Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04890951
Other study ID # REB19-2134
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date December 2024

Study information

Verified date April 2021
Source University of Calgary
Contact Erin A Brennand, MD
Phone 403-944-1636
Email Erin.brennand@albertahealthservices.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Pelvic organ prolapse (POP) is the descent of pelvic organs into the vagina resulting in bulge symptoms and occurs in approximately 50% of women. Almost 20% of women will elect surgical correction of this condition by age 85. Removal of the uterus (hysterectomy) with concomitant vaginal vault suspension is a longstanding practice in POP surgery to address apical (uterine) prolapse. Yet, contemporary evidence on the merits of this approach relative to preservation of the uterus through suspension is needed to better inform surgical decision-making by patients and their healthcare providers. The objective of this trial is to evaluate POP-specific health outcomes and service utilization of women electing uterine suspension compared to those electing hysterectomy and vaginal vault suspension for POP surgery up to 1-year post-surgery.


Recruitment information / eligibility

Status Recruiting
Enrollment 321
Est. completion date December 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Have diagnosed POP of stage =2 using the globally recognized Pelvic Organ Prolapse-Quantification System (POP-Q) - Elect surgical management of POP - Demonstrate presence of apical prolapse on clinical exam deemed to require either a hysterectomy and concomitant vaginal vault suspension or uterine suspension to properly address their POP during surgical correction - Desire no further pregnancy - Can communicate in English - Are =18 years in age Exclusion Criteria: - Prior hysterectomy

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Hysteropexy
Uterine preservation through suspension
Hysterectomy and vaginal vault suspension
Uterine removal and sewing the vagina upwards

Locations

Country Name City State
Canada Pelvic Floor Clinic Calgary Alberta

Sponsors (3)

Lead Sponsor Collaborator
University of Calgary Canadian Institutes of Health Research (CIHR), The MSI Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anatomic failure to correct apical POP Descent of the apex (POP-Q point C) equal to or beyond one half of the total vaginal length 1 year
Secondary Overall failure to correct POP POP-Q stage =2 in any compartment, or re-treatment of POP with physiotherapy, pessary, or repeat surgery 1 year
Secondary Subjective failure to correct POP Patient report of bulge symptoms at 6 weeks or 1 year, using one item on the PFDI-20: "Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?" 6 weeks; 1 year
Secondary Length of surgery (minutes) Peri-operative
Secondary Estimated blood loss during surgery >500 mL Peri-operative
Secondary Procedural complications E.g., peri-operative blood transfusion, visceral injury Peri-operative
Secondary Post-operative infection E.g., abscess, urinary tract infection Peri-operative
Secondary Opioid use in-hospital Measured by Morphine milliequivalent (mEq) Peri-operative
Secondary Resumption of spontaneous voiding (days) Peri-operative
Secondary Length of post-operative stay (days) Peri-operative
Secondary PROM: Total Pelvic Floor Impact Questionnaire-7 (PFIQ-7) score Change from baseline 6 weeks; 1 year
Secondary PROM: Total POP Incontinence Sexual Questionnaire Revised (PISQ-IR) score Change from baseline 6 weeks; 1 year
Secondary PROM: Total Pelvic Floor Distress Inventory-20 (PFDI-20) score Change from baseline 6 weeks; 1 year
Secondary Presentation at the emergency department 30 days (any health complaint); 1 year (pelvic floor-related complaint)
Secondary Hospital readmission 30 days (any health complaint); 1 year (pelvic floor-related complaint)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05420831 - Comparison of Vaginal and Laparoscopic Apical Fixation Techniques for Pelvic Organ Prolapse Treatment N/A
Active, not recruiting NCT05422209 - The Influence of Simultaneous Posterior Colporrhaphy and Perineoplasty on the Efficiency and Safety of Mesh-augmented Sacrospinal Fixation (Apical Sling) in Advanced POP Repair. N/A
Completed NCT05493735 - Lidocaine for Pessary Check Pain Reduction Phase 3
Completed NCT06126328 - Materna Prep Study Phase II Phase 2
Recruiting NCT05542836 - EVeRLAST 2-Year Follow-Up
Recruiting NCT05918367 - Multicenter Ventral Mesh Rectopexy Registry Collaborative
Recruiting NCT04172272 - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures N/A
Recruiting NCT04807920 - BOTOX® at the Time of Prolapse Surgery for OAB Phase 4
Completed NCT06268782 - The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women N/A
Recruiting NCT02919852 - Laparoscopic Retrovesical Colpopectinopexia N/A
Recruiting NCT03146195 - The 3D Reconstruction Research of Pelvic Organ Prolapse Disease N/A
Completed NCT02925585 - Vaginal Tactile Imaging for Pelvic Floor Prolapse
Not yet recruiting NCT02536001 - Prospective Randomized Study to Compare Results of Pelvic Organ Prolapse Repair With One Versus Two Vaginal Meshes N/A
Recruiting NCT02113969 - Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol N/A
Completed NCT02383199 - Polypropylene Mesh in Prolapse Surgery N/A
Terminated NCT01673360 - Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices N/A
Completed NCT01842464 - Sacro-Spinous Ligaments Anterior Apical Anchoring N/A
Withdrawn NCT01530191 - Factors Affecting Perioperative Outcomes N/A
Completed NCT01320631 - Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction N/A
Completed NCT00581412 - Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates N/A