NCT04508062

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 6, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2022

Completed
Last Updated

April 24, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

May 29, 2020

Last Update Submit

April 20, 2023

Conditions

Pelvic Organ Prolapse

Keywords

pelvic organ prolapsepectopexylaparoscopyuterosacral ligaments plication

Outcome Measures

Primary Outcomes (3)

  • questionnaire of lower urinary tract symptoms

    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

    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

    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 Outcomes (3)

  • evaluation of sexual function with Women's Sexual Function Index

    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

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

Study Arms (2)

pectopexy group

ACTIVE COMPARATOR

this group will only have pectopexy operation

Procedure: pectopexy operation

Pectopexy and uterosacral ligaments plication group

ACTIVE COMPARATOR

this group will have pectopexy operation with bilateral uterosacral ligaments plication

Procedure: pectopexy operationProcedure: uterosacral ligaments plication operation.

Interventions

pectopexy operationPROCEDURE

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

Pectopexy and uterosacral ligaments plication grouppectopexy group
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.

Pectopexy and uterosacral ligaments plication group

Eligibility Criteria

Age25 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with stage II-IV apical compartment defect according to the POP-Q classification

You may not qualify if:

  • having severe chronic disease that makes the operation dangerous
  • patients under 25 and patients over 75 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gamze Nur Cimilli Senocak

Erzurum, 25100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Gamze Nur Cimilli Senocak

    Ataturk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

May 29, 2020

First Posted

August 11, 2020

Study Start

August 6, 2020

Primary Completion

March 6, 2021

Study Completion

March 6, 2022

Last Updated

April 24, 2023

Record last verified: 2023-04

Locations

TU(1)