Vaginal Baclofen Suppositories in Chronic Pelvic Pain
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate if baclofen vaginal suppositories improve symptoms of Chronic Pelvic Pain (CPP).
Participants in this study will take four short questionnaires prior to being randomized. Randomization is like flipping a coin; participants have an equal likelihood of being randomized to the treatment group (vaginal baclofen suppositories) or placebo group (vaginal suppository without baclofen ingredient). Participants will take their assigned treatment nightly for 8 weeks. Follow up visits will be at the 4 and 8 week time frames, when questionnaires will again be completed. Participants may receive additional treatments for CPP during the course of the study. After 8 weeks Participants will be offered a prescription for baclofen suppositories and the study drug will be stopped. Follow up on patient symptoms with questionnaires will again occur at 12 weeks.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Study Design/Methodology
This is a single center, double-blinded, placebo-controlled, randomized trial. Women will be recruited from a subspecialty clinic at the University of Louisville and be eligible for participation if they meet the diagnosis of Chronic Pelvic Pain and are between the ages of 18-65 years old. Eligible, consenting participants will undergo randomization with equal probability of assignment to one of the two groups:
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Baclofen 20mg vaginal suppository daily per vagina and
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placebo.
Participants will be blinded to study allocation. Baclofen or placebo suppositories will be continued to 8 weeks, at which time all participants will be offered a baclofen suppository prescription. Patients will then follow up at the 12 week mark and whether they continued baclofen suppositories and pill count will be recorded in addition to the below questionnaires.
Clinical outcomes and questionnaires will be assessed at baseline and after 4, 8, and 12 weeks of treatment. Participants will be randomized with a stratified block randomization scheme (with a random block size of 4, 6, and 8 participants).
Participants will be required to come in for at least 1 visit at 8 weeks to assess pelvic muscle dysfunction and perform pill count.
We hypothesize a significant change in PROMIS Pain Interference score, patient satisfaction, PROMIS global health scores, and PROMIS sexual function scores for patients assigned to the baclofen treatment arm.
Inclusion Criteria:
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Women ages 18-65 years old
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Women are not sexually active, sexually active with same sex partners or are on effective contraception
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Diagnosed with Chronic Pelvic Pain
Exclusion Criteria:
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Gross hematuria
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Currently pregnant or breastfeeding
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Unable to speak and read English
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History of allergic reaction to baclofen tablet
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History of allergic reaction to components of placebo (coconut oil)
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History of gastrointestinal, genitourinary, or pelvic cancer in the last 5 years
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Vaginal baclofen suppository Baclofen 20mg in Supposibase F vaginal suppository daily per vagina |
Drug: 20 mg baclofen vaginal suppository daily per vagina
20 mg baclofen vaginal suppository in Supposibase F daily per vagina - to be compounded by The Louisville Compounding Pharmacy
|
| Placebo Comparator: Vaginal placebo suppository Supposibase F vaginal suppository daily per vagina |
Drug: Placebo
Vaginal suppository composed of Supposibase F daily per vagina
|
Outcome Measures
Primary Outcome Measures
- Visual analogue Score (VAS) 1-100 for pain [at 8 weeks of suppository use]
VAS is a 1-100mm scale with lower scores indicating less pain
Secondary Outcome Measures
- Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score [at baseline and at 4, 8 and 12 weeks]
Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference score is a 40-200 point scale with lower values indicating lower pain interference with quality of life
- Pelvic floor impact questionnaire [at baseline and at 4, 8, and 12 week follow up]
pelvic floor impact questionnaire is a 0-63 point composite scale consisting of questions concerning bladder/urinary, bowel/rectal, and vaginal/pelvic symptoms with higher values indicating higher symptoms
- Pelvic floor disability index (PFDI) questionnaire [at baseline and at 4, 8, and 12 week follow up]
the pelvic floor disability index (PFDI) questionnaire is a composite questionnaire on a 0-80 point scale containing questions regarding pelvic organ prolapse, colorectal/anal distress, and urinary distress questions with higher scores indicating higher symptoms
- Visual analogue Score (VAS) 1-100 for pain [at baseline and at 4 and 12 week follow up]
VAS is a 1-100mm scale with lower scores indicating less pain
- O'Leary Sant questionnaire [at baseline and at 4, 8, and 12 week follow up]
O'Leary Sant questionnaire is a 0 to 37 point score with higher points indicating increased symptoms
- Patient-Reported Outcomes Measurement Information System (PROMIS) global health score [at baseline and at 4, 8, and 12 week follow up]
Patient-Reported Outcomes Measurement Information System (PROMIS) global health score is a 9-45 point scale with higher scores indicating better overall health and quality of life
- Overall Satisfaction [at 4, 8, and 12 week follow up]
Overall Satisfaction is a yes/no questionnaire with if "yes" is selected one selects choices from "somewhat" to "quite a bit" in satisfaction. "quite a bit" would indicate greater satisfaction.
- Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual function score [at 0, 4, 8, and 12 week follow up]
Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual function score is a 9-36 point score with higher scores indicating higher bother related to sexual function
- Number of other treatments for chronic pelvic pain during the trial period [at 4, 8, and 12 week follow up]
Number of other treatments for chronic pelvic pain during the trial period to determine if results are clouded by other, appropriate, evidence based treatments received for chronic pelvic pain.
- Pill Count [at 4, 8, and 12 week follow up]
Pill Count to determine how many doses of the study medication have been missed
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women ages 18-65 years old
-
Women are not sexually active, sexually active with same sex partners or are on effective contraception
-
Diagnosed with Chronic Pelvic Pain
Exclusion Criteria:
-
Gross hematuria
-
Currently pregnant or breastfeeding
-
Unable to speak and read English
-
History of allergic reaction to baclofen tablet
-
History of allergic reaction to components of placebo (coconut oil)
-
History of gastrointestinal, genitourinary, or pelvic cancer in the last 5 years
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Louisville
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Amtmann D, Kim J, Chung H, Askew RL, Park R, Cook KF. Minimally important differences for Patient Reported Outcomes Measurement Information System pain interference for individuals with back pain. J Pain Res. 2016 Apr 27;9:251-5. doi: 10.2147/JPR.S93391. eCollection 2016.
- Brawn J, Morotti M, Zondervan KT, Becker CM, Vincent K. Central changes associated with chronic pelvic pain and endometriosis. Hum Reprod Update. 2014 Sep-Oct;20(5):737-47. doi: 10.1093/humupd/dmu025. Epub 2014 Jun 11.
- Chronic Pelvic Pain: ACOG Practice Bulletin, Number 218. Obstet Gynecol. 2020 Mar;135(3):e98-e109. doi: 10.1097/AOG.0000000000003716.
- Das S, Palappalllil DS, Purushothaman ST, Rajan V. An Unusual Case of Baclofen Abuse. Indian J Psychol Med. 2016 Sep-Oct;38(5):475-476. doi: 10.4103/0253-7176.191383.
- Doggweiler R, Whitmore KE, Meijlink JM, Drake MJ, Frawley H, Nordling J, Hanno P, Fraser MO, Homma Y, Garrido G, Gomes MJ, Elneil S, van de Merwe JP, Lin ATL, Tomoe H. A standard for terminology in chronic pelvic pain syndromes: A report from the chronic pelvic pain working group of the international continence society. Neurourol Urodyn. 2017 Apr;36(4):984-1008. doi: 10.1002/nau.23072. Epub 2016 Aug 26.
- Frederice CP, Brito LGO, Pereira GMV, Lunardi ALB, Juliato CRT. Interventional treatment for myofascial pelvic floor pain in women: systematic review with meta-analysis. Int Urogynecol J. 2021 May;32(5):1087-1096. doi: 10.1007/s00192-021-04725-x. Epub 2021 Feb 27.
- Juergens S. Alprazolam and diazepam: addiction potential. J Subst Abuse Treat. 1991;8(1-2):43-51. doi: 10.1016/0740-5472(91)90026-7.
- Lamvu G, Carrillo J, Ouyang C, Rapkin A. Chronic Pelvic Pain in Women: A Review. JAMA. 2021 Jun 15;325(23):2381-2391. doi: 10.1001/jama.2021.2631.
- Mathias SD, Kuppermann M, Liberman RF, Lipschutz RC, Steege JF. Chronic pelvic pain: prevalence, health-related quality of life, and economic correlates. Obstet Gynecol. 1996 Mar;87(3):321-7. doi: 10.1016/0029-7844(95)00458-0.
- Meister MR, Sutcliffe S, Ghetti C, Chu CM, Spitznagle T, Warren DK, Lowder JL. Development of a standardized, reproducible screening examination for assessment of pelvic floor myofascial pain. Am J Obstet Gynecol. 2019 Mar;220(3):255.e1-255.e9. doi: 10.1016/j.ajog.2018.11.1106. Epub 2018 Dec 7.
- Messelink B, Benson T, Berghmans B, Bo K, Corcos J, Fowler C, Laycock J, Lim PH, van Lunsen R, a Nijeholt GL, Pemberton J, Wang A, Watier A, Van Kerrebroeck P. Standardization of terminology of pelvic floor muscle function and dysfunction: report from the pelvic floor clinical assessment group of the International Continence Society. Neurourol Urodyn. 2005;24(4):374-80. doi: 10.1002/nau.20144. No abstract available.
- Moldwin RM, Fariello JY. Myofascial trigger points of the pelvic floor: associations with urological pain syndromes and treatment strategies including injection therapy. Curr Urol Rep. 2013 Oct;14(5):409-17. doi: 10.1007/s11934-013-0360-7.
- Shafrir AL, Martel E, Missmer SA, Clauw DJ, Harte SE, As-Sanie S, Sieberg CB. Pelvic floor, abdominal and uterine tenderness in relation to pressure pain sensitivity among women with endometriosis and chronic pelvic pain. Eur J Obstet Gynecol Reprod Biol. 2021 Sep;264:247-253. doi: 10.1016/j.ejogrb.2021.07.029. Epub 2021 Jul 22.
- Stone RH, Abousaud M, Abousaud A, Kobak W. A Systematic Review of Intravaginal Diazepam for the Treatment of Pelvic Floor Hypertonic Disorder. J Clin Pharmacol. 2020 Dec;60 Suppl 2:S110-S120. doi: 10.1002/jcph.1775.
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