Comparison of Anatomic Results Between Bilateral and Conventional Abdominal Sacral Hysteropexy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: Bilateral Abdominal Sacral Hysteropexy
* Procedure: Conventional abdominal Sacral Hysteropexy
* Other: Nulliparous women with no uterovaginal prolapsed


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bilateral Abdominal Sacral Hysteropexy<br>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<br>* The mesh will be fixed right and left side of sacrum.<br>|
| Experimental: Classic Abdominal Sacral Hysteropexy<br>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<br>* The mesh will be fixed only right side of sacrum<br>|
| Active Comparator: Women with no uterovaginal prolapsed<br>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<br>* This will be control group which consistent patients with no uterovaginal prolapse.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |