Pelvic Floor DisordersNCT05800678
Cross-sectional Area of Pubovisceral Muscle in Nulliparous and Primiparous Women
An observational study of Pelvic Floor Disorders, run by Institute for the Care of Mother and Child, Prague, Czech Republic at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Apr 2021to 23 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients of the Institute for the care of mother and child, Prague CZ * outpatient clinic * delivery ward and postpartum care unit
Who may be able to join
- reproductive age
- vaginal birth
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Cross-sectional Area of Pubovisceral Muscle in Nulliparous and Primiparous Women
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.
Read the detailed description
Two groups of women were recruited. First, the nulliparous group served as a control. The second group was women after their first vaginal delivery. Personal characteristics, anamnestic and delivery data were collected, and clinical examination, ultrasound (US) and magnetic resonance imaging (MRI) was performed. The number of women to reach significance in the study was 40/per group. The investigators did not expect a transfer of patients between the two groups. Volunteers were recruited from a general gynecological outpatient clinic. They were thoroughly informed and informed consent was provided.
In nulliparous women, all examinations (clinical, US, MRI) were performed only once. In women after vaginal delivery, first US was performed within 72h after childbirth, in order to detect LAM avulsion and exclude these women. In women without avulsion, 6 weeks after delivery, during a general postpartum checkup, the clinical evaluation of pelvic floor muscle contraction was performed. In those where the score is 0-3 the 3D US was performed to confirm no change of hiatal area during contraction. Those scans were recorded as investigated data. Those women underwent MRI within 4 months US images were obtained with a GE Voluson E10 system (General Electric Healthcare, Chicago, IL) by one investigator. US data acquisition was performed translabial as already described.9 Volumes were acquired at rest, during Valsalva and contraction. From acquired volume was assessed PVM avulsion, size of urogenital hiatus. Decrease of hiatal area at contraction proves muscle function. The assessment of US scans was performed off-line at axial plane using the 4D View v 2.1-5.0 software (GE Medical Systems) by two investigators blinded against all clinical data. MRI images were obtained with a 3-T scanner (AchievaTM, Philips Healthcare). MRI included coronal, axial, and sagittal proton density-weighted sequences performed at rest, Valsalva and contraction. Primary outcome evaluated by MRI will be the cross-sectional area of the PVM. The precise MRI technique was already defined by the group of DeLancey and is in detail described in recent publication.7 Evaluation was performed off-line by two investigators blinded against all clinical data using ImageJ software. Intra- and interobserver variability was calculated.
- Conditions
- Pelvic Floor Disorders
- Keywords
- magnetic resonance imaging, levator ani muscle, denervation
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: in nulliparous group measurements performed imediately after MRI. In primiparous group the MRI was performed within 3-6 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start1 Apr 2021
- Primary completion23 Mar 2023
- Study completion23 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for the Care of Mother and Child, Prague, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarina Ivankova, Institute for the Care of Mother and Child, Prague, Czech Republic
- Investigators
- Lucie Hájková Hympánová, PhD, Principal investigator, Ústav pro péči o matku a dítě, Praha, CZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800678
- Sponsor's protocol ID
- UPMDPrague2021/28_1/2
- Status last verified
- Jul 2023
- First submitted
- 23 Mar 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18799443DeLancey 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.
PubMed 15902147MacArthur 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.
PubMed 25846816Weidner 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.
PubMed 17132486Carlson BM. The Denervated Muscle: 45 years later. Neurol Res. 2008 Mar;30(2):119-22. doi: 10.1179/174313208X281127.
PubMed 18397601DeLancey 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.
PubMed 21822711Masteling 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.
PubMed 29974138
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cross-sectional Area of Pubovisceral Muscle in Nulliparous and Primiparous Women
- ClinicalTrials.gov ID
- NCT05800678
- Acronym / sponsor ID
- UPMDPrague2021/28_1/2
- Conditions
- Pelvic Floor Disorders
- Keywords
- magnetic resonance imaging, levator ani muscle, denervation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Institute for the Care of Mother and Child, Prague, Czech RepublicUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Two groups of women were recruited. First, the nulliparous group served as a control. The second group was women after their first vaginal delivery. Personal characteristics, anamnestic and delivery data were collected, and clinical examination, ultrasound (US) and magnetic resonance imaging (MRI) was performed. The number of women to reach significance in the study was 40/per group. The investigators did not expect a transfer of patients between the two groups. Volunteers were recruited from a general gynecological outpatient clinic. They were thoroughly informed and informed consent was provided.
In nulliparous women, all examinations (clinical, US, MRI) were performed only once. In women after vaginal delivery, first US was performed within 72h after childbirth, in order to detect LAM avulsion and exclude these women. In women without avulsion, 6 weeks after delivery, during a general postpartum checkup, the clinical evaluation of pelvic floor muscle contraction was performed. In those where the score is 0-3 the 3D US was performed to confirm no change of hiatal area during contraction. Those scans were recorded as investigated data. Those women underwent MRI within 4 months US images were obtained with a GE Voluson E10 system (General Electric Healthcare, Chicago, IL) by one investigator. US data acquisition was performed translabial as already described.9 Volumes were acquired at rest, during Valsalva and contraction. From acquired volume was assessed PVM avulsion, size of urogenital hiatus. Decrease of hiatal area at contraction proves muscle function. The assessment of US scans was performed off-line at axial plane using the 4D View v 2.1-5.0 software (GE Medical Systems) by two investigators blinded against all clinical data. MRI images were obtained with a 3-T scanner (AchievaTM, Philips Healthcare). MRI included coronal, axial, and sagittal proton density-weighted sequences performed at rest, Valsalva and contraction. Primary outcome evaluated by MRI will be the cross-sectional area of the PVM. The precise MRI technique was already defined by the group of DeLancey and is in detail described in recent publication.7 Evaluation was performed off-line by two investigators blinded against all clinical data using ImageJ software. Intra- and interobserver variability was calculated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients of the Institute for the care of mother and child, Prague CZ * outpatient clinic * delivery ward and postpartum care unit
Key inclusion criteria (2 listed)
- reproductive age
- vaginal birth
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cross-sectional area of pubovisceral muscle
Time frame: in nulliparous group measurements performed imediately after MRI. In primiparous group the MRI was performed within 3-6 months after delivery
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Background: PubMed 18799443Nygaard 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.
- Background: PubMed 15902147DeLancey 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.
- Background: PubMed 25846816MacArthur 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.
- Background: PubMed 17132486Weidner 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.
- Background: PubMed 18397601Carlson BM. The Denervated Muscle: 45 years later. Neurol Res. 2008 Mar;30(2):119-22. doi: 10.1179/174313208X281127.
- Background: PubMed 21822711DeLancey 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.
- Background: PubMed 29974138Masteling 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucie Hájková Hympánová, PhD principal investigator
Ústav pro péči o matku a dítě, Praha, CZ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Disorders, run by Institute for the Care of Mother and Child, Prague, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cross-sectional area of pubovisceral muscle (time frame: in nulliparous group measurements performed imediately after MRI. In primiparous group the MRI was performed within 3-6 months after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05800678, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.