Intradetrusor Botox at the Time of Transurethral Resection of the Prostate for Mixed Lower Urinary Tract Symptoms
NCT ID: NCT06531655
Last Updated: 2024-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2024-08-31
2026-08-31
Brief Summary
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Botox is an FDA approved medication with on-label indications to treat overactive bladder. According to AUA guidelines, it is considered a third-line treatment therapy.
The purpose of this study is to evaluate the outcomes of men who have Botox concurrent with their TURP.
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Detailed Description
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If deemed eligible, participants will be invited to participate in this trial. The International Prostate Symptom Score (IPSS) is a questionnaire that is widely used to assess LUTS in patients and assesses for incomplete emptying, frequency, intermittency, urgency, weak stream, hesitancy, and nocturia. The AUA quality of life score (AUA-QoL) asks how these symptoms affect quality of life. When administered as a combined questionnaire, this is referred to as the AUA symptom score. These scores are summed to produce an overall severity score, which can categorize patients as having mild (score 0-7), moderate (8-19) or severe (20-35) LUTS (11). The AUA symptom score is a benchmark in defining the severity of symptoms, and collection of these scores is recommended in the AUA guidelines as part of the initial management of BPH (3,4,12). The UDI-6 is a validated short form of the urogenital distress inventory, and it assesses for the impact and severity of urinary incontinence (13).
Participants will then undergo their TURP and Botox procedure with one of three surgeons in the department of Urology at Virginia Mason.
At approximately four weeks post-op, participants will have a visit with their provider. Symptoms will be assessed by re-administering the AUA symptom score, the UDI-6, PGI-I and the VM Post-Procedure Questionnaire to assess for change in symptoms as well as satisfaction with their procedure.
Participants will then have an approximate 3 month post-op visit, at which time the questionnaires will be re-administered.. Patients will have the opportunity to follow-up with their provider sooner, if needed, based on individual symptoms.
The total expected duration of participation for any given participant is 4 months.
Demographic data, including comorbidities, urodynamics results, post-void residual, uroflow, operative length, estimated blood loss, length of stay, 30 day readmission rate, and 30 day rate of urinary retention will be collected for each subject via the electronic medical record.
We will be evaluating the impact of Botox concurrent with TURP relative to published rates of overactivity and bother after TURP alone.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Exclusion Criteria
2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
3. History of receiving Botox in the bladder, within the previous 12 months.
18 Years
MALE
No
Sponsors
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Benaroya Research Institute
OTHER
Responsible Party
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Cristina Palmer
Principal Investigator
Principal Investigators
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Cristina Palmer, DO
Role: PRINCIPAL_INVESTIGATOR
Virginia Mason Medical Center
Locations
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Virginia Mason Medical Center
Seattle, Washington, United States
Countries
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References
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Ng M, Leslie SW, Baradhi KM. Benign Prostatic Hyperplasia. 2024 Oct 20. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK558920/
Chen LC, Kuo HC. Pathophysiology of refractory overactive bladder. Low Urin Tract Symptoms. 2019 Sep;11(4):177-181. doi: 10.1111/luts.12262. Epub 2019 Mar 22.
Cornu JN, Grise P. Is benign prostatic obstruction surgery indicated for improving overactive bladder symptoms in men with lower urinary tract symptoms? Curr Opin Urol. 2016 Jan;26(1):17-21. doi: 10.1097/MOU.0000000000000249.
Kim SJ, Al Hussein Alawamlh O, Chughtai B, Lee RK. Lower Urinary Tract Symptoms Following Transurethral Resection of Prostate. Curr Urol Rep. 2018 Aug 20;19(10):85. doi: 10.1007/s11934-018-0838-4.
Al-Shaiji TF. Intradetrusor injection of botulinum toxin for the management of refractory overactive bladder syndrome: an update. Surg Innov. 2013 Aug;20(4):351-5. doi: 10.1177/1553350612460125. Epub 2012 Sep 10.
Zillioux J, Welk B, Suskind AM, Gormley EA, Goldman HB. SUFU white paper on overactive bladder anticholinergic medications and dementia risk. Neurourol Urodyn. 2022 Nov;41(8):1928-1933. doi: 10.1002/nau.25037. Epub 2022 Sep 6.
Yap TL, Cromwell DA, Brown C, van der Meulen J, Emberton M. The relationship between objective frequency-volume chart data and the I-PSS in men with lower urinary tract symptoms. Eur Urol. 2007 Sep;52(3):811-8. doi: 10.1016/j.eururo.2007.01.013. Epub 2007 Jan 12.
Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl JA. Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program for Women Research Group. Neurourol Urodyn. 1995;14(2):131-9. doi: 10.1002/nau.1930140206.
Other Identifiers
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IRB23-046
Identifier Type: -
Identifier Source: org_study_id
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