RESUMEN
OBJECTIVES: Pelvic floor hypertonic disorder is characterized by an involuntary spasm of the levator ani muscles and is associated with several clinical syndromes. Several treatment options have been described; however, treatment efficacy data are limited. The objective of this study was to determine the efficacy of intravaginal diazepam for the treatment of pelvic pain secondary to levator ani muscle spasm in comparison to placebo. METHODS: Adult women with complaints of pelvic pain, who were noted to have levator ani muscle spasm on physical examination, were approached for enrollment in a double-blind, placebo-controlled, randomized clinical trial. Eligible participants were randomized to receive 10-mg diazepam capsules or identical-appearing placebo capsules. The primary outcome was the change in pain scores measured by a 100-mm visual analog scale at 4 weeks. Several validated questionnaires were similarly assessed as secondary outcomes. RESULTS: In total, 49 women were randomized (25 in the diazepam arm and 24 in the placebo arm). At 4 weeks, 35 women returned for follow-up and had complete data available analysis. There was no difference in visual analog scale scores between the treatment groups after 4 weeks (50 vs 39 mm, for diazepam and placebo, respectively; P = 0.36). There were also no differences noted in the questionnaire scores. CONCLUSIONS: It is unlikely that self-administered intravaginal diazepam suppositories promote an improvement in the 100-mm visual analog scale of 20 mm or more or other substantial symptom improvement in women with pelvic floor hypertonic disorder.
Asunto(s)
Diazepam/administración & dosificación , Relajantes Musculares Centrales/administración & dosificación , Trastornos del Suelo Pélvico/tratamiento farmacológico , Dolor Pélvico/tratamiento farmacológico , Administración Intravaginal , Adulto , Método Doble Ciego , Femenino , Humanos , Persona de Mediana Edad , Dimensión del Dolor , Insuficiencia del TratamientoRESUMEN
INTRODUCTION AND HYPOTHESIS: The aim was to test the hypothesis that the pelvic outlet diameter (POD) is associated with pelvic organ prolapse (POP) in squirrel monkeys. METHODS: Magnetic resonance images (MRI) were obtained from 55 females with and without POP. Commercial software was used by two observers to measure the POD. POD, age, parity, and weight for the two groups were compared using Student's t test. Associations of age, parity, and body weight with POD were evaluated with linear regression analysis. Multiple regression analysis examined the relationships of age, parity, and POD with POP. Receiver operating curve methods were used to set thresholds. RESULTS: Observers concurred on measurements (Cronbach's alpha = 0.96 with lower 95% confidence limit of 0.94). POD was not related to parity (p = 0.10) or weight (p = 0.053), but was inversely related to age (p = 0.011). Animals with POP did not differ from those without POP with regard to age (p = 0.10), weight (p = 0.17), or POD (p = 0.99). The groups differed with regard to parity (p = 0.007) and multiple regression methods demonstrated that only parity had a significant relationship with POP (p = 0.002). Parity greater than 2 had 64% specificity and 89% sensitivity for POP. CONCLUSIONS: POD size does not contribute to POP in squirrel monkeys. This study confirms that among variables of age, body weight, POD, and parity, only parity appears as a risk factor for POP in squirrel monkeys.