Pelvic Floor Symptoms After Bilateral Sacrospinous Fixation

NCT ID: NCT02998216

Last Updated: 2016-12-20

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

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-05-31

Brief Summary

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This study aims to the assessment of pelvic floor symptoms and patients´ satisfaction after bilateral sacrospinous fixation for the primary treatment of pelvic organ prolapse stage IV.

Detailed Description

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Conditions

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Pelvic Organ Prolapse

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Bilateral sacrospinous fixation

Bilateral sacrospinous vaginal suspension

Intervention Type PROCEDURE

Other Intervention Names

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Bilateral sacrospinous vaginal suspension

Eligibility Criteria

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Inclusion Criteria

* age 18 and above
* pelvic organ prolapse ICS-POPQ Stage IV, with or without uterus
* signed informed consent

Exclusion Criteria

* gynecologic surgery in the three past months before planned surgery
* history of prolapse surgery
* participation in another study
* need to simultaneously perform other surgical procedures (i.e. rectopexy)
* ongoing chemotherapy of treatment with immunosuppressant drugs
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christl Reisenauer, Professor

Role: PRINCIPAL_INVESTIGATOR

Universitys Hospital Tuebingen

Locations

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University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Tilemachos Kavvadias, MD

Role: CONTACT

Phone: +49 7071 2982211

Email: [email protected]

References

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Kavvadias T, Schoenfisch B, Brucker SY, Reisenauer C. Anatomical and functional outcomes after hysterectomy and bilateral sacrospinous ligament fixation for stage IV uterovaginal prolapse: a prospective case series. BMC Urol. 2020 Aug 19;20(1):126. doi: 10.1186/s12894-020-00694-3.

Reference Type DERIVED
PMID: 32814553 (View on PubMed)

Other Identifiers

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442/2016BO2

Identifier Type: -

Identifier Source: org_study_id