JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
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The efficacy of Implanon for the treatment of chronic pelvic pain associated with pelvic congestion: 1-year randomized controlled pilot study.

OBJECTIVE: To evaluate the beneficial effects of Implanon on pelvic pain in women with pelvic congestion syndrome (PCS). The efficacy of pain control, amount and frequency of menstrual loss, degree of patient's satisfaction and objective pelvic venography scores were investigated.

METHODS: In a prospective open-labelled study, 25 consecutive women complaining of chronic pelvic pain were recruited. Pretreatment objective peruterine venography and diagnostic laparoscopy of pure PCS together with subjective pelvic pain scores, prefilled questionnaire of Hospital Anxiety and Depression Scale (HADS), visual analogue scale (VAS), verbal rating scale (VRS) and quantified menstrual loss using the pictorial blood loss chart were documented in all cases. After identification, 23 subjects with pure PCS were randomly assigned to have either Implanon inserted subcutaneously (12 cases) or no treatment (11 cases). Patients were followed up at 1, 3, 6, 9 and 12 months. A symptom diary for side effects, VAS, VRS and menstrual scores were used to assess the subjective response to treatment. At the end of the study, all patients underwent repeat venography to assess the long-term objective response. After 12 months, subjects having Implanon inserted were requested to rate their overall degree of satisfaction with therapy.

RESULTS: All 25 women recruited in the study completed follow-up. Two cases were excluded from the study and referred to the psychiatry department after a negative evaluation for disease and HADS scores relevant for depression. An improvement in symptoms was observed throughout the 12 months amongst the Implanon group versus no treatment. The greatest changes in pain assessed using either the VAS or VRS were between the pretreatment scores and those after 6 months (7.7 +/- 1.3 vs. 4.6 +/- 3.0 for VAS, P < 0.001; and 25 +/- 13.8 vs. 19 +/- 18.9 for VRS, P < 0.002). The monthly quantified blood loss fell from 204 (196) pretreatment to 90 (157) at 6 months (P < 0.001) and then to 64 (32) at 9 months (P < 0.002). Objective repeat venography score was reduced significantly at 1 year after treatment compared with the baseline evaluation as well as with the control group (4.5 +/- 1.2 vs. 8.6 +/- 0.5; P = 0.001 and 4.2 +/- 0.9 vs. 8.5 +/- 0.6; P = 0.0002, respectively). At final satisfaction assessment, 2 (17%) women were very satisfied 8 (66%) were satisfied, and 2 (17%) were uncertain. The implant was retained by all women at the end of the study.

CONCLUSION: Implanon seems to be an effective hormonal alternative for long-term treatment of properly selected patients with pure PCS-related pelvic pain.

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