NCT_ID: NCT05711446
Clinical Trial Link
Brief Summaries
| Sequence: | 30911362 |
| Description | 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. |
Studies
| Study First Submitted Date | 2022-12-20 |
| Study First Posted Date | 2023-02-03 |
| Last Update Posted Date | 2023-06-02 |
| Start Month Year | June 2023 |
| Primary Completion Month Year | December 2025 |
| Verification Month Year | May 2023 |
| Verification Date | 2023-05-31 |
| Last Update Posted Date | 2023-06-02 |
Detailed Descriptions
| Sequence: | 20820033 |
| 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. |
Facilities
| Sequence: | 200987789 |
| Status | Recruiting |
| Name | Weill Cornell Medical College / NY Presbyterian |
| City | New York |
| State | New York |
| Zip | 10065 |
| Country | United States |
Facility Contacts
| Sequence: | 28247343 | Sequence: | 28247344 |
| Facility Id | 200987789 | Facility Id | 200987789 |
| Contact Type | primary | Contact Type | backup |
| Name | Thangamani Muthukumar, M.D. | Name | Tierra Mack |
| mut9002@med.cornell.edu | tmm4004@med.cornell.edu | ||
| Phone | 212-746-9074 | Phone | 212-746-6112 |
Facility Investigators
| Sequence: | 18419733 |
| Facility Id | 200987789 |
| Role | Principal Investigator |
| Name | Thangamani Muthukumar, M.D. |
Conditions
| Sequence: | 52423241 | Sequence: | 52423242 |
| Name | Urinary Tract Infections | Name | Kidney Transplant; Complications |
| Downcase Name | urinary tract infections | Downcase Name | kidney transplant; complications |
Id Information
| Sequence: | 40337548 |
| Id Source | org_study_id |
| Id Value | 22-03024620 |
Countries
| Sequence: | 42766988 |
| Name | United States |
| Removed | False |
Design Groups
| Sequence: | 55873029 | Sequence: | 55873030 |
| Group Type | Experimental | Group Type | Active Comparator |
| Title | Double Voiding | Title | Regular Voiding |
| Description | The participant will be instructed to void twice. | Description | The participant will be instructed to void normally. |
Interventions
| Sequence: | 52732463 | Sequence: | 52732464 |
| Intervention Type | Other | Intervention Type | Other |
| Name | Double Voiding | Name | Regular Voiding |
| Description | Participant will be instructed to void twice. | Description | Participant will void as usual |
Design Outcomes
| Sequence: | 178323692 | Sequence: | 178323693 | Sequence: | 178323694 | Sequence: | 178323695 | Sequence: | 178323696 | Sequence: | 178323697 |
| Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Number of UTI's | Measure | Time to first bacterial culture | Measure | Number of UTI episodes | Measure | Bacterial colony count of each positive urine culture | Measure | Number of incidences of bacteremia | Measure | Number of hospital admissions |
| Time Frame | First 3 months of transplantation | Time Frame | First 3 months of transplantation | Time Frame | First 3 months of transplantation | Time Frame | First 3 months of transplantation | Time Frame | First 3 months of transplantation | Time Frame | First 3 months of transplantation |
| Description | 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. | Description | Time will be measured in days |
Browse Conditions
| Sequence: | 194444983 | Sequence: | 194444984 | Sequence: | 194444985 | Sequence: | 194444986 | Sequence: | 194444987 | Sequence: | 194444988 | Sequence: | 194444989 |
| Mesh Term | Infections | Mesh Term | Urinary Tract Infections | Mesh Term | Urologic Diseases | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Male Urogenital Diseases |
| Downcase Mesh Term | infections | Downcase Mesh Term | urinary tract infections | Downcase Mesh Term | urologic diseases | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | male urogenital diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48553048 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Weill Medical College of Cornell University |
Overall Officials
| Sequence: | 29416409 |
| Role | Principal Investigator |
| Name | Muthukumar Thangamani, M.D. |
| Affiliation | Weill Medical College of Cornell University |
Central Contacts
| Sequence: | 12074892 | Sequence: | 12074893 |
| Contact Type | primary | Contact Type | backup |
| Name | Muthukumar Thangamani, M.D. | Name | Tierra Mack |
| Phone | 212-746-9074 | Phone | 212-746-6112 |
| mut9002@med.cornell.edu | tmm4004@med.cornell.edu | ||
| Role | Contact | Role | Contact |
Design Group Interventions
| Sequence: | 68492951 | Sequence: | 68492952 |
| Design Group Id | 55873029 | Design Group Id | 55873030 |
| Intervention Id | 52732463 | Intervention Id | 52732464 |
Eligibilities
| Sequence: | 30910143 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Healthy Volunteers | No |
| Criteria | 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) |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254170974 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2022 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | True |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 1 |
| Number Of Secondary Outcomes To Measure | 5 |
Designs
| Sequence: | 30655848 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Prevention |
| Time Perspective | |
| Masking | None (Open Label) |
Responsible Parties
| Sequence: | 29022511 |
| Responsible Party Type | Sponsor |
Study References
| Sequence: | 52334130 | Sequence: | 52334131 | Sequence: | 52334132 | Sequence: | 52334133 |
| Pmid | 23917724 | Pmid | 33508852 | Pmid | 27408706 | Pmid | 1795193 |
| Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
| Citation | Lee JR, Bang H, Dadhania D, Hartono C, Aull MJ, Satlin M, August P, Suthanthiran M, Muthukumar T. Independent risk factors for urinary tract infection and for subsequent bacteremia or acute cellular rejection: a single-center report of 1166 kidney allograft recipients. Transplantation. 2013 Oct 27;96(8):732-8. doi: 10.1097/TP.0b013e3182a04997. | Citation | Sarier M, Yayar O, Yavuz A, Turgut H, Kukul E. Update on the Management of Urological Problems Following Kidney Transplantation. Urol Int. 2021;105(7-8):541-547. doi: 10.1159/000512885. Epub 2021 Jan 28. | Citation | Garcia-Roig ML, Kirsch AJ. Urinary tract infection in the setting of vesicoureteral reflux. F1000Res. 2016 Jun 30;5:F1000 Faculty Rev-1552. doi: 10.12688/f1000research.8390.1. eCollection 2016. | Citation | Staessen J, Celis H, De Cort P, Fagard R, Thijs L, Amery A. Methods for describing the diurnal blood pressure curve. J Hypertens Suppl. 1991 Dec;9(8):S16-8. |