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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorBenaroya Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Survey using a questionnaire.

    Other intervention

    * 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Observational Group1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
4 months

Secondary outcomes

1

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

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

Time frame
4 months
2

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

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

Time frame
4 months

Other outcomes

Sponsors and contacts

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