The Effectiveness of Transvaginal Radiofrequency in Women With Stress Urinary Incontinence

José Casaña Granell

Status: Completed

Conditions: Pelvic Floor Disorders; Pelvic Floor Muscle Weakness; Urinary Incontinence; Urinary Incontinence,Stress

Treatments: Device: RF + PFMT; Other: PFMT + Placebo RF

Study type: Interventional

Funder types: Other

Identifiers

NCT05702567

UV-INV_ETICA-1104660

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: Female

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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42 participants in 2 patient groups, including a placebo group

RF + PFMT

Experimental group

Description:

The participants recieve 18 sessions of radiofrequency (RF) and pelvic floor muscle training (PFMT), divided into three sessions per week for a total of six weeks, with a net treatment time of 40 minutes, each one.

Treatment:

Device: RF + PFMT

PFMT

Placebo Comparator group

Description:

The participants recieve 18 sessions of no radiofrequency (RF) and pelvic floor muscle training (PFMT), divided into three sessions per week for a total of six weeks, with a net treatment time of 40 minutes, each one. The RF device is started, but in this case, the program does not work or apply radiofrequency to the patients.

Treatment:

Other: PFMT + Placebo RF