Study on the correlation between puborectal muscle ultrasound parameters and pelvic organ prolapse evaluated by multiple probes

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2400095053

Enrollment

Unknown

Registered

2024-12-31

Start date

2025-01-01

Completion date

Unknown

Last updated

2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic organ prolapse

Interventions

Gold Standard:Measurement quality control: Imaging measurements of patients were independently measured by two doctors who had been engaged in obstetrics and gynecology ultrasound for more than 5 year

Index test:1) Area of hiatus of levator anal muscle at resting, maximum VALSALVAL and resting state

2) The length of puborectal muscle at rest, maximum VALSALVAL and resting state was examined by VE9-5 convex array probe in cavity

3) The length of puborectalis muscle at rest, maximum VALSALVAL and resting state was examined by intracavitary biplane BCL10-5 probe

4) Ultrasound diagnosis of the patient, whether there is POP.

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: All patients aged 70 years >=18 years underwent pelvic floor ultrasound.

Exclusion criteria

Exclusion criteria: 1) Patients with no sexual life history; 2) Patients who can not cooperate with better anal levator muscle contraction; 3) Patients who are unable to perform > 6sVALSALVA movements; 4) Ultrasound diagnosis of patients with suspected rupture of the puborectal muscle on one side, resulting in asymmetry of the puborectal muscle on both sides; 5) Pregnancy or suspected pregnancy.

Design outcomes

Primary

Measure	Time frame
Measurement of puborectal muscle length with intracavity 2-D probe (resting);Measurement of puborectal muscle length with intracavity 2-D probe (VALSALVA);Measurement of puborectal muscle length with intracavity 2-D probe (Con);Measurement of hiatus area of levator anal muscle with 3D probe (resting);Measurement of hiatus area of levator anal muscle with 3D probe (VALSALVA);Measurement of hiatus area of levator anal muscle with 3D probe (Con);Measurement of puborectal muscle length with biplanar probe (resting);Measurement of puborectal muscle length with biplanar probe (VALSALVA);Measurement of puborectal muscle length with biplanar probe (con);	—

Measure

Time frame

Measurement of puborectal muscle length with intracavity 2-D probe (resting);Measurement of puborectal muscle length with intracavity 2-D probe (VALSALVA);Measurement of puborectal muscle length with intracavity 2-D probe (Con);Measurement of hiatus area of levator anal muscle with 3D probe (resting);Measurement of hiatus area of levator anal muscle with 3D probe (VALSALVA);Measurement of hiatus area of levator anal muscle with 3D probe (Con);Measurement of puborectal muscle length with biplanar probe (resting);Measurement of puborectal muscle length with biplanar probe (VALSALVA);Measurement of puborectal muscle length with biplanar probe (con);

—

Countries

China

Contacts

Public ContactWei Niya

Department of Ultrasound, Peking University Shenzhen Hospital, Shenzhen 518000, P. R. China

weiniya@aliyun.com+86 188 2650 6156

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026