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

Not Applicable

Not yet recruiting

• Conditions: STRESS URINARY INCONTINENCE; VAGINAL RELAXATION SYNDROME

• Registration Number: NCT06788574
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-08
• Study Start: 2025-01-15
• Study First Submitted QC: 2025-01-16
• Last Update Submitted: 2025-01-16
• Study First Posted: 2025-01-23
• Last Update Posted: 2025-01-23
• Primary Completion: 2025-03-15
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
pelvic floor muscle strength assessed using a Peritron (9300) device with a vaginal sensor	after 4 and 8 weeks	At baseline and after 4 and 8 weeks for each female in both groups will be assessed using a Peritron (9300) device with a vaginal sensor (Peritron 9300). Cardio Design Pty, Australia designed Peritron 9300. Description in technical terms: 0-300 cm H2o numerical data, 1 cm H2o resolution, 1 cm H2o accuracy for 95% of data, 3.5 digits liquid crystal panel, 12.7 mm high with a battery charge indication vaginal probe, 28 mm in diameter, and 30 mm in length
urinary incontinence symptoms using Visual Analog Scale and ICIQ-UI short form questionnaire	after 4 and 8 weeks	using Visual Analog Scale and ICIQ-UI short form questionnaire The visual analogue scale (VAS) is a rating tool will be used to graphically evaluate the severity of a patient's reported urinary incontinence symptoms. The patient will instructed to cross the VAS by uniformly spacing numerical values along a 10-centimeter line.; The ICIQ-UI Short Form is a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence
sexual satisfaction using Millheiser Sexual Satisfaction Scale, and the Sexual Quality of Life Questionnaire-Female (SQOL-F)	after 4 and 8 weeks	Millheiser Sexual Satisfaction Scale, and the Sexual Quality of Life Questionnaire-Female (SQOL-F) Millheiser sexual satisfaction scale 1 = None, 2 = Poor, 3 = Fair, 4 = Good, 5 = Very good, 6 = Excellent (Millheiser et al., 2010).; The Sexual Quality of Life-Female (SQOL-F) questionnaire is a short instrument that specifically assesses the relationship between female sexual dysfunction and quality of life. It consists of 18 items, rated using a six-point scale (completely agree to completely disagree).Each item on the scale is scored between 1 and 6 (1 = I completely agree, 2 = I mostly agree, 3= I partially agree, 4 = I partially do not agree, 5= I mostly disagree, 6 = I completely disagree).
Vaginal PH using PH color strips	at baseline, after 4 weeks, and after 8 weeks of treatment	PH color strips will be used to assess vaginal PH for each woman in both groups (A and B) at baseline, after 4 weeks, and after 8 weeks of treatment (orange = 5, yellow = 6, light green = 7, dark green= 8, blue petroleum = 9; Kulp et al., 2008).