Evaluation of Anatomical Results and Sexual Functions After Unilateral and Bilateral Laparoscopic Suture Sacro-hysteropexy Operations

July 14, 2025 updated by: Gamze Nur Cimilli Şenocak, Ataturk University

Evaluation of Anatomical Results and Sexual Functions After Unilateral and Bilateral Laparoscopic Suture Sacro-hysteropexy Operations, a Prospective Randomised Study

The study was planned as prospective and randomized. For the study, patients will be randomized into two groups as unilateral and bilateral suture sacro-hysteropexy operations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was planned as prospective and randomized. For the study, patients will be randomized into two groups as unilateral and bilateral suture sacro-hysteropexy operations.Computerized random number table will be used as randomization method. Patients who agree to participate in the study and fulfill the inclusion criteria will be evaluated on the effects of prolapse on quality of life and sexual function before and after the surgical procedures and their complaints and satisfaction will be questioned. Surgical success and complications will be evaluated. Changes in the level of prolapse will be evaluated.

Study Type

Interventional

Enrollment (Actual)

64

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

  • Turkey
    • Palandöken
      • Erzurum, Palandöken, Turkey
        • Ataturk University

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Patients between the ages of 18-60
  2. No previous prolapse surgery
  3. Not having a chronic disease
  4. Having stage 3-4 prolapse

Exclusion Criteria:

  1. Outside the age range of 18-60 years
  2. Previous prolapse surgery
  3. Having early stage (1-2) prolapse
  4. History of chronic disease

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: unilateral suture sacro-hysteropexy
patients in this group will undergo unilateral sacrouterine ligament plication with nonabsorbable suture and unilaterally suspended to the anterior longitudinal ligament.
Procedure: unilateral suture sacro-hysteropexy
patients in this group will undergo unilateral sacrouterine ligament plication with nonabsorbable suture and unilaterally suspended to the anterior longitudinal ligament.
Active Comparator: bilateral suture sacro-hysteropexy
patients in this group will undergo bilateral sacrouterine ligament plication with nonabsorbable sutures and bilaterally suspended to the anterior longitudinal ligament.
Procedure: bilateral suture sacro-hysteropexy
patients in this group will undergo bilateral sacrouterine ligament plication with nonabsorbable suture and bilaterally suspended to the anterior longitudinal ligament.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anatomical success of the operations
Time Frame: changes at 1 and 3 months after surgery
comparition of preoperative and postoperative pelvic organ prolapse quantification system (POP-Q) measurements of the patients
changes at 1 and 3 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of the sexual functions of the patients
Time Frame: changes at 1 and 3 months after surgery
comparition of preoperative and postoperative FSFI(female sexual function index) scores of the patients
changes at 1 and 3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Investigators

  • Principal Investigator: Gamze Nur Cimilli Senocak, Ataturk University

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)

April 5, 2024

Primary Completion (Actual)

November 5, 2024

Study Completion (Actual)

February 5, 2025

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

July 17, 2025

Last Update Submitted That Met QC Criteria

July 14, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.30.2.ATA.0.01.00/132

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.

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