Actively Recruiting

Age: 18Years +
MALE
ID07377929

Intradetrusor Onabotulinumtoxin A (Botox) with TURP or Aquablation for Mixed Lower Urinary Tract Symptoms in Men

Led by Benaroya Research Institute · Updated on 2026-01-30

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying men with longstanding obstructive lower urinary tract symptoms caused by benign prostatic hypertrophy (BPH) who may also experience symptoms of overactive bladder syndrome (OAB). This study aims to evaluate the outcomes of giving Botox medication at the same time as two standard surgical treatments for BPH: Transurethral Resection of the Prostate (TURP) and Transurethral Waterjet Ablation of the Prostate (Aquablation). Botox is approved to treat overactive bladder, and the study focuses on whether combining these treatments affects post-operative symptoms. The study involves men aged 18 or older who are scheduled for TURP or Aquablation surgery along with Botox injection into the bladder muscle. Participants will be observed to see if this combined approach reduces irritative voiding symptoms that often worsen right after surgery, such as urinary frequency and urgency. The study will monitor hospital stays and rates of urinary retention as secondary outcomes. Participants will have follow-up visits at 1 week, 4 weeks, and 12 weeks after surgery. These visits will include assessments like bladder scans, symptom questionnaires, and evaluations of urinary retention and hospital readmissions. Researchers will track patient-reported outcomes and clinical measures to understand the effects of concurrent Botox and surgery over a four-month period.

CONDITIONS

Brief Title

Intradetrusor Onabotulinumtoxin A (Botox) at the Time of Transurethral Resection of the Prostate or Transurethral Waterjet Ablation of the Prostate for Mixed Lower Urinary Tract Symptoms

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male aged 18 years or older
  • Scheduled to undergo Transurethral Resection of the Prostate (TURP) or Transurethral Waterjet Ablation of the Prostate (Aquablation) with Botox injection
  • Able to provide written informed consent and comply with study requirements
Not Eligible

You will not qualify if you...

  • Non-English speaking
  • Any condition or abnormality that may compromise patient safety or data quality according to the Investigator
  • History of receiving Botox in the bladder within the previous 12 months

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit for screening and enrollment

Surgery and Immediate Post-operative Care

Duration - Hospitalization period

Participants undergo Transurethral Resection of the Prostate (TURP) or Transurethral Waterjet Ablation of the Prostate (Aquablation) with Botox injection and immediate post-operative monitoring.

1 surgical hospitalization

Post-operative Follow-up

Duration - 12 weeks

Participants are assessed post-operatively for urinary retention and symptom improvements using questionnaires and bladder scans.

1 visit at 1 week post-operation, 2 visits at 4 and 12 weeks post-operation

Trial Site Locations

Total: 1 location

1

Virginia Mason Franciscan Health

Seattle, Washington, United States, 98101

Actively Recruiting

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Research Team

T

Thomas W. Fuller, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

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.

J S Uebersax, J F Wyman, S A Shumaker...

https://pubmed.ncbi.nlm.nih.gov/7780440

The relationship between objective frequency-volume chart data and the I-PSS in men with lower urinary tract symptoms.

Tet L Yap, David A Cromwell, Christian Brown...

https://pubmed.ncbi.nlm.nih.gov/17276583

Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019.

Deborah J Lightner, Alexander Gomelsky, Lesley Souter...

https://pubmed.ncbi.nlm.nih.gov/31039103

Is benign prostatic obstruction surgery indicated for improving overactive bladder symptoms in men with lower urinary tract symptoms?

Jean-Nicolas Cornu, Philippe Grise

https://pubmed.ncbi.nlm.nih.gov/26574877

Five-year outcomes for Aquablation therapy compared to TURP: results from a double-blind, randomized trial in men with LUTS due to BPH.

Peter J Gilling, Neil Barber, Mohamed Bidair...

https://pubmed.ncbi.nlm.nih.gov/35150215