- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06176521
Evaluation of the Results of Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Performed Without Mesh in the Surgical Treatment of Pelvic Organ Prolapse
August 4, 2025 updated by: Gaziosmanpasa Research and Education Hospital
Evaluation of the anatomical and functional results of laparoscopic sacrohysteropexy and sacrocolpopexy surgeries performed without using mesh in the surgical treatment of pelvic organ prolapse
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
35
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
-
-
-
Istanbul, Turkey
- Gaziosmanpasa Training and Research Hospital
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- being 18 years old or older
- needing an operation for symptomatic pelvic organ prolapse -
Exclusion Criteria:
- past history of chemotherapy or radiotherapy
- past history of pelvic organ prolapse surgery
- if there is a contraindication of laparoscopy -
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Performed Without Mesh
|
Comparison of pre and postoperative POP-Q values of the patients undergone Laparoscopic Sacrohysteropexy and Sacrocolpopexy SurgeriesWithout Using Mesh Comparison of pre and postoperative PISQ-12 scores of the patients undergone Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Without Using Mesh
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pre and post operative assessment of Pelvic Organ Prolapse / Incontinence Sexual
Time Frame: 1 year
|
Units on a scale of the patients obtained with Pelvic Organ Prolapse / Incontinence Sexual Questionnaire (PISQ-12) will be compared before and after surgery.
|
1 year
|
|
Pre and post operative assessment of POP-Q measurements
Time Frame: 1 year
|
POP-Q values of patients before and after laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Performed Without Mesh on Pelvic Organ Prolapse will be compared.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
November 1, 2023
Primary Completion (Actual)
December 1, 2024
Study Completion (Actual)
June 1, 2025
Study Registration Dates
First Submitted
December 9, 2023
First Submitted That Met QC Criteria
December 9, 2023
First Posted (Actual)
December 19, 2023
Study Record Updates
Last Update Posted (Actual)
August 6, 2025
Last Update Submitted That Met QC Criteria
August 4, 2025
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GaziosmanpasaTREHs
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.
Clinical Trials on Pelvic Organ Prolapse
-
NICHD Pelvic Floor Disorders NetworkEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingPelvic Organ Prolapse | Pelvic Organ Prolapse Vaginal Surgery | Pelvic Organ Prolapse, Patient Education | Pelvic Organ Prolapse (POP)United States
-
Hillel Yaffe Medical CenterCompletedHysterectomy | Pelvic Organ Prolapse Vaginal Surgery | Pelvic Organ Prolapse (POP)Israel
-
University of CalgaryAlberta Health services; Cook Group IncorporatedCompletedAnterior Pelvic Organ ProlapseCanada
-
Wolfson Medical CenterRecruiting
-
Queen's UniversityNot yet recruitingPelvic Organ Prolapse (POP)Canada
-
Coloplast A/SCompletedPelvic Organ Prolapse (POP)United States
-
Chung Shan Medical UniversityActive, not recruitingPelvic Organ Prolapse | Pelvic Organ Prolapse Vaginal Surgery | Sacrocolpopexy | PectopexyTaiwan
-
A.M.I. Agency for Medical Innovations GmbHActive, not recruitingProlapse | Pelvic Organ Prolapse (POP) | SacrocolpopexyGermany
-
University of British ColumbiaCompletedPelvic Organ Prolapse, Patient EducationCanada
-
University of MelbourneCompletedVaginal Hysterectomy | Pelvic Organ Prolapse Vaginal SurgeryAustralia
Clinical Trials on Laparoscopic Sacrohysteropexy and Sacrocolpopexy Surgeries Performed Without Mesh
-
Assistance Publique - Hôpitaux de ParisCompletedPelvic Organ Prolapse | Stress Urinary IncontinenceFrance