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Clinical Trials/NCT03387202
NCT03387202
Completed
Not Applicable

Uterine Preserving Apical Prolapse Correction With Laparoscopic Lateral Mesh Suspension: Initial Experience by Defining Anatomic and Subjective Success

Fatih Sultan Mehmet Training and Research Hospital0 sites15 target enrollmentNovember 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Organ Prolapse
Sponsor
Fatih Sultan Mehmet Training and Research Hospital
Enrollment
15
Primary Endpoint
Change from baseline POP-Q measurements (mm) at 18th month.
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

This study is aimed to share our clinical experience in an uterine-preserving laparoscopic lateral suspension of apical prolapses with mesh operation after minor modifications in technique. Transperineal ultrasonography and several questionnaires are used for objective and subjective outcomes.

Detailed Description

Vaginal length, bladder neck mobility and pelvic floor biometry with anteroposterior hiatal diameter and pelvic organ descent measurements are measured by transperineal ultrasonography to assess anatomic success in the preoperative and at postoperative 18th months if available. Female Sexual Function Index (FSFI), Michigan Incontinence Severity Index (M-ISI), Prolapse Quality of Life questionnaire (PQoL), Pelvic Organ Prolapse Symptom Score (POP-SS) and Visual Analog Score (VAS) are used to assess subjective success in the preoperative and at postoperative 18th months if available. ,

Registry
clinicaltrials.gov
Start Date
November 1, 2016
End Date
February 5, 2018
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Fatih Sultan Mehmet Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

MURAT YASSA

Principal Investigator

Fatih Sultan Mehmet Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • \>18 years old symptomatic women with pelvic organ prolapse needing surgery.
  • Patients who are not comfortable with using or refusing pessary
  • Refusing sacrocolpopexy due to its serious surgical risk

Exclusion Criteria

  • Patients who prefer sacrocolpopexy
  • Any cue for gynecologic oncological condition
  • Patients who approves Le Fort colpocleisis among who does not have any sexual intercourse

Outcomes

Primary Outcomes

Change from baseline POP-Q measurements (mm) at 18th month.

Time Frame: 18 months

Prolapse degree; Point Ba/C/Bp

Secondary Outcomes

  • Subjective Success - Change from baseline Female Sexual Function Index (FSFI) to measure sexual dysfunction at 18th month.(18 months)
  • Subjective Success - Change from baseline Prolapse Quality of Life questionnaire (PQoL) to measure quality of life according to pelvic organ prolapse at 18th month.(18 months)
  • Failure (%)(18 months)
  • Subjective Success - Change from baseline Pelvic Organ Prolapse Symptom Score (POP-SS) to measure quality of life according to pelvic organ prolapse at 18th month.(18 months)
  • Subjective Success - Change from baseline Visual Analog Score (VAS) for pain at 18th month.(18 months)
  • Change from baseline Pelvic Hiatus measurements (mm) at 18th month.(18 months)
  • Change from baseline Pelvic biometry measurements at 18th month.(18 months)
  • Subjective Success - Change from baseline Michigan Incontinence Severity Index (M-ISI) to measure urinary incontinence at 18th month.(18 months)
  • Change from baseline bladder neck mobility measurements at 18th month.(18 months)

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