Treatment for Sexual Dysfunction in Women with Spinal Cord Injury

Официальное название

Vibration and Transcutaneous Tibial Nerve Stimulation As a Treatment for Sexual Dysfunction in Women with Spinal Cord Injury: a Randomized Clinical Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Transcutaneous tibial nerve stimulation TENS® EMS NMS60 device
  Stimulation sessions with a TENS® EMS NMS60 device. These will be carried out for 30 minutes, once a week at 10 Hz, with a pulse width of 200 μs and an intensity between 0 and 100 mA, which will be individually adjusted to each participant. Inicially, frequency between 2-3 Hz, so that when the current passes, a contraction-relaxation will cause the first toe movement visually evident (excitomotor threshold). Once verified, the frequency is raised to what has been established between 10Hz and t
• Устройство Genital vibration with Ferticare 2.0® vibrator
  Women will be instructed in the use of the Ferticare 2.0® vibrator. Initially, a practice will be carried out , indicating that the frequency of use will be 70 Hz with an amplitude of 1.5 mm. It will be recommended to gradually increase its use over time, with a limit of 30 minutes a day.
• Устройство TENS® EMS NMS60 device_sham intervention
  Sham of TTNS intervention with Stimulation sessions with a TENS® EMS NMS60 device. These will be carried out for 30 minutes, once a week. Inicially, frequency between 2-3 Hz, so that when the current passes, a contraction-relaxation will cause the first toe movement visually evident (excitomotor threshold). Once verified, the intensity is decreased to lower the sensitive threshold of treatment.

Первичные конечные точки

• The "Index of female sexual function (IFSF)" [Срок оценки: 5 minutes]
• Sexual Quality of Life-Female (SQOL-F) [Срок оценки: 5 minutes]

Критерии участия

Критерии включения

• 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 T6.
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Cristina Lirio-Romero — Toledo

Идентификаторы

NCT: NCT05122325 · CLirio06

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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