Status:Recruiting
Keywords:Vaginal Prolapse
, Prolapse
IRB Number:00032849
Specialty:Urogyn and Pelvic Reconstructive Surgery
Sub Specialty:
This study will recruit cases and controls to evaluate the following study aims.
Aim 1: To refine and obtain performance characteristics for two novel in situ testing methods in living women. Obtain data on inter-rater reliability and test-retest reproducibility on the following methods:
a. Dynamic MR imaging, with simultaneous abdominal pressure readings, during Valsalva pressurization to demonstrate overall anterior vaginal compartment support compliance (inverse of stiffness).
b. In situ intraoperative measurement of the load-displacement behavior of the apical supports of anterior vaginal wall via caudal traction applied to the anterior lip of the uterine cervix.
Aim 2: Obtain pilot data for power calculations to answer the question: Are in situ material properties altered in pelvic organ prolapse? Obtain pilot data on in situ load-displacement behavior of the apical and anterior vaginal support system comparing women with anterior compartment pelvic organ prolapse to controls with normal support using 1) dynamic MR imaging and 2) an intra-operative in situ testing of apical support.
Alternative hypothesis 1a: Evaluation with dynamic MR imaging will demonstrate that women with anterior compartment prolapse have greater overall anterior compartment system compliance (less stiff) compared to those with normal support.
Alternative hypothesis 1b: Measurements using an intra-operative apical support loading apparatus will demonstrate that the compliance of the apical support of the anterior vaginal wall is greater in women with prolapse compared to those with normal support.
Principle Investigator: Yvonne Hsu
Principle Department: Urogynecology
Co Investigator: Peggy Norton
Name:Kristina Heintz
Phone:801-213-2286
Email:kristina.heintz@hsc.utah.edu
Cases: Prolapse Women between the ages of 30 and 80 years will be recruited for the prolapse group if they manifest prolapse on pelvic examination where the anterior vaginal wall protrudes 1 cm or more beyond the hymen during straining and are planning to have surgical repair. Women may have concomitant apical compartment prolapse, however, women with predominant posterior compartment prolapse and those with cervix only prolapse will not be enrolled. Women must have a uterus in situ and not have undergone prior surgery for pelvic floor disorder.
Controls: Normal support Similar aged and parity women with normal support where all vaginal points are at least 1 cm or more above the hymen during straining and who are planning surgery for a benign gynecological condition that would not affect uterine descent (e.g. fibroids) will be recruited through University of Utah and LDS Hospital clinics as well as through screening the OR schedules at these locations. Women must have a uterus in situ and not have undergone prior surgery for pelvic floor disorder.
Women will be excluded from the study if they have metal implants or imbedded foreign bodies, defibrillators or other absolute contraindications to MR and if they are claustrophobic or express concern about completing the MR studies.
Women will also be excluded if they have a pelvic mass, suspected malignancy, undiagnosed uterine bleeding, have known factors such as fibroids or adhesions that might affect uterine descent or if they are unable to give informed consent for themselves.
Women with current, recent (within 1 year), or expected pregnancy during the study period will not be enrolled.
Women with contraindication to bladder catheterization, known connective tissue disorders, and a history of pelvic radiation will also be excluded.
