The Effectiveness of Transvaginal Radiofrequency in Women With Stress Urinary Incontinence

Not Applicable

Completed

• Conditions: Pelvic Floor Muscle Weakness; Pelvic Floor Disorders; Urinary Incontinence; Urinary Incontinence,Stress
• Interventions: Device: RF + PFMT; Other: PFMT + Placebo RF

• Registration Number: NCT05702567
• Lead Sponsor: José Casaña Granell

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.

Study Timeline

• Study First Submitted: 2022-12-12
• Study Start: 2023-01-09
• Study First Submitted QC: 2023-01-25
• Study First Posted: 2023-01-27
• Primary Completion: 2023-07-27
• Study Completion: 2023-07-27
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
RF + PFMT	RF + PFMT	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.
PFMT	PFMT + Placebo RF	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.

Primary Outcome Measures

Name	Time	Method
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).	Before treatment, six weeks of treatment, and 6 months assessments were required.	PFDI-20 : Pelvic Floor Distress Inventory Questionnaire - 20. It has 20 questions that are in turn divided into three symptomatic scales.; The minimum value is 0, and the maximum is 300, which is the result of the sum of the total of the three subscales of 100 points of maximum value. This scale, the higher the value, the greater the pelvic floor dysfunction.
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)	Before treatment, six weeks of treatment, and 6 months assessments were required.	PFIQ-7 has 7 questions for each subscale, which are three in total. The minimum value is 0, and the maximum is 300, which is the result of the sum of the total of the three subscales of 100 points of maximum value. This scale, the higher the value, the greater the pelvic floor dysfunction.
Changes in the ICIQ-SF scale before, after and six months after treatment in both groups.	Before treatment, six weeks of treatment, and 6 months assessments were required.	ICIQ-SF: International Consultation on Incontinence Questionnaire, short form. The minimum score is 0, and the maximum is 21. Where 0 is the absence of urinary incontinence and everything valued above 0 is a symptom of urinary incontinence. The higher the value, the worse the incontinence.

Secondary Outcome Measures

Name	Time	Method
Changes in sexual function (FSFI) before, after and six months after treatment in both groups.	Before treatment, six weeks of treatment, and 6 months assessments were required.	FSFI: Female Sexual Function Index. The minimum value is 2, and the maximum is 36, which is the result of the sum of the results of each domain, which are 6 in total, with a maximum value of 6 points each. This scale the higher the value, the better sexual function.; It consists of 19 questions, divided into subgroups according to the symptom to be studied: desire, arousal, lubrication, orgasm, satisfaction, and pain.
Changes in the Pad Test 1h before, after and six months after treatment in both groups.	Before treatment, six weeks of treatment, and 6 months assessments were required.	Indications are given for one consecutive hour using a pad that will be given to the researcher, as well as a pad of the same model to weigh the difference obtained. The indications range from the intake of 500 ml of water, to various abdominal hyperpressure exercises.
Changes in Pelvic Muscle Excersice Self-Efficacy (Broome scale) before, after and six months after treatment in both groups.	Before treatment, six weeks of treatment, and 6 months assessments were required.	Evaluates the perception and safety of patients in knowing how to contract the pelvic floor in different situations of daily life and their degree of confidence in them in the face of abdominal hyperpressure.; The minimum value is 0 and the maximum is 100 in both subscales. The higher the value, the greater the awareness and confidence in the pelvic floor contractions.
Changes in muscle tone before, after and six months after treatment in both groups.	Before treatment, six weeks of treatment, and 6 months assessments were required.	Muscle tone is measured with a pelvimeter, which is inserted vaginally and the patient in the supine position and triple flexion of the lower limbs, relaxes and we take the base measurement, resulting from the subtraction of the result obtained minus 170mmHg of base.
Changes in maximum and average strength of the pelvic floor before, after and six months after treatment in both groups. .	Before treatment, six weeks of treatment, and 6 months assessments were required.	The maximum and average muscle strength is the value offered by the pelvimetry at the vaginal level, resulting from three submaximal contractions requested from the woman.
Check the level of physical activity measured with the GPAQ scale, in both groups, before, after and at six months.	Before treatment, six weeks of treatment, and 6 months assessments were required.	GPAQ: global physical activity questionnaire. The GPAQ measures how many MET-min of physical activity is engaged during a typical week. The MET-min per week obtained from the GPAQ is a scale-type variable. Moderate- intensity physical activity corresponds to 4 MET/min, and vigorous-intensity physical activity corresponds to 8 MET/min.\[6\] During the calculation of weekly total MET-min, the durations of each type of physical activity are multiplied by these coefficients.; The minimum value is 0 and the maximum is 3000 MET-min.

Trial Locations

Locations (1)

Yasmin Er Rabiai Boudallaa; 🇪🇸 San Agustín del Guadalix, Madrid, Spain