Botulinum Toxin for Pelvic Pain in Women With Endometriosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01553201|
Recruitment Status : Recruiting
First Posted : March 14, 2012
Last Update Posted : April 4, 2018
- 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.
- To see if botulinum toxin can relieve pain from pelvic floor spasm in women with pelvic pain.
- 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).
- 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|
|Endometriosis Botulinum Toxin A Chronic Pelvic Pain Pelvic Muscle Spasms Quality of Life||Drug: Botuninum toxin A||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effectiveness of Botulinum Toxin on Persistent Pelvic Pain in Women With Endometriosis|
|Study Start Date :||February 27, 2012|
|Estimated Primary Completion Date :||January 1, 2019|
|Estimated Study Completion Date :||December 31, 2019|
- Improvement in pain - a binary measurement of improvement/no improvement will be used.
- 1) Need for re-injection at 1 month as a binary measurement of yes/no; 2) Change in Pelvic Pain: Pain visual analog score; 3) Botulinum toxin patient response inventory; 4) Standardized Pelvic Pain questionnaire; 5) Standardized QOL questionnair...
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01553201
|Contact: Pamela Stratton, M.D.||(301) firstname.lastname@example.org|
|Contact: Barbara I Karp, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Barbara I Karp, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|