Vaginal Baclofen Suppositories in Chronic Pelvic Pain

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.

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: Baclofen 20mg vaginal suppository daily per vagina and 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: 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

Randomization will be carried out by a computer-based algorithm that will generate study/subject number. This number will correspond with treatment and communicate to The Louisville compounding pharmacy the appropriate drug to distribute without the unblinding of patient or provider. with a stratified block randomization scheme (with a random block size of 4, 6, and 8 participants). Randomization will be stratified based on pelvic muscle tenderness on exam - stratifying by 0-5/10 and 6-10/10 tenderness of pelvic floor musculature on physical exam

20 mg baclofen vaginal suppository in Supposibase F daily per vagina - to be compounded by The Louisville Compounding Pharmacy

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 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

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

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 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 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 to determine if results are clouded by other, appropriate, evidence based treatments received for chronic pelvic pain.

Inclusion Criteria: 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

This study information will be sourced from the subjects. Identifying information and data collected during this study will be kept secure and confidential. For confidentiality, only research team members will have access to the study information in the database. Subjects will be assigned a unique study ID that will be used on all case report forms and database reporting. The database that will be used is REDCap which is HIPPA (Health Insurance Portability and Accountability Act of 1996) compliant, encrypted, and password protected. Any hard copies will be maintained in a locked cabinet in a locked office by a member of the research team. The research personnel in this study are CITI and HIPAA trained. If new research personnel are added, an amendment will be submitted to and approved by the IRB before being allowed to participate in the study

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