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gabapentin for Pelvic Organ Prolapse (GROUP Trial)

Phase 3
Waitlist Available
Led By Danny Lovatsis, MD
Research Sponsored by Mount Sinai Hospital, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved

Summary

This trial is testing if gabapentin can reduce pain and the need for strong painkillers after surgery in women with pelvic organ prolapse and urinary incontinence. Gabapentin works by calming nerve activity to reduce pain signals. The goal is to see if patients need fewer strong painkillers after their surgery. Gabapentin has been used clinically to treat certain types of pain and has shown benefits in reducing pain after surgery.

Eligible Conditions
  • Pelvic Organ Prolapse

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
opioid consumption postop

Side effects data

From 2021 Phase 4 trial • 88 Patients • NCT03012815
2%
Allergic reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gabapentin
Benzodiazepine

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: gabapentinExperimental Treatment1 Intervention
gabapentin 300-600 mg 1 hour preop
Group II: placeboPlacebo Group1 Intervention
placebo capsule(s) 1 hour preop
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gabapentin
FDA approved

Find a Location

Who is running the clinical trial?

Mount Sinai Hospital, CanadaLead Sponsor
203 Previous Clinical Trials
69,392 Total Patients Enrolled
2 Trials studying Pelvic Organ Prolapse
43 Patients Enrolled for Pelvic Organ Prolapse
Danny Lovatsis, MDPrincipal InvestigatorSinai Health System
1 Previous Clinical Trials
40 Total Patients Enrolled
~5 spots leftby Nov 2025
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