Effects of the Addition of Uterosacral Ligament Plication to Pectopexy Operation on Anatomical and Subjective Symptoms

Study Overview
=================
Brief Summary
-----------------
The investigators planned to measure the effectiveness of laparoscopic pectopexy in apical prolapse and whether the addition of sacrouterine ligaments plication to pectopexy increases the effectiveness of pectopexy operation. Investigators planned to measure patients' quality of life using the female sexual function scale test 3, 6 and 12 months after the surgery and to determine how the operation affects the quality of sexual life.

Detailed Description
-----------------
In this study, the investigators planned to measure the effectiveness of laparoscopic pectopexy in apical prolapse and whether the addition of sacrouterine ligaments plication to pectopexy increases the effectiveness of pectopexy operation. Investigators planned to measure patients' quality of life using the female sexual function scale test 3, 6 and 12 months after the surgery and to determine how the operation affects the quality of sexual life.

Official Title
-----------------
Effects of the Addition of Uterosacral Ligament Plication to Pectopexy Operation on Anatomical and Subjective Symptoms in the Treatment of Apical Compartment Defects

Conditions
-----------------
Pelvic Organ Prolapse

Intervention / Treatment
-----------------
* Procedure: pectopexy operation
* Procedure: uterosacral ligaments plication operation.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with stage II-IV apical compartment defect according to the POP-Q classification Exclusion Criteria: having severe chronic disease that makes the operation dangerous patients under 25 and patients over 75 years old

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pectopexy group<br>this group will only have pectopexy operation | Procedure: pectopexy operation<br>* Vaginal cuff or uterine cervix will be attached to iliopectineal ligament with polypropylene mesh on both sides.<br>|
| Active Comparator: Pectopexy and uterosacral ligaments plication group<br>this group will have pectopexy operation with bilateral uterosacral ligaments plication | Procedure: pectopexy operation<br>* Vaginal cuff or uterine cervix will be attached to iliopectineal ligament with polypropylene mesh on both sides.<br>Procedure: uterosacral ligaments plication operation.<br>* At least 2/3 of the sacrouterine ligaments will be shortened with helical sutures, starting from the cervix and so douglas will be partially obliterated.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| questionnaire of lower urinary tract symptoms | the questionaire examines these titles by scoring from one to ten points: sudden feeling of ürination sudden feeling of urination with incontinence Frequent urination Difficulty of starting the urination Abnormal discharge of urine nocturia dyspareunia Stress urinary incontinence dysuria constipation | changes in symptoms for each title at the preoperative day 1 and postoperative day 3 period | 
| evaluation of sexual function with Women's Sexual Function Index | Women's Sexual Function Index is a questionnaire about sexual functions of the women. the index definex sexual functions with some questions and scorings. | changes at the preoperative day 1 and postoperative day 40 period | 
| Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification | Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification | changes in the stage of apical compartment defect at the preoperative day 1 and postoperative day 3 period according to POP-Q clasification | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of sexual function with Women's Sexual Function Index | Women's Sexual Function Index is a questionnaire about sexual functions of the women. the index definex sexual functions with some questions and scorings. | changes at 3,6 and 12. month after surgery | 
| Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification | Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification | changes at 3,6 and 12. month after surgery | 
| questionnaire of lower urinary tract symptoms | the questionaire examines these titles by scoring from one to ten points: sudden feeling of ürination sudden feeling of urination with incontinence Frequent urination Difficulty of starting the urination Abnormal discharge of urine nocturia dyspareunia Stress urinary incontinence dysuria constipation | changes in symptoms for each title at 3,6 and 12. month after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pelvic organ prolapse, pectopexy, laparoscopy, uterosacral ligaments plication