Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-27 @ 9:38 PM
Study NCT ID:
NCT04731961
Status:
RECRUITING
Last Update Posted:
2025-01-28
First Post:
2021-01-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction in Number of Botox Injections for Urgency Urinary Incontinence
Sponsor:
University of Virginia
Organization:
Study Overview
Official Title:
Reduced Site Injection Protocol of Intra-detrusor Onabotulinumtoxin-A for Treatment of Idiopathic Refractory Urgency Urinary Incontinence
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall objective of this study is to determine if a reduced injection site protocol (5 injection sites) using an equivalent amount of Botox provides comparable relief of Urgency Urinary Incontinence (UUI) symptoms compared to the standard injection site protocol (15-20 injection sites). Our central hypothesis is that the 5-site injection protocol is non-inferior in terms of relief of UUI symptoms compared to the standard injection site protocol, measured by a non-inferior reduction in the number of UUI episodes per day.
Detailed Description:
English speaking women ≥21 years old with idiopathic refractory urgency urinary incontinence who have failed first and second line treatment (life style modifications and antispasmodic medications) who are undergoing a first injection of intra-detrusor Botox will be recruited to participate in this study. Failure of first and second line treatment will be defined as no improvement in urgency urinary incontinence episodes after trial of lifestyle modifications and use of at least one antispasmodic agent.
Patients who are planning to undergo her first intra-detrusor Botox procedure for refractory idiopathic urgency urinary incontinence at the University of Virginia Pelvic Medicine and Reconstructive Surgery clinic will be approached for inclusion into the study. A study overview, as well as risks and benefits, will be reviewed with the patients. The patient will be screened for inclusion/exclusion criteria. If she meets criteria and agrees to study participation, she will be consented for study participation and the Botox injection procedure.
Prior to receiving treatment, patients will complete a 3-day voiding diary and the following questionnaires: Incontinence Impact Questionnaire short form (IIQ-7) and Urogenital Distress Inventory short form (UDI-6) at the time of consent. As part of usual care, patients in both arms will receive prophylactic antibiotics (oral nitrofurantoin or cephalexin) to complete prior to the procedure date. On the day of treatment, patients will have a clean catch urine specimen obtained and urine dip completed. Patients who have a positive urine dip will have her procedure rescheduled to another day. A positive urine dip is defined as + leukocytes and + blood in the presence of symptoms of urinary tract infection (dysuria, increased urgency/frequency above baseline or hematuria). In this study, we will not offer patients pre-procedure oral Valium as it may affect reporting of pain scores. Patients in both arms will be prepared for the procedure in the same fashion: 50 cc of 1% lidocaine will be instilled into the bladder at least 20 minutes prior to the procedure. Patients will then be prepped and draped in the standard fashion. A 70-degree cystoscope will be inserted through the urethra and into the bladder until the trigone is identified; the bladder will be distended with approximately 200 mL sterile saline.
100 units of Botox will be mixed with 10 mL of Normal Saline for sterile injection into the bladder. In the reduced protocol arm, a single row of 5 injections will be administered into the detrusor muscle. In the standard protocol arm, 3 rows of 5 injections will be administered into the detrusor muscle. In both arms, a final injection with 1 mL of normal saline flush will be injected to remove any residual Botox from the injection needle. The patient will be monitored for 20 minutes post procedure to ensure adequate ability to void after treatment. Approximately 5 minutes post-procedure, patients will rate their pain experienced during the procedure using a 100-point visual analog pain scale.
If the patient is unable to void post-procedure, she will be taught how to perform clean intermittent self-catheterization (CISC) and provided with a log to record void and catheter volumes. She will be called on a weekly basis by the study team to review void/catheterization volumes and encouraged to discontinue when she has 2 successive catheterization volumes of \<150 ml. This is in accordance with standard clinical care in our practice.
At 2 weeks post procedure, patients in both treatment arms will be interviewed by phone to report results of a 3-day voiding diary (Aim 1), complete the IIQ-7 and UDI-6 again, as well as the OAB Treatment Satisfaction Questionnaire (OAB-SATq), Client Satisfaction Questionnaire (CSQ-8)10, Patient Global Impression of Improvement (PGI-I) questionnaire and evaluate for complications (Aim 2, Aim 3). The same evaluation process will be repeated at 3 months and 6 months post procedure.
After completion of all questionnaires at the 4 timepoints (Pre-procedure, 2 weeks, 3 months, 6 months), patients will receive a $50 incentive for their time and participation.
Patients who are planning to undergo her first intra-detrusor Botox procedure for refractory idiopathic urgency urinary incontinence at the University of Virginia Pelvic Medicine and Reconstructive Surgery clinic will be approached for inclusion into the study. A study overview, as well as risks and benefits, will be reviewed with the patients. The patient will be screened for inclusion/exclusion criteria. If she meets criteria and agrees to study participation, she will be consented for study participation and the Botox injection procedure.
Prior to receiving treatment, patients will complete a 3-day voiding diary and the following questionnaires: Incontinence Impact Questionnaire short form (IIQ-7) and Urogenital Distress Inventory short form (UDI-6) at the time of consent. As part of usual care, patients in both arms will receive prophylactic antibiotics (oral nitrofurantoin or cephalexin) to complete prior to the procedure date. On the day of treatment, patients will have a clean catch urine specimen obtained and urine dip completed. Patients who have a positive urine dip will have her procedure rescheduled to another day. A positive urine dip is defined as + leukocytes and + blood in the presence of symptoms of urinary tract infection (dysuria, increased urgency/frequency above baseline or hematuria). In this study, we will not offer patients pre-procedure oral Valium as it may affect reporting of pain scores. Patients in both arms will be prepared for the procedure in the same fashion: 50 cc of 1% lidocaine will be instilled into the bladder at least 20 minutes prior to the procedure. Patients will then be prepped and draped in the standard fashion. A 70-degree cystoscope will be inserted through the urethra and into the bladder until the trigone is identified; the bladder will be distended with approximately 200 mL sterile saline.
100 units of Botox will be mixed with 10 mL of Normal Saline for sterile injection into the bladder. In the reduced protocol arm, a single row of 5 injections will be administered into the detrusor muscle. In the standard protocol arm, 3 rows of 5 injections will be administered into the detrusor muscle. In both arms, a final injection with 1 mL of normal saline flush will be injected to remove any residual Botox from the injection needle. The patient will be monitored for 20 minutes post procedure to ensure adequate ability to void after treatment. Approximately 5 minutes post-procedure, patients will rate their pain experienced during the procedure using a 100-point visual analog pain scale.
If the patient is unable to void post-procedure, she will be taught how to perform clean intermittent self-catheterization (CISC) and provided with a log to record void and catheter volumes. She will be called on a weekly basis by the study team to review void/catheterization volumes and encouraged to discontinue when she has 2 successive catheterization volumes of \<150 ml. This is in accordance with standard clinical care in our practice.
At 2 weeks post procedure, patients in both treatment arms will be interviewed by phone to report results of a 3-day voiding diary (Aim 1), complete the IIQ-7 and UDI-6 again, as well as the OAB Treatment Satisfaction Questionnaire (OAB-SATq), Client Satisfaction Questionnaire (CSQ-8)10, Patient Global Impression of Improvement (PGI-I) questionnaire and evaluate for complications (Aim 2, Aim 3). The same evaluation process will be repeated at 3 months and 6 months post procedure.
After completion of all questionnaires at the 4 timepoints (Pre-procedure, 2 weeks, 3 months, 6 months), patients will receive a $50 incentive for their time and participation.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: