STRESS URINARY INCONTINENCE, VAGINAL RELAXATION SYNDROME
Conditions
Keywords
Vaginal Relaxation Syndrome, Tecar Therapy
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
Interventions
DEVICETECAR 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;
PROCEDUREpelvic 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
DEVICESham device
sham treatment by Tecar device for 15 min without producing any waves.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Contacts
Primary ContactSara magdy Ahmed, PHD
Backup ContactEman A. Elhosary, proffessor
Outcome results
None listed