Comparison of Anatomic Results Between Bilateral and Conventional Abdominal Sacral Hysteropexy

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Status: Completed

Conditions: Pelvic Organ Prolapse

Treatments: Procedure: Bilateral Abdominal Sacral Hysteropexy; Procedure: Conventional abdominal Sacral Hysteropexy; Other: Nulliparous women with no uterovaginal prolapsed

Study type: Interventional

Funder types: Other

Identifiers

NCT02667002

162

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Bilateral Abdominal Sacral Hysteropexy

Experimental group

Description:

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.

Treatment:

Procedure: Bilateral Abdominal Sacral Hysteropexy

Classic Abdominal Sacral Hysteropexy

Experimental group

Description:

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.

Treatment:

Procedure: Conventional abdominal Sacral Hysteropexy

Women with no uterovaginal prolapsed

Active Comparator group

Description:

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

Treatment:

Other: Nulliparous women with no uterovaginal prolapsed