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Botulinum Toxin for Pelvic Pain in Women With Endometriosis

NCT01553201 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-07-28

Study results available
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Summary

Background:

\- Some women with endometriosis have chronic pelvic pain. This pain may be caused by spasms of the pelvic floor muscles. These spasms can be detected by an examination. Studies suggest that botulinum toxin can help treat problems caused by muscle spasms. Researchers want to see if botulinum toxin injections into the pelvic floor muscles can decrease pain and spasms in women with pelvic pain.

Objectives:

\- To see if botulinum toxin can relieve pain from pelvic floor spasm in women with pelvic pain.

Eligibility:

\- Women between 18 and 50 years of age with pain associated with pelvic muscle spasm and endometriosis. Pain must be persistent (lasting for at least 3 months).

Design:

* Participants will keep a pain diary and record their pain medication use for a month before the first visit.
* Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Participants will also answer questions about their pain levels and quality of life.
* Participants will receive either botulinum toxin or a placebo (salt water) injection. The injection will be given into the pelvic floor muscles through the vaginal wall. Participants will take a muscle relaxant like Valium and have anesthetic cream put on the vaginal wall before the injection.
* After the injection, participants will keep a pain diary for another month.
* At a 1-month followup visit, participants will answer questions about their pain. If the pain has not improved, all participants may have a botulinum toxin injection (no placebo) into the pelvic floor muscles as before.
* Participants will have followup visits for up to a year after the initial 1-month followup visit.

Conditions

  • Endometriosis
  • Chronic Pelvic Pain
  • Pelvic Muscle Spasm
  • Quality of Life

Interventions

DRUG

Botulinum toxin (BoNT)

OnabotulinumtoxinA 100 Units diluted in 4cc saline, one time intramuscular administration

DRUG

Placebo

Saline, 4cc, one time intramuscular administration

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    lead NIH

Principal Investigators

  • Barbara I Karp, M.D. · National Institute of Neurological Disorders and Stroke (NINDS)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-07-30
Primary Completion
2018-07-31
Completion
2019-07-24
FDA Drug
Yes

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 NCT01553201 on ClinicalTrials.gov