Treatment for Sexual Dysfunction in Women with Spinal Cord Injury

Sponsor
Cristina Lirio
Study ID
NCT05122325
Status
Enrolling By Invitation

Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcutaneous tibial nerve stimulation TENS® EMS NMS60 device — 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 there the intensity is increased without having to now reach the excitomotor threshold, as long as the physiotherapist notice it is enough (it must be tolerable).
  • Genital vibration with Ferticare 2.0® vibrator — DEVICE
    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.
  • TENS® EMS NMS60 device_sham intervention — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Nov 16, 2021
Start date
Jun 30, 2026
Status verified
Dec 2024
Primary completion
Oct 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention group 1: Transcutaneous tibial nerve stimulation (TTNS)
    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.
  • Experimental: Intervention group 2: Genital vibration
    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.
  • Sham Comparator: Control group
    A sham of TTNS intervention with the device turned off, twice a week.

Primary Outcome Measure

The "Index of female sexual function (IFSF)" [ Time Frame: 5 minutes ]

Related Studies