Benign Prostatic Hypertrophy (BPH), Lower Urinary Track Symptoms
Conditions
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
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.
Interventions
OTHERSurvey 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.
Sponsors
Benaroya Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To identify whether concurrent Botox and TURP or Aquablation are effective at reducing post-operative irritative voiding symptoms. | 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
| Measure | Time frame | Description |
|---|---|---|
| To identify whether concurrent Botox and TURP or Aquablation lead to longer hospitalizations. | 4 months | Analyzing admission data to determine if there are any changes to the hospital admission rates. |
| To identify whether concurrent Botox and TURP or Aquablation lead to higher rates of urinary retention. | 4 months | Analyzing admission data to determine if there are any changes to the urinary retention episodes. |
Countries
United States
Contacts
CONTACTThomas W. Fuller, MD
Outcome results
None listed