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

Trial Summary

What is the purpose of this trial?

The goal of this randomized clinical trial is to determine if removal of transurethral urinary catheters by patients at home is as safe as catheter removal in the office following urogynecologic surgery. Participants will be randomized to either standard catheter removal in the office or catheter self-removal at home.

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 data supports the effectiveness of the treatment for self-removal of catheters after urogynecologic surgery?

Research suggests that self-removal of a urinary catheter at home is as effective as having it removed in a medical office for patients who need a catheter after pelvic surgery. This approach can also reduce hospital stays and the risk of infections, making recovery more comfortable for patients. ^{1 2 3 4 5}

Is it safe for patients to remove their own urinary catheters at home after urogynecologic surgery?

Research suggests that self-removal of urinary catheters at home after surgery is generally safe, with no significant increase in complications compared to removal in a medical office. However, proper education on the procedure is important to minimize risks. ^{1 2 6 7 8}

How does the self-removal of catheters after urogynecologic surgery differ from other treatments?

This treatment is unique because it allows patients to remove their own urinary catheters at home after surgery, rather than requiring a visit to the doctor's office. This approach can reduce the need for additional medical appointments and may help patients feel more comfortable and in control of their recovery process. ^{1 3 4 9 10}

Research Team

Mary M Rieger, MD

Principal Investigator

University of Texas at Austin

Collin M McKenzie, MD

Principal Investigator

University of Texas at Austin

Eligibility Criteria

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 am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Self-Removal of a Urinary Catheter After Urogynecologic Surgery: A Randomized Controlled Trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Prolonged catheterization after vaginal prolapse surgery. [2004]

3. United States pubmed.ncbi.nlm.nih.gov

Case report: a novel and easy technique to remove stitched urethral foley catheter after radical retropubic prostatectomy. [2016]

4. Germany pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

Morbidity and the impact on daily activities associated with catheter drainage after acute urinary retention. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

[Transurethral bladder catheterization in male patients: prevention and treatment of iatrogenic lesions]. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Transvaginal bladder-neck closure: a step-by-step video for female pelvic surgeons. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Assessing Health Care Utilization and Feasibility of Transurethral Catheter Self-Discontinuation. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Parental home removal of urethral catheters after urological surgery-a prospective benchmarking study. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Laser division of encircling sutures to remove retained urethral catheter after radical retropubic prostatectomy. [2016]