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Botulinum Toxin Type A Versus Saline Trigger Point Injections for Myofascial Pelvic Pain

NCT01905137 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2019-04-12

No results posted yet for this study

Summary

The purpose of this study is to determine whether there is a change in patient-reported pelvic pain following pelvic floor injections of 200 units of Botox compared with 20cc of normal saline.

Conditions

  • Myofascial Pelvic Pain

Interventions

DRUG

Intervention-Botulinum Toxin Type A

Patients will receive 200 units of Botulinum Toxin A diluted in 20 mL of preservative free saline to their pelvic floor followed by pelvic floor physical therapy.

DRUG

placebo

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Boston Urogynecology Associates

    lead OTHER

Principal Investigators

  • Eman A Elkadry, MD · Mount Auburn Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2018-03-09
Completion
2019-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01905137 on ClinicalTrials.gov