NCT06524700

Brief Summary

prospective comparative study describing using autologous graft for uterine- vault - cervical suspension vs mesh in treatment of apical prolapse

Trial Health

58
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
2 countries

2 active sites

Status
active not recruiting

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

First Submitted

Initial submission to the registry

July 24, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

November 6, 2024

Status Verified

November 1, 2024

Enrollment Period

1.1 years

First QC Date

July 24, 2024

Last Update Submit

November 4, 2024

Conditions

Uterine ProlapseVault Prolapse, Vaginal

Keywords

vaultuterineprolapse

Outcome Measures

Primary Outcomes (1)

  • POP-Q

    assesment of degree of prolapse correction after surgery

    3 month

Study Arms (2)

A

ACTIVE COMPARATOR
Procedure: pectopexy mesh

B

ACTIVE COMPARATOR
Procedure: pectopexy autologous

Interventions

pectopexy meshPROCEDURE

pectopexy with mesh

A
pectopexy autologousPROCEDURE

pectopexy using autologous graft

B

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • uterine - vault prolapse

You may not qualify if:

  • previous vaginal repair for uterine or vaginal prolapse previous suspension procedures for apical prolapse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Urogynecology Unit

Cairo, Cairo Governorate, Egypt

Location

Armed forces Hospital Wadi Aldwaser

Riyadh, Wadi Aldwaser, Saudi Arabia

Location

MeSH Terms

Conditions

Uterine ProlapsePelvic Organ ProlapseProlapse

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Hamdy Saaid

    UROGYNECOLOGY UNIT

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow

Study Record Dates

First Submitted

July 24, 2024

First Posted

July 29, 2024

Study Start

August 1, 2024

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

November 6, 2024

Record last verified: 2024-11

Locations

SA(1)EG(1)