Chronic Pelvic Pain Syndrome
Conditions
Keywords
Baclofen, vaginal suppository, pelvic floor muscle dysfunction
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.
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: 1. Baclofen 20mg vaginal suppository daily per vagina and 2. 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
Interventions
DRUG20 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
DRUGPlacebo
Vaginal suppository composed of Supposibase F daily per vagina
Sponsors
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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
Intervention model description
This is a single-center, double-blinded, placebo-controlled, randomized trial.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
STUDY_DIRECTORRodger W Rothenberger, MD
University of Louisville
Outcome results
None listed