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Completed

NCT Number: NCT02667002

Comparison of Anatomic Results Between Bilateral and Conventional Abdominal Sacral Hysteropexy

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.

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Key information

Conditions

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

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

Since vaginal hysterectomy and mc call culdoplasty, many techniques have been described. Before, correcting only prolapsed part, now, we can measure anatomical and functional results more objectively by using different tool such us MRI, perineal ultrasonography, PISQ-12, IIQ-7 (Incontinence impact questionnaire). Hence pelvic organ prolapse surgery is important in terms of anatomic and functional results. Unilateral abdominal sacral hysteropexy can put vaginal axis to right side slightly. Therefore investigators hypothesized that bilateral sacral hysteropexy which mimic sacrouterine ligament can be more suitable in terms of anatomic results.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Women with stage 3 or more pelvic organ prolapse

Exclusion criteria

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

Treatment and study plan

Bilateral Abdominal Sacral Hysteropexy

Procedure

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

Conventional abdominal Sacral Hysteropexy

Procedure

The mesh will be fixed only right side of sacrum

Nulliparous women with no uterovaginal prolapsed

Other

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

Primary outcomes

  1. Anatomic Success

    Time frame: One month

    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

Sponsors and collaborators

Lead sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Other

Registry information

Official study title

Randomized Single Blind Controlled Trial of Comparison of Anatomic and Sexual Outcomes Between Conventional and Bilateral Sacral Hysteropexy

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 28, 2016
Registry last updated
Mar 28, 2022

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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