An interventional study of TECAR device: MCRR. The sign producer is an INDIBA® 448 kHz RF device that has a vaginal/ or rectum electrode (made in Barcelona, Spain) and pelvic floor exercises in STRESS URINARY INCONTINENCE and VAGINAL RELAXATION SYNDROME, sponsored by Cairo University. Not yet recruiting. Open to female participants aged 50 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-01-23.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's planned enrollment of 40 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
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Exclusion Criteria:
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) · Procedure: pelvic floor exercises
consist of 20 females who will receive sham tecar and PFM exercises
Procedure: pelvic floor exercises · Device: Sham device
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;
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 treatment by Tecar device for 15 min without producing any waves.
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
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: at baseline, after 4 weeks, and after 8 weeks of treatment
No study locations are listed for this record.
Plan to share: Undecided
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Cairo University