Preliminary Outcome Of Tecar On Stress Urinary Incontinence, Pelvic Floor Strength And Sexual Satisfaction In Women With Vaginal Relaxation Syndrome

Cairo University (CU)

Status: Not yet enrolling

Conditions: STRESS URINARY INCONTINENCE; VAGINAL RELAXATION SYNDROME

Treatments: Procedure: pelvic floor exercises; Device: Sham device; Device: TECAR device: MCRR. The sign producer is an INDIBA® 448 kHz RF device that has a vaginal/ or rectum electrode (made in Barcelona, Spain)

Study type: Interventional

Funder types: Other

Identifiers

NCT06788574

(P.T.WH/3/2021/9).

Details and patient eligibility

About

Forty women aged 50-60 years with a body mass index (BMI) of 25 kg/m2 to 30 kg/m2, who complain of stress urinary incontinence and vaginal laxity, will be separated randomly into two equivalent groups. In group (A) 20 women will receive TECAR therapy for 15 min and pelvic floor exercise for 20 min, while in group (B), 20 females will receive sham treatment for 15 min and pelvic floor exercise for 20 min twice per week for 8 weeks. Both groups wil be assessed using a perineometer as an assessment tool for pelvic floor muscle strength muscles and the Visual Analog Scale, ICIQ-UI short form questionnaire about the frequency of urinary incontinence symptoms, Millheiser Sexual Satisfaction Scale, and the Sexual Quality of Life Questionnaire-Female (SQOL-F) to assess sexual satisfaction by each patient before, after 4 weeks, and after 8 weeks of treatment

Enrollment: 40 estimated patients

Sex: Female

Ages: 50 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• participants are multipara at least two times with sexual activity for at least 1/month with normal cell cytology (PAP smear), integrity of the vaginal canal mucosa, and negative urine culture (without injuries or bleeding).

Exclusion criteria

• pregnancy, use of photosensitive medicines, vaginal bleeding injury or infection in the treated area, and use of an IUD.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Tecar group

Experimental group

Description:

consists of 20 females who will receive TECAR therapy and PFM exercises

Treatment:

Device: TECAR device: MCRR. The sign producer is an INDIBA® 448 kHz RF device that has a vaginal/ or rectum electrode (made in Barcelona, Spain)

Procedure: pelvic floor exercises

Control group

Sham Comparator group

Description:

consist of 20 females who will receive sham tecar and PFM exercises

Treatment:

Device: Sham device

Procedure: pelvic floor exercises