Timing of Catheter Removal for Post-Surgery Walking Recovery

(EDUCaRe Trial)

Overseen By Sharon Bradshaw Bradshaw

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Lower extremity amputation, Bladder/kidney dysfunction, Spinal cord injuries, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the optimal timing for removing a urinary catheter to help patients walk sooner after minimally invasive lumbar spine surgery. Some participants will have their catheter removed immediately after surgery, while others will have it removed the next morning. The goal is to determine which timing helps patients regain mobility faster. Individuals who have undergone minimally invasive lumbar fusion surgery and do not have conditions like lower limb weakness may be suitable for this study. As an unphased trial, it offers participants the chance to contribute to enhancing post-surgical recovery practices.

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 this protocol is safe for post-surgery walking recovery?

Research shows that removing urinary catheters soon after surgery can help the bladder recover faster. Some studies suggest this does not significantly increase the risk of urinary tract infections (UTIs). However, there might be a small chance of temporary difficulty in fully emptying the bladder, known as post-operative urinary retention (POUR).

Specific data on catheters removed the morning after surgery is limited. Generally, this method is believed to have similar risks to early removal, with a potential benefit of reducing POUR. Both methods appear well-tolerated, with no strong evidence of serious side effects.

In summary, studies suggest that both early and delayed catheter removal are generally safe, with only minor differences in risks like POUR. Participants are unlikely to encounter major safety concerns with either method. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores when to remove a urethral catheter after surgery to help patients start walking again faster. The focus is on comparing two approaches: removing the catheter early, right in the operating room, versus the next morning. Early removal could potentially reduce discomfort and risk of infection, allowing patients to regain mobility sooner than the usual method. This trial could lead to a shift in post-surgery care, enhancing recovery experiences for patients.

What evidence suggests that this trial's treatments could be effective for post-surgery walking recovery?

This trial will compare the timing of urethral catheter removal for post-surgery recovery. Research has shown that removing a urethral catheter immediately after surgery, as in the "Early Urethral Catheter Removal" arm of this trial, can help patients start walking sooner. Studies have found that early catheter removal is crucial for recovery, enabling quicker mobility after surgery. One study found that removing the catheter soon after surgery can reduce the risk of urinary tract infections (UTIs) and shorten hospital stays. Evidence also suggests that early removal can lead to less post-surgery pain. Overall, early catheter removal appears to promote a faster and smoother recovery. ^{1 4 6 7 8}

Who Is on the Research Team?

Brandon Carlson, MD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18 and older who are undergoing one- or two-level minimally invasive lumbar fusion procedures. It's not specified, but typically people with other health issues that could affect walking or catheter use might be excluded.

Inclusion Criteria

I had a minor surgery to fuse one or two bones in my lower back.

Exclusion Criteria

I have weakness in my legs and trouble moving around.

I have a spinal cord injury.

I have had major surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Surgery and Immediate Postoperative Care

Participants undergo minimally invasive lumbar spine surgery and immediate postoperative care, including early or delayed urinary catheter removal

1 day

In-hospital stay

Postoperative Monitoring

Participants are monitored for ambulation time, urinary tract infections, pain medication usage, and other postoperative outcomes

1 to 3 days

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after discharge, including urinary tract infection and catheter reinsertion

Up to 1 month

What Are the Treatments Tested in This Trial?

Interventions

• Active comparator
• Experimental

Trial Overview The study compares the effects of removing a urinary catheter early versus later on how soon patients can walk after minimally invasive back surgery. Participants will be divided into two groups to test this.

How Is the Trial Designed?

Group I: Early Urethral Catheter Removal Experimental Treatment 1 Intervention

Removal of the urethral catheter in the operating room at the conclusion of surgery

Group II: Delayed Urethral Catheter Removal Active Control 1 Intervention

Removal of the urethral catheter in next morning after surgery

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Published Research Related to This Trial

The study evaluated the measurement properties of three fatigue scales (FACIT-F, SF-36 Vitality, and LupusQoL Fatigue) using data from two phase 3 clinical trials involving systemic lupus erythematosus (SLE) patients, revealing that while FACIT-F had good reliability (0.93), the other scales showed significant limitations, particularly SF-36 Vitality with a low reliability of 0.53.

Pooled fatigue items from the scales improved psychometric properties and were more sensitive in detecting changes in fatigue over time, indicating a need for further research to enhance fatigue measurement tools for better application in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric Analysis from EMBODY1 and 2 Clinical Trials to Help Select Suitable Fatigue PRO Scales for Future Systemic Lupus Erythematosus Studies. Cleanthous, S., Bongardt, S., Marquis, P., et al.[2023]

In a study of 51 Swedish patients with systemic lupus erythematosus (SLE), seven different fatigue questionnaires were evaluated to determine the minimal clinically important difference (MCID) for measuring fatigue, with estimates ranging from 4.3 to 17.0 depending on the method used.

While all seven questionnaires were effective in detecting MCIDs for fatigue, the Numeric Rating Scale (NRS) was less favored by respondents and provided the least favorable estimates, suggesting it may not be the best tool for assessing fatigue in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determination of the minimal clinically important difference for seven measures of fatigue in Swedish patients with systemic lupus erythematosus. Pettersson, S., Lundberg, IE., Liang, MH., et al.[2022]

In a study of 81 patients with systemic lupus erythematosus (SLE), disease status was found to be a direct predictor of fatigue, indicating that managing the underlying disease may help reduce fatigue levels.

Helplessness and depression were identified as mediating factors between disease status and fatigue, but over time, disease status remained the sole predictor of fatigue, highlighting the importance of addressing the disease itself for effective fatigue management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disease status predicts fatigue in systemic lupus erythematosus. Tayer, WG., Nicassio, PM., Weisman, MH., et al.[2006]

Designing randomized controlled trials (RCTs) for systemic lupus erythematosus (SLE) is challenging due to the variability of disease symptoms and the inadequacy of existing disease activity indices, which were not specifically designed for RCT outcomes.

The medical outcomes survey short form-36 (SF-36) has been shown to better reflect the effects of SLE and correlate with disease activity, treatment intensity, and patient outcomes, suggesting it could be a valuable tool in assessing treatment efficacy in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical trial design in systemic lupus erythematosus: lessons learned and future directions. Strand, V.[2017]

In a study of 515 systemic lupus erythematosus (SLE) patients, factors such as Caucasian ethnicity, pain levels, abnormal illness-related behaviors, and feelings of helplessness were linked to increased fatigue, highlighting the importance of psychological and social factors in managing fatigue.

Interestingly, traditional SLE-specific measures like disease activity and damage did not correlate with fatigue levels, suggesting that interventions to reduce fatigue should focus on addressing pain and psychological well-being rather than just disease severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disease activity and damage are not associated with increased levels of fatigue in systemic lupus erythematosus patients from a multiethnic cohort: LXVII. Burgos, PI., Alarcón, GS., McGwin, G., et al.[2022]

In a study of 130 women with systemic lupus erythematosus (SLE), fatigue was found to be multidimensional, with general and physical fatigue being the most pronounced, influenced by factors like disease activity, damage, and depressed mood.

Depressed mood was identified as the strongest contributor to mental fatigue, while physical fatigue was linked to disease-related factors and lifestyle aspects, highlighting the need for tailored interventions to address both dimensions of fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dimensions of fatigue in systemic lupus erythematosus: relationship to disease status and behavioral and psychosocial factors. Da Costa, D., Dritsa, M., Bernatsky, S., et al.[2022]

The Lupus Intervention Fatigue Trial (LIFT) is a randomized controlled trial involving 236 participants aimed at reducing fatigue in individuals with systemic lupus erythematosus (SLE) through a six-month motivational interviewing program compared to an educational control.

The primary outcome of the study is the change in fatigue levels measured by the Fatigue Severity Score after six months, with additional assessments of physical activity and dietary adherence, which will help develop future strategies for managing fatigue in SLE patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing intervention for increasing physical activity and improving dietary behaviors: The Lupus Intervention Fatigue Trial protocol. Kinnett-Hopkins, D., Ehrlich-Jones, L., Chmiel, JS., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11212151/

Evaluating the effectiveness of early urethral catheter ... The primary outcome measure for this study is the rate of bladder function recovery (Bladder Function Recovery Grade II or higher) 2 weeks post- ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06769087

Comparing Immediate Removal and Postoperative 1 Day ... Secondary outcomes are the incidence of symptomatic urinary tract infection (UTI), postvoid residual (PVR), length of hospital stay, postoperative pain score, ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jocn.16393

Impact of early postoperative indwelling urinary catheter ... One study (6%) found a statistically significant effect between IDUC removal after 6 h and removal the morning after surgery, with 9% and 0% ...

4. europeanjournalofmidwifery.eu europeanjournalofmidwifery.eu/Association-between-duration-of-urinary-catheterization-and-post-operative-mobilization,193602,0,2.html

Association between duration of urinary catheterization ... The enhanced recovery recommendations are early urinary catheter removal and early mobilization, as essential elements of post-operative care.

5. link.springer.com link.springer.com/article/10.1007/s00384-023-04460-3

Immediate urinary catheter removal after colorectal surgery ... The primary outcome was the occurrence of POUR following immediate UC removal after surgery, and the secondary outcomes were the identification ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12133045/

Risks associated with early postoperative urinary catheter ... Early removal of urinary catheters during epidural analgesia may increase the POUR without significantly impacting the incidence of urinary tract infections.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666262022000912

Effect of reduced urinary catheter duration on time to ... We hypothesized that patients with reduced urinary catheter duration have shorter time to ambulation after VATS lobectomy.

8. karger.com karger.com/vis/article/40/5/256/912193/Effect-of-Early-Removal-of-Urinary-Catheter-in

Effect of Early Removal of Urinary Catheter in Patients ... The primary outcome assessed was the incidence of POUR, while secondary outcomes included urinary tract infections (UTI), hospital length of ...