Vibration and Transcutaneous Tibial Nerve Stimulation As a Treatment for Sexual Dysfunction in Women with Spinal Cord Injury: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- The "Index of female sexual function (IFSF)"
研究概览
简要总结
Women with spinal cord injury frequently experience sexual dysfunction such as disturbances during arousal and an increased time to orgasm. However, little evidence has been found on its therapeutic approach and low adherence. To verify the effectiveness of two interventions: the application of genital vibration and transcutaneous stimulation of the tibial nerve.
This is a randomized clinical trial. 54 women will be recruited who suffer from sexual dysfunction.
详细描述
The allocation will be randomly assign to the three groups: an intervention group 1 transcutaneous electrostimulation of tibial nerve (n = 18), an intervention group 2 genital vibration (n = "18) and a control group (n = 18). The treatment time will be 12 weeks. Treatment adherence, as well as treatment effectiveness, will be evaluated through the Female Sexual Function Index, the "Sexual Quality of Life-Female" questionnaire, quantitative sensory tests and the improvement reported by the patient in arousal and orgasm. Evaluations will be carried out before treatment, at the end of the treatment, and at 3 and 6 months after the end of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blind and concealed randomisation will be performed in assessment and data analysis. The assignment to groups will only be known by the main researcher who will be in charge of indicating in a sealed envelope to care providers and each participant the group to which participants have been assigned.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with incomplete spinal cord injury B, C or D (with preservation of the sacral arch and sensitive assessment of the lower dermatomes not absent, paying special attention to the sensitivity of the genital area) level below T
- •between 18-60 years
- •hormonal analysis. Participants do not present menopausal values of the hormone FSH (follicle stimulating hormone ) (31- 134 U / L)
- •present some type of sexual disorder secondary to spinal cord injury with at least 12 months of evolution
- •from Spain
- •willing to attend the evaluation and treatment center
- •seeking to improve in the sexual area.
排除标准
- •women with active pregnancy
- •present pre-existing pathologies in the genital area
- •genital malformation, previous neurosurgery that affects the genital response capacity
- •sexual disorders before the injury
- •pressure ulcers, serious medical illness or any type of pathology in which the use of sick leave is contraindicated frequency
- •psychiatric disorder, narcotic dependence, use of specific serotonin reuptake inhibitors, antipsychotics or other drugs that affect sexual response.
- •does not sign the informed consent.
结局指标
主要结局
The "Index of female sexual function (IFSF)"
时间窗: 5 minutes
This questionnaire showed validity, internal consistency in all its domains, specifically Cronbach's Alpha 0.745 in arousal and 0.753 in orgasm and test-retest reliability of ICC 0.96. This questionnaire consists of 19 questions and is grouped into six domains. The score for each domain is multiplied by a factor and the final result is the arithmetic sum of the domains. The higher the score, the better sexuality.
Sexual Quality of Life-Female (SQOL-F)
时间窗: 5 minutes
SQOL-F showed good validity and reliability. The questionnaire was developed to measure the impact of sexual disorders on quality of life. This questionnaire consists of 18 questions with a response scale of 6 options. The quality of sexual life will be considered poor if the score is between 18-51, moderate between 51-84 and good if it is greater than 84.
次要结局
未报告次要终点
研究者
Cristina Lirio
Director
University of Castilla-La Mancha