Vaginal Baclofen Suppositories in Chronic Pelvic Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Baclofen in Chronic Pelvic Pain, a Randomized, Double-Blind, Placebo Controlled Trial

Conditions
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Chronic Pelvic Pain Syndrome

Intervention / Treatment
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* Drug: 20 mg baclofen vaginal suppository daily per vagina
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a single-center, double-blinded, placebo-controlled, randomized trial.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vaginal baclofen suppository<br>Baclofen 20mg in Supposibase F vaginal suppository daily per vagina | Drug: 20 mg baclofen vaginal suppository daily per vagina<br>* 20 mg baclofen vaginal suppository in Supposibase F daily per vagina - to be compounded by The Louisville Compounding Pharmacy<br>|
| Placebo Comparator: Vaginal placebo suppository<br>Supposibase F vaginal suppository daily per vagina | Drug: Placebo<br>* Vaginal suppository composed of Supposibase F daily per vagina<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue Score (VAS) 1-100 for pain | VAS is a 1-100mm scale with lower scores indicating less pain | at 8 weeks of suppository use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score | 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 | at baseline and at 4, 8 and 12 weeks | 
| Pelvic floor impact questionnaire | 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 | at baseline and at 4, 8, and 12 week follow up | 
| Pelvic floor disability index (PFDI) questionnaire | 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 | at baseline and at 4, 8, and 12 week follow up | 
| Visual analogue Score (VAS) 1-100 for pain | VAS is a 1-100mm scale with lower scores indicating less pain | at baseline and at 4 and 12 week follow up | 
| O'Leary Sant questionnaire | O'Leary Sant questionnaire is a 0 to 37 point score with higher points indicating increased symptoms | at baseline and at 4, 8, and 12 week follow up | 
| Patient-Reported Outcomes Measurement Information System (PROMIS) global health score | 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 | at baseline and at 4, 8, and 12 week follow up | 
| Overall Satisfaction | 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. | at 4, 8, and 12 week follow up | 
| Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual function score | 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 | at 0, 4, 8, and 12 week follow up | 
| Number of other treatments for chronic pelvic pain during the trial period | 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. | at 4, 8, and 12 week follow up | 
| Pill Count | Pill Count to determine how many doses of the study medication have been missed | at 4, 8, and 12 week follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Baclofen, vaginal suppository, pelvic floor muscle dysfunction