Phase
Condition
Genitourinary Prolapse
Treatment
Transvaginal sacrospinous rectopexy
Laparoscopic abdominal ventral rectopexy
Clinical Study ID
Ages 18-80 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Female, between the age of 18 and 80
OD symptoms as indicated by an affirmative response to either questions 7, 8 or 14of the Pelvic Floor Distress Inventory (PFDI):
Do you feel you need to strain too hard to have a bowel movement?
Do you feel you have not completely emptied your bowels at the end of a bowelmovement?
Does part of your bowel ever pass through the rectum and bulge outside duringor after a bowel movement?
Rectal hypermobility defined as a compression ratio greater than 50% according toultrasound
Patient planning on undergoing surgery for the repair of pelvic organ prolapsewithin the next 12 months
Patient who is not pregnant and does not intend to become pregnant in the next 2years
Available for 24-months of follow-up
Stated willingness to comply with all study procedures and availability for theduration of the study
Able to complete study assessments, per clinician judgment
Able and willing to provide independent written informed consent
Stable cardiovascular and respiratory status to meet candidacy in vaginal orlaparoscopic surgeries
Exclusion
Exclusion Criteria:
Contraindication to abdominal and transvaginal rectopexy in the opinion of thetreating surgeon
History of previous surgery that included any type of surgery for rectal prolapse
Pelvic pain or dyspareunia due to levator ani spasm that would preclude a PMTprogram
Previous adverse reaction to synthetic mesh
Current cytotoxic chemotherapy or current or history of pelvic radiation therapywithin 12 months
History of two inpatient hospitalizations for medical comorbidities in the previous 12 months
Study Design
Connect with a study center
Endeavor Health
Skokie, Illinois 60076
United StatesActive - Recruiting
Weill Cornell Medicine
New York, New York 10065
United StatesActive - Recruiting
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