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

NCT05800678 | Completed DMC

• 1 other identifier: UPMDPrague2021/28_1/2
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pelvic Floor Disorders

Keywords

magnetic resonance imaging; levator ani muscle; denervation

Outcome Measures

Primary Outcomes (1)

• cross-sectional area of pubovisceral muscle

  The PVM CSA was measured as previously described by Masteling et al.. Briefly, the MR images were imported into 3D Slicer, where slices containing the volume of interest were identified in a plane perpendicular to the muscle direction. To identify a plane perpendicular to the PVM, the PVM fibres direction was first established between origin and insertion, namely the inner surface of the pubic bone and its insertion into the perineal structures. In the coronal plane perpendicular to the muscle direction, the boundaries of the PVM were identified and images of this region were taken. The captured images were then exported into ImageJ for measurement of CSA.

  in nulliparous group measurements performed imediately after MRI. In primiparous group the MRI was performed within 3-6 months after delivery

Study Arms (2)

nulliparous

inclusion: reproductive age exclusion: history of gynecological surgery or disorder with possible impact on pelvic floor

primiparous

Inclusion: reproductive age, vaginal birth exclusion: * history of gynecological surgery or disorder with possible impact on pelvic floor * assisted vaginal delivery (forceps, vaccumextraction) * labour induction * pregnancy-related disorders * perineal tear grade III-IV (women with episiotomy were included) * suspicion of LAM avulsion by ultrasound or palpation * Oxford score 4 or 5 after delivery

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients of the Institute for the care of mother and child, Prague CZ * outpatient clinic * delivery ward and postpartum care unit

You may qualify if:

• reproductive age
• vaginal birth

You may not qualify if:

• history of gynecological surgery or disorder with possible impact on pelvic floor
• forceps, vaccumextraction)
• labour induction
• pregnancy-related disorders
• perineal tear grade III-IV (women with episiotomy were included)
• suspicion of LAM avulsion by ultrasound or palpation
• Oxford score 4 or 5 after delivery

Sponsors & Collaborators

• Institute for the Care of Mother and Child, Prague, Czech Republic: lead

Study Sites (1)

Institute for mother and child care

Prague, 147 00, Czechia

Location

Related Publications (7)

• Nygaard I, Barber MD, Burgio KL, Kenton K, Meikle S, Schaffer J, Spino C, Whitehead WE, Wu J, Brody DJ; Pelvic Floor Disorders Network. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008 Sep 17;300(11):1311-6. doi: 10.1001/jama.300.11.1311.

  PMID: 18799443 BACKGROUND

• DeLancey JO. The hidden epidemic of pelvic floor dysfunction: achievable goals for improved prevention and treatment. Am J Obstet Gynecol. 2005 May;192(5):1488-95. doi: 10.1016/j.ajog.2005.02.028.

  PMID: 15902147 BACKGROUND

• MacArthur C, Wilson D, Herbison P, Lancashire RJ, Hagen S, Toozs-Hobson P, Dean N, Glazener C; Prolong study group. Urinary incontinence persisting after childbirth: extent, delivery history, and effects in a 12-year longitudinal cohort study. BJOG. 2016 May;123(6):1022-9. doi: 10.1111/1471-0528.13395. Epub 2015 Apr 2.

  PMID: 25846816 BACKGROUND

• Weidner AC, Jamison MG, Branham V, South MM, Borawski KM, Romero AA. Neuropathic injury to the levator ani occurs in 1 in 4 primiparous women. Am J Obstet Gynecol. 2006 Dec;195(6):1851-6. doi: 10.1016/j.ajog.2006.06.062.

  PMID: 17132486 BACKGROUND

• Carlson BM. The Denervated Muscle: 45 years later. Neurol Res. 2008 Mar;30(2):119-22. doi: 10.1179/174313208X281127.

  PMID: 18397601 BACKGROUND

• DeLancey JO, Sorensen HC, Lewicky-Gaupp C, Smith TM. Comparison of the puborectal muscle on MRI in women with POP and levator ani defects with those with normal support and no defect. Int Urogynecol J. 2012 Jan;23(1):73-7. doi: 10.1007/s00192-011-1527-8. Epub 2011 Aug 6.

  PMID: 21822711 BACKGROUND

• Masteling M, Ashton-Miller JA, DeLancey JOL. Technique development and measurement of cross-sectional area of the pubovisceral muscle on MRI scans of living women. Int Urogynecol J. 2019 Aug;30(8):1305-1312. doi: 10.1007/s00192-018-3704-5. Epub 2018 Jul 5.

  PMID: 29974138 BACKGROUND

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• Lucie Hájková Hympánová, PhD

  Ústav pro péči o matku a dítě, Praha, CZ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 5, 2023
• Study Start: April 1, 2021
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)