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Evaluation of Intradetrusor AbobotulinumtoxinA and IncobotulinumtoxinA in Women With Overactive Bladder

NCT06250543 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-02-12

No results posted yet for this study

Summary

A randomized, single blind, non-inferiority clinical study was performed evaluating the efficacy and safety of AbobotulinumtoxinA vs. IncobotulinumtoxinA intradetrusor injections in women with overactive bladder and urge urinary incontinence. Also the effect of local anesthesia on pain level of the procedure was assessed.

Conditions

Interventions

DRUG

AbobotulinumtoxinA 300 UNT

20 evenly distributed intradetrusor injections, 1 ml per site, were performed

DRUG

IncobotulinumtoxinA 100 UNT

20 evenly distributed intradetrusor injections, 1 ml per site, were performed

DRUG

Lidocain

30 minutes before the procedure the bladder was instilled with 40 ml of 1% lidocaine solution using a 16Fr urethral Foley catheter

OTHER

placebo

30 minutes before the procedure the bladder was instilled with 40 ml of 0.9% NaCl solution

Sponsors & Collaborators

  • Niko Kavcic

    lead OTHER

Principal Investigators

  • Niko Kavčič, MD · University Medical Centre Maribor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-14
Primary Completion
2022-11-25
Completion
2022-11-25

Countries

  • Slovenia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06250543 on ClinicalTrials.gov