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

NCT ID: NCT03640364

Last Updated: 2018-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2021-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Urinary Urge Incontinence

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Helios Medical Center Schleswig

OTHER

Sponsor Role lead

Responsible Party

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Dirk G. Kieback, M.D., Ph.D

Head, Dept. of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dirk G Kieback, MD,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Helios Medical Center Schleswig

Locations

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Helios Medical Center

Schleswig, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Dirk G Kieback, MD, Ph.D

Role: CONTACT

+49 4621 812 ext. 1271

Marek Volkmer, MD

Role: CONTACT

+49 4621 812 ext. 1271

Facility Contacts

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Marek Volkmer, MD

Role: primary

+49 4621 812 ext. 1271

Mona Litz

Role: backup

+49 4621 812 ext. 1271

Other Identifiers

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HCR051631

Identifier Type: -

Identifier Source: org_study_id

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