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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

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Benaroya Research Institute

Status

Enrolling

Conditions

Lower Urinary Track Symptoms
Benign Prostatic Hypertrophy (BPH)

Treatments

Other: Survey using a questionnaire.

Study type

Observational

Funder types

Other

Identifiers

NCT07377929
IRB24-069

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

20 participants in 1 patient group

Observational Group
Description:
This group will contain men (\>=18 years) and will be scheduled to undergo TURP or Aquablation and Botox procedure.
Treatment:
Other: Survey using a questionnaire.

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Thomas W. Fuller, MD

Data sourced from clinicaltrials.gov

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