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Completed

NCT Number: NCT04508062

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

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.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

25 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gamze Nur Cimilli Senocak

Erzurum, 25100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pectopexy operation

Procedure

Vaginal cuff or uterine cervix will be attached to iliopectineal ligament with polypropylene mesh on both sides.

uterosacral ligaments plication operation.

Procedure

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.

Primary outcomes

  1. questionnaire of lower urinary tract symptoms

    Time frame: 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:

    • 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

  2. evaluation of sexual function with Women's Sexual Function Index

    Time frame: 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.

  3. Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification

    Time frame: 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 outcomes

  1. evaluation of sexual function with Women's Sexual Function Index

    Time frame: 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.

  2. Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification

    Time frame: changes at 3,6 and 12. month after surgery

    Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification

  3. questionnaire of lower urinary tract symptoms

    Time frame: 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:

    • 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

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Aug 11, 2020
Registry last updated
Apr 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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