Clinical trial NCT05122325: Treatment for Sexual Dysfunction in Women with Spinal Cord Injury
Official title: Vibration and Transcutaneous Tibial Nerve Stimulation As a Treatment for Sexual Dysfunction in Women with Spinal Cord Injury: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Spinal cord injuries
Women
Pelvic floor disorders
Sexuality
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will randomize to three groups: an intervention group 1 contracted transcutaneous electrostimulation through the tibial nerve (n = 18), an intervention group 2 that occurred with genital vibration (n = "18) and a control group (n = 18)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The "Index of female sexual function (IFSF)"
timeFrame: 5 minutes
measure: Sexual Quality of Life-Female (SQOL-F)
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: Cristina Lirio-Romero
Study officials:
affiliation: University of Castilla-La Mancha
name: Cristina Lirio-Romero, PhD
role: STUDY_DIRECTOR
References: