Self-Removal of Catheters After Urogynecologic Surgery

(CATH Trial)

Recruiting at 3 trial locations

Overseen By Mary M Rieger, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Texas at Austin

Disqualifiers: Voiding dysfunction, Physical impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

118 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether patients can safely remove their urinary catheters at home after urogynecologic surgery (surgery related to the urinary and reproductive systems) instead of returning to the doctor's office. Participants will be divided into two groups: one will remove the catheter at home (catheter self-discontinuation), and the other will have it removed in the office. This trial is particularly suitable for those who have undergone specific surgeries like uterosacral ligament suspension or mid-urethral sling and have a catheter in place after surgery but are otherwise healthy enough to manage the process themselves. As an unphased trial, this study offers patients the chance to contribute to innovative research that could simplify post-surgical care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that catheter self-removal is safe after urogynecologic surgery?

Research has shown that removing a urinary catheter at home after surgery is usually safe. Studies have found no increased risk of complications compared to removal at a doctor's office. Patients who carefully follow the instructions for self-removal at home are likely to experience no issues. Some studies even followed patients 30 days after self-removal and found no major problems. This evidence reassures that self-removal is a safe option for many after urogynecologic surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores whether patients can safely remove their own urinary catheters at home after urogynecologic surgery. Traditionally, catheter removal is done in a medical office, requiring patients to return for a follow-up. This self-removal method could offer greater convenience and comfort for patients, potentially reducing the need for additional office visits and allowing for recovery in the comfort of one's home. If successful, this approach could streamline postoperative care and empower patients with more control over their recovery process.

What evidence suggests that catheter self-removal is effective for post-surgery recovery?

Research has shown that removing urinary catheters at home can be safe and effective. In one study, 27 patients removed their catheters at home after surgery, and 79% regained normal bladder function. Another study found that all participants who removed their catheters at home did not require additional medical assistance. In this trial, participants in the catheter self-discontinuation group will remove their catheters at home, while those in the catheter office-discontinuation group will have their catheters removed in a doctor's office. These findings suggest that home removal could be as effective as, or even better than, office removal. This method may save time and reduce the need for extra doctor visits without increasing risks. ^{1 2 3 4 6}

Who Is on the Research Team?

Mary M Rieger, MD

Principal Investigator

University of Texas at Austin

Collin M McKenzie, MD

Principal Investigator

University of Texas at Austin

Are You a Good Fit for This Trial?

This trial is for adults fluent in English or Spanish who have had urogynecologic surgery, need a catheter afterwards, and are sent home the same day. It's not for those with preoperative voiding issues requiring self-catheterization, mental or physical impairments affecting catheter removal ability, or additional urinary tract procedures needing longer catheter use.

Inclusion Criteria

I was diagnosed with urinary retention right after surgery.

I will have a catheter placed through the urethra after surgery as usual care.

I went home the same day I had surgery.

Exclusion Criteria

I cannot remove my catheter by myself due to a physical or mental condition.

I've had a urinary tract surgery that required a long-term catheter.

I use a catheter for urination due to bladder issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo catheter removal either in the office or self-removal at home on post-operative day 1

1 day

1 visit (in-person) for office group

Follow-up

Participants are monitored for postoperative urinary retention, urinary tract infections, and patient satisfaction

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Catheter self-discontinuation

Trial Overview The study tests if patients can safely remove their urinary catheters at home after urogynecology surgery compared to standard removal in the office. Participants will be randomly assigned to either self-removal at home or office removal.

How Is the Trial Designed?

Group I: Catheter self-discontinuation group Experimental Treatment 1 Intervention

The patients randomized to the catheter self-discontinuation group will be provided with a diagrammatic handout and will be instructed to remove their indwelling urinary catheter at home on the morning of Postoperative day 1.

Group II: Catheter office-discontinuation group Active Control 1 Intervention

The patients randomized to the office-discontinuation group will visit the office for a repeat voiding trial on postoperative day 1. At this visit, the patients will undergo a backfill voiding trial.

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Published Research Related to This Trial

Self-discontinuation of a transurethral catheter after pelvic reconstructive surgery was found to be noninferior to office discontinuation, with similar rates of postoperative urinary retention (14.1% vs 13.9%).

Patients who self-discontinued reported fewer encounters with healthcare providers and had better experiences regarding pain and ease of the process, suggesting that self-discontinuation may enhance patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Removal of a Urinary Catheter After Urogynecologic Surgery: A Randomized Controlled Trial. Shatkin-Margolis, A., Yook, E., Hill, AM., et al.[2022]

In a study of 124 patients who underwent transvesical adenomectomy, early catheter removal on the 5th postoperative day was found to be safe and effective, with only one case of temporary fistulization.

The early removal of the catheter led to benefits such as shorter hospital stays, reduced risk of urinary tract infections, and improved patient comfort, with 96% of patients discharged with sterile urine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Early catheter removal in water-tight bladder closure following transversical prostatic adenometomy]. Patel, VJ.[2006]

The inability to remove a urethral catheter after radical retropubic prostatectomy is a rare complication, but it can occur when the catheter is entrapped in surgical sutures.

This case demonstrates that endoscopic removal of the catheter using a holmium laser is a safe and effective method for addressing this complication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser division of encircling sutures to remove retained urethral catheter after radical retropubic prostatectomy. Nagarajan, M., Weston, PM., Biyani, CS.[2016]

In a study of 27 patients who used a transurethral Foley catheter at home after vaginal prolapse surgery, 79% successfully restored normal bladder function after catheter removal, indicating its efficacy as a treatment option.

However, 37% of patients found the catheterization experience unpleasant, highlighting a potential drawback of this method despite its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged catheterization after vaginal prolapse surgery. Vierhout, ME.[2004]

Transvaginal bladder-neck closure is an effective surgical option for treating urethral erosion caused by chronic catheterization in patients with neurogenic bladder, particularly those with conditions like Guillain-Barré syndrome.

The video demonstration serves as an educational tool to enhance the training of surgeons in female pelvic reconstructive surgery, highlighting the importance of understanding complications from prolonged catheter use and the techniques for bladder-neck closure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transvaginal bladder-neck closure: a step-by-step video for female pelvic surgeons. Petrikovets, A., Sun, H., Sheyn, D., et al.[2020]

In a study of 101 patients with acute urinary retention, 84 were discharged home with a catheter, and 93% of those who completed a quality-of-life questionnaire reported that having a catheter was not very inconvenient.

Despite experiencing side effects like urinary leaks and mild hematuria, the majority of patients felt their daily activities were not impaired, suggesting that discharging patients with a catheter can be a practical approach to manage acute urinary retention while optimizing healthcare resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morbidity and the impact on daily activities associated with catheter drainage after acute urinary retention. Khoubehi, B., Watkin, NA., Mee, AD., et al.[2019]

A rare complication after radical retropubic prostatectomy is the inability to remove a urethral catheter due to inadvertent stitching or entrapped sutures.

The study presents a novel method using a pediatric optical urethrotome for endoscopic removal of a Foley catheter encircled by sutures, providing a potential solution for this challenging issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case report: a novel and easy technique to remove stitched urethral foley catheter after radical retropubic prostatectomy. Ersoy, H., Sagnak, L., Ozok, U., et al.[2016]

A study involving 38 pediatric patients showed that parents can safely and successfully remove urethral Foley catheters at home by cutting the balloon port, with a success rate of 92%.

This method not only minimizes stress for families by allowing catheter removal in a familiar environment but also saves the NHS approximately £4550 in costs associated with professional catheter removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parental home removal of urethral catheters after urological surgery-a prospective benchmarking study. Braungart, S., Goyal, A.[2020]

Transurethral catheterization is a common procedure in hospitals, but it carries significant risks, with 45% of urethral strictures resulting from iatrogenic causes, leading to complicated and recurrent treatments for patients.

There is a critical need for improved education and training for healthcare professionals on proper catheterization techniques and recognizing complications to minimize the risk of iatrogenic injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transurethral bladder catheterization in male patients: prevention and treatment of iatrogenic lesions]. Renard, J., Tran, SN., lselin, CE.[2013]

In a study of 140 women undergoing outpatient gynecologic surgery, catheter self-discontinuation on postoperative day 1 was found to be safe and effective, with 81.3% of patients successfully voiding at home after the procedure.

Patients who had unsuccessful voiding trials on postoperative day 0 required more follow-up office visits and calls, indicating that early voiding success may reduce healthcare utilization after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing Health Care Utilization and Feasibility of Transurethral Catheter Self-Discontinuation. Davenport, A., Li, Y., Melvin, E., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05860634

Urinary Catheter Self-Discontinuation After Urogynecology ... This study will evaluate whether self-discontinuation of transurethral catheter by patients is non-inferior to standard office discontinuation based on rates of ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38373241/

A Retrospective Cohort Study of At-Home Catheter ... The purpose of this study was to compare 30-day postoperative outcomes between participants who performed an at-home autofill VT after catheter self- ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02996968

Self-discontinuation of a Transurethral Catheter This study is to determine if self-discontinuation of transurethral foley catheters in patients diagnosed with postoperative urinary retention (POUR), which is ...

4. withpower.com withpower.com/trial/phase-prolapse-6-2023-b59db

Self-Removal of Catheters After Urogynecologic Surgery In a study of 27 patients who used a transurethral Foley catheter at home after vaginal prolapse surgery, 79% successfully restored normal bladder function ...

5. cureus.com cureus.com/articles/420640-self-urinary-catheter-removal-for-urology-day-cases-a-safe-efficient-sustainable-and-patient-centred-approach

Self-Urinary Catheter Removal for Urology Day Cases Results. In the study cohort, all patients were successful in removing their catheter at home and did not need to attend the accident and ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05860634/urinary-catheter-self-discontinuation-after-urogynecology-surgery

Urinary Catheter Self-Discontinuation After Urogynecology ... The goal of this randomized clinical trial is to determine if removal of transurethral urinary catheters by patients at home is as safe as ...