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Completed

NCT Number: NCT06341088

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

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.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Atatürk University

Erzurum, Palandöken, Turkey (Türkiye)

About this 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.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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

unilateral suture sacro-hysteropexy

Procedure

patients in this group will undergo unilateral sacrouterine ligament plication with nonabsorbable suture and unilaterally suspended to the anterior longitudinal ligament.

bilateral suture sacro-hysteropexy

Procedure

patients in this group will undergo bilateral sacrouterine ligament plication with nonabsorbable suture and bilaterally suspended to the anterior longitudinal ligament.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 2, 2024
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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