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

Primary Purpose

Pelvic Organ Prolapse

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
pectopexy operation
uterosacral ligaments plication operation.
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring pelvic organ prolapse, pectopexy, laparoscopy, uterosacral ligaments plication

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Gamze Nur Cimilli Senocak

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

pectopexy group

Pectopexy and uterosacral ligaments plication group

Arm Description

this group will only have pectopexy operation

this group will have pectopexy operation with bilateral uterosacral ligaments plication

Outcomes

Primary Outcome Measures

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
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.
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

Secondary Outcome Measures

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.
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
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

Full Information

First Posted
May 29, 2020
Last Updated
April 20, 2023
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT04508062
Brief Title
Effects of the Addition of Uterosacral Ligament Plication to Pectopexy Operation on Anatomical and Subjective Symptoms
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 6, 2020 (Actual)
Primary Completion Date
March 6, 2021 (Actual)
Study Completion Date
March 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
pelvic organ prolapse, pectopexy, laparoscopy, uterosacral ligaments plication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pectopexy group
Arm Type
Active Comparator
Arm Description
this group will only have pectopexy operation
Arm Title
Pectopexy and uterosacral ligaments plication group
Arm Type
Active Comparator
Arm Description
this group will have pectopexy operation with bilateral uterosacral ligaments plication
Intervention Type
Procedure
Intervention Name(s)
pectopexy operation
Intervention Description
Vaginal cuff or uterine cervix will be attached to iliopectineal ligament with polypropylene mesh on both sides.
Intervention Type
Procedure
Intervention Name(s)
uterosacral ligaments plication operation.
Intervention Description
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 Outcome Measure Information:
Title
questionnaire of lower urinary tract symptoms
Description
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
Time Frame
changes in symptoms for each title at the preoperative day 1 and postoperative day 3 period
Title
evaluation of sexual function with Women's Sexual Function Index
Description
Women's Sexual Function Index is a questionnaire about sexual functions of the women. the index definex sexual functions with some questions and scorings.
Time Frame
changes at the preoperative day 1 and postoperative day 40 period
Title
Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification
Description
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
Secondary Outcome Measure Information:
Title
evaluation of sexual function with Women's Sexual Function Index
Description
Women's Sexual Function Index is a questionnaire about sexual functions of the women. the index definex sexual functions with some questions and scorings.
Time Frame
changes at 3,6 and 12. month after surgery
Title
Stage of apical compartment defect according to the Pelvic Organ Prolapse (POP-Q) classification
Description
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
Title
questionnaire of lower urinary tract symptoms
Description
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
Time Frame
changes in symptoms for each title at 3,6 and 12. month after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gamze Nur Cimilli Senocak
Organizational Affiliation
Ataturk University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gamze Nur Cimilli Senocak
City
Erzurum
ZIP/Postal Code
25100
Country
Turkey

12. IPD Sharing Statement

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

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