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Botulinum Toxin for Pelvic Pain in Women With Endometriosis

Primary Purpose

Endometriosis, Chronic Pelvic Pain, Pelvic Muscle Spasm

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Botulinum toxin (BoNT)
Placebo
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Quality of Life, Endometriosis, Botulinum Toxin A, Pelvic Floor Muscle Spasm, Chronic Pelvic Pain

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers
  • INCLUSION CRITERIA:
  • Female gender
  • Age between 18 and 55
  • History of endometriosis at surgery
  • Persistent pelvic pain for at least 3 months
  • Pelvic floor spasm
  • Negative pregnancy test (in women who have not had a hysterectomy)
  • Willing to use reliable method of contraception for the month after botulinum toxin injection including oral contraceptives, IUD, and barrier with spermicide.
  • Willing and able to give informed consent
  • Willing and able to comply with study requirements

EXCLUSION CRITERIA:

  • Women with other causes of chronic pelvic pain including infectious, gastrointestinal, psychological disorders, fibromyalgia and chronic fatigue syndrome based on review of medical history within 1 year of first study visit,
  • Untreated severe cervical dysplasia or other gynecologic condition clinically significant abnormalities on physical or laboratory examinations that require evaluation or treatment or that would make participation unsafe
  • Hysterectomy and bilateral salpingo-oophorectomy
  • Pregnancy
  • Lactation
  • Allergy to albumen or botulinum toxin
  • Presence of antibodies to botulinum toxin or loss of response to previous injections for any indication
  • A known neuromuscular junction disorder such as myasthenia gravis or Eaton-Lambert syndrome
  • History of urinary or fecal incontinence

  • Known pelvic prolapse

    • Eligibility will be based on a physical exam at NIH at the first study visit, as well as history and available medical records within 1 year before the study visit. Negative test results will be documented to confirm study eligibility. If the Pap and the GC and chlamydia tests were not done outside of the NIH within the previous year, or if documentation of the negative test results is not available, we will await the results of the screening tests done at the NIH before administering the study medication.

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Botulinum toxin (BoNT)

Placebo

Arm Description

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

Saline, 4cc, one time intramuscular administration

Outcomes

Primary Outcome Measures

Number of Participants With Improvement in Pain
Self reported improvement in pain symptoms - a binary measurement of improvement/no improvement

Secondary Outcome Measures

Full Information

First Posted
March 10, 2012
Last Updated
July 15, 2020
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT01553201
Brief Title
Botulinum Toxin for Pelvic Pain in Women With Endometriosis
Official Title
The Effectiveness of Botulinum Toxin on Persistent Pelvic Pain in Women With Endometriosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
July 30, 2014 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
Chronic pelvic pain associated with endometriosis is poorly understood. Some women with chronic pelvic pain have muscle spasm of their pelvic muscles. Muscle spasm may be a significant part of pain in women with endometriosis and other types of chronic pelvic pain. Botulinum toxin injection is widely used to treat conditions associated with excessive muscle activity and spasm. Studies of botulinum toxin injected into pelvic muscles of women with pelvic pain have shown a decrease pain and spasm, but too few women have been studied to conclude its effectiveness. We expect to show that botulinum toxin injection in women with pelvic pain will relieve some of their pelvic pain. Eligible subjects will be otherwise healthy women who have chronic pelvic pain and a history of endometriosis. Subjects will be randomized to either botulinum toxin injection or placebo (salt water) injection. After one month, we will evaluate the presence of the pain and all women will be offered botulinum toxin injection. We will also evaluate the need for reinjection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Chronic Pelvic Pain, Pelvic Muscle Spasm, Quality of Life
Keywords
Quality of Life, Endometriosis, Botulinum Toxin A, Pelvic Floor Muscle Spasm, Chronic Pelvic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botulinum toxin (BoNT)
Arm Type
Experimental
Arm Description
OnabotulinumtoxinA 100 Units diluted in 4cc saline, one time intramuscular administration
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline, 4cc, one time intramuscular administration
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin (BoNT)
Intervention Description
OnabotulinumtoxinA 100 Units diluted in 4cc saline, one time intramuscular administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline, 4cc, one time intramuscular administration
Primary Outcome Measure Information:
Title
Number of Participants With Improvement in Pain
Description
Self reported improvement in pain symptoms - a binary measurement of improvement/no improvement
Time Frame
1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: Female gender Age between 18 and 55 History of endometriosis at surgery Persistent pelvic pain for at least 3 months Pelvic floor spasm Negative pregnancy test (in women who have not had a hysterectomy) Willing to use reliable method of contraception for the month after botulinum toxin injection including oral contraceptives, IUD, and barrier with spermicide. Willing and able to give informed consent Willing and able to comply with study requirements EXCLUSION CRITERIA: Women with other causes of chronic pelvic pain including infectious, gastrointestinal, psychological disorders, fibromyalgia and chronic fatigue syndrome based on review of medical history within 1 year of first study visit, Untreated severe cervical dysplasia or other gynecologic condition clinically significant abnormalities on physical or laboratory examinations that require evaluation or treatment or that would make participation unsafe Hysterectomy and bilateral salpingo-oophorectomy Pregnancy Lactation Allergy to albumen or botulinum toxin Presence of antibodies to botulinum toxin or loss of response to previous injections for any indication A known neuromuscular junction disorder such as myasthenia gravis or Eaton-Lambert syndrome History of urinary or fecal incontinence Known pelvic prolapse Eligibility will be based on a physical exam at NIH at the first study visit, as well as history and available medical records within 1 year before the study visit. Negative test results will be documented to confirm study eligibility. If the Pap and the GC and chlamydia tests were not done outside of the NIH within the previous year, or if documentation of the negative test results is not available, we will await the results of the screening tests done at the NIH before administering the study medication.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara I Karp, M.D.
Organizational Affiliation
National Institute of Neurological Disorders and Stroke (NINDS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17012454
Citation
Abbott JA, Jarvis SK, Lyons SD, Thomson A, Vancaille TG. Botulinum toxin type A for chronic pain and pelvic floor spasm in women: a randomized controlled trial. Obstet Gynecol. 2006 Oct;108(4):915-23. doi: 10.1097/01.AOG.0000237100.29870.cc.
Results Reference
background
PubMed Identifier
15990116
Citation
Bhidayasiri R, Truong DD. Expanding use of botulinum toxin. J Neurol Sci. 2005 Aug 15;235(1-2):1-9. doi: 10.1016/j.jns.2005.04.017.
Results Reference
background
PubMed Identifier
15201348
Citation
Jankovic J. Botulinum toxin in clinical practice. J Neurol Neurosurg Psychiatry. 2004 Jul;75(7):951-7. doi: 10.1136/jnnp.2003.034702.
Results Reference
background
PubMed Identifier
33326662
Citation
Phan VT, Stratton P, Tandon HK, Sinaii N, Aredo JV, Karp BI, Merideth MA, Shah JP. Widespread myofascial dysfunction and sensitisation in women with endometriosis-associated chronic pelvic pain: A cross-sectional study. Eur J Pain. 2021 Apr;25(4):831-840. doi: 10.1002/ejp.1713. Epub 2021 Jan 8.
Results Reference
derived
PubMed Identifier
31289238
Citation
Tandon HK, Stratton P, Sinaii N, Shah J, Karp BI. Botulinum toxin for chronic pelvic pain in women with endometriosis: a cohort study of a pain-focused treatment. Reg Anesth Pain Med. 2019 Jul 8:rapm-2019-100529. doi: 10.1136/rapm-2019-100529. Online ahead of print.
Results Reference
derived
Links:
URL
https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2012-N-0083.html
Description
NIH Clinical Center Detailed Web Page

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Botulinum Toxin for Pelvic Pain in Women With Endometriosis

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