NCT03221725

Brief Summary

Surgery for Stage II-III Pelvic organ prolapse

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 19, 2017

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

6 months

First QC Date

July 14, 2017

Last Update Submit

January 27, 2019

Conditions

Pelvic Organ Prolapse

Keywords

sacrospinous ligament fixationstress urinary incontinence

Outcome Measures

Primary Outcomes (1)

  • development of stress urinary incontinence

    in one year

Secondary Outcomes (1)

  • postoperative vaginal length

    in one year

Study Arms (1)

sacrospinosus fixation group

EXPERIMENTAL

The group which sacrospinous fixation was performed

Procedure: sacrospinous ligament fixation

Interventions

sacrospinous ligament fixationPROCEDURE

sacrospinous ligament fixation will be applied to prevent vaginal vault prolapse

sacrospinosus fixation group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pelvic organ prolapse stage II-III
  • has no incontinence before surgery

You may not qualify if:

  • had surgery before
  • Pelvic organ prolapse stage I or IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kerem Doga Seckin

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pelvic Organ ProlapseUrinary Incontinence, Stress

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ass prof

Study Record Dates

First Submitted

July 14, 2017

First Posted

July 19, 2017

Study Start

February 1, 2017

Primary Completion

August 1, 2017

Study Completion

February 1, 2018

Last Updated

January 30, 2019

Record last verified: 2019-01

Locations

TU(1)