Impedance Spectroscopy in Detection of Obstetric Anal Sphincter Injuries

Summary

The main purpose of the study is to evaluate the effectiveness and safety of the impedance spectroscopy device prototype in detection of anal sphincter injuries in women in the early postpartum period. The study is prospective. The study group comprises 24 patients; included in it 6-8 weeks after natural delivery. The planned participation of each patient in the study is up to 4 weeks and three visits will take place at that time.

After obtaining written consent, at the screening visit (V0) each patient will undergo a physical examination, blood samples for laboratory tests and stool samples for calprotectin concentration assessment will be collected.

On the second visit (V1), after the final verification of inclusion/exclusion criteria, impedance spectroscopy using tested device will be performed in each patient, the electrical impedance of pelvic floor muscles will be measured and the degree of anal sphincter damage will be evaluated. Full gynecological and proctological examination (including a gynecological speculum, two-handed examination, rectal examination and anoscopy) will be carried out.

On the third visit (V2), two reference diagnostic tests (with evidenced effectiveness and safety), transanal ultrasonography and anorectal manometry, will be conducted. The collected data will be used to select the optimal therapeutic method for each participant individually.

Conditions

• Obstetric Anal Sphincter Injury
• Delivery, Obstetric

Interventions

DIAGNOSTIC_TEST

Blood and faeces tests

During V0 - Laboratory tests, particularly for calprotectin concentration assessment

DEVICE

Impedance spectroscopy test

During V1 - the electrical impedance of pelvic floor muscles will be measured

DIAGNOSTIC_TEST

Full gynecological and proctological examination

During V1 - Examination with a gynecological speculum, Two-handed examination, Rectal examination and Anoscopy

DIAGNOSTIC_TEST

Transanal ultrasonography

During V2 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.

DIAGNOSTIC_TEST

Anorectal manometry

During V2 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.

Sponsors & Collaborators

• OASIS Diagnostics S.A.

  lead INDUSTRY

Principal Investigators

• Grzegorz Surkont, MD, PhD · Centrum Medyczne Byc Kobieta s.c.

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-02-04

Primary Completion

2019-10-30

Completion

2019-12-23

Countries

• Poland

Study Locations