non-invasive biofeedback tool that can used at the bedside in order to assess pelvic floor muscle contractions. Our aim is to assess if using transperineal ultrasound can enhance the ability of postpartum patients to perform effective pelvic floor muscle therapy.

Conditions

Pelvic Floor Muscle Training; Transperineal Ultrasound; Biofeedback Therapy; Postpartum; Pelvic Floor Disorder; Pelvic Floor Muscle Exercise; Pelvic Floor, Obstetric; Pelvic Floor Dysfunction; Pelvic Floor Health After Childbirth; Physiotherapy; Physiotherapy Specialty

Keywords

pelvic floor muscle training; biofeedback; transperineal ultrasound; pelvic floor exercises; physiotherapy; pelvic floor dysfunction; pelvic floor disorder; pelvic floor contraction

Outcome Measures

Primary Outcomes (1)

• Does visual feedback with transperineal ultrasound improve the effectiveness of pelvic floor muscle therapy in postpartum patients?

  Is the change in antero-posterior pelvic hiatal diameter between rest and pelvic floor contraction better in the study arm compared to the control arm?

  Baseline

Secondary Outcomes (3)

• Are postpartum patients who have trained with visual biofeedback more likely to continue to perform pelvic floor muscle therapy than those who do not train with visual biofeedback?

  Baseline and 3 months later

• Do postpartum patients who train with visual biofeedback continue to perform effective pelvic floor muscle contractions 3 months after pelvic floor muscle training

  Baseline and at 3 months

• Does pelvic floor contraction strength improve after 3 months of pelvic floor muscle therapy with visual biofeedback compared to those who did not receive visual biofeedback

  Baseline and 3 months

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

Participants will receive tranperineal ultrasound scan but will not receive visual biofeedback (i.e. they will not be able to see images of their pelvic floor when attempting to perform pelvic floor muscle contractions)

Diagnostic Test: Transperineal ultrasound without visual biofeedback

Study Arm

EXPERIMENTAL

Participants will receive tranperineal ultrasound scan with visual biofeedback

Diagnostic Test: Visual biofeedback using transperineal ultrasound

Interventions

Visual biofeedback using transperineal ultrasound DIAGNOSTIC_TEST

Transperineal ultrasound with visual biofeedback

Study Arm

Transperineal ultrasound without visual biofeedback DIAGNOSTIC_TEST

Transperineal ultrasound without visual biofeedback

Control Arm

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Division of Obstetrics and Gynaecology

Singapore, 169608, Singapore

RECRUITING

Related Publications (4)

• Nyhus MO, Oversand SH, Salvesen O, Salvesen KA, Mathew S, Volloyhaug I. Ultrasound assessment of pelvic floor muscle contraction: reliability and development of an ultrasound-based contraction scale. Ultrasound Obstet Gynecol. 2020 Jan;55(1):125-131. doi: 10.1002/uog.20382. Epub 2019 Dec 13.

  PMID: 31237722 BACKGROUND

• Frank DL, Khorshid L, Kiffer JF, Moravec CS, McKee MG. Biofeedback in medicine: who, when, why and how? Ment Health Fam Med. 2010 Jun;7(2):85-91.

  PMID: 22477926 BACKGROUND

• Bo K, Owe KM, Nystad W. Which women do pelvic floor muscle exercises six months' postpartum? Am J Obstet Gynecol. 2007 Jul;197(1):49.e1-5. doi: 10.1016/j.ajog.2007.02.014.

  PMID: 17618754 BACKGROUND

• Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.

  PMID: 32378735 BACKGROUND

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Central Study Contacts

Asad A Rahim, MB BS BMedSci MRCOG

CONTACT

+65 9050 0004; rahim.asad.abdul@sgh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 15, 2025
• Study Start: May 20, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)