Second-generation Radiofrequency Application and Therapeutic Exercise for Stress Urinary Incontinence

Cardenal Herrera University

Status: Completed

Conditions: Stress Urinary Incontinence

Treatments: Diagnostic Test: Sandvik Severity Index; Diagnostic Test: Short International Consultation on Incontinence Questionnaire (ICIQ-SF); Diagnostic Test: Oxford's scale; Diagnostic Test: King's Health Questionnaire (KHQ); Diagnostic Test: Biofeedback; Diagnostic Test: Ultrasound evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT07095283

CEEI25/646

Details and patient eligibility

About

Stress urinary incontinence (SUI) is defined as the loss of the ability to hold urine after exertion, i.e., as a result of imbalances in intra-abdominal pressure, which directly affect the lower urinary tract. SUI has been shown to have a significant impact on the quality of life of those affected, impacting physical, social, and psycho-emotional aspects. Among the proposed treatments is a physiotherapeutic approach, which is offered as a less invasive and painless therapy with fewer adverse effects than pharmacological or surgical treatment. Pelvic floor muscle training (PFMT) is the most effective physiotherapeutic treatment for SUI, increasing the contractile capacity of the muscles and restoring stability throughout the pelvic diaphragm, thereby ensuring proper support of the pelvic organs. Radiofrequency (RF) therapy is currently being proposed as a therapeutic option that may offer certain advantages over those reported for photoplethysmography (PPMT). The potential benefits of RF therapy are attributed to its ability to stimulate collagen metabolism, thereby promoting tissue regeneration. Radiofrequency (RF) is a non-invasive and painless method that has the potential to yield analogous results to pelvic physical therapy (PPMT) as a standalone treatment or enhance the efficacy of PPMT when administered in conjunction with RF for stress urinary incontinence (SUI).

The objective of the present study is to analyse the effectiveness of PFMT and RF as single or combined treatments for SUI in women at Clínica Traña, a clinic specialising in the treatment of pelvic floor dysfunction in Costa Rica. Following the process of obtaining informed consent, patients will be offered a single or combined treatment of RF and/or PFMT. The strength of the pelvic floor muscles, pelvic function and the impact of pelvic dysfunctions on quality of life will be evaluated with a one-year follow-up after the conclusion of treatment.

The project possesses the facilities, equipment, and personnel necessary to ensure its viability, as well as proven clinical experience.

The scientific and technical impact of the proposed treatment protocol will be achieved by establishing an effective therapeutic strategy to address SUI. The social impact of SUI is significant, given its high prevalence and the fact that it has physical consequences as well as a negative impact on the social activities, work functions and emotions of women who suffer from it.

Enrollment: 207 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women over the age of 18 who meet the International Continence Society (ICS)
• diagnostic criteria for SUI, which consists of involuntary leakage of urine during increased intra-abdominal pressure in the absence of bladder contractions such as coughing, sneezing, and other physical activities.

Exclusion criteria

• diagnosis of urgent or mixed UI
• diagnosis of pelvic organ prolapse
• taking any treatment for UI
• pregnancy
• history of pelvic surgery, urinary tract infection, or diagnosed psychological disorders
• presence of scars, malformations, abnormal pelvic masses, tissue irritation, or any other condition in the area that could be causing pelvic and urinary function problems

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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207 participants in 3 patient groups

RF Therapy

Experimental group

Description:

Participants will be placed in the lithotomy position. The treatment temperature will be set at 41°C, with a frequency of 1 MHz and power of 75 kJ. Once the indicated temperature has been reached, the physical therapist will perform small upward and downward movements along the urethral canal, dividing the time equally between both sides. One RF session will be performed every 7 days, as described by the author, for a total of 5 sessions. We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test).

Treatment:

Diagnostic Test: Ultrasound evaluation

Diagnostic Test: Biofeedback

Diagnostic Test: King's Health Questionnaire (KHQ)

Diagnostic Test: Oxford's scale

Diagnostic Test: Sandvik Severity Index

Diagnostic Test: Short International Consultation on Incontinence Questionnaire (ICIQ-SF)

Pelvic floor muscle training (PFMT)

Experimental group

Description:

The PFMT will consist of a targeted program with a protocol of core and pelvic floor exercises established based on an assessment of the patients' strength, endurance, and fatigue, with a frequency of twice a week led by a physical therapist and a duration of 45 minutes each day for a period of 16 weeks. It will be carried out in groups of 8 people and accompanied by a physical therapist experienced in therapeutic exercise. We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test).

Treatment:

Diagnostic Test: Ultrasound evaluation

Diagnostic Test: Biofeedback

Diagnostic Test: King's Health Questionnaire (KHQ)

Diagnostic Test: Oxford's scale

Diagnostic Test: Sandvik Severity Index

Diagnostic Test: Short International Consultation on Incontinence Questionnaire (ICIQ-SF)

combination of RF Therapy and PFMT

Experimental group

Description:

We divided the subjects into mild SUI (1-2 points in the Sandvik test); moderate SUI (Sandvik test of 3 to 6 points), severe SUI (8-9 points Sandvik test); and very severe SUI (12 points in Sandvik test).

Treatment:

Diagnostic Test: Ultrasound evaluation

Diagnostic Test: Biofeedback

Diagnostic Test: King's Health Questionnaire (KHQ)

Diagnostic Test: Oxford's scale

Diagnostic Test: Sandvik Severity Index

Diagnostic Test: Short International Consultation on Incontinence Questionnaire (ICIQ-SF)