NCT05702567

The Effectiveness of Transvaginal Radiofrequency in Women With Stress Urinary Incontinence

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: José Casaña Granell · Academic / Other
• Sex: Female
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Urinary incontinence (UI) is a health burden for more than 200 million people in the world. 34% of women over the age of 40 experience or have already experienced some significant experience with UI, thus affecting their health-related quality of life (QoHR). SUI is endowed with a complex and multifactorial pathophysiology, generally involving the pelvic floor musculature and adjacent collagen-dependent tissues that help in support. According to the literature, there are two clearly described mechanisms: * The loss of urethral support, of the anterior vaginal wall, transforming into urethral hypermobility. * Deficiency of urethral closure, such as rotational descent of the proximal part of the urethra, of the pubourethral ligament, with loss of internal urethral integrity. The pelvic floor musculature plays an important role in helping the urethral support, during voluntary contraction. If the muscles are weak, urine loss is greater. RF is an electrophysical and medical technique that generates tissue heating for therapeutic purposes. This technology uses electromagnetic RF fields with frequencies between 434 and 925 MHz, these forming part of the techniques classified as high frequency. The increases in temperature can reach 41.5ºC to 45ºC, according to some studies, and in another reaching 50ºC, acting at 6 and 8 cm3 depth, and generating biological effects on the skin and in the deeper layers. It is known that RF promotes angiogenesis and increases local vascularization, stimulating collagen and elastin, resulting in changes in the helical structure of collagen, due to the denaturation and restructuring of its fibers. Changing the nature of connective tissues. Investigators will make use of the non-ablative resistive RF mode, which does not have the capacity to section, but does have cell stimulation through superficial application on the skin, generating anti-inflammatory effects at the physiological level and collagen contraction, as an effect of short duration, and the stimulation of collagen synthesis or neocollagenesis thanks to the inflammation of the fibroblasts, to repair the damage present, as a long-lasting effect. Which would be interesting, because the pelvic floor is formed in its great majority by connective tissue and this would help to regenerate the tissue. Treatment with this technology has not been sufficiently investigated in the intravaginal treatment of the pelvic floor. Previous studies lead to transurethral medical treatments that require local anesthesia, and the pathologies treated are the different types of urinary incontinence (stress, urgency, and mixed) and vaginal laxity. However, from the transvaginal approach the investigators found few studies.

Conditions

• Urinary Incontinence,Stress
• Pelvic Floor Disorders
• Urinary Incontinence
• Pelvic Floor Muscle Weakness

Interventions

Type	Name	Description
DEVICE	RF + PFMT	During each session the patient is lying face up, with knees bent and feet resting on the stretcher. Then, the vaginal probe is introduced into the cavity using a lubricant suitable for intracavitary use and radiofrequency. The device is started at 15% intensity and adapting to a 10-point Likert scale, at point 3 or 4 of intensity. At the same time that the radiofrequency is applied, pelvic floor contractions are performed guided by the physiotherapist, and these contractions are three: * 10 fast contractions of one second each, with 10 seconds of rest. * 5 seconds of sustained contraction and 10 seconds of rest. * 10 seconds of contraction maintained with 10 seconds of rest. The contraction maintenance time will be adapted to what each woman can keep the pelvic floor contracted, with a view to the goal being to complete these exercises cyclically during the entire session.
OTHER	PFMT + Placebo RF	The intervention is exactly the same as the group RF + PFMT, unlike the non-functioning of the RF in the patients belonging to this group. The patient is lying face up, with knees bent and feet resting on the stretcher. Then, the vaginal probe is introduced into the cavity using a lubricant suitable for intracavitary use and radiofrequency, the device is started at 15% intensity, but in this case, the program does not work or apply radiofrequency to the patients. At the same time, that the radiofrequency's probe is applied, pelvic floor contractions are performed guided by the physiotherapist, and these contractions are the three named in the Radiofrequency + PFMT. The contraction maintenance time will be adapted to what each woman can keep the pelvic floor contracted, with a view to the goal being to complete these exercises cyclically during the entire session.

Timeline

• Start date: 2023-01-09
• Primary completion: 2023-07-27
• Completion: 2023-07-27
• First posted: 2023-01-27
• Last updated: 2023-08-23

Locations

1 site across 1 country: Spain