Vaginal Baclofen in Chronic Pelvic Pain – a Retrospective Cohort Study

Objectives: To determine whether the use of vaginally placed baclofen is safe in the treatment of chronic pelvic pain.

Methods: A retrospective cohort study of patients who were treated for chronic pelvic pain with vaginally baclofen at a single institution was performed. Chronic pelvic pain conditions and additional treatments were assessed as well as dosage and frequency of use baclofen. Any reported side effects or adverse events were recorded.

Results: Between January 2018 and January, 2024, 291 women received a prescription for vaginal baclofen. The mean age of participants was 42.2 ± 14.11 years and the mean body mass index was 30.1 ± 19.8 kg/m2. Dosage varied across the cohort, 73.5% (214/291) receiving10 mg of baclofen and 26.5% (77/291) receiving 20 mg of baclofen. Frequency of administration varied within the cohort as well with 64.3% of patients receiving nightly baclofen, 19.2% receiving two times per day baclofen, and 16.5% receiving three times per day baclofen for vaginal insertion. These patients represented a number of different pelvic pain diagnoses, though all had pelvic floor muscle dysfunction. Within the cohort, 63.6% had interstitial cystitis (185/291), 15% had irritable bowel syndrome (44/291), 11.3% had endometriosis (33/291), and 59.1% had vulvodynia (172/291).
Adverse events were rare within the cohort. One patient developed a rash with a compounded vaginal suppository and was then switched to a vaginally placed baclofen oral tablet and had no skin reaction. Two patients had to discontinue the vaginal baclofen due to anxiety and tiredness which resolved upon discontinuation.

Conclusions: Vaginally placed baclofen is a safe treatment for chronic pelvic pain. Dose and frequency of administration differed over the cohort. Adverse events were rare across the cohort.