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

Prolapse Genital Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03772015
• Other study ID #: 240918
• Status: Completed
• Start date: December 9, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: May 2020
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 1, 2020
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anatomical Pathological Condition
• Pathological Conditions, Anatomical
• Prolapse
• Prolapse Genital

Intervention

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.

Locations

Country	Name	City	State
Turkey	Hamidiye Sisli Etfal Training and Research Hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital	Bartin State Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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