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NCT05702567
The Effectiveness of Transvaginal Radiofrequency in Women With Stress Urinary Incontinence
Conditions: Urinary Incontinence,Stress, Pelvic Floor Disorders, Urinary Incontinence, Pelvic Floor Muscle Weakness
Sex: Female
Ages: 20 Years – 75 Years
Phase: NA
Enrollment: 45
Sponsor: José Casaña Granell
Location: Spain
Summary
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.
Eligibility Criteria
Inclusion Criteria:Women between 20 - 75 yearsPreviously 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 urinatingHematuriaPregnancyPatients with any type of cancer or with a personal history of it.Previous surgeries for the treatment of SUIGynecological 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)ToterodineTrospiumSolifenacinDarifenacinFesoterodineAtropineAnticholinergicsAntidepressants:DuloxetineImipramineEstrogensBotulinum ToxinAlpha-adrenergic agonistsEphedrinePseudoephedrineAntidiuretics (desmopressin)
Source: ClinicalTrials.gov (NCT05702567). StuddyBuddy aggregates publicly available trial information.