Data Collection Demographic characteristics (i.e. age, race, body mass index, medical history) will be collected at the time of preoperative visit. On the day of surgery, operative data will be recorded on a standard form to document procedures performed, intra-operative complications (if any), EBL and operative time. Prior to discharge the randomized void trial will be preformed. Data regarding the void trial will be documented on a standard form and will include which void trial was performed, amount backfilled, amount voided, post void residual when assessed, and if the patient was discharged voiding spontaneously, with a Foley catheter or performing CISC. All subjects will be instructed to call our clinical office to report any urinary complaints and treatment for UTI. Information will be collected from electronic medical records regarding any office visits, urine cultures performed or treatment for UTI during this 6-week period. Participants will be called 1 week from the time of surgery to complete the Short-term Catheter Burden Questionnaire.
Pre-operative Visit The preoperative visit may occur up to 3 months prior to surgery. Patients electing to participate in the study will be consented in a private exam to protect confidentiality. Once consented the subjects will be assigned a subject identification number for study identification purposes, which will consist of "A" if the patient's surgery is performed at Rex Hospital or "B" if the patient's surgery is performed at Hillsborough. A number will then follow the letter.
Void Trial Protocols
1. Traditional backfill assisted voiding trial (control): Backfill the bladder with up to 300 ml as tolerated of normal saline or sterile water through an indwelling Foley catheter. The catheter is removed and the patient is given 15 minutes to void and the voided volume is measured. A post void residual (PVR) is measured after voiding (or attempt to void) using either an in and out catheter or a bladder scanner. The participant is considered to have passed the void trial if they have a PVR of less than 100 mL or less than half the voided volume if voided volume is greater than 200 mL.
2. The post-void residual free voiding trial (intervention): Backfill the bladder with up to 300 ml as tolerated of normal saline or sterile water through an indwelling Foley catheter. The catheter is removed and the patient is given 15 minutes to void and the voided volume is measured. The participant is considered to have passed the void trial if they void more than 1/2 the instilled volume. A PVR will not be performed.
If the participant fails the voiding trial through either method they will be discharged to home with an indwelling catheter or with clean intermittent self-catheterization (CISC) per the participants preference. Subjects with an indwelling catheter will return to clinic within 1-3 days for a repeat voiding trial using the same voiding trial guidelines. If the subject is discharged on clean intermittent self-catheterization (CISC) she will document her voided volumes and PVRs at home. Our nurse will then call the participant every 1-2 business days to determine when they can stop CISC (2 consecutive PVRs less than 100 mL). Nurses will document all information into a standardized template in EPIC per routine clinic protocol.
Follow-Up Participants will be scheduled for their post-operative appointment at the time of scheduling their surgery per usual protocol. They will be called 1 week after surgery to complete a questionnaire. The postoperative visit usually takes place approximately 6 weeks after surgery. Any additional visits or calls to Urogynecology clinic prior to their post-operative appointment will be documented in the electronic medical record per routine clinical practice.
All efforts will be made to ensure minimal loss to follow-up of participants. This plan may include efforts such as telephone follow-up or electronic medical record communication with the patient.
Week 1 Phone Call The patient will be called one week after their surgery to answer the questions from the Short-Term Catheter Burden Questionnaire.
Week 6 Visit (-2 weeks/+2 weeks) The primary outcome will be assessed at the time of the post-operative visit with confirmation of need for catheterization. At this visit the subject will also have the patient complete a questionnaire regarding catheter use.
