Comparison of Anatomic Results Between Bilateral and Conventional Abdominal Sacral Hysteropexy

Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02667002
Collaborator
(none)
30
Enrollment
3
Arms
19
Duration (Months)

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Bilateral Abdominal Sacral Hysteropexy
  • Procedure: Conventional abdominal Sacral Hysteropexy
  • Other: Nulliparous women with no uterovaginal prolapsed
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Single Blind Controlled Trial of Comparison of Anatomic and Sexual Outcomes Between Conventional and Bilateral Sacral Hysteropexy
Study Start Date :
Nov 1, 2015
Actual Primary Completion Date :
May 1, 2017
Actual Study Completion Date :
Jun 1, 2017

Arms and Interventions

ArmIntervention/Treatment
Experimental: 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.

Procedure: Bilateral Abdominal Sacral Hysteropexy
The mesh will be fixed right and left side of sacrum.

Experimental: Classic 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.

Procedure: Conventional abdominal Sacral Hysteropexy
The mesh will be fixed only right side of sacrum

Active Comparator: 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.

Other: Nulliparous women with no uterovaginal prolapsed
This will be control group which consistent patients with no uterovaginal prolapse.

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Investigators

  • Study Director: Mehmet Baki Şentürk, MD, Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Mehmet Baki Senturk, Principal Investigator, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
ClinicalTrials.gov Identifier:
NCT02667002
Other Study ID Numbers:
  • 162
First Posted:
Jan 28, 2016
Last Update Posted:
Mar 28, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 28, 2022