Comparison of Anatomic Results Between Bilateral and Conventional Abdominal Sacral Hysteropexy

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Other: Nulliparous women with no uterovaginal prolapsed; Procedure: Bilateral Abdominal Sacral Hysteropexy; Procedure: Conventional abdominal Sacral Hysteropexy

• Registration Number: NCT02667002
• Lead Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-01-27
• Study First Posted: 2016-01-28
• Primary Completion: 2017-05
• Study Completion: 2017-06
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-13
• Last Update Posted: 2022-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Women with no uterovaginal prolapsed	Nulliparous women with no uterovaginal prolapsed	Ten nulliparous participants with no uterovaginal prolapsed will be evaluate by MRI and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) form.
Bilateral Abdominal Sacral Hysteropexy	Bilateral Abdominal Sacral Hysteropexy	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.
Classic Abdominal Sacral Hysteropexy	Conventional abdominal Sacral Hysteropexy	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.

Primary Outcome Measures

Name	Time	Method
Anatomic Success	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