Status:
UNKNOWN
The Effect of Local Anesthetic Solution in the Bladder Prior to Botox Injections in the Bladder
Lead Sponsor:
Herlev and Gentofte Hospital
Collaborating Sponsors:
Region Hovedstadens Apotek
Conditions:
Urge Incontinence
Overactive Bladder
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate the effect of Lidocaine solution versus placebo (isotonic Sodium Chloride NaCl) disposed inside the urinary bladder as intravesical anesthesia prior to onab...
Detailed Description
The aim of the study is to investigate if bladder installed Lidocaine solution have an effect on reported pain during BTX-A injections compared to placebo. The study participants will be recruited fr...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Female, age ≥18 years
- Admitted to treatment with BTX-A injections at the Urogynecological Clinic at Herlev Hospital due to UUI
- Able to read and understand Danish
- The female accepts to receive BTX-A injections as an outpatient treatment without the option of receiving sedative drugs
- Exclusion criteria:
- BTX-A allergy
- Neurological disorder that may affect bladder function (e.g. Multiple sclerosis or spinal cord inju-ry)
- Neurological disorder with neuromuscular transmission failure (i.e. Mystenia Gravis)
- Ongoing UTI or symptoms of UTI prior to treatment, assessed by principal investigator
- Any other bladder pathology at the time of cystoscopy if identified (includes trauma, stones, tu-mor)
- Pregnancy/breastfeeding women
Exclusion
Key Trial Info
Start Date :
September 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05415865
Start Date
September 12 2022
End Date
May 1 2024
Last Update
September 22 2022
Active Locations (1)
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1
Kvinde- og Bækkenbundssygdomme, klinik 1
Herlev, Capital Region, Denmark, 2730