Intradetrusor Botox at the Time of Transurethral Resection of the Prostate for Mixed Lower Urinary Tract Symptoms

NCT06531655 | Withdrawn

• 1 other identifier: IRB23-046
• Study Type: observational
• Target: N/A
• 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) is the gold standard treatment for BPH. However, in the immediate post-operative period, TURP 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. According to AUA guidelines, it is considered a third-line treatment therapy. The purpose of this study is to evaluate the outcomes of men who have Botox concurrent with their TURP.

Conditions

Transurethral Resection of the Prostate

Outcome Measures

Primary Outcomes (1)

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

  At the post-operative visit: Trial of Void assessment will be used to assess for rates of postoperative urinary retention.

  1 week

Secondary Outcomes (5)

• To identify whether concurrent Botox and TURP lead to higher rates of urinary retention using the American Urological Association symptom score

  Four and twelve-week

• To identify whether concurrent Botox and TURP lead to rates of urinary retention using internal Virginia Mason Post-Procedure questionnaire

  Four and twelve-week

• To identify whether concurrent Botox and TURP lead to higher rates of urinary retention using the Patient Global Impression of Improvement (PGI-I) to assess patient observed improvement in urinary incontinence.

  Four and twelve-week

• To identify whether concurrent Botox and TURP lead to higher rates of urinary retention using the Urinary Distress Inventory, Short Form (UDI-6)

  Four and twelve-week

• To identify whether concurrent Botox and TURP lead to higher rates of urinary retention using a bladder scan to assess the amount of residual urine in bladder post trial of void.

  Four and twelve-week

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

Study population will include males who have undergone a transurethral resection of the prostate (TURP) as treatment for benign prostatic hypertrophy and obstructive LUTS. The study population will be utilizing Botox as the treatment for overactive bladder (OAB) at the time of TURP.

You may qualify if:

• Male ≥ 18 years of age, and being scheduled to undergo TURP 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 Medical Center

Seattle, Washington, 98101, United States

Location

Related Publications (8)

• Ng M, Leslie SW, Baradhi KM. Benign Prostatic Hyperplasia. 2024 Oct 20. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK558920/

  PMID: 32644346 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Officials

• Cristina Palmer, DO

  Virginia Mason Medical Center

  PRINCIPAL INVESTIGATOR

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: February 15, 2024
• First Posted: August 1, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)