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Clinical Trials/NCT04508062
NCT04508062
Completed
Not Applicable

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

Ataturk University1 site in 1 country38 target enrollmentAugust 6, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Organ Prolapse
Sponsor
Ataturk University
Enrollment
38
Locations
1
Primary Endpoint
questionnaire of lower urinary tract symptoms
Status
Completed
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 6, 2020
End Date
March 6, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gamze Nur Cimilli Şenocak

assistant professor

Ataturk University

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

Outcomes

Primary Outcomes

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

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.

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

  • 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(changes in symptoms for each title at 3,6 and 12. month after surgery)
  • evaluation of sexual function with Women's Sexual Function Index(changes at 3,6 and 12. month after surgery)

Study Sites (1)

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