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

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: pectopexy operation; Procedure: uterosacral ligaments plication operation.

• Registration Number: NCT04508062
• Lead Sponsor: Ataturk University

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.

Study Timeline

• Study First Submitted: 2020-05-29
• Study Start: 2020-08-06
• Study First Submitted QC: 2020-08-08
• Study First Posted: 2020-08-11
• Primary Completion: 2021-03-06
• Study Completion: 2022-03-06
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pectopexy group	pectopexy operation	this group will only have pectopexy operation
Pectopexy and uterosacral ligaments plication group	uterosacral ligaments plication operation.	this group will have pectopexy operation with bilateral uterosacral ligaments plication
Pectopexy and uterosacral ligaments plication group	pectopexy operation	this group will have pectopexy operation with bilateral uterosacral ligaments plication

Primary Outcome Measures

Name	Time	Method
questionnaire of lower urinary tract symptoms	changes in symptoms for each title at the preoperative day 1 and postoperative day 3 period	the questionaire examines these titles by scoring from one to ten points: 1. sudden feeling of ürination; 2. sudden feeling of urination with incontinence; 3. Frequent urination; 4. Difficulty of starting the urination; 5. Abnormal discharge of urine; 6. nocturia; 7. dyspareunia; 8. Stress urinary incontinence; 9. dysuria; 10. constipation
evaluation of sexual function with Women's Sexual Function Index	changes at the preoperative day 1 and postoperative day 40 period	Women's Sexual Function Index is a questionnaire about sexual functions of the women. the index definex sexual functions with some questions and scorings.
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	Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification

Secondary Outcome Measures

Name	Time	Method
Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification	changes at 3,6 and 12. month after surgery	Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification
questionnaire of lower urinary tract symptoms	changes in symptoms for each title at 3,6 and 12. month after surgery	the questionaire examines these titles by scoring from one to ten points: 1. sudden feeling of ürination; 2. sudden feeling of urination with incontinence; 3. Frequent urination; 4. Difficulty of starting the urination; 5. Abnormal discharge of urine; 6. nocturia; 7. dyspareunia; 8. Stress urinary incontinence; 9. dysuria; 10. constipation
evaluation of sexual function with Women's Sexual Function Index	changes at 3,6 and 12. month after surgery	Women's Sexual Function Index is a questionnaire about sexual functions of the women. the index definex sexual functions with some questions and scorings.

Trial Locations

Locations (1)

Gamze Nur Cimilli Senocak; 🇹🇷 Erzurum, Turkey