Iatrogenic Impairment of Urethral Coitus Owing to Miduret... | NCT03800615

Studies
Iatrogenic Impairment of Urethral Coitus Owing to Midurethral Sling Procedure in a Woman With Vaginal Agenesis.

NCT03800615

Sponsor

Far Eastern Memorial Hospital

Status

Completed

Last Update Posted

Mar 8, 2019Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Stress Urinary Incontinence
Vaginal Agenesis

Interventions

Cut the sling

Countries

Taiwan

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

Jan 9, 2019Actual

Primary Completion Date

Feb 1, 2019Actual

Completion Date

Feb 1, 2019Actual

First Submitted Date

Jan 9, 2019

First Submission Date that Met QC Criteria

Jan 9, 2019

First Posted Date

Jan 11, 2019Actual

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

Mar 6, 2019

Last Update Posted Date

Mar 8, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sheng-Mou Hsiao, Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial HospitalPrincipal Investigator

Lead Sponsor

Far Eastern Memorial HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Description Module

Brief Summary

To report a case of impairment urethral coitus after the midurethral sling procedure

Detailed Description

To report a case of impairment urethral coitus after the midurethral sling procedure.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cut the sling	Procedure	Cut the mid-urethral sling for stress urinary incontinence

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sexual function	Asking the patient whether she can resume sexual intercourse or not after surgery	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

midurethral sling procedure for stress urinary incontinence
woman with vaginal agenesis.

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

A 59-year-old woman had previous history of hysterectomy due to nonfunctional uterine obstruction at 19 years old and urinary incontinence status post transvaginal tape procedure at 45 years old with clinical symptoms of difficulty in urethral coitus after midurethral sling procedure.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital		Banqiao District	New Taipei	22050	Taiwan

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
D014550	Urinary Incontinence, Stress
C536523	Vagina, absence of

Ancestor Terms

ID	Term
D014549	Urinary Incontinence
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided