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Effect of Adding Interferential Current to Pelvic Floor Muscle Training on Vaginismus

Effect of Adding Interferential Current to Pelvic Floor Muscle Training on Vaginismus: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06486896
Enrollment
30
Registered
2024-07-05
Start date
2024-07-20
Completion date
2024-11-20
Last updated
2024-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginismus

Keywords

Interferential, pelvic floor training, vaginismus

Brief summary

This study aims to determine the effect of adding interferential current to pelvic floor muscle training on vaginismus.

Detailed description

Vaginismus is a common sexual problem with a prevalence of 20% in Egyptian women, that has a significant impact on a person's life, affecting their physical, emotional, and psychological well-being, as well as their relationships and overall quality of life. There were previous studies that studied the effect of pelvic floor rehabilitation on vaginismus and found that there was a highly significant decrease in pain and pelvic floor muscle spasms, as well as a highly significant increase in sexual function. Also, only one previous protocol explored the effect of interferential current on treating vaginismus. But, till now, there is no prior study that investigated the impact of adding interferential current to pelvic floor muscle training on treating vaginismus. this trial has two groups; one will receive interferential current, and the other group will receive interferential current + pelvic floor muscle training

Interventions

It will be in the form of pelvic floor relaxation with biofeedback, as well as stretching exercises for the pelvic floor and the adjacent muscles. The patient will be asked to lie in a comfortable crock lying position. She will be instructed to do diaphragmatic breathing exercises. The vaginal electrode of the biofeedback will be gently introduced into the vagina to start pelvic floor relaxation training. Then, the patient will be asked to perform pelvic floor relaxation by slightly contracting the pubococcygeus muscle. After 10 minutes of pelvic floor relaxation training, the patient will then be instructed to return to the active state gradually, the treatment procedure will be performed 3 times/ week for 8 weeks. Stretching exercises for the pelvic floor and the adjacent muscles: Levator ani & perineal muscles stretch, hip adductor muscles stretch, piriform muscle stretch, hip flexor muscles stretch, and obturator internus muscle stretch.

Each female in the experimental group will receive interferential current, 3o minutes per session, 2 sessions per week, for 8 weeks. The applied parameters will be a frequency of 2000Hz, a modulated amplitude of frequency of 80Hz, pulse width of 200μs, and the intensity is modulated according to the sensory level of each participant. While the participant is in a comfortable crock lying position with abducted hips, the position of the electrodes will be maintained in all sessions

BEHAVIORALGeneral advice

The patients in both groups will follow general advice to help vaginismus for 8 weeks

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

1. Women suffer from primary vaginismus with a duration of marriage ranging from 1 to 12 months. They are diagnosed and referred by the gynecologist. 2. Their pain level is ≥ 4 on the visual analogue scale. 3. They have a sedentary lifestyle.

Exclusion criteria

1. Vaginismus requiring surgical treatment. 2. Any gynecological diseases such as pelvic organ prolapse, vulvar vestibulitis, vulvar pain, clitorodynia, vulvar dysesthesia, or any pelvic inflammatory diseases. 3. Lower urinary tract infection. 4. Husband with sexual dysfunction that prevents penetration. 5. Diseases involving nerves and muscles, such as myasthenia gravis. 6. Severe psychiatric disorder or cognitive relegation.

Design outcomes

Primary

MeasureTime frameDescription
Assessment of pain intensity.Eight weeksThe visual analogue scale (VAS): will be used to measure pain intensity for each woman in both groups. Each woman will be asked to mark the point on the scale that represents her pain level.
Quantification of pressure pain threshold in the perineum.Eight weeksThe pressure pain threshold in the perineum region will be evaluated with a pressure algometer.
Assessment of pelvic floor muscle tone.Eight weeksIt will be assessed by biofeedback perineometer.

Secondary

MeasureTime frameDescription
Measurement of cognition regarding vaginal penetration in women with lifelong vaginismus.Eight weeksThe Vaginal Penetration Cognition Scale (VPCQ) will be used to evaluate cognition regarding to vaginal penetration for all participants in both groups before and after the end of the treatment program.

Contacts

Primary ContactRana Zaky, Student
Ranazaky1993@gmail.com01102628352
Backup ContactManal El-Shafeay, PHD
manal.ahmed@pt.cu.edu.eg01220664518

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026