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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Benaroya Research Institute
Study ID
NCT07377929
Status
Recruiting
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Conditions

  • Benign Prostatic Hypertrophy (BPH)
  • Lower Urinary Track Symptoms

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Survey using a questionnaire. — OTHER
    * 1 week post-operative visit for: trial of void, to assess for rates of postoperative urinary retention. * 4 and 12 week post-operative visits for: post void residual assessment via bladder scan, AUA symptom score, PGI-I, UDI-6, and VM Post Procedure questionnaires will be administered * Hospitalization readmission rates, urinary retention episodes will also be recorded.

Study Details

Patients with longstanding obstructive lower urinary tract symptoms (LUTS) due to benign prostatic hypertrophy (BPH) can also develop symptoms of overactive bladder syndrome (OAB). Transurethral resection of the prostate (TURP) and Transurethral Waterjet Ablation of the Prostate (Aquablation) are amongst the gold standard surgical treatments for BPH. However, in the immediate post-operative period, TURP and Aquablation can also include OAB-like symptoms, including urinary frequency and urgency. For men with baseline OAB symptoms, this initial worsening of symptoms can be distressing. Botox is an FDA approved medication with on-label indications to treat overactive bladder. The purpose of this study is to evaluate the outcomes of men who have Botox concurrent with their TURP or Aquablation.

Key Dates

Start date
Jan 19, 2026
Status verified
Jan 2026
Primary completion
May 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: Observational Group
    This group will contain men (\>=18 years) and will be scheduled to undergo TURP or Aquablation and Botox procedure.

Primary Outcome Measure

To identify whether concurrent Botox and TURP or Aquablation are effective at reducing post-operative irritative voiding symptoms. [ Time Frame: 4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Mason Franciscan HealthSeattleWashington98101
Thomas W. Fuller, MD
[email protected]
206-223-6772

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By research site
Virginia Mason Franciscan Health· Seattle, WA

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