Bilateral Sacrospinous Colposuspension (BSC) in the Femal... | NCT03640364

Studies
Bilateral Sacrospinous Colposuspension (BSC) in the Female Genital Prolapse With Urinary Urge Symptomatology

NCT03640364

Sponsor

Helios Medical Center Schleswig

Status

Unknown status

Last Update Posted

Aug 21, 2018Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Urinary Urge Incontinence

Interventions

Not provided

Countries

Germany

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

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2018Actual

Primary Completion Date

Jun 2020Estimated

Completion Date

Jun 2021Estimated

First Submitted Date

Aug 6, 2018

First Submission Date that Met QC Criteria

Aug 17, 2018

First Posted Date

Aug 21, 2018Actual

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

Aug 17, 2018

Last Update Posted Date

Aug 21, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dirk G. Kieback, M.D., Ph.D, Head, Dept. of Obstetrics and Gynecology, Helios Medical Center SchleswigPrincipal Investigator

Lead Sponsor

Helios Medical Center SchleswigOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Prospective non-randomised trial investigating the effect of vaginal vault Suspension on urge symptomatology in female patients with pelvic organ prolapse

Detailed Description

A multicenter multinational Trial is performed in 250 female patients with pelvic organ prolapse (POP) and symptoms of urinary urge incontinence.

Dependent on the presence or abscence of the uterus patients are treated with bilateral sacrospinous uterine or vaginal vault suspension (BSC) by means of a tape specifically designed for this purpose.

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

250Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Influence of BSC placement on symptoms of urinary urge expressed by change in clinical examination	The change in symptoms after the surgical intervention is evaluated by clinical examination . The clinical examination is descriptive, not quantitative and no units are applicable or reportable.	Checked after 6 weeks, six months and twelve months
Change in score of standardized ICIQ documentation	The International Consultation on Incontinence Questionnaire is used to evaluate Change in Quality of life and urge symptomatology	Checked after 6 weeks, six months and twelve months

Secondary Outcomes

Measure	Description	Time Frame
Anatomical correction of female pelvic organ prolapse	Clinical examination of pelvic floor anatomy	Checked after 6 weeks, six months and twelve months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

urge urinary incontinence or symptoms thereof
18 years old or older
Compliance regarding data collection, therapy and follow-up
written informed consent
simultaneous performance of surgical colporrhaphy permitted

Exclusion Criteria:

pelvic organ prolapse without symptoms of urinary urge
age less than 18 years
no informed consent
lack of compliance
adverse reaction to polypropylene
life expectancy less than anticipated duration of protocol
ASA 4

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

female patients with pelvic organ prolapse suffering from symptoms of urinary urge incontinence

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dirk G Kieback, MD, Ph.D	Contact	+49 4621 812	1271	dirk.kieback@helios-gesundheit.de
Marek Volkmer, MD	Contact	+49 4621 812	1271	marek.volkmer@helios-gesundheit.de

Overall Officials

Name	Affiliation	Role
Dirk G Kieback, MD,Ph.D	Helios Medical Center Schleswig	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helios Medical Center	Recruiting	Schleswig		24837	Germany

Condition Browse Module

MeSH Terms

ID	Term
D053202	Urinary Incontinence, Urge
D056887	Pelvic Organ Prolapse

Ancestor Terms

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

Browse Leaves

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Browse Branches

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