Pelvic Floor Symptoms After Bilateral Sacrospinous Fixation
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
1 other identifier
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2016
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 11, 2016
CompletedFirst Posted
Study publicly available on registry
December 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedDecember 20, 2016
November 1, 2016
1 year
November 11, 2016
December 15, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of pelvic floor symptoms
Using the validated Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004)
Twelve months
Secondary Outcomes (3)
Anatomical outcome / Prolapse stage after surgery
Twelve months
Changes in quality of life
Twelve months
Changes in sexual activity
Twelve months
Interventions
Bilateral sacrospinous vaginal suspension
Eligibility Criteria
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.
You may qualify if:
- age 18 and above
- pelvic organ prolapse ICS-POPQ Stage IV, with or without uterus
- signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, 72072, Germany
Related Publications (1)
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.
PMID: 32814553DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christl Reisenauer, Professor
Universitys Hospital Tuebingen
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2016
First Posted
December 20, 2016
Study Start
May 1, 2016
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
December 20, 2016
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will not share