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

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A

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

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. History of chronic pain or pain syndromes