Overactive Bladder Syndrome
Conditions
Brief summary
Treatment of overactive bladder (OAB) has been treated successfully by the injection of Botox. The Repris injection needle has a deflection that may assist in injection difficult to reach with standard straight needles. This study will assess the success, safety and patient tolerance of this new injection needle.
Detailed description
This is a prospective, multicenter, single arm study of the Repris injection needle to administer Botox to the bladder wall in patients with an overactive bladder. Following advancement of a cystoscope to the patient's bladder, the Repris needle will be advanced to the area of interest and into the bladder wall in order to administer the recommended volume of Botox. After injection, the needle will be removed and the procedure will be concluded. The patient will be asked to rank her tolerance of the procedure and level of discomfort using a standardized pain scale before being released. Five days after the procedure the patient will be contacted by telephone to determine whether any adverse events had occurred since release.
Interventions
DEVICERepris Needle
Injection of Botox
Sponsors
Uro-1 Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (18 years of age or older) * Able to undergo routine cystoscopy * Willing to provide verbal assessment of her condition within 5 days after the procedure
Exclusion criteria
* History of urethral strictures * Presence of a suprapubic catheter or tube due to urethral trauma * history of interstitial cystitis * currently being treated for a urinary tract infection (UTI) * gross hematuria present * Known allergy or sensitivity to any component of the medication or solution to be injected during the study * is pregnant, lactating, or with child-bearing potential unable or unwilling to use a reliable form of contraception while participating in the study * cannot empty her bladder on her own and is routinely catheterizing the urethra * unable to read, understand, and/or provide a ranking of pain level during the procedure, * unable or unwilling to provide consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Success | 1 Day of the procedure | Percentage of subjects with successful injection of medication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Tolerance of Injection | 1 Day of the procedure | Level of pain from use of the needle measured on Likert Scale 1 to 5 |
| Adverse Events during Procedure | Day 0 and Day 5 | Incidence and Severity of Adverse events associated with the injection |
Countries
United States
Contacts
Primary ContactThomas Lawson, PhD
Backup ContactJack Snoke
Outcome results
None listed