Botulinum Toxin for Pelvic Pain in Women With Endometriosis
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Botulinum toxin (BoNT) OnabotulinumtoxinA 100 Units diluted in 4cc saline, one time intramuscular administration |
Drug: Botulinum toxin (BoNT)
OnabotulinumtoxinA 100 Units diluted in 4cc saline, one time intramuscular administration
|
| Placebo Comparator: Placebo Saline, 4cc, one time intramuscular administration |
Drug: Placebo
Saline, 4cc, one time intramuscular administration
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Improvement in Pain [1 month]
Self reported improvement in pain symptoms - a binary measurement of improvement/no improvement
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | United States | 20892 |
Sponsors and Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
- Principal Investigator: Barbara I Karp, M.D., National Institute of Neurological Disorders and Stroke (NINDS)
Study Documents (Full-Text)
More Information
Additional Information:
Publications
- 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.
- Bhidayasiri R, Truong DD. Expanding use of botulinum toxin. J Neurol Sci. 2005 Aug 15;235(1-2):1-9. Review.
- Jankovic J. Botulinum toxin in clinical practice. J Neurol Neurosurg Psychiatry. 2004 Jul;75(7):951-7. Review.
- 120083
- 12-N-0083
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Botulinum Toxin (BoNT) | Placebo |
|---|---|---|
| Arm/Group Description | OnabotulinumtoxinA 100 Units diluted in 4cc saline, one time intramuscular administration | Saline, 4cc, one time intramuscular administration |
| Period Title: Overall Study | ||
| STARTED | 15 | 15 |
| COMPLETED | 15 | 15 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Botulinum Toxin (BoNT) | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | OnabotulinumtoxinA 100 Units diluted in 4cc saline, one time intramuscular administration | Saline, 4cc, one time intramuscular administration | Total of all reporting groups |
| Overall Participants | 15 | 14 | 29 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
15
100%
|
14
100%
|
29
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
15
100%
|
14
100%
|
29
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
1
6.7%
|
3
21.4%
|
4
13.8%
|
| Not Hispanic or Latino |
14
93.3%
|
11
78.6%
|
25
86.2%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
6.7%
|
0
0%
|
1
3.4%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
3
20%
|
0
0%
|
3
10.3%
|
| White |
10
66.7%
|
13
92.9%
|
23
79.3%
|
| More than one race |
1
6.7%
|
1
7.1%
|
2
6.9%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Botulinum Toxin (BoNT) | Placebo |
|---|---|---|
| Arm/Group Description | OnabotulinumtoxinA 100 Units diluted in 4cc saline, one time intramuscular administration | Saline, 4cc, one time intramuscular administration |
| Measure Participants | 15 | 14 |
| Count of Participants [Participants] |
11
73.3%
|
4
28.6%
|
Adverse Events
| Time Frame | 1 month | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Botulinum Toxin (BoNT) | Placebo | ||
| Arm/Group Description | OnabotulinumtoxinA 100 Units diluted in 4cc saline, one time intramuscular administration | Saline, 4cc, one time intramuscular administration | ||
All Cause Mortality |
||||
| Botulinum Toxin (BoNT) | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/15 (0%) | 0/15 (0%) | ||
Serious Adverse Events |
||||
| Botulinum Toxin (BoNT) | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/15 (0%) | 0/15 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Botulinum Toxin (BoNT) | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/15 (46.7%) | 2/15 (13.3%) | ||
| Nervous system disorders | ||||
| Muscular weakness | 0/15 (0%) | 0 | 1/15 (6.7%) | 1 |
| Migraine | 1/15 (6.7%) | 1 | 1/15 (6.7%) | 1 |
| Pelvic pain | 3/15 (20%) | 3 | 0/15 (0%) | 0 |
| Renal and urinary disorders | ||||
| Urinary hesitation | 2/15 (13.3%) | 2 | 0/15 (0%) | 0 |
| Micturition urgency | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Barbara Karp, MD |
|---|---|
| Organization | National Institute of Neurological Disorders & Stroke |
| Phone | 301-496-0150 |
| karpb@ninds.nih.gov |
- 120083
- 12-N-0083