Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07377929

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Benign Prostatic Hypertrophy (BPH) Genital Diseases Genital Diseases, Male Lower Urinary Track Symptoms Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Virginia Mason Franciscan Health

Seattle, Washington, 98101, United States

Location status: Recruiting

Location contact

Thomas W. Fuller, MD

CONTACT

[email protected]

206-223-6772

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Non-English speaking
  • 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.
  • History of receiving Botox in the bladder, within the previous 12 months.

Treatment and study plan

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.

Other names: AUA symptom score, PGI-I, UDI-6, VM Post Procedure questionnaires, post void residual assessment via bladder scan

Primary outcomes

  1. To identify whether concurrent Botox and TURP or Aquablation are effective at reducing post-operative irritative voiding symptoms.

    Time frame: 4 months

    This will be measured using Postoperative Urinary Retention (POUR):

    At 1 week post-operative visit for trial of void to assess for rates of postoperative urinary retention.

    At 4 and 12 week post-operative visits for post void residual assessment

Secondary outcomes

  1. To identify whether concurrent Botox and TURP or Aquablation lead to longer hospitalizations.

    Time frame: 4 months

    Analyzing admission data to determine if there are any changes to the hospital admission rates.

  2. To identify whether concurrent Botox and TURP or Aquablation lead to higher rates of urinary retention.

    Time frame: 4 months

    Analyzing admission data to determine if there are any changes to the urinary retention episodes.

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas W. Fuller, MD

CONTACT

[email protected]

206-223-6772

Sponsors and collaborators

Lead sponsor

Benaroya Research Institute

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 30, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.