Pregabalin for Chronic Pelvic Pain in Women

Chronic Pelvic Pain, Chronic Pelvic Pain Syndrome

chronic pain, pregabalin, chronic pelvic pain

This multicenter, randomized, prospective, open-label, controlled trial will evaluate the efficacy and safety of oral pregabalin as an adjunct to standard conservative treatment in women with chronic pelvic pain (CPP). Approximately 308 women aged 18 to 65 years with moderate to severe CPP lasting more than 6 months will be enrolled and randomly assigned in a 1:1 ratio to either standard conservative treatment alone or standard conservative treatment plus oral pregabalin. Standard conservative treatment will follow a biopsychosocial management approach and may include patient education, body awareness therapy, cognitive interventions, and individualized conservative care. Participants assigned to the pregabalin group will receive oral pregabalin beginning at 150 mg/day in two divided doses. The dose may be gradually increased according to pain relief and tolerability, up to a maximum of 600 mg/day, and maintained for 12 weeks. The primary outcome is the change in mean pain intensity from baseline to Week 12, measured using a visual analogue scale (VAS), with scores ranging from 0 (no pain) to 10 (worst pain imaginable). Secondary outcomes include pain intensity at Weeks 2, 4, 8, and 12; pregabalin dosage; overall treatment satisfaction; health-related quality of life assessed using the Short Form-12 questionnaire; gynecologic pain assessed using the McCormack scale; and adverse events throughout the study. The total follow-up period is 12 weeks, with assessments conducted at Weeks 2, 4, 8, and 12. Because of the open-label design, participants and treating physicians will know the treatment assignment. Outcome assessors and statisticians will be blinded to treatment allocation. The study will determine whether adding pregabalin to standard conservative treatment improves pain and related patient-reported outcomes while maintaining an acceptable safety profile in women with CPP.

Chronic pelvic pain (CPP) in women is a persistent and multifactorial condition that can substantially affect physical functioning, emotional well-being, sexual health, and quality of life. Pain may arise from multiple overlapping pelvic, urinary, gynecologic, musculoskeletal, and psychosocial factors. Central sensitization, characterized by increased responsiveness of the nervous system to painful and nonpainful stimuli, is considered an important contributor to persistent pain in some patients. Consequently, symptom control often requires an individualized, multimodal approach. Conservative management, including education, physical and behavioral therapies, and other biopsychosocial interventions, is recommended for women with CPP. However, the response is variable, and some patients continue to experience clinically important pain despite these measures. Common pharmacologic options have limitations: evidence for long-term benefit from nonsteroidal anti-inflammatory drugs is limited, hormonal treatments are applicable only to selected pain conditions, and prolonged opioid therapy is generally discouraged because of safety concerns. Evidence for gabapentinoids in women with CPP is also inconsistent, creating a need to evaluate alternative treatment strategies. Pregabalin binds to the alpha-2-delta subunit of voltage-gated calcium channels and reduces the release of excitatory neurotransmitters involved in abnormal pain processing. Compared with gabapentin, pregabalin has more predictable absorption and dose-related pharmacokinetics, which may facilitate individualized dose adjustment. Although pregabalin has been studied in other chronic pain conditions and in men with chronic prostatitis/chronic pelvic pain syndrome, high-quality evidence in women with CPP remains limited. This study is designed to determine whether adding pregabalin to standard conservative care provides clinically meaningful symptom relief for women with moderate to severe CPP. The flexible dose-adjustment approach is intended to reflect clinical practice by balancing analgesic response and tolerability. In addition to pain, the study will examine patient satisfaction, health-related quality of life, gynecologic pain-related symptoms, treatment adherence, and adverse events. The findings may clarify the role of pregabalin as an adjunctive option for women whose symptoms remain insufficiently controlled with conservative treatment alone.

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