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

April 20, 2023 updated by: Gamze Nur Cimilli Şenocak, Ataturk University

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

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 Overview

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Erzurum, Turkey, 25100
        • Gamze Nur Cimilli Senocak

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: pectopexy group
this group will only have pectopexy operation
Vaginal cuff or uterine cervix will be attached to iliopectineal ligament with polypropylene mesh on both sides.
Active Comparator: Pectopexy and uterosacral ligaments plication group
this group will have pectopexy operation with bilateral uterosacral ligaments plication
Vaginal cuff or uterine cervix will be attached to iliopectineal ligament with polypropylene mesh on both sides.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

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

  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
changes in symptoms for each title at 3,6 and 12. month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Gamze Nur Cimilli Senocak, Atatürk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2020

Primary Completion (Actual)

March 6, 2021

Study Completion (Actual)

March 6, 2022

Study Registration Dates

First Submitted

May 29, 2020

First Submitted That Met QC Criteria

August 8, 2020

First Posted (Actual)

August 11, 2020

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 20, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • B.30.2.ATA.0.01.00/6

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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