Laparoscopic Lateral Mesh Suspension for Pelvic Organ Prolapse

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03387202
• Other study ID #: FSM KAEHK
• Status: Completed
• Phase: N/A
• First received: April 1, 2017
• Last updated: February 6, 2018
• Start date: November 1, 2016
• Est. completion date: February 5, 2018

Study information

• Verified date: February 2018
• Source: Fatih Sultan Mehmet Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 5, 2018
• Est. primary completion date: January 12, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Floor Prolapse
• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• Laparoscopic lateral suspension with mesh
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

Diagnostic Test:
• Transperineal ultrasound
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fatih Sultan Mehmet Training and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline POP-Q measurements (mm) at 18th month.	Prolapse degree; Point Ba/C/Bp	18 months
Secondary	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).	18 months
Secondary	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).	18 months
Secondary	Subjective Success - Change from baseline Prolapse Quality of Life questionnaire (PQoL) to measure quality of life according to pelvic organ prolapse at 18th month.	Validated into Turkish language form will be used to compare preoperative and postoperative period. he questionnaire included 20 questions grouped in sections (domains) related to a particular aspect of quality of life. A total of nine domains covering general health, prolapse impact, role limitations, physical and social limitations, personal relationships, emotional problems, sleep/energy disturbance as well as severity symptoms measurements were defined. Questions regarding bladder, bowel and sexual function were also separately included and validated for reproducibility and internal consistency. Responses ranged from 'none/not at all', through 'slightly/a little' and 'moderately' to 'a lot' to produce a four-point scoring system for each item. Scores in each domain ranged between 0 and 100 with a high total score indicating a greater impairment of quality of life.	18 months
Secondary	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.	Validated into Turkish language form will be used to compare preoperative and postoperative period. Total range scores: 28 (min:0, max:28). Higher values represent a worse outcome.	18 months
Secondary	Subjective Success - Change from baseline Visual Analog Score (VAS) for pain at 18th month.	Participant describes the pain related to the mesh. The respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain with a format of a horizontal bar.	18 months
Secondary	Change from baseline Pelvic Hiatus measurements (mm) at 18th month.	Anteroposterior hiatal length (mm)	18 months
Secondary	Change from baseline Pelvic biometry measurements at 18th month.	Prolapse degree over symphysis pubis (mm) Anterior compartment over 10, Posterior compartment over 15 mm are clinically relevant	18 months
Secondary	Change from baseline bladder neck mobility measurements at 18th month.	Urethral rotation (degree) between rest and valsalva maneuver states	18 months
Secondary	Failure (%)	Failure is defined by any recurrence of prolapse, mesh erosion and need for additional surgery	18 months