## Protocol Section
### Identification Module
**NCT ID:** NCT06017479

**Brief Title:** Effectiveness of Single Dose Fosfomycin and Single Dose Levofloxacin as Pre-urodynamic Antibiotic for UTI Prevention

**Official Title:** Effectiveness of Single Dose Fosfomycin and Single Dose Levofloxacin as Pre-urodynamic Antibiotic Prophylaxis for Urinary Tract Infection Prevention in Post-Urodynamic Examination

#### Organization Study ID Info
**ID:** 22-11-1343
#### Organization
**Class:** OTHER
**Full Name:** Indonesia University
### Status Module
#### Completion Date
**Date:** 2024-03-25

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-18

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-17

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-03-25

**Type:** ACTUAL

#### Start Date
**Date:** 2022-12-30

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2023-08-30
**Type:** ACTUAL
**Study First Submit Date:** 2023-08-24
**Study First Submit QC Date:** 2023-08-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Indonesia University

#### Responsible Party

**Investigator Affiliation:** Indonesia University

**Investigator Full Name:** dr. Harrina Erlianti Rahadjo, Sp.U(K), PhD

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The goal of this clinical trial is to compare the use of single dose fosfomycin and single dose levofloxacin as pre-urodynamic antibiotic prophylaxis for urinary tract infection prevention post-urodynamic in patients with lower urinary tract symptoms. The main question\[s\] it aims to answer are:

* What is the difference between the effectiveness of administering a single dose of fosfomycin and levofloxacin prior to the procedure in terms of the incidence rate of urinary tract infection (UTI) post-urodynamic examination?
* What is the incidence rate of UTI in the administration of single-dose fosfomycin and levofloxacin prior to the procedure on the incidence rate of UTI post-urodynamic examination? Participants fulfilling the inclusion criteria will be taken their history and vital signs and consume either fosfomycin or levofloxacin based on the randomisation prior to urodynamic procedure. Afterwards, participants will undergo urine analysis 4 days post urodynamic to evaluate if there's any urinary tract infection. If there is any bacteria present, the sample will be cultured to identify bacteria found in the urine.

**Detailed Description:** This study employs a single-blinded randomized clinical trial design to compare the proportion of UTI post-urodynamic examination between the group receiving single-dose levofloxacin pre-urodynamic examination and the group receiving levofloxacin post-urodynamic examination for three days. The target population is patients undergoing urodynamic examination at Dr. Cipto Mangunkusumo National Referral Hospital, Persahabatan National Hospital, and Siloam Asri Hospital. The total sample size in this study is 126 patients. On the fourth day post-urodynamic examination, urinalysis and urine culture are performed to determine the diagnosis of UTI. To analyze the association between UTI and therapy groups, a chi-square test is used. Results are considered statistically significant if p \< 0.05.

### Conditions Module

**Conditions:**

- Urological System Complication of Procedure

- Urinary Tract Infections

**Keywords:**

- urodynamic

- urinary tract infections

- fosfomycin

- levofloxacin

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** This study is an experimental study with a single-blinded randomized clinical trial design to compare the proportion of UTIs in a group of patients receiving fosfomycin 3 grams and patients receiving levofloxacin 500 miligrams single dose one hour before urodynamic examination. To determine the sample treatment group, blocked randomization technique is used in this study.

##### Masking Info

**Masking:** SINGLE

**Masking Description:** This study uses a single-blinded design because the outcome assessed in this study is urinalysis which is the objective outcome. The urinalysis evaluator is blinded to the drug regimen obtained by the research subjects.

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 126

**Type:** ACTUAL

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Fosfomycin 3 g single dosage 1 hour before the urodynamic examination

**Intervention Names:**

- Drug: Fosfomycin 3000 MG

**Label:** Pre-urodynamic Fosfomycin

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Levofloxacin 500 miligrams single dosage 1 hour before the urodynamic examination

**Intervention Names:**

- Drug: Levofloxacin 500mg

**Label:** Pre-urodynamic Levofloxacin

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Pre-urodynamic Fosfomycin

**Description:** Fosfomycin 3 g single dosage 1 hour before the urodynamic examination

**Name:** Fosfomycin 3000 MG

**Other Names:**

- Monuril

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Pre-urodynamic Levofloxacin

**Description:** Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination

**Name:** Levofloxacin 500mg

**Other Names:**

- Levaquin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Urinary tract infection is defined based on the result of urinalysis in which one of the following condition present : leukocytes \> 5 / high power field, bacteria positive, nitrite positive, and/or positive leukocyte esterase

**Measure:** Number of Participant With Urinary Tract Infection

**Time Frame:** 4 days post-urodynamic procedure

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Male/female patients \> 18 years who have indications for urodynamics
* Willing to participate in research

Exclusion Criteria:

* Allergy to levofloxacin
* Allergy to fosfomycin
* History of taking antibiotics in 1 month
* Pregnant
* Uncontrolled DM
* Use of urinary catheter
* Having a UTI before urodynamics, based on clinical symptoms and urine examination results
* Refuse to participate in research

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Jakarta Pusat

**Country:** Indonesia

**Facility:** Cipto Mangunkusumo Hospital

**State:** DKI Jakarta

**Zip:** 10430

#### Overall Officials

**Official 1:**

**Affiliation:** Indonesia University

**Name:** Harrina E Rahardjo, Professor

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** Anyone who wishes to access the data

**Description:** These are the study protocol used in this study

**Info Types:**

- STUDY_PROTOCOL

**IPD Sharing:** YES

**Time Frame:** Immediately following publication. No end date

### References Module

#### References

**Citation:** Rahardjo HE, Tirtayasa PM, Afriansyah A, Parikesit D, Akbar MI. The Effectiveness of a Three Day Course Antibiotic Post-urodynamic Study in Preventing Lower Urinary Tract Infection. Acta Med Indones. 2016 Apr;48(2):84-90.

**PMID:** 27550876

**Citation:** Chu CM, Lowder JL. Diagnosis and treatment of urinary tract infections across age groups. Am J Obstet Gynecol. 2018 Jul;219(1):40-51. doi: 10.1016/j.ajog.2017.12.231. Epub 2018 Jan 2.

**PMID:** 29305250

**Citation:** Fajfr M, Balik M, Cermakova E, Bostik P. Effective Treatment for Uncomplicated Urinary Tract Infections with Oral Fosfomycin, Single Center Four Year Retrospective Study. Antibiotics (Basel). 2020 Aug 13;9(8):511. doi: 10.3390/antibiotics9080511.

**PMID:** 32823650

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17302

- Name: Urinary Tract Infections

- Relevance: HIGH

- As Found: Urinary Tract Infections

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000014552

- Term: Urinary Tract Infections

### Intervention Browse Module - Ancestors

- ID: D000000892

- Term: Anti-Infective Agents, Urinary

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000000900

- Term: Anti-Bacterial Agents

- ID: D000059005

- Term: Topoisomerase II Inhibitors

- ID: D000059003

- Term: Topoisomerase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000065609

- Term: Cytochrome P-450 CYP1A2 Inhibitors

- ID: D000065607

- Term: Cytochrome P-450 Enzyme Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: ANeo

- Name: Antineoplastic Agents

### Intervention Browse Module - Browse Leaves

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M30370

- Name: Levofloxacin

- Relevance: HIGH

- As Found: Sodium chloride

- ID: M17946

- Name: Ofloxacin

- Relevance: LOW

- As Found: Unknown

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

- ID: M8700

- Name: Fosfomycin

- Relevance: HIGH

- As Found: Course of treatment

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M30537

- Name: Cytochrome P-450 Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000064704

- Term: Levofloxacin

- ID: D000005578

- Term: Fosfomycin

### Misc Info Module

#### Submission Tracking

- Estimated Results First Submit Date: 2024-04-23

##### Submission Infos

- MCP Release N: Unknown

- Release Date: 2024-04-23

- Reset Date: Unknown

- Unrelease Date: Unknown

- Unrelease Date Unknown: Unknown

- Version Holder: 2024-05-24
