Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06059066
Other study ID # PRO00037721
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 4, 2023
Est. completion date October 2024

Study information

Verified date September 2023
Source The Methodist Hospital Research Institute
Contact Annie Chen, MD
Phone (713) 441-6455
Email achen@houstonmethodist.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate and standardize the way providers perform OnabotulinumtoxinA (BTX-A) injections into the bladder for the diagnosis of neurogenic lower urinary tract dysfunction (NLUTD)/overactive bladder (OAB). NLUTD/OAB is a syndrome that affects many people, and includes urinary frequency, urinary urgency, urgency incontinence, and nocturia. This syndrome can be challenging to treat and often requires procedural management - including BTX-A injections into the bladder.


Description:

Neurological disorders such as Multiple Sclerosis (MS), Spinal Cord Injury (SCI), Parkinson's Disease (PD), Spina Bifida (SB), and stroke disrupt neural control of voiding and lead to the development of neurogenic lower urinary tract dysfunction (NLUTD), which develops when either the detrusor muscle fails to maintain effective contractions (voiding phase) or fails to relax appropriately with low pressures (storage phase), if the urethral sphincter (internal or external) fails to lower its tonicity and resistance, or if there is an asynchrony in events eventually leading to detrusor sphincter dyssynergia (DSD). Different patterns of NLUTD (including both storage and voiding) can arise depending on the level of injury or type of neurological disease. It can be characterized by urinary urgency, frequency and incontinence or urinary hesitancy and retention that leads to urinary tract infections (UTIs). Some patients develop neurogenic overactive bladder (NOAB). Management of NOAB symptoms is complex. Treatment with BTX-A has been shown to decrease episodes of urinary incontinence and improve quality of life in this population. It has also been shown to ameliorate a multitude of devastating complications, such as upper tract deterioration, recurrent urinary tract infections, sepsis, and death. According to the current manufacturer's recommendation, a standard 200-unit vial of Botox® should be diluted in 30cc of 0.9% saline and injected across 30 different sites in the detrusor muscle (Figure 2). Despite these guidelines, there are wide variations in administration techniques, raising the question what is the best depth and location for injection, and optimal concentration and volume of toxin per injection site. The objective of this study is to determine the optimal injection schema for 200 units or more of intradetrusor BTX-A in patients with NOAB in the office setting. The investigators hypothesize that patients with NOAB symptoms undergoing intradetrusor injection of 200 units (or more) of BTX-A will be more willing to pursue additional sessions of BTX-A injections with a protocol utilizing less injection sites, while still maintaining effectiveness of the procedure.


Recruitment information / eligibility

Status Recruiting
Enrollment 78
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult men and women (>18 years of age) with a diagnosis of neurological conditions such as MS, PD, CVA, myelomeningocele, SCI, or traumatic brain injury longer than 6 months prior to treatment. - Diagnosis of neurogenic bladder indicated for treatment with BTX-A for OAB symptoms. - Participants must be able to provide informed consent, as well as understand and be willing to undergo. follow-up procedures and completion of all questionnaires provided during the study. Exclusion Criteria: - Symptomatic UTI at the time of procedure, defined as positive nitrites or high-volume leukocyte esterase on urine dip in addition to at least one of the following symptoms: dysuria, gross hematuria, suprapubic pain, frequency/urgency above baseline. - Diagnosis of bladder pain syndrome or other chronic pain syndrome including fibromyalgia, chronic pelvic pain, pelvic floor dysfunction, levator myalgia. - Untreated bladder malignancy. - Women who are currently pregnant or breast feeding. - Contraindications to intradetrusor BTX-A injections.

Study Design


Intervention

Procedure:
Standard number of injection sites
200 units or 300 units BTX-A reconstituted in 20 mL normal saline, injected into the bladder detrusor in 20 separate injections of 1 mL including the trigone.
Reduced number of injection sites
200 units or 300 units BTX-A reconstituted in 5 mL normal saline, injected into the bladder detrusor in 5 separate injections of 1 mL including the trigone.

Locations

Country Name City State
United States Houston Methodist Hospital Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
The Methodist Hospital Research Institute Collaborating for the Advancement of Interdisciplinary Research in Benign Urology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Willingness to repeat procedure visual analog scale A likert scale to measure the patient's willingness to repeat procedure. 0=Never (worst outcome), 7=Definitely (best outcome) Immediately after injection, 6 week follow-up after BTX-A injection
Secondary ICIQ-UI SF Questionnaire International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form standardized survey to measure change in neurogenic bladder symptoms before and after BTX-A. 12=Worst, 0=Best. Immediately prior to injection, 6 week follow-up after BTX-A injection
Secondary NBSS-SF Neurogenic bladder symptom score-short form standardized survey to measure change in neurogenic bladder symptoms before and after BTX-A. 21=worst score possible, 0=best score possible Immediately prior to injection, 6 week follow-up after BTX-A injection
Secondary PGI score Patient global impression of improvement after adminstration of BTX-A. 1=Very much worse, 7=Very much better Immediately after injection, 6 week follow-up after BTX-A injection
Secondary Numeric Pain Rating Scale Patient's rating of pain before and after BTX-A treatment. 0=no pain (best), 10=worst pain of my life (worst outcome) Immediately prior to injection, immediately after BTX-A injection
See also
  Status Clinical Trial Phase
Recruiting NCT04578899 - "The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity" N/A
Active, not recruiting NCT03556891 - Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence N/A
Not yet recruiting NCT05977634 - Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder N/A
Completed NCT01955408 - Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment N/A
Recruiting NCT06201013 - Efficacy and Safety of Vitamin D in the Treatment of OAB-wet in Children N/A
Recruiting NCT03727711 - TPTNS: Home vs Hospital Treatment for Overactive Bladder N/A
Completed NCT00768521 - A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107) Phase 1
Completed NCT03625843 - Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing N/A
Completed NCT02211846 - A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder Phase 1
Completed NCT02835846 - Investigation of the Effect of the Female Urinary Microbiome on Incontinence Phase 4
Completed NCT02857816 - PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation System in Patients With OAB N/A
Completed NCT02202031 - Controlling Urgency Through Relaxation Exercises N/A
Withdrawn NCT02320201 - Foot Neuromodulation for Overactive Bladder in Children N/A
Not yet recruiting NCT01423838 - Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder Phase 4
Completed NCT01437670 - Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin N/A
Completed NCT01458197 - A Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo in Patients Suffering From Overactive Bladder. Phase 2
Not yet recruiting NCT01409512 - Evaluation of Autonomic System Before and After Anticholinergic Treatment in Women With Overactive Bladder N/A
Withdrawn NCT01210859 - Effects of Antimuscarinic Drugs on Overactive Bladder (OAB) Symptoms After Insertion of Ureteral Stents N/A
Terminated NCT01758848 - Physical Therapy for Overactive Bladder N/A
Completed NCT00928070 - A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder Phase 4