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Treatment for Sexual Dysfunction in Women with Spinal Cord Injury

NCT05122325 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-02-19

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injuries

Interventions

DEVICE

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 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).

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • Cristina Lirio

    lead OTHER

Principal Investigators

  • Cristina Lirio-Romero, PhD · University of Castilla-La Mancha

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2026-10-31
Completion
2027-01-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05122325 on ClinicalTrials.gov