RESUMEN
OBJECTIVE: To evaluate quality of life (Qol), pain level and medical consumption before and after uterine botulinum toxin (BT) injections in severe dysmenorrhea, dyspareunia and chronic pelvic pain. METHODS: This was a before and after study using the database of a pilot study (Open-label non comparative study, on 30 patients, with severe dysmenorrhoea in therapeutic failure) assessing efficacy and cost of uterine injection of BT in women with chronic pelvic pain after failure of conventional treatment (hormonal and analgesics) (CT). Main clinical outcome: Patient Global Impression of Improvement (PGI-I), EuroQol health-related QoL (EQ-5D-5L), EuroQol-visual analogue scale (EQ-VAS), Female Sexual Function Index (FSFI), utility measure of health-related quality of life (also called health state preference values), cost and of health care consumption were collected prospectively and analysed in the two phases (before and after). The two timepoints were 12 months before uterine BT injection, when the patient had been receiving CT, and 12 months after uterine BT injection. RESULTS: Median visual analogue scale scores were significantly improved by BT regarding the patients' main source of pain (31.6 vs 80.55; p < 0.00001). We also noted a significant reduction in the proportion of patients who reported dyspareunia [15 (75%) vs 3 (15%) patients, p = 0.001] and pain during menstruation (p < 0.0001). The PGI-I scale showed a significant increase in the proportion of patients who were satisfied with their treatment after receiving the BT injection. The injection of BT was frequently associated with increase in QoL and a reduction in health care consumption, and cost: 714.82 +/- 336.43 (BT) versus 1104.16 +/- 227.37 (CT), which could result in substantial savings approximately (389,34) per patient. CONCLUSION: This study revealed the clinical effectiveness of BT injections on dysmenorrhea, chronic pelvic pain as well as reduction of cost and health care consumption, in our population, which is innovative since no standard of treatment exists in this domain.
Asunto(s)
Toxinas Botulínicas , Dolor Crónico , Dispareunia , Femenino , Humanos , Dismenorrea/tratamiento farmacológico , Calidad de Vida , Dispareunia/tratamiento farmacológico , Dispareunia/etiología , Proyectos Piloto , Dolor Pélvico/tratamiento farmacológico , Dolor Pélvico/etiología , Dolor Crónico/tratamiento farmacológico , Toxinas Botulínicas/uso terapéuticoRESUMEN
BACKGROUND: Acute dysmenorrhoea in women which has been shown to be anatomically negative for endometriosis is a very common condition. It is frequently associated with Chronic Pelvic Pain (CPP) from uterine origin, including painful uterine contractions and deep dyspareunia. We call this association Painful Uterine Syndrome (PUS). SEARCH STRATEGY: In these women in failure of the usual treatments, we proposed a new treatment, with Uterine Toxin Botulinic injections (BTX) under hysteroscopy, as a compassionate option, among women in severe pain and therapeutic failure. Indeed, increased uterine contractility has been confirmed using cine magnetic resonance imaging in patients with acute dysmenorrhea and PUS. These findings, associated with the hypothesis of a possible uterine sensitization on the same model as irritable bowel syndrome (IBS) or painful bladder syndrome (PBS), led to the application of botulinum toxin (BTX) injections under hysteroscopy of the uterine myometrium in this indication. MATERIAL AND METHODS: In 2018, we conducted an open-label non comparative study, on 30 patients, with severe dysmenorrhea and PUS in therapeutic failure situation. All women had failure of usual treatments, with painkillers, anti-inflammatory drugs, contraceptive pill, menstrual suppressant therapy and a negative MRI and laparoscopy. The BTX units (200 IU of Incobotulinum-toxin A) were evenly distributed in the anterior and posterior myometrial wall under hysteroscopic control. Patients were reviewed between 8 and 12 weeks after BTX injections and then, at 6 months. MAIN RESULTS: Median VAS scores were significantly improved at 8-12 weeks follow up for dysmenorrhoea, deep dyspareunia, and pelvic pain outside of menstruation. Quality of life scores all improved dramatically. No major side effect has been reported in this pilot study. At 6 months, 12 patients (40 %), were given new injections for pain reccurence. But 14 patients (47 %), were still improved and did not require repeat injection at that time. 4 patients, were improvement was not significant, did not ask for repat BTX injections. These patients were all positive for Pelvic Sensitization criteria. CONCLUSIONS: Uterine BTX injection could be a very interesting therapeutic option in women with acute dysmenorrheoa and PUS in therapeutic failure. Only long-term randomised studies will be able to confirm that BTX injections are useful as a treatment for this condition. The randomised long-term study, Uteroxine, will shortly release its results.