N/A
N=64
Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery
Pelvic Organ Prolapse · Urinary Incontinence,Stress · Surgery
Bottom Line
View on ClinicalTrials.gov: NCT03048682 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Failed Office Voiding Trials — 7; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Foley catheter - Early Voiding Trial (Device); Foley catheter - Late Voiding Trial (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The Cleveland Clinic
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Failed Office Voiding Trials |
7; 1 | — |
| SECONDARY Urinary Tract Infections |
7; 2 | — |
| SECONDARY Rate of Bother From Urinary Catheter |
3; 2 | — |
Summary
This study is a randomized controlled trial designed to assess the rate of failure of voiding trials in the early and late post-operative period within patients who underwent outpatient pelvic floor surgery that failed initial same day voiding trials.
Eligibility Criteria
Inclusion Criteria
- Female patients
- Over 18 years old
- Speak English and are capable of giving informed consent and are able to complete the English patient questionnaire
- Are willing to return to the office for all necessary visits associated with the study
- Had outpatient gynecology pelvic floor surgery for prolapse or stress urinary incontinence
- Failed the voiding trial in the recovery room
- Discharged to home on POD#0
Exclusion Criteria
- Pre-operative urinary retention as defined as PVR > 200ml
- Prior incontinence surgery
- Passed the voiding trial in the recovery room
- Require prolonged catheterization due to urethral/bladder abnormality (ie vesicovaginal fistula, urethral diverticulum) or intra-op urethral or bladder injury or for intensive post-operative monitoring
- Patients who take any post-operative antibiotics, other than prophylaxis during catheterization, for reasons other than a UTI as diagnosed and prescribed as part of the study
- Patients who take any supplements to prevent UTIs, including but not limited to D-Mannose, Hiprex, or Ellura
- Receive any post-operative vaginal estrogen during the study period
- Have any neurological conditions that may affect bladder function (ie. Multiple sclerosis, spinal cord injuries, etc.)
- Patients with pre-operative narcotic medication use due to chronic pain
- Patients who take any over-active bladder medication within one week of their surgery
Data sourced from ClinicalTrials.gov (NCT03048682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.