The Change in Vaginal Axis on MRI After Uterus Preserving Laparoscopic Lateral Mesh Suspension

NCT03772015 — Completed, 21 participants, Sisli Hamidiye Etfal Training and Research Hospital

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  
RegistryNCT03772015
StatusCompleted
Study typeObservational
Enrollment21 (Actual)
SponsorSisli Hamidiye Etfal Training and Research Hospital (Other); collaborators: Bartin State Hospital
ConditionsProlapse Genital, Anatomical Pathological Condition
InterventionsMagnetic resonance imaging (Diagnostic test)
Datesstart 2018-12-09, primary completion 2019-09-01, completion 2020-03-01, first posted 2018-12-11, last updated 2020-05-19
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Prolapse Genital All trials for Anatomical Pathological Condition All trials of Magnetic resonance imaging

-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.

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
StudyDiagnostic 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
ControlDiagnostic 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
  • Magnetic resonance imaging (Diagnostic 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.

+Outcome measures

Primary outcomes

  • Vaginal axis [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 [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.

Secondary outcomes

  • Urge Symptoms [Evaluation at postoperative 6th month]: 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).
  • Prolapse symptoms [Evaluation at postoperative 6th month]: 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.
  • Sexual functions [Evaluation at postoperative 6th month]: 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.

+Eligibility

Sex: Female, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Female genital prolapse

Exclusion Criteria:

* Patients who had pouch of Douglas obliteration
* Patients with enterocele
* Patients who have any congenital or acquired anatomic and reproductive anomaly

+Locations (1)

FacilityCityCountryStatus
Hamidiye Sisli Etfal Training and Research HospitalIstanbulTurkey (Türkiye)

+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. PMID 28816554

+Investigators

  • Ozan Dogan, MD, Principal investigator, Hamidiye Sisli Etfal Training and Research Hospital
  • Murat Yassa, MD, Principal investigator, Bartin State Hospital