Clinical trial NCT06531655: Intradetrusor Botox at the Time of Transurethral Resection of the Prostate for Mixed Lower Urinary Tract Symptoms
Official title: Intradetrusor Onabotulinumtoxin A (Botox) at the Time of Transurethral Resection of the Prostate for Mixed Lower Urinary Tract Symptoms
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Transurethral Resection of the Prostate
Lead sponsor: Benaroya Research Institute
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: An observational study of the effect of Botox injection at the time of TURP will be performed.

If deemed eligible, participants will be invited to participate in this trial. The International Prostate Symptom Score (IPSS) is a questionnaire that is widely used to assess LUTS in patients and assesses for incomplete emptying, frequency, intermittency, urgency, weak stream, hesitancy, and nocturia. The AUA quality of life score (AUA-QoL) asks how these symptoms affect quality of life. When administered as a combined questionnaire, this is referred to as the AUA symptom score. These scores are summed to produce an overall severity score, which can categorize patients as having mild (score 0-7), moderate (8-19) or severe (20-35) LUTS (11). The AUA symptom score is a benchmark in defining the severity of symptoms, and collection of these scores is recommended in the AUA guidelines as part of the initial management of BPH (3,4,12). The UDI-6 is a validated short form of the urogenital distress inventory, and it assesses for the impact and severity of urinary incontinence (13).

Participants will then undergo their TURP and Botox procedure with one of three surgeons in the department of Urology at Virginia Mason.

At approximately four weeks post-op, participants will have a visit with their provider. Symptoms will be assessed by re-administering the AUA symptom score, the UDI-6, PGI-I and the VM Post-Procedure Questionnaire to assess for change in symptoms as well as satisfaction with their procedure.

Participants will then have an approximate 3 month post-op visit, at which time the questionnaires will be re-administered.. Patients will have the opportunity to follow-up with their provider sooner, if needed, based on individual symptoms.

The total expected duration of participation for any given participant is 4 months.

Demographic data, including comorbidities, urodynamics results, post-void residual, uroflow, operative length, estimated blood loss, length of stay, 30 day readmission rate, and 30 day rate of urinary retention will be collected for each subject via the electronic medical record.

We will be evaluating the impact of Botox concurrent with TURP relative to published rates of overactivity and bother after TURP alone.

Eligibility criteria: Inclusion Criteria:

1. Male ≥ 18 years of age, and being scheduled to undergo TURP and Botox procedure.
2. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

1. Non-English Speaking
2. 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.
3. History of receiving Botox in the bladder, within the previous 12 months.

Primary outcomes:
measure: To identify whether concurrent Botox and TURP are effective at reducing post-operative irritative voiding symptoms.
timeFrame: 1 week
Secondary outcomes:
measure: To identify whether concurrent Botox and TURP lead to higher rates of urinary retention using the American Urological Association symptom score
timeFrame: Four and twelve-week
measure: To identify whether concurrent Botox and TURP lead to rates of urinary retention using internal Virginia Mason Post-Procedure questionnaire
timeFrame: Four and twelve-week
measure: 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.
timeFrame: Four and twelve-week
measure: To identify whether concurrent Botox and TURP lead to higher rates of urinary retention using the Urinary Distress Inventory, Short Form (UDI-6)
timeFrame: Four and twelve-week
measure: 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.
timeFrame: Four and twelve-week
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: Virginia Mason Medical Center
name: Cristina Palmer, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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/
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.