The Development of De-novo Stress Urinary Incontinence Af... | NCT03221725

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

NCT03221725

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Status

Completed

Last Update Posted

Jan 30, 2019Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Pelvic Organ Prolapse

Interventions

sacrospinous ligament fixation

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2017Actual

Primary Completion Date

Aug 1, 2017Actual

Completion Date

Feb 1, 2018Actual

First Submitted Date

Jul 14, 2017

First Submission Date that Met QC Criteria

Jul 17, 2017

First Posted Date

Jul 19, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2019

Last Update Posted Date

Jan 30, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kerem Doga Seckin, ass prof, Kanuni Sultan Suleyman Training and Research HospitalPrincipal Investigator

Lead Sponsor

Kanuni Sultan Suleyman Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sacrospinosus fixation group	Experimental	The group which sacrospinous fixation was performed	Procedure: sacrospinous ligament fixation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sacrospinous ligament fixation	Procedure	sacrospinous ligament fixation will be applied to prevent vaginal vault prolapse	sacrospinosus fixation group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
development of stress urinary incontinence		in one year

Secondary Outcomes

Measure	Description	Time Frame
postoperative vaginal length		in one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kerem Doga Seckin		Istanbul			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D056887	Pelvic Organ Prolapse
D014550	Urinary Incontinence, Stress

Ancestor Terms

ID	Term
D011391	Prolapse
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D014549	Urinary Incontinence

Browse Leaves

Not provided

Browse Branches

Not provided