Bladder Catheterization for Cesarean Section Complications

Overseen By Stephen L. Wood, MD, MSc

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Abnormal placentation, others

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

Compensation: Varies

Number of Visits: 1

Duration: During surgery

140 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this randomized controlled trial is to investigate the impact of routine bladder catheterization in uncomplicated cesarean sections on hospitalization time (readiness to discharge), time to ambulation, urinary retention, development of urinary tract infections, prevention of bladder injury, operating time, and patient satisfaction.

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 Bladder Catheterization for Cesarean Section Complications?

Research indicates that while bladder catheterization is commonly used during cesarean sections, it is associated with a higher risk of urinary tract infections and discomfort, which may lead to delayed movement and longer hospital stays. Therefore, its effectiveness in reducing complications is questionable, as it may introduce other issues. ^{1 2 3 4 5}

Is bladder catheterization generally safe for humans?

Bladder catheterization during cesarean sections is linked to a higher chance of urinary tract infections and discomfort, as well as delayed movement and longer hospital stays. ^{1 2 5 6 7}

How does bladder catheterization differ from other treatments for cesarean section complications?

Bladder catheterization is a unique treatment for cesarean section complications as it involves inserting a tube into the bladder to drain urine, which can help prevent or manage urinary retention and reduce the risk of bladder injury during surgery. Unlike drug treatments, it is a mechanical intervention rather than a medication, making it distinct in its approach to managing complications. ^{8 9 10 11 12}

Research Team

Stephen L. Wood, MD, MSc

Principal Investigator

University of Calgary

Eligibility Criteria

This trial is for women aged 18 or older who are pregnant with one baby and scheduled for an elective first-time or repeat cesarean section (CS), without complications like abnormal placenta placement.

Exclusion Criteria

I have been diagnosed with a placental condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo elective cesarean delivery with or without bladder catheterization

During surgery

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for urinary retention, time to ambulation, and readiness for discharge

2 days postpartum

Daily monitoring (in-person)

Follow-up

Participants are monitored for urinary tract infections and patient satisfaction

4 weeks postpartum

Treatment Details

Interventions

• Bladder Catheterization

Trial Overview The study is testing if using a bladder catheter during elective CS affects the time to get ready for discharge, walking ability post-surgery, urinary issues, risk of bladder injury, surgery duration, and patient happiness.

Participant Groups

Group I: Bladder catheterization Experimental Treatment 1 Intervention

Patients placed in the catheterized group will have an indwelling catheter placed after anesthetic has been administered. It would be removed at 12 hours post Cesarean section.

Group II: Non-use of bladder catheterization Active Control 1 Intervention

Participants in the non-catheterized group would be encouraged to empty their bladders just prior to transfer to the operating room where they will undergo surgery without an indwelling catheter.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Findings from Research

In a study of 270 women undergoing cesarean delivery, those who did not receive a urinary catheter experienced significantly less discomfort during their first postoperative void and were able to ambulate faster, averaging 6.8 hours compared to 12.9 hours for those with a catheter.

The findings suggest that routine use of indwelling urinary catheters is unnecessary for stable patients after cesarean delivery, as only 4.4% of women without a catheter required recatheterization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indwelling urinary catheters in cesarean delivery. Ghoreishi, J.[2019]

A study involving 150 patients showed that cesarean sections performed without urethral catheterization significantly reduced discomfort and the incidence of urinary tract infections compared to those who were catheterized.

Patients who did not have a catheter experienced shorter hospital stays without any increase in surgical complications, indicating that cesarean sections can be safely performed without this routine procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cesarean section without urethral catheterization: a randomized control trial. Acharya, S., Uprety, DK., Pokharel, HP., et al.[2019]

The study reviewed 8,488 cesarean section records and found that the risk of bladder injury is significantly higher in repeat cesarean sections (odds ratio of 7.4) and emergency cesarean sections (odds ratio of 5.7) compared to primary and scheduled cesarean sections.

Intraoperative consultations with urology or urogynecology were significantly more common in cases of bladder injury, highlighting the importance of careful monitoring and follow-up for patients at higher risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased bladder injury rate during emergency and repeat cesarean section Khalil, AS., Flora, S., Hagglund, K., et al.[2023]

In a study of 258 women undergoing cesarean deliveries, omitting the bladder flap resulted in a shorter incision-to-delivery time (9 minutes vs. 10 minutes), indicating a potential efficiency in the surgical process.

Importantly, the omission of the bladder flap did not lead to any increase in intraoperative or postoperative complications, such as bladder injuries or infections, suggesting it is a safe practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of the bladder flap at cesarean delivery: a randomized controlled trial. Tuuli, MG., Odibo, AO., Fogertey, P., et al.[2018]

Bladder injury during cesarean sections (CS) occurred in 0.44% of cases, with a higher incidence in repeat CS (0.81%) compared to primary CS (0.27%), indicating that previous surgeries increase risk.

All identified bladder injuries were recognized and repaired during surgery, leading to satisfactory outcomes, suggesting that with proper management, complications from such injuries are rare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bladder injuries during cesarean section in a University Hospital: a 25-year review. Rahman, MS., Gasem, T., Al Suleiman, SA., et al.[2009]

Bladder injury during cesarean delivery is rare, occurring in 0.2% of cases, but certain factors like age (≥35 years), endometriosis, and Crohn's disease significantly increase the risk.

The presence of conditions such as placenta previa, previous cesarean deliveries, and cesarean hysterectomies greatly heightens the risk of bladder injury, which is associated with serious complications like sepsis and longer hospital stays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and risk factors of bladder injury during cesarean delivery: a cohort study. Ibrahim, N., Spence, AR., Czuzoj-Shulman, N., et al.[2023]

In a study of 14,757 cesarean deliveries, bladder injuries occurred in 42 cases, indicating an incidence rate of 0.28%.

Women with a history of prior cesarean delivery had a significantly higher risk of bladder injury (3.82 times more likely), especially if the delivery was emergent or involved labor before the cesarean.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for bladder injury during cesarean delivery. Phipps, MG., Watabe, B., Clemons, JL., et al.[2009]

Intravesical BCG treatment for high-grade superficial bladder cancer can lead to serious complications, including pelvic and inguinal abscesses, highlighting the need for careful monitoring.

This case emphasizes the potential systemic risks associated with BCG therapy, which, while effective for bladder cancer, can result in significant local complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevesical and inguinal abscess following intravesical BCG instillation. Martinez-Caceres, P., Rubio-Briones, J., Palou, J., et al.[2019]

In a study of 16 patients, complications from intravesical bacille Calmette-Guérin (BCG) treatment for bladder cancer were found to cause radiographic findings that can resemble primary or metastatic tumors.

Radiologists need to be aware of these potential imaging similarities to ensure proper management and to prevent unnecessary procedures in bladder cancer patients undergoing BCG treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging appearance of granulomatous disease after intravesical Bacille Calmette-Guerin (BCG) treatment of bladder carcinoma. Ma, W., Kang, SK., Hricak, H., et al.[2013]

Intravesical BCG therapy, while effective for bladder carcinoma, can lead to rare but serious complications such as mycotic aneurysms, as demonstrated in a case of a patient with ruptured abdominal and femoral artery aneurysms after treatment.

Histopathological analysis confirmed the presence of the BCG strain Mycobacterium bovis in the patient's tissue, highlighting the need for clinicians to be vigilant about potential extravesical infections following BCG therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mycobacterium bovis abdominal aortic and femoral artery aneurysms following intravesical bacillus Calmette-Guérin therapy for bladder cancer. Costiniuk, CT., Sharapov, AA., Rose, GW., et al.[2010]

Intravesical bacillus Calmette-Guérin (BCG) therapy is safe for patients with asymptomatic bacteriuria, with only a 1.6% incidence of febrile urinary tract infections and no hospital admissions for complications.

The 2-year recurrence-free survival rate for patients receiving BCG therapy was 71%, which is comparable to the 73% rate in uninfected patients, indicating that BCG therapy is effective regardless of the presence of asymptomatic bacteriuria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravesical bacillus Calmette-Guérin outcomes in patients with bladder cancer and asymptomatic bacteriuria. Herr, HW.[2012]

Intravesical treatment with bacillus Calmette-Guérin (BCG) for nonmuscle-invasive bladder tumors can lead to common complications like bladder irritation, malaise, and fever, affecting about 8% of patients who may need to stop treatment, while severe complications are rare but can occur anywhere in the body.

Management of BCG-related complications requires clear communication of potential adverse events to patients and healthcare providers, as well as specific treatments like tuberculostatics and corticosteroids for severe cases, since previous preventive methods have been shown ineffective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing the adverse events of intravesical bacillus Calmette-Guérin therapy. Decaestecker, K., Oosterlinck, W.[2020]

References

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

Indwelling urinary catheters in cesarean delivery. [2019]

2. Nepal pubmed.ncbi.nlm.nih.gov

Cesarean section without urethral catheterization: a randomized control trial. [2019]

3. Turkey pubmed.ncbi.nlm.nih.gov

Increased bladder injury rate during emergency and repeat cesarean section [2023]

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

Utility of the bladder flap at cesarean delivery: a randomized controlled trial. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

Bladder injuries during cesarean section in a University Hospital: a 25-year review. [2009]

6. Germany pubmed.ncbi.nlm.nih.gov

Incidence and risk factors of bladder injury during cesarean delivery: a cohort study. [2023]

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

Risk factors for bladder injury during cesarean delivery. [2009]

8. England pubmed.ncbi.nlm.nih.gov

Prevesical and inguinal abscess following intravesical BCG instillation. [2019]

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

Imaging appearance of granulomatous disease after intravesical Bacille Calmette-Guerin (BCG) treatment of bladder carcinoma. [2013]

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

Mycobacterium bovis abdominal aortic and femoral artery aneurysms following intravesical bacillus Calmette-Guérin therapy for bladder cancer. [2010]

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

Intravesical bacillus Calmette-Guérin outcomes in patients with bladder cancer and asymptomatic bacteriuria. [2012]

12. England pubmed.ncbi.nlm.nih.gov

Managing the adverse events of intravesical bacillus Calmette-Guérin therapy. [2020]