Pelvic Organ Prolapse Clinical Trial
Official title:
Catheter Management After Pelvic Reconstructive Surgery: a Randomized Controlled Trial
Verified date | January 2019 |
Source | Hartford Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized controlled trial comparing plug-unplug catheter management, continuous drainage catheter systems and patients that do not get discharged with catheters after inpatient pelvic reconstructive surgery.
Status | Completed |
Enrollment | 96 |
Est. completion date | January 31, 2019 |
Est. primary completion date | December 7, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 89 Years |
Eligibility |
Inclusion Criteria: - Female - Age 18-89 - Inpatient surgery - surgery for pelvic organ prolapse with or without mid-urethral slings who fail initial voiding trial at the time of hospital discharge - willing/able to provide written informed consent Exclusion Criteria: - male - age < 18 or >89 - unwilling or unable to provide written informed consent - undergoing outpatient surgery. - planned postoperative catheter use - discharged to a nursing facility or who are not candidates for the plug-unplug method for another reason (e.g., poor hand dexterity, paraplegia) - suprapubic catheter placement - procedures involving urethral bulking or Onabotulinum toxin A (Botox) injection - procedures involving planned urethral or bladder surgery (e.g., fistula excision, mesh excision, excision of urethral diverticulum) - procedures with only posterior vaginal repair - presence of a neurologic condition affecting urinary function |
Country | Name | City | State |
---|---|---|---|
United States | Hartford Hospital | Hartford | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Hartford Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Activity Assessment Scale | Participants complete this 18-question survey preoperatively and 3-5 days postoperatively. | Postoperative day 3-5 | |
Secondary | Preoperative expectations | Patients complete a preoperative expectations survey prior to surgery. | At the time of consent | |
Secondary | Days until passing voiding trial | Evaluate rates of passing voiding trial between arms | up to 6 weeks postoperatively | |
Secondary | Urinary Tract infection | Rates of urinary tract infection between arms | up to 6 weeks postoperatively |
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