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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational Group | This group will contain men (>=18 years) and will be scheduled to undergo TURP or Aquablation and Botox procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survey using a questionnaire. | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 months |
| To identify whether concurrent Botox and TURP or Aquablation lead to higher rates of urinary retention. |
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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.
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The study population will be identified by patients visiting the Virginia Mason Medical Centers Urology department.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas W. Fuller, MD | Contact | 206-223-6772 | will.fuller@commonspirit.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Mason Franciscan Health | Recruiting | Seattle | Washington | 98101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7780440 | Background | Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl JA. Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program for Women Research Group. Neurourol Urodyn. 1995;14(2):131-9. doi: 10.1002/nau.1930140206. | |
| 17276583 |
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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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 20, 2025 | Mar 11, 2025 |
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|
|
Analyzing admission data to determine if there are any changes to the urinary retention episodes. |
| 4 months |
| Yap TL, Cromwell DA, Brown C, van der Meulen J, Emberton M. The relationship between objective frequency-volume chart data and the I-PSS in men with lower urinary tract symptoms. Eur Urol. 2007 Sep;52(3):811-8. doi: 10.1016/j.eururo.2007.01.013. Epub 2007 Jan 12. |
| 9634046 | Background | Palnaes Hansen C, Klarskov P. The accuracy of the frequency-volume chart: comparison of self-reported and measured volumes. Br J Urol. 1998 May;81(5):709-11. doi: 10.1046/j.1464-410x.1998.00627.x. |
| 36066046 | Background | Zillioux J, Welk B, Suskind AM, Gormley EA, Goldman HB. SUFU white paper on overactive bladder anticholinergic medications and dementia risk. Neurourol Urodyn. 2022 Nov;41(8):1928-1933. doi: 10.1002/nau.25037. Epub 2022 Sep 6. |
| 22964263 | Background | Al-Shaiji TF. Intradetrusor injection of botulinum toxin for the management of refractory overactive bladder syndrome: an update. Surg Innov. 2013 Aug;20(4):351-5. doi: 10.1177/1553350612460125. Epub 2012 Sep 10. |
| 23098785 | Background | Gormley EA, Lightner DJ, Burgio KL, Chai TC, Clemens JQ, Culkin DJ, Das AK, Foster HE Jr, Scarpero HM, Tessier CD, Vasavada SP; American Urological Association; Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. J Urol. 2012 Dec;188(6 Suppl):2455-63. doi: 10.1016/j.juro.2012.09.079. Epub 2012 Oct 24. |
| 31039103 | Background | Lightner DJ, Gomelsky A, Souter L, Vasavada SP. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019 Sep;202(3):558-563. doi: 10.1097/JU.0000000000000309. Epub 2019 Aug 8. |
| 30128964 | Background | Kim SJ, Al Hussein Alawamlh O, Chughtai B, Lee RK. Lower Urinary Tract Symptoms Following Transurethral Resection of Prostate. Curr Urol Rep. 2018 Aug 20;19(10):85. doi: 10.1007/s11934-018-0838-4. |
| 26574877 | Background | Cornu JN, Grise P. Is benign prostatic obstruction surgery indicated for improving overactive bladder symptoms in men with lower urinary tract symptoms? Curr Opin Urol. 2016 Jan;26(1):17-21. doi: 10.1097/MOU.0000000000000249. |
| 35150215 | Background | Gilling PJ, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Kaufman RP Jr, Badlani G, Plante M, Desai M, Doumanian L, Te AE, Roehrborn CG. Five-year outcomes for Aquablation therapy compared to TURP: results from a double-blind, randomized trial in men with LUTS due to BPH. Can J Urol. 2022 Feb;29(1):10960-10968. |
| 34384236 | Background | Lerner LB, McVary KT, Barry MJ, Bixler BR, Dahm P, Das AK, Gandhi MC, Kaplan SA, Kohler TS, Martin L, Parsons JK, Roehrborn CG, Stoffel JT, Welliver C, Wilt TJ. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELINE PART II-Surgical Evaluation and Treatment. J Urol. 2021 Oct;206(4):818-826. doi: 10.1097/JU.0000000000002184. Epub 2021 Aug 13. |
| 34384237 | Background | Lerner LB, McVary KT, Barry MJ, Bixler BR, Dahm P, Das AK, Gandhi MC, Kaplan SA, Kohler TS, Martin L, Parsons JK, Roehrborn CG, Stoffel JT, Welliver C, Wilt TJ. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELINE PART I-Initial Work-up and Medical Management. J Urol. 2021 Oct;206(4):806-817. doi: 10.1097/JU.0000000000002183. Epub 2021 Aug 13. |
| 30900373 | Background | Chen LC, Kuo HC. Pathophysiology of refractory overactive bladder. Low Urin Tract Symptoms. 2019 Sep;11(4):177-181. doi: 10.1111/luts.12262. Epub 2019 Mar 22. |
| 32644346 | Background | Ng M, Leslie SW, Baradhi KM. Benign Prostatic Hyperplasia. 2024 Oct 20. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK558920/ |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 20, 2025 | Mar 11, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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