NCT02667002

Brief Summary

Investigators separated 20 patients with uterovaginal prolapse into 2 groups according to random numbers table. In one group, conventional abdominal sacral hysteropexy will be perform and another group bilateral abdominal sacral hysteropexy will be perform with polypropylene mesh. After 1 mont operation vaginal configuration will be evaluate with MRI on three plane (axial, sagittal, coronal). Then the results of thus two groups will be compare to results of nullipara patients. Investigators will investigate which technique keep the vaginal axis is closer to the original anatomic position.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Status
completed

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

Study Start

First participant enrolled

November 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

March 28, 2022

Status Verified

March 1, 2022

Enrollment Period

1.5 years

First QC Date

January 21, 2016

Last Update Submit

March 13, 2022

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

  • Anatomic Success

    anatomic success will be evaluated by using magnetic resonance imaging. Vaginal axis (distance to spin ischiadic a and sacrum) will be measure on three plane

    One month

Study Arms (3)

Bilateral Abdominal Sacral Hysteropexy

EXPERIMENTAL

Bilateral abdominal sacral hysteropexy will be perform in 10 patients. One month after patients will be evaluate by MRI and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) form.

Procedure: Bilateral Abdominal Sacral Hysteropexy

Classic Abdominal Sacral Hysteropexy

EXPERIMENTAL

Conventional abdominal sacral hysteropexy will be perform in 10 patients. One month after patients will be evaluate by MRI and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) form.

Procedure: Conventional abdominal Sacral Hysteropexy

Women with no uterovaginal prolapsed

ACTIVE COMPARATOR

Ten nulliparous participants with no uterovaginal prolapsed will be evaluate by MRI and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) form.

Other: Nulliparous women with no uterovaginal prolapsed

Interventions

Bilateral Abdominal Sacral HysteropexyPROCEDURE

The mesh will be fixed right and left side of sacrum.

Bilateral Abdominal Sacral Hysteropexy
Conventional abdominal Sacral HysteropexyPROCEDURE

The mesh will be fixed only right side of sacrum

Classic Abdominal Sacral Hysteropexy
Nulliparous women with no uterovaginal prolapsedOTHER

This will be control group which consistent patients with no uterovaginal prolapse.

Women with no uterovaginal prolapsed

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women with stage 3 or more pelvic organ prolapse

You may not qualify if:

  • Women with abnormal uterine bleeding, abnormal cervical screening test, myoma uteri and want to hysterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Jager W, Mirenska O, Brugge S. Surgical treatment of mixed and urge urinary incontinence in women. Gynecol Obstet Invest. 2012;74(2):157-64. doi: 10.1159/000339972. Epub 2012 Aug 9.

    PMID: 22890409RESULT

  • Sze EH, Meranus J, Kohli N, Miklos JR, Karram MM. Vaginal configuration on MRI after abdominal sacrocolpopexy and sacrospinous ligament suspension. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(6):375-9; discussion 379-80. doi: 10.1007/s001920170016.

    PMID: 11795640RESULT

  • Joukhadar R, Meyberg-Solomayer G, Hamza A, Radosa J, Bader W, Barski D, Ismaeel F, Schneider G, Solomayer E, Baum S. A Novel Operative Procedure for Pelvic Organ Prolapse Utilizing a MRI-Visible Mesh Implant: Safety and Outcome of Modified Laparoscopic Bilateral Sacropexy. Biomed Res Int. 2015;2015:860784. doi: 10.1155/2015/860784. Epub 2015 Apr 19.

    PMID: 25961042RESULT

Related Links

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Mehmet Baki Şentürk, MD

    Zeynep Kamil Maternity and Pediatric Research and Training Hospital

    STUDY DIRECTOR

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
Principal Investigator

Study Record Dates

First Submitted

January 21, 2016

First Posted

January 28, 2016

Study Start

November 1, 2015

Primary Completion

May 1, 2017

Study Completion

June 1, 2017

Last Updated

March 28, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

Data will be available within 1 week of study completion.