Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06531655
Status:
WITHDRAWN
Last Update Posted:
None
First Post:
2024-02-15
Brief Title:
Intradetrusor Botox at the Time of Transurethral Resection of the Prostate for Mixed Lower Urinary Tract Symptoms
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Intradetrusor Onabotulinumtoxin A Botox at the Time of Transurethral Resection of the Prostate for Mixed Lower Urinary Tract Symptoms
Status:
WITHDRAWN
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
TURP procedure bring studied was discontinued due to new Aquablation technology replacing it Therefore this study focusing on the outcomes of TURP is being discontinued
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 3412 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
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 3412 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None