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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04270526
Other study ID # 037-2019
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 15, 2020
Est. completion date June 30, 2023

Study information

Verified date July 2023
Source Boston Urogynecology Associates
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This will be a prospective double-blinded randomized controlled trial comparing two pre-treatment protocols for patients undergoing intradetrussor botox injections to determine if a buffered lidocaine solution offers superior pain control.


Description:

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Study Design


Intervention

Drug:
Bicarbonate protocol
Intradetrussor treatment with 50 mL 1% lidocaine + 45ml of 0.9% normal saline + 5 mL 8.4% sodium bicarbonate
Standard protocol
Intradetrussor treatment with 50 mL 1% lidocaine + 50ml of 0.9% normal saline

Locations

Country Name City State
United States Boston Urogynecology Associates Cambridge Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Boston Urogynecology Associates

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain: VAS Pain on VAS Immediately after the procedure
Secondary Satisfaction: Likert scale Likert scale questions assessing overall satisfaction with the procedure with responses from very dissatisfied to very satisfied Immediately after the procedure
Secondary Willingness to undergo repeat procedure Likert scale questions assessing the patient's willingness to undergo a repeat procedure from very likely to very unlikely Immediately after the procedure
Secondary Adverse events Urinary retention, defined as a post-void residual of greater than 100cc, will be assessed with a bladder scan at the two week post-procedure appointment Immediately after the procedure, 2 weeks post treatment
Secondary Pelvic Floor Distress Inventory (PFDI-20) Scores baseline Pelvic Floor Distress Inventory (PFDI-20), scores range from 0-300 with higher scores representing higher symptom burden Baseline, pre-procedure
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