---
title: Double Voiding and Post-transplant UTI
nct_id: NCT05711446
overall_status: RECRUITING
phase: NA
sponsor: Weill Medical College of Cornell University
study_type: INTERVENTIONAL
primary_condition: Urinary Tract Infections
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05711446.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05711446"
ct_last_update_post_date: 2025-06-19
last_seen_at: "2026-05-12T06:14:42.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Double Voiding and Post-transplant UTI

**Official Title:** A Randomized Trial of Double Voiding Versus Usual Voiding to Reduce the Incidence of Urinary Tract Infections in Kidney Transplant Recipients

**NCT ID:** [NCT05711446](https://clinicaltrials.gov/study/NCT05711446)

## Key Facts

- **Status:** RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 438
- **Lead Sponsor:** Weill Medical College of Cornell University
- **Conditions:** Urinary Tract Infections, Kidney Transplant; Complications
- **Start Date:** 2023-04-07
- **Completion Date:** 2026-12
- **CT.gov Last Update:** 2025-06-19

## Brief Summary

Urinary tract infections (UTI) are common in kidney transplant recipients and are an important cause of illness and hospital admissions. Past studies have shown that about 1 out of 5 of newly transplanted patients develop UTI within their first 3 months of transplantation. Such UTIs increase the risk for blood stream infection and acute rejection of the kidney, Improvements in urinary voiding techniques may reduce the frequency of UTI. The purpose of this study is to evaluate the benefits of "double voiding" in kidney transplant recipients.

## Detailed Description

Urinary tract infections are common in kidney transplant recipients and are an important cause of morbidity and hospital readmissions. Several risk factors for UTI, both modifiable and unmodifiable, have been described in the literature. In normal (non-transplant) individuals, because of the anatomy of the ureter insertion into the bladder that creates a valve-like effect during voiding, reflux of urine into the kidney is prevented . However, after kidney transplantation, urine refluxing into the transplanted kidney is common. Depending on the surgical technique used for connecting the transplant ureter to the urinary bladder, reflux may occur in up to 79% of kidney transplant recipients. In addition, the routine usage of ureteral stents (double J stents) for the first 4-6 weeks after transplantation results in reflux. Vesicoureteral reflux increases the risk of UTI Double voiding, a process of passing urine more than once each time, is a technique that may assist the bladder to empty more effectively when urine is left in the bladder. 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 transplant recipients.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* All adult kidney transplant recipients who undergo routine follow-up at the New York Presbyterian - Weill Cornell Medicine (NYP-WCM) Transplant Clinic.

Exclusion Criteria:

* Kidney transplant recipients who are discharged after a transplant with an indwelling catheter (Foley)
```

## Arms

- **Double Voiding** (EXPERIMENTAL) — The participant will be instructed to void twice.
- **Regular Voiding** (ACTIVE_COMPARATOR) — The participant will be instructed to void normally.

## Interventions

- **Double Voiding** (OTHER) — Participant will be instructed to void twice.
- **Regular Voiding** (OTHER) — Participant will void as usual

## Primary Outcomes

- **Number of UTI's** _(time frame: First 3 months of transplantation)_ — UTI will be defined as a clean catch urine bacterial culture that is reported as anything other than "\<1000 CFU/ml (Colony Forming Unit / Milliliter)- Negative". Clean catch urine cultures are done at each follow-up visit as a standard of care, irrespective of patient symptoms. Hence the outcome will include both asymptomatic and symptomatic UTIs.

## Secondary Outcomes

- **Time to first bacterial culture** _(time frame: First 3 months of transplantation)_
- **Number of UTI episodes** _(time frame: First 3 months of transplantation)_
- **Bacterial colony count of each positive urine culture** _(time frame: First 3 months of transplantation)_
- **Number of incidences of bacteremia** _(time frame: First 3 months of transplantation)_
- **Number of hospital admissions** _(time frame: First 3 months of transplantation)_

## Locations (1)

- Weill Cornell Medical College / NY Presbyterian, New York, New York, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.weill cornell medical college / ny presbyterian|new york|new york|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05711446.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05711446*  
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