Pelvic Floor Symptoms After Bilateral Sacrospinous Fixation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02998216
Recruitment Status : Unknown
Verified November 2016 by University Hospital Tuebingen.
Recruitment status was:  Recruiting
First Posted : December 20, 2016
Last Update Posted : December 20, 2016
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief 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.

Condition or disease Intervention/treatment
Pelvic Organ Prolapse Procedure: Bilateral sacrospinous fixation

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pelvic Floor Symptoms and Patients´ Satisfaction After Bilateral Sacrospinous Fixation for the Primary Treatment of Pelvic Organ Prolapse ICS-POPQ Stage IV: A Prospective Observational Study
Study Start Date : May 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

Intervention Details:
  • Procedure: Bilateral sacrospinous fixation
    Bilateral sacrospinous vaginal suspension
    Other Name: Bilateral sacrospinous vaginal suspension

Primary Outcome Measures :
  1. Assessment of pelvic floor symptoms [ Time Frame: Twelve months ]
    Using the validated Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004)

Secondary Outcome Measures :
  1. Anatomical outcome / Prolapse stage after surgery [ Time Frame: Twelve months ]
    Using the POP-Q classification tool of the International Continence Society (Bump RC et al, Am J Obstet Gynecol 1996)

  2. Changes in quality of life [ Time Frame: Twelve months ]
    Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004)

  3. Changes in sexual activity [ Time Frame: Twelve months ]
    Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All female patients who are planned to receive a bilateral sacrospinous fixation as a treatment for pelvic organ prolapse Stage IV will be eligible for inclusion in the study.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02998216

Contact: Tilemachos Kavvadias, MD +49 7071 2982211

University Hospital Tuebingen Recruiting
Tubingen, Baden-Wuerttemberg, Germany, 72072
Sponsors and Collaborators
University Hospital Tuebingen
Principal Investigator: Christl Reisenauer, Professor Universitys Hospital Tuebingen

Responsible Party: University Hospital Tuebingen Identifier: NCT02998216     History of Changes
Other Study ID Numbers: 442/2016BO2
First Posted: December 20, 2016    Key Record Dates
Last Update Posted: December 20, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Pathological Conditions, Anatomical