Treatment for Sexual Dysfunction in Women with Spinal Cord Injury

Cristina Lirio

Status: Invitation-only

Conditions: Spinal Cord Injuries

Treatments: Device: TENS® EMS NMS60 device_sham intervention; Device: Genital vibration with Ferticare 2.0® vibrator; Device: Transcutaneous tibial nerve stimulation TENS® EMS NMS60 device

Study type: Interventional

Funder types: Other

Identifiers

NCT05122325

CLirio06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 3 patient groups

Intervention group 1: Transcutaneous tibial nerve stimulation (TTNS)

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous tibial nerve stimulation TENS® EMS NMS60 device

Intervention group 2: Genital vibration

Experimental group

Description:

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.

Treatment:

Device: Genital vibration with Ferticare 2.0® vibrator

Control group

Sham Comparator group

Description:

A sham of TTNS intervention with the device turned off, twice a week.

Treatment:

Device: TENS® EMS NMS60 device_sham intervention