Laparoscopic Lateral Mesh Suspension for Pelvic Organ Prolapse

Fatih Sultan Mehmet Training and Research Hospital15 enrolled

Overview

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.

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. ,

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pelvic Organ Prolapse Pelvic Floor Prolapse

Interventions

Laparoscopic lateral suspension with meshPROCEDURE

V-shaped ccm wide and 25cm length mesh strip is prepared from a 30x30cm Prolene mesh (Ethicon J\&J).Deep dissection of the uterovesical space is performed.Cutaneous incisions are bilaterally made 3cmsuperoposterior to the anteriosuperior iliac spine.A grasper is introduced retroperitoneally through the subperitoneum holding the beginning part of mesh until reaching the vesicovaginal space in an oblique route rather than transverse.Broad ligament is lifted upward and tunnel is practiced in its lower third.Assistant grasper catches the distal mesh and pulls out through the opposite subperitoneal tunnel.Corner of mesh is fixed to the pubocervical fascia,uterine cervix and isthmus with Absorba Tack™(Covidien, Mansfield,USA).Tension-free lateral mesh suspension is achieved at the desired level

Transperineal ultrasoundDIAGNOSTIC_TEST

Vaginal length, bladder neck mobility and pelvic floor biometry with anterioposterior hiatal diameter and pelvic organ descent measurements are measured by transperineal ultrasonography to assess anatomic success in the preoperative and at postoperative first third and sixth months if available.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Prolapse degree; Point Ba/C/Bp

Time frame: 18 months

Secondary Outcomes

Subjective Success - Change from baseline Female Sexual Function Index (FSFI) to measure sexual dysfunction at 18th month.

Validated into Turkish language form will be used to compare preoperative and postoperative period. The FSFI is a multiple-trait scoring, self-report document used to assess female SF during the previous 4 weeks. It consists of 19 items that encompass six separate domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The maximum score is 36 points and the minimum score is 2 points. After completion of the questionnaire, the total SF score was calculated as follows: no sexual dysfunction (SD) (≥ 30 points) , mild SD (between \<29 and \> 23 points), and severe SD (≤ 22 points).

Time frame: 18 months

Subjective Success - Change from baseline Michigan Incontinence Severity Index (M-ISI) to measure urinary incontinence at 18th month.

Validated into Turkish language form will be used to compare preoperative and postoperative period. It 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 UUI, and items 7 and 8 for 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. The total M-ISI domain ranges from 0 to 32, the Bother domain ranges from 0 to 8, the SUI and UUI subdomains range from 0 to 12, and the PU subdomain ranges from 0 to 8. 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).

Time frame: 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.

Data from ClinicalTrials.gov

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