Clinical trial NCT03387202: Laparoscopic Lateral Mesh Suspension for Pelvic Organ Prolapse
Official title: Uterine Preserving Apical Prolapse Correction With Laparoscopic Lateral Mesh Suspension: Initial Experience by Defining Anatomic and Subjective Success
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Pelvic Floor Prolapse
Keywords: Pelvic Organ Prolapse
Translabial ultrasound
Transperineal ultrasound
Lateral Mesh Suspension
Descensus uteri
Laparoscopic pelvic organ prolapse repair
Lead sponsor: Fatih Sultan Mehmet Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-01-02
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Symptomatic women with pelvic organ prolapse

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.

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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

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