Overactive Bladder Clinical Trial
— FETOCOfficial title:
Feasibility and Efficacy of Transvaginal Botulinum Toxin A Chemodenervation of the Bladder for the Third Line Treatment of Refractory Overactive Bladder
Verified date | July 2022 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Overactive bladder (OAB) is a highly prevalent disease process that, when refractory to oral medication therapy, can be effectively managed with injection of botulinum toxin A (BTA) into the detrusor muscle of the bladder. However, the traditional procedure requires a cystoscope inserted into the bladder which can be painful and is associated with a risk of urinary tract infection. The purpose of this study is to determine if transvaginal injection of BTA into the detrusor muscle of the bladder wall is feasible to perform, and efficacious for the treatment of refractory overactive bladder.
Status | Completed |
Enrollment | 15 |
Est. completion date | September 27, 2021 |
Est. primary completion date | September 27, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Females with overactive bladder - Females who are considering intradetrusor botulinum toxin A chemodenervation for the treatment of refractory overactive bladder Exclusion Criteria: - Overactive bladder caused by neurological condition (i.e. spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, etc.) - Predominance of stress urinary incontinence as reported by the patient - Involvement in other studies with potentially overlapping indications or symptoms - Patients who are unable to undergo a transvaginal ultrasound intervention as a result of anatomic barriers or discomfort will be excluded from enrollment - Patients known to be pregnant or breastfeeding - Known allergy to botulinum toxin A injection therapy |
Country | Name | City | State |
---|---|---|---|
United States | Urology Clinic (Stanford University), 1000 Welch Road, Suite 100 | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | Society for Urodynamics & Female Urology Foundation |
United States,
Abdel-Meguid TA. Botulinum toxin-A injections into neurogenic overactive bladder--to include or exclude the trigone? A prospective, randomized, controlled trial. J Urol. 2010 Dec;184(6):2423-8. doi: 10.1016/j.juro.2010.08.028. Epub 2010 Oct 16. — View Citation
Dobberfuhl AD, van Uem S, Versi E. Trigone as a diagnostic and therapeutic target for bladder-centric interstitial cystitis/bladder pain syndrome. Int Urogynecol J. 2021 Dec;32(12):3105-3111. doi: 10.1007/s00192-021-04878-9. Epub 2021 Jun 22. — View Citation
Dobberfuhl AD. Pathophysiology, assessment, and treatment of overactive bladder symptoms in patients with interstitial cystitis/bladder pain syndrome. Neurourol Urodyn. 2022 May 24. doi: 10.1002/nau.24958. [Epub ahead of print] Review. — View Citation
Gormley EA, Lightner DJ, Burgio KL, Chai TC, Clemens JQ, Culkin DJ, Das AK, Foster HE Jr, Scarpero HM, Tessier CD, Vasavada SP; American Urological Association; Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. J Urol. 2012 Dec;188(6 Suppl):2455-63. doi: 10.1016/j.juro.2012.09.079. Epub 2012 Oct 24. — View Citation
Kuo HC. Bladder base/trigone injection is safe and as effective as bladder body injection of onabotulinumtoxinA for idiopathic detrusor overactivity refractory to antimuscarinics. Neurourol Urodyn. 2011 Sep;30(7):1242-8. doi: 10.1002/nau.21054. Epub 2011 May 10. — View Citation
Lucioni A, Rapp DE, Gong EM, Fedunok P, Bales GT. Intravesical botulinum type A toxin injection in patients with overactive bladder: Trigone versus trigone-sparing injection. Can J Urol. 2006 Oct;13(5):3291-5. — View Citation
Nitti VW, Dmochowski R, Herschorn S, Sand P, Thompson C, Nardo C, Yan X, Haag-Molkenteller C; EMBARK Study Group. OnabotulinumtoxinA for the treatment of patients with overactive bladder and urinary incontinence: results of a phase 3, randomized, placebo controlled trial. J Urol. 2013 Jun;189(6):2186-93. doi: 10.1016/j.juro.2012.12.022. Epub 2012 Dec 14. — View Citation
Sun Y, Luo D, Tang C, Yang L, Shen H. The safety and efficiency of onabotulinumtoxinA for the treatment of overactive bladder: a systematic review and meta-analysis. Int Urol Nephrol. 2015 Nov;47(11):1779-88. doi: 10.1007/s11255-015-1125-7. Epub 2015 Oct 3. Review. — View Citation
Syan R, Briggs MA, Olivas JC, Srivastava S, Comiter CV, Dobberfuhl AD. Transvaginal ultrasound guided trigone and bladder injection: A cadaveric feasibility study for a novel route of intradetrusor chemodenervation. Investig Clin Urol. 2019 Jan;60(1):40-45. doi: 10.4111/icu.2019.60.1.40. Epub 2018 Dec 24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Assessment of post void residual | Assessing post void residuals of patients following therapy at follow up appointments using ultrasound, routinely performed in a Urology practice on initial and follow up visits | baseline injection visit (week 0) and then at 6 weeks and 12 weeks following intervention | |
Other | Tolerability of the Procedure using the Procedural Pain Questionnaire | This is a qualitative questionnaire. The first question asks patient to select how uncomfortable the procedure was, from 0-10, where 0 is no pain and 10 is maximum pain. A higher score implies worse discomfort, and will be measured across all patients. Question 2 asks which part of the procedure was most uncomfortable: initial entry, during injection of medication, and not relevant. Question 3 asks if the procedure had to be terminated early due to discomfort. Score of "yes" indicate poor tolerability. Question 4 asks if patients would be willing to undergo the procedure again if beneficial. Answers of "no" indicate poor tolerability. Responses to each question will be collected and will together indicate if the procedure was well tolerated or not. | at time of intervention (week 0) | |
Primary | Response to the Treatment Benefit Scale (TBS) Questionnaire | Assessing improvement in urinary symptoms following intervention. The Treatment Benefit Scale Questionnaire asks patients to state if their condition (overactive bladder) has 1) greatly improved, 2) improved, 3) not changed, or 4) worsened during treatment. Patients who select 1 or 2 are considered to have derived a perceived benefit from the treatment, and will represent those patients who had a positive TBS response. | at 6 weeks and 12 weeks following baseline injection visit (week 0) | |
Secondary | Change in Voiding Diary Symptoms - number of mean daily urgency episodes | Assessing the mean change in number of urgency episodes recorded in a three day Voiding Diary. A higher number implies worse urinary symptoms. Efficacy of treatment is associated with a 50% reduction in urgency episodes daily | baseline injection visit (week 0) and then at 6 weeks and 12 weeks following intervention | |
Secondary | Change in Voiding Diary Symptoms - number of mean daily micturition episodes | Assessing the mean change in number of micturition episodes recorded in a three day Voiding Diary. A higher number implies worse urinary symptoms. Efficacy of treatment is associated with a 50% reduction in micturition episodes daily | baseline injection visit (week 0) and then at 6 weeks and 12 weeks following intervention | |
Secondary | Change in Overactive Bladder questionnaire, Short Form | Assessing changes in Overactive Bladder questionnaire, Short Form (OABq-SF, a validated questionnaire evaluating lower urinary tract symptoms) following intervention. This questionnaire is composed of 6 questions asking patients, "during the past 4 weeks, how bothered were you by..." 1. an uncomfortable urge to urinate? 2. A sudden urge to urinate with little or no warning? 3. Accidental loss of small amounts of urine? 4. nighttime urination? 5. Waking up at night because you had to urinate? 6. Urine loss associated with a strong desire to urinate? For each question, patients select 1) not at all, 2) a little bit, 3) somewhat, 4) quite a bit, 5) a great deal, 6) a very great deal. Total scores range from a score of 6 - 36. A higher score implies worse urinary symptoms. A reduction of the overall score by 50% will be considered a treatment benefit. | baseline injection visit (week 0) and then at 6 weeks and 12 weeks following intervention | |
Secondary | Change in International Consultation on Incontinence Questionnaire - short form | Assessing changes in International Consultation on Incontinence Questionnaire - short form (ICIQ-SF, a validated questionnaire evaluating lower urinary tract symptoms) following intervention. This questionnaire asks 3 questions on urinary symptoms: 1) How often do you leak? to which patients respond 0-never, 1-about once a week or less often, 2-two or three times a week, 3-about once a day, 4-several times a day, 5-all the time. 2) how much urine do you usually leak? to which patients respond 0-none, 2-a small amount, 4-a moderate amount, 6-a large amount. 3) Overall, how much does leaking urine interfere with your everyday life? patients select a score from 0-10, where 0 is not at all, and 10 is a great deal. The sum of these questions composes the overall ICIQ score. A higher score implies worse urinary symptoms. A reduction of the overall score by 50% will be considered a treatment benefit. | baseline injection visit (week 0) and then at 6 weeks and 12 weeks following intervention |
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