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

January 22, 2026 updated by: Will Fuller, Benaroya Research Institute

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will be identified by patients visiting the Virginia Mason Medical Centers Urology department.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational Group
This group will contain men (>=18 years) and will be scheduled to undergo TURP or Aquablation and Botox procedure.
Other: 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.
Other Names:
  • AUA symptom score
  • PGI-I
  • UDI-6
  • VM Post Procedure questionnaires
  • post void residual assessment via bladder scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months
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.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benaroya Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 19, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

March 24, 2025

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 30, 2026

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB24-069

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Virginia Mason Urology providers will identify patients for potential study participation.

Informed consent will be obtained for all subjects who wish to participate in this trial. Upon consent, study staff will obtain baseline and demographic data, administer AUA symptom score and the UDI-6. At follow up visits, the AUA symptom score, UDI-6, PGI-I, and VM post-procedure questionnaire will be obtained for participating patients. Additional data points under study will be obtained from the subject's electronic medical record.

All study data will be entered into a secure password-protected clinical research database maintained on a Virginia Mason computer. No PHI will be transferred outside of Virginia Mason.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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