The Development of De-novo Stress Urinary Incontinence After Stage II-III Pelvic Organ Prolapse Surgery

January 27, 2019 updated by: Kerem Doga Seckin, Kanuni Sultan Suleyman Training and Research Hospital

The Effect of Sacrospinous Ligament Fixation After Vaginal Hysterectomy to Development of De-novo Stress Urinary Incontinence and Postoperative Vaginal Length in Treating Stage II-III Pelvic Organ Prolapse Patients

Surgery for Stage II-III Pelvic organ prolapse

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İstanbul, Turkey
        • Kerem Doga Seckin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sacrospinosus fixation group
The group which sacrospinous fixation was performed
Procedure: sacrospinous ligament fixation
sacrospinous ligament fixation will be applied to prevent vaginal vault prolapse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
development of stress urinary incontinence
Time Frame: in one year
in one year

Secondary Outcome Measures

Outcome Measure
Time Frame
postoperative vaginal length
Time Frame: in one year
in one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

July 14, 2017

First Submitted That Met QC Criteria

July 17, 2017

First Posted (Actual)

July 19, 2017

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 27, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pelvic Organ Prolapse

Clinical Trials on sacrospinous ligament fixation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe