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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02998216
Other study ID # 442/2016BO2
Secondary ID
Status Recruiting
Phase N/A
First received November 11, 2016
Last updated December 15, 2016
Start date May 2016
Est. completion date May 2017

Study information

Verified date November 2016
Source University Hospital Tuebingen
Contact Tilemachos Kavvadias, MD
Phone +49 7071 2982211
Email tilemachos.kavvadias@med.uni-tuebingen.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date May 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
Bilateral sacrospinous fixation
Bilateral sacrospinous vaginal suspension

Locations

Country Name City State
Germany University Hospital Tuebingen Tubingen Baden-Wuerttemberg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of pelvic floor symptoms Using the validated Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004) Twelve months No
Secondary Anatomical outcome / Prolapse stage after surgery Using the POP-Q classification tool of the International Continence Society (Bump RC et al, Am J Obstet Gynecol 1996) Twelve months No
Secondary Changes in quality of life Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004) Twelve months No
Secondary Changes in sexual activity Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004) Twelve months No
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