Active treatment for Urge Incontinence

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Urge Incontinence+3 MoreBicarbonate protocol - Drug
Eligibility
18+
Female
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Study Summary

This trial will compare two protocols for pain control during botox injections for people with urinary incontinence.

Eligible Conditions
  • Urge Incontinence
  • Overactive Bladder
  • Hyperactivity

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Immediately after the procedure, 2 weeks post treatment

Baseline, pre-procedure
Pelvic Floor Distress Inventory (PFDI-20) Scores
Immediately after the procedure
Pain: VAS
Satisfaction: Likert scale
Willingness to undergo repeat procedure
Week 2
Adverse events

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Active treatment
1 of 2
Placebo treatment
1 of 2

Active Control

Non-Treatment Group

72 Total Participants · 2 Treatment Groups

Primary Treatment: Active treatment · Has Placebo Group · Phase 4

Placebo treatment
Drug
PlaceboComparator Group · 1 Intervention: Standard protocol · Intervention Types: Drug
Active treatment
Drug
ActiveComparator Group · 1 Intervention: Bicarbonate protocol · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: immediately after the procedure, 2 weeks post treatment

Who is running the clinical trial?

Boston Urogynecology AssociatesLead Sponsor
9 Previous Clinical Trials
868 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 4 Total Inclusion Criteria

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