Prolapse GenitalNCT03772015
The Change in Vaginal Axis on MRI After Uterus Preserving Laparoscopic Lateral Mesh Suspension
An observational study of Prolapse Genital and Anatomical Pathological Condition, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic lateral mesh suspension is emerged as a practical, safe and feasible alternative to sacropexy to treat female genital apical prolapse. Investigators hypothesized that uterus-preserving lateral suspension provides a better anatomical positioning. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prolapse Genital, Anatomical Pathological Condition
- What is being tested?
- Magnetic resonance imaging
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Dec 2018to 1 Mar 2020
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who are scheduled for lateral mesh suspension operation to treat apical prolapse.
Who may be able to join
- Female genital prolapse
Who cannot join
- Patients who had pouch of Douglas obliteration
- Patients with enterocele
- Patients who have any congenital or acquired anatomic and reproductive anomaly
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hamidiye Sisli Etfal Training and Research Hospital
Istanbul
About this study
Laparoscopic lateral mesh suspension is emerged as a practical, safe and feasible alternative to sacropexy to treat female genital apical prolapse. Investigators hypothesized that uterus-preserving lateral suspension provides a better anatomical positioning.
Read the detailed description
Suspending the cervix to the bilateral abdominal wall through subperitoneal tunnels may properly mimic cardinal ligament and restore the normal vaginal axis. To prove the null hypothesis, it is planned to compare the vaginal axis on Magnetic Resonans Imaging taken preoperatively and postoperatively in patients who are scheduled for lateral mesh suspension for apical prolapse.
- Being tested
- Magnetic resonance imaging
- Keywords
- laparoscopic lateral mesh suspension, lateral abdominocervicopexy, apical prolapse, anterior prolapse, vaginal axis, magnetic resonance imaging
- Medical subject headings
- Pathological Conditions, Anatomical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingDiagnostic test
MRI will be performed using a standard body spiral in the supine position with 5 mm section thickness, on the axial, coronal and sagittal planes and the diffusion weighted images acquired will be evaluated by a specialised radiologist who will be blind to the participants.
| Study group | Role | What they receive |
|---|---|---|
| Study | Patients who had the operation of "laparoscopic lateral mesh suspension" for apical prolapse will have magnetic resonance imaging preoperatively and at postoperative 6th month Receives: Diagnostic Test: Magnetic resonance imaging | |
| Control | Multiparous, sexually active participants who have grade 0 or 1 (asymptomatic if exists) prolapse will have magnetic resonance imaging as a control group Receives: Diagnostic Test: Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal axis
From the images obtained in the sagittal plane, the vagina, which will be observed as a high signal intensity linear structure in T2A images, and the levator plate extending as a flow-signal intensity flat structure in T1A images, will be evaluated.
The angles between the pubococcygeal line and lower vaginal segment (angle A), between the levator plate and the pubococcygeal (angle B) and between lower and upper vaginal segments (angle C) will be measured.
Measured: at 6th months after the operation
Vaginal distances
The distance between the posterior vaginal fornix and the midpoint of the anterior side of the 2nd vertebra will be measured in the mid-sagittal plane (PF-S2). The distance between the right spina ischiadica and right vaginal fornix (RSI-RF), and, the distance between the left spina ischiadica and left vaginal fornix (LSI-LF) will be measured on T2A images acquired in the axial plane.
Measured: at 6th months after the operation
Secondary outcomes (3)
Urge Symptoms
Michigan Incontinence Severity Index (M-ISI) scale will be used to assess subjective outcome including urge symptoms. This scale has ten items, consisting of a total M-ISI domain (the sum of items 1-8) and a distinct Bother domain (the sum of items 9 and 10). The total M-ISI score consists of three subdomains (items 1-3 for stress urinary incontinence [SUI], items 4-6 for urge urinary incontinence [UUI], and items 7 and 8 for Pad usage [PU]. The responses for each item range from 0 to 4 on a Likert-type scale, with higher values representing greater symptoms and greater bother. Total domain and subdomain scores are obtained by simply adding the respective answers. The minimally important difference has been determined for the following domains/subdomains: total M-ISI (4 points), SUI (2 points), UUI (2 points), and PU (1 point).
Measured: Evaluation at postoperative 6th month
Prolapse symptoms
The POP-SS consists of seven items, each with a 5-point Likert response set (0 = never, 1 = occasionally, 2 = sometimes, 3 = most of the time and 4 = all of the time). A total score (range 0-28) is calculated by summing the seven individual symptom responses to derive the POP-SS score. In addition, women indicate which one of the seven symptoms causes them most bother.
Measured: Evaluation at postoperative 6th month
Sexual functions
The FSFI evaluates sexual functioning in women and comprises of 19 questions with different answer choice scales referring the sexual life in the previous 4 weeks. The answer choices in the FSFI carry a number of points and are summed to obtain six domain scores and an overall score. For the latter, there is a threshold at 26.55 which means tFhat all values below are classed as indicating female sexual dysfunction (FSD). The domain scores are obtained as the sum of points attributed to questions in that domain multiplied by the domain factor.
Measured: Evaluation at postoperative 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start9 Dec 2018
- Primary completion1 Sep 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prolapse GenitalStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bartin State Hospital
- Responsible party
- Principal investigator, OZAN DOGAN, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Ozan Dogan, MD, Principal investigator, Hamidiye Sisli Etfal Training and Research HospitalMurat Yassa, MD, Principal investigator, Bartin State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772015
- Sponsor's protocol ID
- 240918
- Status last verified
- May 2020
- First submitted
- 9 Dec 2018
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Senturk MB, Kilicci C, Aydin S, Polat M, Abide Yayla C, Karateke A. Vaginal axis on MRI after unilateral and bilateral sacral hysteropexy: a controlled study. J Obstet Gynaecol. 2018 Jan;38(1):115-120. doi: 10.1080/01443615.2017.1336754. Epub 2017 Aug 17.
PubMed 28816554
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Change in Vaginal Axis on MRI After Uterus Preserving Laparoscopic Lateral Mesh Suspension
- ClinicalTrials.gov ID
- NCT03772015
- Acronym / sponsor ID
- 240918
- Keywords
- laparoscopic lateral mesh suspension, lateral abdominocervicopexy, apical prolapse, anterior prolapse, vaginal axis, magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Collaborators
- Bartin State Hospital
- Study start
- 9 Dec 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 11 Dec 2018 (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.
Laparoscopic lateral mesh suspension is emerged as a practical, safe and feasible alternative to sacropexy to treat female genital apical prolapse. Investigators hypothesized that uterus-preserving lateral suspension provides a better anatomical positioning.
Detailed description
Suspending the cervix to the bilateral abdominal wall through subperitoneal tunnels may properly mimic cardinal ligament and restore the normal vaginal axis. To prove the null hypothesis, it is planned to compare the vaginal axis on Magnetic Resonans Imaging taken preoperatively and postoperatively in patients who are scheduled for lateral mesh suspension for apical prolapse.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | – | Diagnostic Test: Magnetic resonance imagingPatients who had the operation of "laparoscopic lateral mesh suspension" for apical prolapse will have magnetic resonance imaging preoperatively and at postoperative 6th month |
| Control | – | Diagnostic Test: Magnetic resonance imagingMultiparous, sexually active participants who have grade 0 or 1 (asymptomatic if exists) prolapse will have magnetic resonance imaging as a control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are scheduled for lateral mesh suspension operation to treat apical prolapse.
Key inclusion criteria (1 listed)
- Female genital prolapse
Key exclusion criteria (3 listed)
- Patients who had pouch of Douglas obliteration
- Patients with enterocele
- Patients who have any congenital or acquired anatomic and reproductive anomaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance imagingMRI will be performed using a standard body spiral in the supine position with 5 mm section thickness, on the axial, coronal and sagittal planes and the diffusion weighted images acquired will be evaluated by a specialised radiologist who will be blind to the participants. | Diagnostic test | Control, Study |
Primary outcome
Vaginal axis
Time frame: at 6th months after the operation
From the images obtained in the sagittal plane, the vagina, which will be observed as a high signal intensity linear structure in T2A images, and the levator plate extending as a flow-signal intensity flat structure in T1A images, will be evaluated. The angles between the pubococcygeal line and lower vaginal segment (angle A), between the levator plate and the pubococcygeal (angle B) and between lower and upper vaginal segments (angle C) will be measured.
Vaginal distances
Time frame: at 6th months after the operation
The distance between the posterior vaginal fornix and the midpoint of the anterior side of the 2nd vertebra will be measured in the mid-sagittal plane (PF-S2). The distance between the right spina ischiadica and right vaginal fornix (RSI-RF), and, the distance between the left spina ischiadica and left vaginal fornix (LSI-LF) will be measured on T2A images acquired in the axial plane.
3 secondary outcomes
Urge Symptoms
Time frame: Evaluation at postoperative 6th month
Prolapse symptoms
Time frame: Evaluation at postoperative 6th month
Sexual functions
Time frame: Evaluation at postoperative 6th month
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 19 May 2020.
- Background: PubMed 28816554Senturk MB, Kilicci C, Aydin S, Polat M, Abide Yayla C, Karateke A. Vaginal axis on MRI after unilateral and bilateral sacral hysteropexy: a controlled study. J Obstet Gynaecol. 2018 Jan;38(1):115-120. doi: 10.1080/01443615.2017.1336754. Epub 2017 Aug 17.
- 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.
Ozan Dogan, MD principal investigator
Hamidiye Sisli Etfal Training and Research Hospital
Murat Yassa, MD principal investigator
Bartin State Hospital
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 Prolapse Genital and Anatomical Pathological Condition, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 3 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 19 May 2020. 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 Turkey (Türkiye). 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?
Vaginal axis (time frame: at 6th months after the operation). The study lists 2 primary outcomes in all. 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 NCT03772015, which also lists 1 linked publication.
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 19 May 2020.