Clinical trial NCT05702567: The Effectiveness of Transvaginal Radiofrequency in Women With Stress Urinary Incontinence
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence,Stress
Pelvic Floor Disorders
Urinary Incontinence
Pelvic Floor Muscle Weakness
Keywords: Urinary loss
Pelvic floor dysfunctions
Women
Pelvic floor muscle training
Indiba Therapy
Physiotherapy
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: University of Alcalá. Physiotherapy in Women's Health (FPSM) Research Group.
First posted: 2023-01-27
Enrollment: 42
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Changes in the ICIQ-SF scale before, after and six months after treatment in both groups.
timeFrame: Before treatment, six weeks of treatment, and 6 months assessments were required.
measure: The change of signs, symptoms and impact of pelvic floor dysfunction (PFDI-20) between reviews (before, after and at six months of treatment in both groups).
timeFrame: Before treatment, six weeks of treatment, and 6 months assessments were required.
measure: The change of signs, symptoms and impact of pelvic floor dysfunction (PFIQ-7) between reviews (before, after and at six months of treatment in both groups)
timeFrame: Before treatment, six weeks of treatment, and 6 months assessments were required.
Secondary outcomes:
measure: Changes in maximum and average strength of the pelvic floor before, after and six months after treatment in both groups. .
timeFrame: Before treatment, six weeks of treatment, and 6 months assessments were required.
measure: Changes in muscle tone before, after and six months after treatment in both groups.
timeFrame: Before treatment, six weeks of treatment, and 6 months assessments were required.
measure: Changes in sexual function (FSFI) before, after and six months after treatment in both groups.
timeFrame: Before treatment, six weeks of treatment, and 6 months assessments were required.
measure: Check the level of physical activity measured with the GPAQ scale, in both groups, before, after and at six months.
timeFrame: Before treatment, six weeks of treatment, and 6 months assessments were required.
measure: Changes in the Pad Test 1h before, after and six months after treatment in both groups.
timeFrame: Before treatment, six weeks of treatment, and 6 months assessments were required.
measure: Changes in Pelvic Muscle Excersice Self-Efficacy (Broome scale) before, after and six months after treatment in both groups.
timeFrame: Before treatment, six weeks of treatment, and 6 months assessments were required.
Other outcomes:
Locations:
city: San Agustín del Guadalix
country: Spain
facility: Yasmin Er Rabiai Boudallaa
state: Madrid
Study officials:
affiliation: University of Valencia (Spain)
name: Yasmin Er Rabiai Boudallaa, Phd Student
role: PRINCIPAL_INVESTIGATOR
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