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

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.

Study Overview

• Status: Completed
• Conditions: Anatomical Pathological Condition; Prolapse Genital
• Intervention / Treatment: Diagnostic test: Magnetic resonance imaging

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 Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Hamidiye Sisli Etfal Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Patients who are scheduled for lateral mesh suspension operation to treat apical prolapse.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Diagnostic test: Magnetic resonance imaging; 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.
Control; Multiparous, sexually active participants who have grade 0 or 1 (asymptomatic if exists) prolapse will have magnetic resonance imaging as a control group	Diagnostic test: Magnetic resonance imaging; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	at 6th months after the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	Evaluation at postoperative 6th month

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
• Collaborators: Bartin State Hospital
• Investigators: Principal Investigator: Ozan Dogan, MD, Hamidiye Sisli Etfal Training and Research Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2018
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: December 9, 2018
• First Submitted That Met QC Criteria: December 9, 2018
• First Posted (Actual): December 11, 2018

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 18, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: magnetic resonance imaging; anterior prolapse; apical prolapse; laparoscopic lateral mesh suspension; lateral abdominocervicopexy; vaginal axis
• Additional Relevant MeSH Terms: Prolapse; Pathological Conditions, Anatomical
• Other Study ID Numbers: 240918

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No