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

Withdrawn

• Conditions: Transurethral Resection of the Prostate

• Registration Number: NCT06531655
• Lead Sponsor: Benaroya Research Institute

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.

Study Timeline

• Study First Submitted: 2024-02-15
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-30
• Last Update Submitted: 2024-07-30
• Study Start: 2024-08
• Study First Posted: 2024-08-01
• Last Update Posted: 2024-08-01
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To identify whether concurrent Botox and TURP are effective at reducing post-operative irritative voiding symptoms.	1 week	At the post-operative visit: Trial of Void assessment will be used to assess for rates of postoperative urinary retention.

Secondary Outcome Measures

Name	Time	Method
To identify whether concurrent Botox and TURP lead to rates of urinary retention using internal Virginia Mason Post-Procedure questionnaire	Four and twelve-week	At the post-operative visit the VM Post Procedure Questionnaire will be administered.
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	Post void residual obtained via bladder scan.
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	Administer the short 6 question form of the Urinary Distress Inventory at the post-operative visits
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	Administer the Patient Global Impression of Improvement (PGI-I)
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	Post-op visits when AUA symptom score: (0 to 7 (Mild), 8 to 19 (Moderate), 20 to 35 (Severe))

Trial Locations

Locations (1)

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States