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

Preliminary Outcome Of Tecar Therapy Effect On Stress Urinary Incontinence, Pelvic Floor Strength And Sexual Satisfaction In Women Complaining Of Vaginal Relaxation Syndrome: A Randomized Controlled Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: STRESS URINARY INCONTINENCE; VAGINAL RELAXATION SYNDROME
• Intervention / 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; Device: Sham device

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara magdy Ahmed, PHD; Phone Number: +20 01063998331; Email: saramagdy87@cu.edu.eg
• Study Contact Backup: Name: Eman A. Elhosary, proffessor; Phone Number: +20 12 76754277

Participation Criteria

Eligibility Criteria

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

Description

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 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
Experimental: Tecar group; consists of 20 females who will receive TECAR therapy and PFM exercises	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); TECAR (Transfer Electrical, Capacitive, and Resistive) is originally used in Italy. TECAR therapy is a radiofrequency (RF) therapy, which produces high-frequency waves. RF can be capacitive or resistive The capacitive mode (CET) generates energy in electrolyte-rich soft tissues such as muscles and vascular or lymphatic tissues . The resistive mode (RET) directs energy to deeper tissues that contain more fat and fibers (such as bones, ligaments, and tendons; Procedure: pelvic floor exercises; pelvic floor exercise will be performed with the perineometer twice a week for eight weeks (16 sessions), with five sets of 20 repetitions each
Sham Comparator: Control group; consist of 20 females who will receive sham tecar and PFM exercises	Procedure: pelvic floor exercises; pelvic floor exercise will be performed with the perineometer twice a week for eight weeks (16 sessions), with five sets of 20 repetitions each; Device: Sham device; sham treatment by Tecar device for 15 min without producing any waves.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pelvic floor muscle strength assessed using a Peritron (9300) device with a vaginal sensor	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	after 4 and 8 weeks
urinary incontinence symptoms using Visual Analog Scale and ICIQ-UI short form questionnaire	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	after 4 and 8 weeks
sexual satisfaction using Millheiser Sexual Satisfaction Scale, and the Sexual Quality of Life Questionnaire-Female (SQOL-F)	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).	after 4 and 8 weeks
Vaginal PH using PH color strips	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).	at baseline, after 4 weeks, and after 8 weeks of treatment

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2025
• Primary Completion (Estimated): March 15, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: January 8, 2025
• First Submitted That Met QC Criteria: January 16, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Tecar Therapy; Vaginal Relaxation Syndrome
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Disease; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Syndrome
• Other Study ID Numbers: (P.T.WH/3/2021/9).

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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