Pelvic Floor Symptoms After Bilateral Sacrospinous Fixation

Pelvic Organ Prolapse Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02998216
• Other study ID #: 442/2016BO2
• 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

• Pelvic Organ Prolapse
• Prolapse

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