Impedance Spectroscopy for Obstetric Anal Sphincter Injuries Detection

Summary

The main purpose of the study is to evaluate the effectiveness and safety of the impedance spectroscopy device prototype in the detection of anal sphincter injuries in women in the early postpartum period. The study is prospective. The study group comprises up to 56 patients; up to 16 weeks from a natural delivery. The planned participation of each patient in the study is up to 4 weeks and two visits will take place at that time.

After obtaining written consent, at the first visit (V1) each patient will undergo a physical examination (both proctological and gynecological examination), blood samples for laboratory tests and stool samples for calprotectin concentration assessment will be collected. The presence of clinical symptoms of both gas and stool incontinence will be assessed during the visit with the use of Wexner's scale. Then, the dates of two reference tests will be planned: Trans-rectal USG and Recto-anal manometry which will be performed as part of the V1 visit within a period not exceeding 27 days.

The V2 visit, which will also be the final visit, will include a reassessment of the patient's general condition, recording the values of basic vital parameters, subjective and physical examination, and then the doctor conducting the examination will finally determine the extent of sphincter damage, present the patient with therapeutic options and decide on the treatment or rehabilitation of sphincter.

During the visits, all adverse events will also be monitored, both those reported by patients and those related to the examined diagnostic device.

Conditions

• Obstetric Anal Sphincter Injury
• Delivery Complication
• Obstetric Complication

Interventions

DIAGNOSTIC_TEST

Blood and faeces tests

During V1 - Laboratory tests, particularly for calprotectin concentration assessment

DEVICE

Impedance spectroscopy test

During V1 - the electrical impedance of anal sphincter muscles will be measured

DIAGNOSTIC_TEST

Full gynecological and proctological examination

During V1 and V2 - Examination with a gynecological speculum, Two-handed examination, Rectal examination, and Anoscopy

DIAGNOSTIC_TEST

Transanal ultrasonography

During V1 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.

DIAGNOSTIC_TEST

Anorectal manometry

During V1 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.

OTHER

Determining the degree of sphincter injury

During V2 - conducting the examination will finally determine the extent of sphincter damage, present the patient with therapeutic options and decide on the treatment or rehabilitation of sphincter.

Sponsors & Collaborators

• OASIS Diagnostics S.A.

  lead INDUSTRY

Principal Investigators

• Małgorzata Uchman-Musielak, MD, PhD · Specialist Medical Practice

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

2019-10-15

Primary Completion

2020-06-26

Completion

2020-07-20

Countries

• Poland

Study Locations