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AzTrials

Benign Prostatic Hypertrophy (BPH)NCT07377929

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

An observational study of Benign Prostatic Hypertrophy (BPH) and Lower Urinary Track Symptoms, run by Benaroya Research Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Survey using a questionnaire.
How many people
20 participants
Where
1 siteUnited States
Study dates
19 Jan 2026to 1 May 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Thomas W. Fuller, MD contact

206-223-6772

will.fuller@commonspirit.org

United States1 site, 1 recruiting

  • Virginia Mason Franciscan Health

    Seattle, Washington, 98101

    Thomas W. Fuller, MD, 206-223-6772, will.fuller@commonspirit.org

    Recruiting

Other trials in United States

About this study

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.

Being tested
Survey using a questionnaire.
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
Medical subject headings
Prostatic Hyperplasia, Lower Urinary Tract Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Survey using a questionnaire.Other

    Also called AUA symptom score, PGI-I, UDI-6, VM Post Procedure questionnaires

    • 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.
Study groups in NCT07377929
Study groupRoleWhat they receive
Observational GroupThis group will contain men (>=18 years) and will be scheduled to undergo TURP or Aquablation and Botox procedure.
Receives: Other: Survey using a questionnaire.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 4 months

Secondary outcomes (2)

  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.

    Measured: 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.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2026
  2. Study start19 Jan 2026 (estimated)
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07377929
Sponsor's protocol ID
IRB24-069
Status last verified
Jan 2026
First submitted
24 Mar 2025
Last updated
30 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 7780440

  • 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.

    PubMed 17276583

  • 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.

    PubMed 9634046

  • 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.

    PubMed 36066046

  • 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.

    PubMed 22964263

  • 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.

    PubMed 23098785

  • 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.

    PubMed 31039103

  • 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.

    PubMed 30128964

  • 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.

    PubMed 26574877

  • 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.

    PubMed 35150215

  • 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.

    PubMed 34384236

  • 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.

    PubMed 34384237

  • 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.

    PubMed 30900373

  • 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/

    PubMed 32644346

Questions about this trial

What is this clinical trial studying?

An observational study of Benign Prostatic Hypertrophy (BPH) and Lower Urinary Track Symptoms, run by Benaroya Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Thomas W. Fuller, MD (206-223-6772, will.fuller@commonspirit.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To identify whether concurrent Botox and TURP or Aquablation are effective at reducing post-operative irritative voiding symptoms. (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07377929, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.

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