Double Voiding for Urinary Tract Infection Prevention Post-Kidney Transplant

Overseen By Ananda Kimm-Drapeau

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Indwelling catheter

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

438 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether "double voiding" can prevent urinary tract infections (UTIs) in kidney transplant patients. Double voiding involves using the bathroom twice in a row to fully empty the bladder. The trial compares this method to regular bathroom habits to determine which better reduces UTIs. Individuals who recently had a kidney transplant and visit the New York Presbyterian - Weill Cornell Medicine Transplant Clinic might be suitable candidates. As an unphased trial, this study allows patients to contribute to innovative research that could enhance post-transplant care.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the double voiding technique is safe for kidney transplant recipients?

Research has shown that peeing twice in a row, known as double voiding, might help reduce urinary tract infections (UTIs) in kidney transplant patients. One study found that this method lowered the risk of urine infections for patients with certain types of stents.

Double voiding appears to help by reducing the amount of urine left in the bladder, leading to fewer infections. Generally, no major side effects have been reported with this technique. It is considered safe because it only changes how the bladder is emptied, without requiring any new medication or surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the double voiding technique for preventing urinary tract infections (UTIs) after a kidney transplant because it offers a simple, non-invasive strategy that could enhance current care. Unlike standard treatments that typically involve antibiotics to prevent or treat UTIs, double voiding encourages patients to urinate twice in one bathroom visit, potentially flushing out bacteria more effectively. This method could reduce reliance on antibiotics, helping to prevent antibiotic resistance and minimize side effects. By offering a proactive, drug-free approach, double voiding might improve patient outcomes and quality of life post-transplant.

What evidence suggests that the double voiding technique is effective for preventing UTIs in kidney transplant recipients?

Research shows that double voiding, a technique studied in this trial, can lower the risk of urinary tract infections (UTIs) in kidney transplant patients. Double voiding involves going to the bathroom and attempting to empty the bladder twice during the same visit. This technique reduces leftover urine in the bladder, a common issue. Studies have found that less leftover urine decreases the chance of infections. Specifically, past research found that kidney transplant patients using double voiding experienced fewer UTIs. This makes double voiding a promising method to help keep these patients healthier. Meanwhile, another group in this trial will follow regular voiding practices to compare outcomes. ^{1 2 4 5 6}

Who Is on the Research Team?

Muthukumar Thangamani, M.D.

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for adult kidney transplant recipients who are being routinely followed at the NYP-WCM Transplant Clinic. It's not for those discharged with an indwelling catheter (Foley) after their transplant.

Inclusion Criteria

All adults who have had a kidney transplant and are regularly seen at the New York Presbyterian - Weill Cornell Medicine Transplant Clinic.

Exclusion Criteria

You recently had a kidney transplant and still have a catheter in place.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are instructed to follow either double voiding or regular voiding techniques

12 weeks

Regular follow-up visits for urine culture

Follow-up

Participants are monitored for the incidence of UTIs and other complications

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Double Voiding
• Regular Voiding

Trial Overview The study compares 'double voiding'—a technique to empty the bladder more completely—with regular voiding to see if it reduces urinary tract infections in new kidney transplant patients.

How Is the Trial Designed?

Group I: Double Voiding Experimental Treatment 1 Intervention

The participant will be instructed to void twice.

Group II: Regular Voiding Active Control 1 Intervention

The participant will be instructed to void normally.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Published Research Related to This Trial

In a study of 14 renal transplant recipients, immunization with inactivated bacterial strains significantly reduced the incidence of recurrent urinary tract infections (UTIs) from an average of 3.4 to 0.9 episodes per year, representing a 74.9% decrease.

The immunization strategy was well-tolerated with no reported side effects or development of new donor-specific antibodies, suggesting it is a safe and effective alternative for preventing UTIs in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccination Against Urinary Tract Infection After Renal Transplantation. Zgoura, P., Waldecker, C., Bauer, F., et al.[2021]

In a study of 1038 transplant patients, the use of a double-J catheter was linked to a higher incidence of urinary tract infections (UTIs), with 24.6% of catheter users developing UTIs compared to 16.8% of non-users.

The findings suggest that while double-J catheters are commonly used to prevent urinary complications, they may actually increase the risk and severity of UTIs, leading to higher healthcare costs without reducing other urinary complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between the Placement of a Double-J Catheter and the Risk of Urinary Tract Infection in Renal Transplantation Recipients: A Retrospective Cohort Study of 1038 Patients. Mosqueda, AO., Hernández, EEL., Morales, GC., et al.[2021]

In a study of 1011 kidney transplantations, the routine use of double J catheters and the Lich-Gregoir technique significantly reduced the incidence of urinary fistulae from 7% to 2%, indicating improved surgical outcomes.

While the use of double J catheters did not show a statistically significant reduction in ureteric strictures (5.3% in group A vs. 3% in group B), the overall findings suggest that combining this technique with established surgical methods can enhance patient safety in kidney transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lich-Gregoir technique and routine use of double J catheter as the best combination to avoid urinary complications in kidney transplantation. Moreno-Alarcón, C., López-Cubillana, P., López-González, PÁ., et al.[2014]

A study involving 200 kidney transplant patients demonstrated that nonoperative removal of double J stents, tied to a Foley catheter, is a safe and effective alternative to traditional endoscopic removal.

The rates of complications such as urinary fistula, ureteral stenosis, and wound infections were similar between the nonoperative group and the endoscopic group, indicating that the nonoperative method does not increase risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stent Removal in 200 Kidney Transplant Recipients: Nonoperative Versus Endoscopic Removal. Simforoosh, N., Obeid, K., Javanmard, B., et al.[2017]

In a study of 65 live kidney transplant recipients, those who practiced the double voiding technique had a significantly lower incidence of urinary tract infections (UTIs) compared to the control group, with only 3.3% testing positive for infections versus 34.2% in the control group.

The findings suggest that implementing the double voiding technique after the removal of urethral catheters may effectively reduce the risk of UTIs in patients with double J stents, highlighting a simple intervention that could improve post-transplant care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double urinary bladder voiding technique post removal of urethral catheter in renal allograft recipients. Zomorrodi, A., Bohluli, A.[2015]

In a study of 40 patients with chronic renal insufficiency, 20% had vesicoureteral reflux (VUR) affecting their kidneys, highlighting the prevalence of this condition in such patients.

The new ureterocystostomy technique showed a significant advantage in preventing VUR in kidney transplants, as none of the patients who underwent this method experienced VUR, compared to 30% of those who had other surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Vesicoureteral reflux in renal transplantation]. Kazimirov, VG., Butrin, SV., Kharitonov, BI., et al.[2008]

In a study of 818 renal transplant patients, the optimal timing for the removal of double-J stents (DJS) was suggested to be between 14 to 21 days post-surgery, based on observed outcomes.

The study highlights that while there is no universally accepted timing for DJS removal, earlier removal (within 5 to 14 days) may lead to complications, indicating the importance of careful monitoring after transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal Timing for Removal of the Double-J Stent After Kidney Transplantation. Yuksel, Y., Tekin, S., Yuksel, D., et al.[2022]

In a study of 60 patients with recurrent urinary tract infections (UTIs) and significant vesico-ureteric reflux (VUR) after kidney transplantation, open surgical correction effectively reduced the number of UTI episodes from a median of 4 before surgery to 1 after surgery, indicating a significant improvement in patient outcomes.

The surgery also demonstrated safety and efficacy, as evidenced by a decrease in median serum creatinine levels from 1.5 mg/dL to 1.3 mg/dL, suggesting that the renal function was preserved or improved post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical correction of vesico-ureteric reflux for recurrent febrile urinary tract infections after kidney transplantation. Dinckan, A., Aliosmanoglu, I., Kocak, H., et al.[2013]

In a study of 310 kidney transplant recipients, the use of double-J stents did not significantly affect the incidence of urinary tract infections (UTIs) within the first three months post-transplant, with rates of 43.3% in the stent group and 40.1% in the no-stent group.

The study found that female patients had a higher risk of developing UTIs compared to males, but factors like age, immunosuppressive agents, BMI, and diabetes did not influence UTI rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stented ureterovesical anastomosis in renal transplantation: does it influence the rate of urinary tract infections? Mathe, Z., Treckmann, JW., Heuer, M., et al.[2022]

Double J ureteral stents are effective for urinary drainage from the kidney to the bladder and are generally safe and well tolerated in patients.

However, both short and long-term use can lead to complications ranging from minor issues like hematuria and dysuria to serious problems such as stent migration and urinary infections, often necessitating removal of the stent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Complications of double J ureteral stents]. el Khader, K.[2006]

In a study of 212 kidney transplant recipients, urinary tract infections (UTIs) occurred in 20.75% of patients, with female gender, prolonged catheter use, and postoperative urinary fistula identified as significant risk factors for developing UTIs after transplantation.

UTIs after kidney transplantation were associated with worse graft function at 3 months and increased hospital stays and antibiotic costs, highlighting the need for effective prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for urinary tract infection in kidney transplantation from brain death donor and its role in graft function. Ye, Q., Wu, L., Zhu, B., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17951938/

Double urinary bladder voiding technique post removal of ... We conclude that double voiding may reduce risk of urine infection in patients with double J stents in renal allograft ureters.

2. journals.lww.com journals.lww.com/sjkd/fulltext/2007/18040/double_urinary_bladder_voiding_technique_post.4.aspx

Double Urinary Bladder Voiding Technique Post Removal ... We conclude that double voiding may reduce risk of urine infection in patients with double J stents in renal allograft ureters.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05711446/double-voiding-and-post-transplant-uti?page=5&id=275&slug=urinary-tract-infections

Double Voiding and Post-transplant UTI Past studies have shown that about 1 out of 5 of newly transplanted patients develop UTI within their first 3 months of transplantation. Such ...

4. clinicaltrial.be clinicaltrial.be/en/details/190626?per_page=100&only_recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Double Voiding and Post-transplant UTI By reducing the amount of left-over urine in the bladder after each void, double voiding may help reduce the incidence of UTI in kidney ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2721610/

Kidney transplantation in abnormal bladder - PMC For patients who have sufficient urine output, a voiding diary that documents urinary continence, voided volumes and times of voiding is helpful to determine ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/nau.25641

Can We Prevent Recurrent UTIs Without Antibiotics, in Both ... Improved voiding techniques, such as double voiding and timed voiding, promote complete bladder emptying, leading to fewer UTIs [9]. d ...