The Effectiveness of Transvaginal Radiofrequency in Women With Stress Urinary Incontinence
Condition: Urinary Incontinence,Stress; Pelvic Floor Disorders; Urinary Incontinence; Pelvic Floor Muscle Weakness
MeSH terms: Muscle Weakness; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Pelvic Floor Disorders
Study type: Interventional

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.
    

Intervention name(s): RF + PFMT; PFMT + Placebo RF
Intervention type(s): Device; Other
Intervention description(s): 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.; 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.
Other intervention name(s): INDIBA Activ CT9 SN: 19A150410; INDIBA Activ CT9 SN: 19A150410
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: The present study is a double-blind randomized clinical trial. Two groups are located, case group and placebo group.
The total number of sessions will be 18 sessions per patient, divided into three sessions per week for a total of six weeks. These sessions last one hour, with a net treatment time of 40 minutes in the supine position.
The vaginal probe is inserted into the cavity using a lubricant suitable for intracavitary use and RF, the device is turned on, while the RF is applied, pelvic floor contractions are performed guided by the physiotherapist 2 (Marta Martínez Colmenar) .
The evaluations before and after the study will be carried out by the physiotherapist 1 (Yasmin Er Rabiai Boudallaa) who is blinded to group allocation. All participants will be assessed before, after six weeks and 6 months after the start of the study.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Urinary loss; Pelvic floor dysfunctions; Women; Pelvic floor muscle training; Indiba Therapy; Physiotherapy