Skip to content

Comparison of Anatomic Results Between Bilateral and Conventional Abdominal Sacral Hysteropexy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02667002
Enrollment
30
Registered
2016-01-28
Start date
2015-11-30
Completion date
2017-06-30
Last updated
2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

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.

Interventions

PROCEDUREBilateral Abdominal Sacral Hysteropexy

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

PROCEDUREConventional abdominal Sacral Hysteropexy

The mesh will be fixed only right side of sacrum

OTHERNulliparous women with no uterovaginal prolapsed

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

Sponsors

Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026