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

Not Applicable

Not yet recruiting

• Conditions: Vaginismus
• Interventions: Other: Pelvic floor training; Device: Interferential current; Behavioral: General advice

• Registration Number: NCT06486896
• Lead Sponsor: Cairo University

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

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-27
• Study First Submitted QC: 2024-06-27
• Last Update Submitted: 2024-06-27
• Study First Posted: 2024-07-05
• Last Update Posted: 2024-07-05
• Study Start: 2024-07-20
• Primary Completion: 2024-10-20
• Study Completion: 2024-11-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interferential current	Pelvic floor training	Patients will receive interferential current+pelvic floor training+advice
Interferential current	Interferential current	Patients will receive interferential current+pelvic floor training+advice
Interferential current	General advice	Patients will receive interferential current+pelvic floor training+advice
Pelvic floor training	Pelvic floor training	The patients will receive pelvic floor training exercise+ advice 3 times/weekly for 8 weeks
Pelvic floor training	General advice	The patients will receive pelvic floor training exercise+ advice 3 times/weekly for 8 weeks

Primary Outcome Measures

Name	Time	Method
Assessment of pelvic floor muscle tone.	Eight weeks	It will be assessed by biofeedback perineometer.
Assessment of pain intensity.	Eight weeks	The 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 weeks	The pressure pain threshold in the perineum region will be evaluated with a pressure algometer.

Secondary Outcome Measures

Name	Time	Method
Measurement of cognition regarding vaginal penetration in women with lifelong vaginismus.	Eight weeks	The 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.