Clinical trial NCT05968937: Vaginal Baclofen Suppositories in Chronic Pelvic Pain
Official title: Baclofen in Chronic Pelvic Pain, a Randomized, Double-Blind, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Pelvic Pain Syndrome
Keywords: Baclofen
vaginal suppository
pelvic floor muscle dysfunction
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-center, double-blinded, placebo-controlled, randomized trial.
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Visual analogue Score (VAS) 1-100 for pain
timeFrame: at 8 weeks of suppository use
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference score
timeFrame: at baseline and at 4, 8 and 12 weeks
measure: Pelvic floor impact questionnaire
timeFrame: at baseline and at 4, 8, and 12 week follow up
measure: Pelvic floor disability index (PFDI) questionnaire
timeFrame: at baseline and at 4, 8, and 12 week follow up
measure: Visual analogue Score (VAS) 1-100 for pain
timeFrame: at baseline and at 4 and 12 week follow up
measure: O'Leary Sant questionnaire
timeFrame: at baseline and at 4, 8, and 12 week follow up
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) global health score
timeFrame: at baseline and at 4, 8, and 12 week follow up
measure: Overall Satisfaction
timeFrame: at 4, 8, and 12 week follow up
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual function score
timeFrame: at 0, 4, 8, and 12 week follow up
measure: Number of other treatments for chronic pelvic pain during the trial period
timeFrame: at 4, 8, and 12 week follow up
measure: Pill Count
timeFrame: at 4, 8, and 12 week follow up
Other outcomes:
Locations:
city: Louisville
country: United States
facility: ULP Female Pelvic Medicine and Reconstructive Surgery - Springs Medical Center Suite 190
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Rodger W Rothenberger, MD
role: STUDY_DIRECTOR
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