The Urinary Microbiome in Patients Receiving Intradetrusor Botox Injections

NCT04479709 | Completed

• 1 other identifier: IRB20-00120
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

An altered urinary microbiome (UM) may explain the symptoms in overactive bladder (OAB) patients who were previously considered to have "idiopathic" OAB. To date, most research on the relationship between OAB and the UM has focused on differentiating between the UM of a normal bladder and that of an OAB bladder. There is currently a paucity of data on the way that OAB therapy impacts the UM. One of the few studies to evaluate the UM pre- and post-OAB treatment focused on how management with solifenacin affected the UM, but no studies have evaluated how intravesical onabotulinumtoxin A injections (IOI) affects the UM. Understanding IOI's impact on the UM is particularly interesting because despite both anticholinergics and IOI exerting antimuscarinic affects on the bladder, IOI is often successful when anticholinergics are not. This raises the question of what other mechanisms of action IOI may have in the bladders of OAB patients - one hypothesis is that it might stabilize the UM in those select patients who suffer from OAB due to an altered UM. The primary objective of this study is therefore to determine the UM profiles of OAB patients before and after treatment with IOI.

Conditions

Overactive Bladder

Keywords

Overactive bladder; Urinary microbiome

Outcome Measures

Primary Outcomes (1)

• Urinary Microbiome

  To evaluate whether administration of intradetrusor botox injections for the treatment of overactive bladder results in changes to the urinary microbiome.

  08/2020 - 08/2021

Secondary Outcomes (3)

• Urinary Microbiome by response

  08/2020 - 08/2021

• Urinary tract infection

  08/2020 - 08/2021

• Adverse events

  08/2020 - 08/2021

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women undergoing intradetrusor botox injection with botox 100 U

You may qualify if:

• \- Women undergoing intradetrusor botox injection with botox 100 U

You may not qualify if:

• Current UTI
• History of recurrent UTI
• History of antibiotic exposure for any reason (including if response is "unknown")
• Antibiotic exposure for any reason other than post-procedure prophylaxis during the four-week follow-up period.

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (1)

MetroHealth

Cleveland, Ohio, 44109, United States

Location

Related Publications (1)

• Palm KM, Abrams MK, Sears SB, Wherley SD, Alfahmy AM, Kamumbu SA, Chakraborty NN, Mahajan ST, El-Nashar SA, Henderson JW, Hijaz AK, Mangel JM, Pollard RR, Al-Shakhshir H, Retuerto MA, Steller KM, Elshaer M, Ghannoum MA, Sheyn D. The Response of the Urinary Microbiome to Botox. Int Urogynecol J. 2024 Jan;35(1):237-251. doi: 10.1007/s00192-023-05703-1. Epub 2024 Jan 2.

  PMID: 38165444 RESULT

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Case Western Reserve University School of Medicine

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 21, 2020
• Study Start: January 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

US (1)