Vulvodynia (Investigational)

Краткая информация для пациента

Есть ли FDA-допуск для этого показания?

Not FDA-cleared for vulvodynia. FDA cleared medicinal leeches only for venous congestion in microsurgical reconstruction (K040187, 2004). Use here is highly investigational, paraspinal placement only.

Какие доказательства существуют?

Tier C (highly investigational). Only isolated case reports describe sacral / paraspinal application; there are no randomized controlled trials. Evidence-based management per ACOG and ISSVD includes pelvic floor physical therapy (a cornerstone), topical lidocaine 5 percent or topical estrogen for hormonal-mediated vestibulodynia, tricyclic antidepressants (amitriptyline, nortriptyline), gabapentin or pregabalin, and selective surgical vestibulectomy for refractory provoked vestibulodynia. Cognitive behavioral therapy and sex therapy are valuable adjuncts.

Основные риски

• Bleeding from bite sites for 6 to 24 hours after detachment
• Bruising and tenderness over the sacrum / lower back for 5 to 10 days
• Local skin infection or, rarely, Aeromonas infection
• Allergic reaction to leech saliva (uncommon)
• Worsening of vulvar pain in the first 24 hours
• Small permanent scars at bite sites
• Delay or replacement of pelvic floor physical therapy or evidence-based pharmacotherapy
• Dangerous mucosal contamination if any vulvar / vaginal placement is attempted

Кому не следует это рассматривать

• Patients who are pregnant
• Any consideration of vulvar, vaginal, or perineal placement (mucosal placement is absolutely contraindicated)
• Patients with active vulvovaginal infection (candidiasis, bacterial vaginosis, herpes) or dermatosis (lichen sclerosus, lichen planus, lichen simplex chronicus)
• Patients with untreated comorbid depression or anxiety contributing to pain perception
• Patients who have not engaged with pelvic floor physical therapy
• Patients on anticoagulants, with hemophilia, or with severe anemia

О чём спросить врача

• Has my vulvodynia been classified (localized vs generalized, provoked vs spontaneous, primary vs secondary)?
• Have other causes been ruled out (lichen sclerosus, lichen planus, atrophic vulvitis, recurrent yeast / BV, infection, pudendal neuralgia)?
• Am I engaged with a pelvic floor physical therapist?
• Have I tried topical lidocaine, topical estrogen (if appropriate), TCAs, or gabapentinoids?
• If provoked vestibulodynia is refractory, am I a candidate for surgical vestibulectomy?
• Has the practitioner explained that NO vulvar / vaginal placement is permitted — only sacral / paraspinal?
• What is the practitioner's experience and Aeromonas-prevention plan?

Когда срочно обратиться за медицинской помощью

• New severe vulvar pain with ulceration, blistering, or discharge (rule out herpes, candida, bacterial infection)
• Severe pelvic pain unrelated to typical vulvodynia
• Sudden urinary retention, severe dysuria, or hematuria
• Spreading redness, warmth, pus, or red streaks on the lower back (cellulitis)
• Bleeding from a bite site lasting more than 24 to 48 hours
• Fever above 38.0 C / 100.4 F or chills
• Hives, throat tightness, or breathing difficulty