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Is 10 Injections of Bladder Botox Less Painful Than 20 Injections?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04124939
Recruitment Status : Suspended (COVID19)
First Posted : October 14, 2019
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
The purpose of this research study is to help determine if 10 injections of Botox ® 100 units is less painful than 20 injections of Botox ® 100 units based on effectiveness in reducing urge incontinence episodes. Study will also be assessed for the pain of procedure and adverse outcomes of 20 injections versus 10 injections.

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: OnabotulinumtoxinA 100 UNT Phase 4

Detailed Description:
This study is a randomized clinical trial to assess whether or not 10 injections of 100 units of intradetrusor Botox® toxin is perceived as less painful compared to 20 injections of 100 units of intradetrusor Botox® toxin for the treatment of refractory overactive bladder.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of 100 Units of Intradetrusor Onabotulinum Toxin A for Refractory Overactive Bladder - Is 10 Injections Less Painful Than 20 Injections?
Actual Study Start Date : November 10, 2019
Estimated Primary Completion Date : December 25, 2020
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 10 Botox Injections
100 units of Botox® (onabotulinumtoxinA) will be combined with 10 cc of sterile saline for the purpose of 10 injections. The bladder will be instilled with 2% lidocaine solution through a catheter for at least 5 minutes prior to the procedure. Cystoscopy with either a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile technique. The Botox® will be injected in a grid like pattern avoiding the trigone.
Drug: OnabotulinumtoxinA 100 UNT

BOTOX for injection is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for:

• Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

Other Name: BOTOX

Active Comparator: 20 Botox Injections
100 units of Botox® (onabotulinumtoxinA) will be combined with 20 cc of sterile saline for the purpose of 20 injections. The bladder will be instilled with 2% lidocaine solution through a catheter for at least 5 minutes prior to the procedure. Cystoscopy with either a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile technique. The Botox® will be injected in a grid like pattern avoiding the trigone.
Drug: OnabotulinumtoxinA 100 UNT

BOTOX for injection is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for:

• Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

Other Name: BOTOX




Primary Outcome Measures :
  1. Numeric Pain Rating Scale (NPRS) [ Time Frame: Post Procedure Day 1 ]
    The patients will rate their level of pain from 0 as no pain to 10 as a severe pain immediately following the completion of bladder injections by selecting a whole number from 0 to 10 that represents their level of pain during the procedure.


Secondary Outcome Measures :
  1. Difference in mean urge incontinence episodes [ Time Frame: Baseline, Week 12 after procedure ]
    The mean urge incontinence episodes which will be calculated by averaging the amount of urge urinary incontinence episodes over 3 days as recorded in a bladder diary at baseline and week 12 after the procedure

  2. Over Active Bladder (OAB) Questionnaire Short Form - Symptoms [ Time Frame: Baseline ]
    Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. The OAB-SF contains 6 items to assess symptom bother and 13 items to assess health Related Quality of Life (HRQOL). Total range 0 to 100. A higher score on the symptom bother scale indicates a greater symptom severity.

  3. Over Active Bladder (OAB) Questionnaire Short Form - Symptoms [ Time Frame: 2 weeks post procedure ]
    Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. The OAB-SF contains 6 items to assess symptom bother and 13 items to assess health Related Quality of Life (HRQOL). Total range 0 to 100. A higher score on the symptom bother scale indicates a greater symptom severity.

  4. Over Active Bladder (OAB) Questionnaire Short Form - Symptoms [ Time Frame: 12 weeks post procedure ]
    Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. The OAB-SF contains 6 items to assess symptom bother and 13 items to assess health Related Quality of Life (HRQOL). Total range 0 to 100. A higher score on the symptom bother scale indicates a greater symptom severity.

  5. Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life [ Time Frame: Baseline ]
    Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. The OAB-SF contains 6 items to assess symptom bother and 13 items to assess health Related Quality of Life (HRQOL). Total range 0 to 100. A higher score on the HRQOL scale indicates a better HRQO.

  6. Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life [ Time Frame: 2 weeks post procedure ]
    Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. The OAB-SF contains 6 items to assess symptom bother and 13 items to assess health Related Quality of Life (HRQOL). Total range 0 to 100. A higher score on the HRQOL scale indicates a better HRQO.

  7. Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life [ Time Frame: 12 weeks post procedure ]
    Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. The OAB-SF contains 6 items to assess symptom bother and 13 items to assess health Related Quality of Life (HRQOL). Total range 0 to 100. A higher score on the HRQOL scale indicates a better HRQO.

  8. Post-Void Residual (PVR) [ Time Frame: 2 weeks post procedure ]
    PVR using bladder scanner evaluates the post void residual in the bladder.

  9. Post-Void Residual (PVR) [ Time Frame: 12 weeks post procedure ]
    PVR using bladder scanner evaluates the post void residual in the bladder.

  10. Participant's Global Impression of Change (PGIC) Scale [ Time Frame: 2 weeks post procedure ]
    PGIC to determine the clinical significance of change. PGIC consist of 7 choices for a patient to pick from no change to a great deal better. PGIC is a 7 point scale (1 to 7) depicting a patient's rating of overall improvement. Higher numbers signify higher levels of change.

  11. Participant's Global Impression of Change (PGIC) Scale [ Time Frame: 12 weeks post procedure ]
    PGIC to determine the clinical significance of change. PGIC consist of 7 choices for a patient to pick from no change to a great deal better. PGIC is a 7 point scale (1 to 7) depicting a patient's rating of overall improvement. Higher numbers signify higher levels of change.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Female gender
  • 2. At least 18 years of age
  • 3. Have already decided to undergo intradetrusor Botox® injections for treatment of refractory overactive bladder.
  • 4. Able and willing to learn clean intermittent catheterization (or care provider is willing and able to perform intermittent catheterization).
  • 5. Understands and is willing to undergo follow up and complete questionnaires as described in this protocol
  • 6. Able to give informed consent
  • 7. Currently not on anticholinergics or beta-3 agonists, or willing to stop medications at least 3 weeks prior to completing the baseline bladder diary.

Exclusion Criteria:

  • 1. Male gender
  • 2. Neurological conditions (Examples: Cerebral vascular accident within 6 months prior to treatment, Parkinson's disease, Multiple Sclerosis, and Spina Bifida).
  • 3. Acute urinary tract infection
  • 4. Treatment with Botox® toxin for other conditions
  • 5. Allergy to Botox® toxin
  • 6. Hematuria that has not been worked up
  • 7. Known bladder malignancy
  • 8. Previous history of bladder augmentation
  • 9. Currently pregnant (with no plans to become pregnant within 6 months of enrollment) or breastfeeding
  • 10. Currently taking aminoglycoside antibiotics
  • 11. PVR >150 cc (measured by bladder scan or by catheterization) prior to enrollment
  • 12. Prior use of third line treatments for overactive bladder
  • 13. History of chronic pain or pain syndromes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124939


Locations
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United States, North Carolina
Urology clinic locations at Wake Forest Baptist Medical Center
Greensboro, North Carolina, United States, 27455
Urology clinic locations at Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Catherine Matthews, MD Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04124939    
Other Study ID Numbers: IRB00059454
First Posted: October 14, 2019    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Wake Forest University Health Sciences:
Overactive Bladder
Botox/OnabotulinumtoxinA
Pain
OAB
Non-neurogenic Overactive bladder
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
abobotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents