N/A
N=173
Comparing Force of Stream to Retrograde Fill Voiding Trial After Vaginal Apex Suspension
Vaginal Apical Prolapse
Bottom Line
View on ClinicalTrials.gov: NCT02753920 ↗Enrolled (actual)
173
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Number of Subjects Catheterized Within the Six-week Post-operative Period Following Surgical Repair of Prolapse, Among Those Discharged Without a Urinary Catheter. — 2; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- voiding trial (Other); Foley catheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Northwell Health
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Catheterized Within the Six-week Post-operative Period Following Surgical Repair of Prolapse, Among Those Discharged Without a Urinary Catheter. |
2; 2 | — |
| SECONDARY Number of Subjects Discharged With a Catheter (This is Essentially the Proportion of Patients Who Failed the Voiding Trial) |
23; 15 | — |
| SECONDARY Proportion of Patients With Unexpected Visits to the Clinic, Within the Six-week Post-operative Period. |
8; 6 | — |
Summary
Voiding difficulties are common after prolapse and incontinence surgeries. All patients after vaginal prolapse surgery must complete a voiding trial if they are to be discharged home without a catheter. Accepted protocols for voiding trials after prolapse and incontinence surgeries do not exist. The purpose of this study is to compare two different types of postoperative voiding trials to determine which leads to less postoperative issues, such as urinary retention requiring catheterization. You are being asked to participate because you are having a vaginal apex suspension surgery.
Eligibility Criteria
Inclusion Criteria
- Women undergoing vaginal apex surgery (sacrocolpopexy, sacrospinous ligament suspension, uterosacral ligament suspension, colpocleisis) with or without mid-urethral sling, with or without anterior or posterior colporrhaphy
Exclusion Criteria
- Patients who underwent a surgery that requires long term catheterization (i.e fistula repair or urethral diverticulum)
- Patients who sustained a cystotomy during surgery as our divisional protocol is to send these patients home with a Foley catheter for 5-14 days without a voiding trial
- Patients with baseline urinary retention and the inability to urinate without catheterization
- Pregnant women
Data sourced from ClinicalTrials.gov (NCT02753920). 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.