Optimal Injection Interval for Intra-Detrusor Botulinum Toxin

NCT06483217 | Not Yet Recruiting

• 1 other identifier: #7564
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to see if patients deciding their own follow up times can increase the effectiveness of botulinum toxin (BTX or "Botox") injection for overactive bladder (OAB). The main questions it aims to answer are:

• Does the time between repeat injections differ from the 6-month standard when it is based on patient symptoms alone?
• Does symptom control or patient satisfaction change when patients control their own follow up times? Participants will undergo standard botulinum toxin injection into the bladder for OAB treatment and will then be randomly assigned to follow up either at a standard 6-month interval or whenever they feel their symptoms return.

Conditions

Overactive Bladder; Urinary Urgency; Urinary Incontinence; Urge Urinary Incontinence

Keywords

intradetrusor botulinum toxin; intravesical botox; intradetrusor botox; bladder chemodenervation; botox; chemodenervation; overactive bladder; urge urinary incontinence; intravesical botulinum toxin

Outcome Measures

Primary Outcomes (1)

• Injection interval

  time to repeat injection (days)

  Days from initial injection to repeat injection, up to 365 days

Secondary Outcomes (2)

• Patient Satisfaction

  1-2 weeks post-injection

• Symptom Control

  baseline scores immediately pre-injection, post-treatment scores 1-2 weeks post-injection

Study Arms (2)

Standard of care

NO INTERVENTION

Standard 6 month post-operative follow up interval for repeat injection

Patient-directed follow up

EXPERIMENTAL

Post-operative follow up interval for repeat injection decided by patient based on OAB symptomatology (3-12 months)

Behavioral: Patient-directed follow up

Interventions

Patient-directed follow up BEHAVIORAL

Patients will be instructed to follow up for repeat injection based on bladder symptomatology at their own self-determined time interval.

Patient-directed follow up

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of overactive bladder, detrusor overactivity, urinary urgency, urinary frequency, nocturnal polyuria, or urge urinary incontinence
• pursuing treatment with intravesical botulinum toxin injections

You may not qualify if:

• \- non-OAB diagnosis such as pelvic pain or interstitial cystitis

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead

Study Sites (1)

Louisiana State University Health Science Center

New Orleans, Louisiana, 70112, United States

Location

Related Publications (6)

• Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010 Jan;21(1):5-26. doi: 10.1007/s00192-009-0976-9. Epub 2009 Nov 25.

  PMID: 19937315 BACKGROUND

• de Groat WC, Yoshimura N. Afferent nerve regulation of bladder function in health and disease. Handb Exp Pharmacol. 2009;(194):91-138. doi: 10.1007/978-3-540-79090-7_4.

  PMID: 19655106 BACKGROUND

• Amundsen CL, Richter HE, Menefee SA, Komesu YM, Arya LA, Gregory WT, Myers DL, Zyczynski HM, Vasavada S, Nolen TL, Wallace D, Meikle SF. OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial. JAMA. 2016 Oct 4;316(13):1366-1374. doi: 10.1001/jama.2016.14617.

  PMID: 27701661 BACKGROUND

• Amundsen CL, Komesu YM, Chermansky C, Gregory WT, Myers DL, Honeycutt EF, Vasavada SP, Nguyen JN, Wilson TS, Harvie HS, Wallace D; Pelvic Floor Disorders Network. Two-Year Outcomes of Sacral Neuromodulation Versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: A Randomized Trial. Eur Urol. 2018 Jul;74(1):66-73. doi: 10.1016/j.eururo.2018.02.011. Epub 2018 Feb 24.

  PMID: 29482936 BACKGROUND

• Granese R, Adile G, Gugliotta G, Cucinella G, Saitta S, Adile B. Botox((R)) for idiopathic overactive bladder: efficacy, duration and safety. Effectiveness of subsequent injection. Arch Gynecol Obstet. 2012 Oct;286(4):923-9. doi: 10.1007/s00404-012-2349-8. Epub 2012 May 24.

  PMID: 22622849 BACKGROUND

• Dowson C, Watkins J, Khan MS, Dasgupta P, Sahai A. Repeated botulinum toxin type A injections for refractory overactive bladder: medium-term outcomes, safety profile, and discontinuation rates. Eur Urol. 2012 Apr;61(4):834-9. doi: 10.1016/j.eururo.2011.12.011. Epub 2011 Dec 13.

  PMID: 22204745 BACKGROUND

Related Links

• FDA Medication Guide for onabotulinumtoxinA, accessed June 28th 2024

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence; Urinary Incontinence, Urge

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; Urination Disorders

Study Officials

• Lisa Peacock, MD

  Louisiana State University Health Science Center - New Orleans

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zachary Selzler, MD

CONTACT

504-568-2383; zselzl@lsuhsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zachary Selzler MD, Urogynecology Fellow

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 3, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 17, 2024

Record last verified: 2024-07

Locations

US (1)