NCT05715489

Brief Summary

it is aimed to examine the effect of laparoscopic pectopexy surgery without mesh on Pelvic Organ Prolapse Measurement (POP-Q) and quality of life of the patient.

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 May 2022

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2024

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

2 years

First QC Date

January 18, 2023

Last Update Submit

September 28, 2024

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (2)

  • Pre and post operative assessment of POP-Q measurements

    POP-Q values of patients before and after laparoscopic pectopexy surgery without mesh on Pelvic Organ Prolapse will be compared.

    2 year

  • Pre and post operative assessment of Pelvic Organ Prolapse / Incontinence Sexual

    Units on a scale of the patients obtained with Pelvic Organ Prolapse / Incontinence Sexual Questionnaire (PISQ-12) will be compared before and after surgery.

    2 year

Study Arms (1)

Patients with pelvic organ prolapse undergone pectopexy without using mesh

OTHER
Procedure: Comparison of pre and postoperative POP-Q values of the patientsProcedure: Comparison of pre and postoperative PISQ-12 scores of the patients

Interventions

Comparison of pre and postoperative POP-Q values of the patientsPROCEDURE

Pectopexy Without Using Mesh will be applied to the patients and POP-Q values will be compared pre and postoperatively

Patients with pelvic organ prolapse undergone pectopexy without using mesh
Comparison of pre and postoperative PISQ-12 scores of the patientsPROCEDURE

Pectopexy Without Using Mesh will be applied to the patients and PISQ-12 scores will be compared pre and postoperatively

Patients with pelvic organ prolapse undergone pectopexy without using mesh

Eligibility Criteria

Age30 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • having pelvic organ prolapse greater than stage 2 according to POP-Q evaluation system
  • being sexually active

You may not qualify if:

  • Disease requiring chronic steroid use
  • Asthma
  • Having chronic obstructive pulmonary disease
  • Having malignancy,
  • Having metabolic and rheumatological diseases that impair tissue healing, such as scleroderma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Suleyman Salman

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 18, 2023

First Posted

February 8, 2023

Study Start

May 11, 2022

Primary Completion

May 11, 2024

Study Completion

May 11, 2024

Last Updated

October 1, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

Locations

TU(1)