NCT06341088

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

April 5, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2025

Completed
Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

7 months

First QC Date

March 19, 2024

Last Update Submit

July 14, 2025

Conditions

Pelvic Organ Prolapse

Keywords

suture sacro hysteropexyPelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

  • anatomical success of the operations

    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 Outcomes (1)

  • evaluation of the sexual functions of the patients

    changes at 1 and 3 months after surgery

Study Arms (2)

unilateral suture sacro-hysteropexy

ACTIVE COMPARATOR

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

bilateral suture sacro-hysteropexy

ACTIVE COMPARATOR

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

Interventions

unilateral suture sacro-hysteropexyPROCEDURE

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

unilateral suture sacro-hysteropexy
bilateral suture sacro-hysteropexyPROCEDURE

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

bilateral suture sacro-hysteropexy

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University

Erzurum, Palandöken, 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
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

March 19, 2024

First Posted

April 2, 2024

Study Start

April 5, 2024

Primary Completion

November 5, 2024

Study Completion

February 5, 2025

Last Updated

July 17, 2025

Record last verified: 2025-07

Locations

TU(1)