Urinary Incontinence Clinical Trial
Official title:
The Effectiveness of Transvaginal Radiofrequency and Pelvic Floor Muscle Training Compared to Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence: a Double-blind Randomized Controlled Trial
Verified date | August 2023 |
Source | University of Valencia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The following clinical trial investigates the efficacy of transvaginal radiofrequency in the physiotherapy treatment of stress urinary incontinence (SUI). The treatment compares transvaginal radiofrequency with pelvic floor muscle training (PFMT) and PFMT alone. The present study is a randomized controlled trial with double blinding (evaluator and patients). The objective is to evaluate what radiofrequency can provide in the improving of the quality of life, symptoms and pelvic floor muscle strength of patients with SUI. The reason for the combination with PFMT, is that it is the golden standard treatment in pelvic floor rehabilitation and SUI improvement.
Status | Completed |
Enrollment | 42 |
Est. completion date | July 27, 2023 |
Est. primary completion date | July 27, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 75 Years |
Eligibility | Inclusion Criteria: - Women between 20 - 75 years - Previously diagnosed SUI through assessment and questionnaires. - PAD Test of 1h with > or = 1gr of urine loss. - Urine losses in the last week. - Nulliparous and multiparous. Exclusion Criteria: - Women > 75 years. - Another type of urinary incontinence, urge or mixed. - Difficulty urinating - Hematuria - Pregnancy - Patients with any type of cancer or with a personal history of it. - Previous surgeries for the treatment of SUI - Gynecological surgeries (hysterectomy, containment mesh for different prolapses). - Neurological and cognitive problems. - Injury to the spinal cord, lower limbs or pelvis. - Grade II, III or IV pelvic organ prolapse. - Vaginal or urinary infection. - Drugs: - Antimuscarinics (oxybutinin) - Toterodine - Trospium - Solifenacin - Darifenacin - Fesoterodine - Atropine - Anticholinergics - Antidepressants: - Duloxetine - Imipramine - Estrogens - Botulinum Toxin - Alpha-adrenergic agonists - Ephedrine - Pseudoephedrine - Antidiuretics (desmopressin) |
Country | Name | City | State |
---|---|---|---|
Spain | Yasmin Er Rabiai Boudallaa | San Agustín del Guadalix | Madrid |
Lead Sponsor | Collaborator |
---|---|
José Casaña Granell | University of Alcalá. Physiotherapy in Women's Health (FPSM) Research Group. |
Spain,
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* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in the ICIQ-SF scale before, after and six months after treatment in both groups. | ICIQ-SF: International Consultation on Incontinence Questionnaire, short form. The minimum score is 0, and the maximum is 21. Where 0 is the absence of urinary incontinence and everything valued above 0 is a symptom of urinary incontinence. The higher the value, the worse the incontinence. | Before treatment, six weeks of treatment, and 6 months assessments were required. | |
Primary | The change of signs, symptoms and impact of pelvic floor dysfunction (PFDI-20) between reviews (before, after and at six months of treatment in both groups). | PFDI-20 : Pelvic Floor Distress Inventory Questionnaire - 20. It has 20 questions that are in turn divided into three symptomatic scales.
The minimum value is 0, and the maximum is 300, which is the result of the sum of the total of the three subscales of 100 points of maximum value. This scale, the higher the value, the greater the pelvic floor dysfunction. |
Before treatment, six weeks of treatment, and 6 months assessments were required. | |
Primary | The change of signs, symptoms and impact of pelvic floor dysfunction (PFIQ-7) between reviews (before, after and at six months of treatment in both groups) | PFIQ-7 has 7 questions for each subscale, which are three in total. The minimum value is 0, and the maximum is 300, which is the result of the sum of the total of the three subscales of 100 points of maximum value. This scale, the higher the value, the greater the pelvic floor dysfunction. | Before treatment, six weeks of treatment, and 6 months assessments were required. | |
Secondary | Changes in maximum and average strength of the pelvic floor before, after and six months after treatment in both groups. . | The maximum and average muscle strength is the value offered by the pelvimetry at the vaginal level, resulting from three submaximal contractions requested from the woman. | Before treatment, six weeks of treatment, and 6 months assessments were required. | |
Secondary | Changes in muscle tone before, after and six months after treatment in both groups. | Muscle tone is measured with a pelvimeter, which is inserted vaginally and the patient in the supine position and triple flexion of the lower limbs, relaxes and we take the base measurement, resulting from the subtraction of the result obtained minus 170mmHg of base. | Before treatment, six weeks of treatment, and 6 months assessments were required. | |
Secondary | Changes in sexual function (FSFI) before, after and six months after treatment in both groups. | FSFI: Female Sexual Function Index. The minimum value is 2, and the maximum is 36, which is the result of the sum of the results of each domain, which are 6 in total, with a maximum value of 6 points each. This scale the higher the value, the better sexual function.
It consists of 19 questions, divided into subgroups according to the symptom to be studied: desire, arousal, lubrication, orgasm, satisfaction, and pain. |
Before treatment, six weeks of treatment, and 6 months assessments were required. | |
Secondary | Check the level of physical activity measured with the GPAQ scale, in both groups, before, after and at six months. | GPAQ: global physical activity questionnaire. The GPAQ measures how many MET-min of physical activity is engaged during a typical week. The MET-min per week obtained from the GPAQ is a scale-type variable. Moderate- intensity physical activity corresponds to 4 MET/min, and vigorous-intensity physical activity corresponds to 8 MET/min.[6] During the calculation of weekly total MET-min, the durations of each type of physical activity are multiplied by these coefficients.
The minimum value is 0 and the maximum is 3000 MET-min. |
Before treatment, six weeks of treatment, and 6 months assessments were required. | |
Secondary | Changes in the Pad Test 1h before, after and six months after treatment in both groups. | Indications are given for one consecutive hour using a pad that will be given to the researcher, as well as a pad of the same model to weigh the difference obtained. The indications range from the intake of 500 ml of water, to various abdominal hyperpressure exercises. | Before treatment, six weeks of treatment, and 6 months assessments were required. | |
Secondary | Changes in Pelvic Muscle Excersice Self-Efficacy (Broome scale) before, after and six months after treatment in both groups. | Evaluates the perception and safety of patients in knowing how to contract the pelvic floor in different situations of daily life and their degree of confidence in them in the face of abdominal hyperpressure.
The minimum value is 0 and the maximum is 100 in both subscales. The higher the value, the greater the awareness and confidence in the pelvic floor contractions. |
Before treatment, six weeks of treatment, and 6 months assessments were required. |
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