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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Vaginismus
• Intervention / Treatment: Other: Pelvic floor training; Behavioral: General advice; Device: Interferential current

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

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rana Zaky, Student; Phone Number: 01102628352; Email: Ranazaky1993@gmail.com
• Study Contact Backup: Name: Manal El-Shafeay, PHD; Phone Number: 01220664518; Email: manal.ahmed@pt.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pelvic floor training; The patients will receive pelvic floor training exercise+ advice 3 times/weekly for 8 weeks	Other: Pelvic floor training; 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.; Behavioral: General advice; The patients in both groups will follow general advice to help vaginismus for 8 weeks
Experimental: Interferential current; Patients will receive interferential current+pelvic floor training+advice	Other: Pelvic floor training; 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.; Behavioral: General advice; The patients in both groups will follow general advice to help vaginismus for 8 weeks; Device: Interferential current; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of cognition regarding vaginal penetration in women with lifelong vaginismus.	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.	Eight weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Doaa A. Osman, PHD, Department of Women's Health, Faculty of Physical Therapy, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): July 20, 2024
• Primary Completion (Estimated): October 20, 2024
• Study Completion (Estimated): November 20, 2024

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Interferential, pelvic floor training, vaginismus
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Vaginal Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vaginismus
• Other Study ID Numbers: P.T.REC/012/004953

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No