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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
20
During V0 - Laboratory tests, particularly for calprotectin concentration assessment
During V1 - the electrical impedance of pelvic floor muscles will be measured
During V1 - Examination with a gynecological speculum, Two-handed examination, Rectal examination and Anoscopy
During V2 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.
During V2 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.
Centrum Medyczne Byc Kobieta s.c.
Lodz, Łódź Voivodeship, Poland
Anal sphincters injury
Assessed by subsequent measures: 1. Sphincter continuity in physical examination, 2. Sphincter tension in physical examination, 3. OASIS classification of perineal tears in transanal ultrasonography 4. Starck scale for classification of anal sphincter injuries in transanal ultrasound (0-16 scale, no defect - 0; maximum - 16, means severe damage of both sphincters on a considerable length and circumference) 5. Norderval scale for classification of anal sphincter injuries in transanal ultrasound (0-7 scale, no defect - 0, 7 is the maximal damage of both anal sphincters) 6. anorectal manometry assessment to measure anal sphincters function All measurements are used to estimate the presence, extent and severity of anal sphincter injury. The main aim of the study is to establish whether the extension and severity of obstetric anal sphincter injury can be precisely assessed with parameters calculated from pelvic floor muscles using impedance spectroscopy.
Time frame: 8 weeks
Adverse events
Evaluation of the frequency and intensity of adverse events associated with the use of the new diagnostic method.
Time frame: 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.