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

NCT07377929 | Recruiting

• 1 other identifier: IRB24-069
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Urinary Track Symptoms; Benign Prostatic Hypertrophy (BPH)

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

Outcome Measures

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

  4 months

Secondary Outcomes (2)

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

  4 months

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

  4 months

Study Arms (1)

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.

Interventions

Survey using a questionnaire. OTHER

* 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.

Also known as: AUA symptom score, PGI-I, UDI-6, VM Post Procedure questionnaires, post void residual assessment via bladder scan

Observational Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benaroya Research Institute: lead

Study Sites (1)

Virginia Mason Franciscan Health

Seattle, Washington, 98101, United States

RECRUITING

Related Publications (14)

• 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.

  PMID: 7780440 BACKGROUND

• 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.

  PMID: 17276583 BACKGROUND

• Palnaes H.C., Klarskov P.: The accuracy of the frequency-volume chart: comparison of self-reported and measured volumes. Br J Urol 1998; 81: pp. 709-711

  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.

  PMID: 36066046 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.

  PMID: 22964263 BACKGROUND

• Gormley EA, Lightner DJ, Burgio KL et al: Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. J Urol 2012; 188: 2455

  BACKGROUND

• Lightner DJ, Gomelsky A, Souter L et al: Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU Guideline amendment 2019. J Urol 2019; 202: 558

  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.

  PMID: 30128964 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.

  PMID: 26574877 BACKGROUND

• Gilling PJ, Barber N, Bidair M et al. 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

  BACKGROUND

• Lerner LB, McVary, KT, Barry MJ et al: Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia: AUA Guideline part II, surgical evaluation and treatment . J Urol 2021; 206: 818

  BACKGROUND

• Lerner LB, McVary, KT, Barry MJ et al: Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia: Make it since she anything that change in point being between resident it level at and exchanged between if something to do it and it would not is I am still and she feels with the numbers she old Knee she I put there is no Guideline part I, initial work-up and medical management. J Urol 2021; 206: 806.

  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.

  PMID: 30900373 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/

  PMID: 32644346 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Thomas W. Fuller, MD

CONTACT

206-223-6772; will.fuller@commonspirit.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: January 30, 2026
• Study Start: January 19, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)