CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT05800678
NCT05800678N/ACompleted

Comparison of Cross-sectional Area of Pubovisceral Muscle in Nulliparous and Primiparous Women

Institute for the Care of Mother and Child, Prague, Czech Republic·observational·Posted Apr 5, 2023·Updated Jul 27, 2023

In Brief

An observational study for Pelvic Floor Disorders. Completed, enrolled 80 participants across 1 site.

Detailed Summary

Pelvic-floor disorders (PFD), including pelvic organ prolapse, urinary and fecal incontinence, decrease quality of life of every fourth women. 1 The main known risk factor for PFD is vaginal delivery 2,3 causing pelvic floor muscle avulsion, ischemia or denervation.4 Ultrasound (US) and magnetic resonance imaging (MRI) are frequently used to investigate structural changes in pelvic floor muscles. The investigators aimed to focus on structural changes (atrophy) caused by muscle denervation. 5 The pubovisceral muscle (PVM) is the part of the levator ani muscle (LAM) which is most frequently injured and it is thought to be possibly denervated by overstretching 6 Recently, the most precise measurement of PVM cross-sectional area was performed by the group of DeLancey. 7 In our study, the investigators aimed to describe which are the normal values of PVM volume in nulliparous women. The investigators performed a measurement of PVM volume in women after the first vaginal delivery. The investigators hypothesized that there will be a decrease of the cross-sectional area of the PVM developed after denervation trauma.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesCzechia
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedApr 5, 2023
Enrollment StartApr 1, 2021
Primary CompletionMar 23, 2023
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 3.2 years ago