Treatment for Sexual Dysfunction in Women with Spinal Cord Injury
- Conditions
- Spinal Cord Injuries
- Interventions
- Device: TENS® EMS NMS60 device_sham interventionDevice: Transcutaneous tibial nerve stimulation TENS® EMS NMS60 deviceDevice: Genital vibration with Ferticare 2.0® vibrator
- Registration Number
- NCT05122325
- Lead Sponsor
- Cristina Lirio
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Female
- Target Recruitment
- 54
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group TENS® EMS NMS60 device_sham intervention A sham of TTNS intervention with the device turned off, twice a week. Intervention group 1: Transcutaneous tibial nerve stimulation (TTNS) Transcutaneous tibial nerve stimulation TENS® EMS NMS60 device Transcutaneous application of low frequency electrical current over the tibial nerve TENS® EMS NMS60 for a 30 minutes session, twice a week. Placing a small electrode 3 fingers up to the internal malleolus and 1 cm posterior (adjusting its placement with a point finder or testing with low frequencies of 2-3 Hz). A large electrode placed in the calcaneus. Intervention group 2: Genital vibration Genital vibration with Ferticare 2.0® vibrator Women will be instructed in the use of the Ferticare 2.0® vibrator with a frequency of 70 Hz, amplitude of 1.5 mm. It will be recommended to gradually increase its use over time, with a limit of 30 minutes a day.
- Primary Outcome Measures
Name Time Method The "Index of female sexual function (IFSF)" 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) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cristina Lirio-Romero
🇪🇸Toledo, Spain