Recruiting

Botox with TURP

Sponsor:

Benaroya Research Institute

Code:

NCT07377929

Conditions

Benign Prostatic Hypertrophy (BPH)

Lower Urinary Track Symptoms

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Survey using a questionnaire.

Study Details

Brief summary:

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.

Conditions

Benign Prostatic Hypertrophy (BPH)

Lower Urinary Track Symptoms

Study ID

NCT07377929

Start date

Jan 19, 2026

Status verified date

Jan, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male >= 18 years of age and being scheduled to undergo TURP or Aquablation and Botox procedure.
2. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:
3. Non-English speaking
4. 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.
5. History of receiving Botox in the bladder, within the previous 12 months.

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational Group

This group will contain men (>=18 years) and will be scheduled to undergo TURP or Aquablation and Botox procedure.

Interventions

Survey using a questionnaire.

  • 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.

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 and Locations

Central contacts

Thomas W. Fuller, MD

206-223-6772will.fuller@commonspirit.org

Locations

Virginia Mason Franciscan Health

Recruiting

Seattle, Washington, United States, 98101

Contacts

Thomas W. Fuller, MD

206-223-6772will.fuller@commonspirit.org

More Information

Sponsor

Benaroya Research Institute

Last update posted

Jan 30, 2026

Last verified

Jan, 2026

Keywords

  • lower urinary tract symptoms (LUTS)
  • benign prostatic hypertrophy (BPH)
  • overactive bladder syndrome (OAB)
  • Transurethral resection of the prostate (TURP)
  • Transurethral Waterjet Ablation of the Prostate (Aquablation)
  • Botox

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Benaroya Research Institute on 2026-01-30.