Self-Removal of a Urinary Catheter After Urogynecologic Surgery: A Randomized Controlled Trial
Open accessAbstract
OBJECTIVE: To evaluate whether self-discontinuation of a transurethral catheter is noninferior to office discontinuation in patients requiring indwelling catheterization for postoperative urinary retention after pelvic reconstructive surgery. METHODS: In this randomized noninferiority trial, patients with postoperative urinary retention after pelvic reconstructive surgery were assigned to self-discontinuation or office discontinuation of their catheter 1 week after surgery. The primary outcome was a noninferiority comparison of postoperative urinary retention at 1 week. Self-discontinuation patients were instructed on home catheter removal on postoperative day 7. Office discontinuation patients underwent a standard voiding trial on postoperative day 6–8. Postoperative urinary retention at 1 week was defined as continued catheterization on postoperative day 6–8. Secondary outcomes included urinary tract infections (UTI), residual volume at 2 weeks, duration of catheter use, recurrent postoperative urinary retention, number of patient encounters, and visual analog scales (VAS) regarding patient experience. Given a known incidence of postoperative urinary retention at 1 week (16%) and 15% noninferiority margin, a sample size of 74 per group (n=148) was planned. RESULTS: From January 2017 through March 2019, 217 women were screened and 157 were analyzed: 78 self-discontinuation and 79 office discontinuation. Demographic characteristics and surgeries performed were similar. Eleven patients in each group experienced postoperative urinary retention at 1 week (14.1% self-discontinuation vs 13.9% office discontinuation, P=.97), establishing noninferiority (difference 0.2%, 95% CI: −1.00, 0.10). There were significantly fewer patient encounters with self-discontinuation (42/78, 53.8% vs 79/79, 100%). Self-discontinuation patients demonstrated better VAS scores regarding pain, ease, disruption, and likelihood to use the same method again (all P<.05). Though the rate of UTI was high, there was no difference between groups (59.0% self-discontinuation vs 66.7% office discontinuation, P=.32). Residual volume at 2 weeks, recurrent postoperative urinary retention, and duration of catheter use were also similar. CONCLUSION: Self-discontinuation of a transurethral catheter was noninferior to office-based discontinuation in the setting of postoperative urinary retention after pelvic reconstructive surgery. Self-discontinuation resulted in fewer patient encounters and improved patient experience. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02996968.
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Four trials with a total of 582 women evaluated POP surgery and management of catheters once trial of void (TOV) fails.
“POP surgery and management of catheters once trial of void (TOV) fails: four trials with a total of 582 women (Boyd 2019; Hakvoort 2011; Shatkin‐Margolis 2019; Weemhoff 2010).”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Shatkin‐Margolis 2019
In Shatkin‐Margolis 2019, the risk of attrition bias from incomplete outcome data was low.
“Incomplete outcome data (attrition bias) All outcomes Low risk One participant lost to follow‐up”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Shatkin‐Margolis 2019
In Shatkin‐Margolis 2019, the risk of selection bias from allocation concealment was unclear.
“Allocation concealment (selection bias) Unclear risk No statement on allocation”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Shatkin‐Margolis 2019
In Shatkin‐Margolis 2019, the risk of other bias was low.
“Other bias Low risk Funded by TriHealth Research Foundation”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Shatkin‐Margolis 2019
In Shatkin‐Margolis 2019, a power calculation was performed.
“Power calculation: 148 trialists allowed 15% non‐inferiority margin and rate of failed TOV 16% (if upper limit of 95% CI was less than predetermined margin, non‐inferiority declared)”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Shatkin‐Margolis 2019
In Shatkin‐Margolis 2019, the risk of detection bias from blinding of outcome assessment was high.
“Blinding of outcome assessment (detection bias) All outcomes High risk Unable to blind”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Shatkin‐Margolis 2019
In Shatkin‐Margolis 2019, the randomisation method was computer randomisation.
“Randomisation method: computer randomisation”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Shatkin‐Margolis 2019
In Shatkin‐Margolis 2019, the risk of reporting bias from selective reporting was low.
“Selective reporting (reporting bias) Low risk Compliant with pre‐trial registration”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Shatkin‐Margolis 2019
In Shatkin‐Margolis 2019, the risk of performance bias from blinding of participants and personnel was high.
“Blinding of participants and personnel (performance bias) All outcomes High risk Unable to blind”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Shatkin‐Margolis 2019
In Shatkin‐Margolis 2019, the risk of selection bias from random sequence generation was unclear.
“Random sequence generation (selection bias) Unclear risk No statement on randomisation”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Shatkin‐Margolis 2019
Cites
Understanding Equivalence and Noninferiority Testing
Walker, E., & Nowacki, A. S. (2011) · Journal of General Internal Medicine · doi:10.1007/s11606-010-1513-8 · Cited by 751 · see citing works
Methodology of superiority vs. equivalence trials and non-inferiority trials
Christensen, E. (2007) · Journal of Hepatology · doi:10.1016/j.jhep.2007.02.015 · Cited by 205 · see citing works
To pack or not to pack? A randomized trial of vaginal packing after vaginal reconstructive surgery
Westermann, L. B., Crisp, C. C., Oakley, S. H., Mazloomdoost, D., Kleeman, S. D., Benbouajili, J. M., Ghodsi, V., & Pauls, R. N. (2016) · Female Pelvic Medicine & Reconstructive Surgery · doi:10.1097/spv.0000000000000238 · Cited by 25 · see citing works
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Perioperative interventions in pelvic organ prolapse surgery
Shahid, U., Haya, N., Baessler, K., Christmann-Schmid, C., Yeung, E., Chen, Z., & Maher, C. (2025) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd013105.pub2 · Cited by 5 · see citing works
- Authors
- Shatkin-Margolis, A., Yook, E., Hill, A. M., Crisp, C. C., Yeung, J., Kleeman, S., & Pauls, R. N.
- Affiliations
- Good Samaritan Hospital (US)
- Venue
- Obstetrics & Gynecology
- Published
- 2019-11
- Volume
- 134
- Issue
- 5
- Pages
- 1027-1036
- ISSN
- 0029-7844 (ISSN-L)
- OpenAlex
- W2979960286
- Cited by
- 32
- References
- 3
- Citations by year
- 2026: 3 · 2025: 6 · 2024: 3 · 2023: 8 · 2022: 4 · 2021: 3 · 2020: 4
- FWCI
- 2.09
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- other-oa
- Locations
- Obstetrics and Gynecology (publishedVersion, other-oa)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Rheumatology › Pelvic floor disorders treatments
- Health Sciences › Medicine › Urology › Urinary Bladder and Prostate Research
- Health Sciences › Medicine › Epidemiology › Urinary Tract Infections Management
- Keywords
- postoperative urinary retention, pelvic reconstruction, urogynecologic surgery, transurethral catheter, urinary tract infection, patient experience, non-inferiority, voiding trial, residual urine, patient encounters, shared decision-making
- MeSH terms
- Female, Humans, Middle Aged, Postoperative Complications, Recurrence, Self Care, Urinary Catheterization, Urinary Retention, Outcome Assessment, Health Care, Plastic Surgery Procedures, Device Removal, Pelvic Organ Prolapse
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