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

Wake Forest University (WFU)

Status and phase: Completed; Phase 4

Conditions: Overactive Bladder

Treatments: Drug: OnabotulinumtoxinA 100 Units

Study type: Interventional

Funder types: Other

Identifiers

NCT04124939

IRB00059454

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female gender
• At least 18 years of age
• Have already decided to undergo intradetrusor Botox® injections for treatment of refractory overactive bladder.
• Able and willing to learn clean intermittent catheterization (or care provider is willing and able to perform intermittent catheterization).
• Understands and is willing to undergo follow up and complete questionnaires as described in this protocol
• Able to give informed consent

Exclusion criteria

• Male gender
• Neurological conditions (Examples: Cerebral vascular accident within 6 months prior to treatment, Parkinson's disease, Multiple Sclerosis, and Spina Bifida).
• Acute urinary tract infection
• Treatment with Botox® toxin for other conditions
• Allergy to Botox® toxin
• Hematuria that has not been worked up
• Known bladder malignancy
• Previous history of bladder augmentation
• Currently pregnant (with no plans to become pregnant within 6 months of enrollment) or breastfeeding
• Currently taking aminoglycoside antibiotics
• Post-void residual (PVR) >150 cc (measured by bladder scan or by catheterization) prior to enrollment
• History of chronic pain or pain syndromes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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41 participants in 2 patient groups

10 Botox Injections

Active Comparator group

Description:

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.

Treatment:

Drug: OnabotulinumtoxinA 100 Units

20 Botox Injections

Active Comparator group

Description:

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.

Treatment:

Drug: OnabotulinumtoxinA 100 Units