The Effectiveness of Transvaginal Radiofrequency in Women With Stress Urinary Incontinence
NCT ID: NCT05702567
Last Updated: 2023-08-23
Study Results
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Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2023-01-09
2023-07-27
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
FACTORIAL
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.
TREATMENT
TRIPLE
The evaluations of the study will be carried out by the physiotherapist 1 (Yasmin Er Rabiai Boudallaa) who is blinded during the clinical trial.
And by the physiotherapist 2 (Marta Martínez Colmenar), is the responsible for the treatment of patients.
Study Groups
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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.
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.
PFMT
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
20 Years
75 Years
FEMALE
No
Sponsors
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University of Alcalá. Physiotherapy in Women's Health (FPSM) Research Group.
UNKNOWN
José Casaña Granell
OTHER
Responsible Party
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José Casaña Granell
Director, Head of the Department of Physiotherapy (University of Valencia), Clinical Professor.
Principal Investigators
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Yasmin Er Rabiai Boudallaa, Phd Student
Role: PRINCIPAL_INVESTIGATOR
University of Valencia (Spain)
Locations
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Yasmin Er Rabiai Boudallaa
San Agustín del Guadalix, Madrid, Spain
Countries
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References
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Lukban JC. Transurethral radiofrequency collagen denaturation for treatment of female stress urinary incontinence: a review of the literature and clinical recommendations. Obstet Gynecol Int. 2012;2012:384234. doi: 10.1155/2012/384234. Epub 2011 Oct 12.
KEGEL AH, POWELL TO. The physiologic treatment of urinary stress incontinence. J Urol. 1950 May;63(5):808-14. doi: 10.1016/S0022-5347(17)68832-3. No abstract available.
Kumaran B, Watson T. Thermal build-up, decay and retention responses to local therapeutic application of 448 kHz capacitive resistive monopolar radiofrequency: A prospective randomised crossover study in healthy adults. Int J Hyperthermia. 2015;31(8):883-95. doi: 10.3109/02656736.2015.1092172. Epub 2015 Nov 2.
Giombini A, Giovannini V, Di Cesare A, Pacetti P, Ichinoseki-Sekine N, Shiraishi M, Naito H, Maffulli N. Hyperthermia induced by microwave diathermy in the management of muscle and tendon injuries. Br Med Bull. 2007;83:379-96. doi: 10.1093/bmb/ldm020.
Smith WB, Melton W, Davies J. Midsubstance Tendinopathy, Percutaneous Techniques (Platelet-Rich Plasma, Extracorporeal Shock Wave Therapy, Prolotherapy, Radiofrequency Ablation). Clin Podiatr Med Surg. 2017 Apr;34(2):161-174. doi: 10.1016/j.cpm.2016.10.005. Epub 2017 Jan 18.
Lalji S, Lozanova P. Evaluation of the safety and efficacy of a monopolar nonablative radiofrequency device for the improvement of vulvo-vaginal laxity and urinary incontinence. J Cosmet Dermatol. 2017 Jun;16(2):230-234. doi: 10.1111/jocd.12348. Epub 2017 May 29.
Herman RM, Berho M, Murawski M, Nowakowski M, Rys J, Schwarz T, Wojtysiak D, Wexner SD. Defining the histopathological changes induced by nonablative radiofrequency treatment of faecal incontinence--a blinded assessment in an animal model. Colorectal Dis. 2015 May;17(5):433-40. doi: 10.1111/codi.12874.
Sodre DSM, Sodre PRS, Brasil C, Teles A, Doria M, Cafe LE, Lordelo P. New concept for treating urinary incontinence after radical prostatectomy with radiofrequency: phase 1 clinical trial. Lasers Med Sci. 2019 Dec;34(9):1865-1871. doi: 10.1007/s10103-019-02784-7. Epub 2019 Apr 15.
Caruth JC. Evaluation of the Safety and Efficacy of a Novel Radiofrequency Device for Vaginal Treatment. Surg Technol Int. 2018 Jun 1;32:145-149.
Kang D, Han J, Neuberger MM, Moy ML, Wallace SA, Alonso-Coello P, Dahm P. Transurethral radiofrequency collagen denaturation for the treatment of women with urinary incontinence. Cochrane Database Syst Rev. 2015 Mar 18;2015(3):CD010217. doi: 10.1002/14651858.CD010217.pub2.
Lordelo P, Vilas Boas A, Sodre D, Lemos A, Tozetto S, Brasil C. New concept for treating female stress urinary incontinence with radiofrequency. Int Braz J Urol. 2017 Sep-Oct;43(5):896-902. doi: 10.1590/S1677-5538.IBJU.2016.0621.
Imamura M, Abrams P, Bain C, Buckley B, Cardozo L, Cody J, Cook J, Eustice S, Glazener C, Grant A, Hay-Smith J, Hislop J, Jenkinson D, Kilonzo M, Nabi G, N'Dow J, Pickard R, Ternent L, Wallace S, Wardle J, Zhu S, Vale L. Systematic review and economic modelling of the effectiveness and cost-effectiveness of non-surgical treatments for women with stress urinary incontinence. Health Technol Assess. 2010 Aug;14(40):1-188, iii-iv. doi: 10.3310/hta14400.
Radziminska A, Straczynska A, Weber-Rajek M, Styczynska H, Strojek K, Piekorz Z. The impact of pelvic floor muscle training on the quality of life of women with urinary incontinence: a systematic literature review. Clin Interv Aging. 2018 May 17;13:957-965. doi: 10.2147/CIA.S160057. eCollection 2018.
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Dumoulin C, Hay-Smith J, Frawley H, McClurg D, Alewijnse D, Bo K, Burgio K, Chen SY, Chiarelli P, Dean S, Hagen S, Herbert J, Mahfooza A, Mair F, Stark D, Van Kampen M; International Continence Society. 2014 consensus statement on improving pelvic floor muscle training adherence: International Continence Society 2011 State-of-the-Science Seminar. Neurourol Urodyn. 2015 Sep;34(7):600-5. doi: 10.1002/nau.22796. Epub 2015 May 21.
Sigurdardottir T, Steingrimsdottir T, Geirsson RT, Halldorsson TI, Aspelund T, Bo K. Can postpartum pelvic floor muscle training reduce urinary and anal incontinence?: An assessor-blinded randomized controlled trial. Am J Obstet Gynecol. 2020 Mar;222(3):247.e1-247.e8. doi: 10.1016/j.ajog.2019.09.011. Epub 2019 Sep 14.
Garcia-Sanchez E, Avila-Gandia V, Lopez-Roman J, Martinez-Rodriguez A, Rubio-Arias JA. What Pelvic Floor Muscle Training Load is Optimal in Minimizing Urine Loss in Women with Stress Urinary Incontinence? A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2019 Nov 8;16(22):4358. doi: 10.3390/ijerph16224358.
Hirakawa T, Suzuki S, Kato K, Gotoh M, Yoshikawa Y. Randomized controlled trial of pelvic floor muscle training with or without biofeedback for urinary incontinence. Int Urogynecol J. 2013 Aug;24(8):1347-54. doi: 10.1007/s00192-012-2012-8. Epub 2013 Jan 11.
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Related Links
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Guy AW, Lehmann JF, Stonebridge JB (1974) Therapeutic application of electromagnetic power. Proc IEEE, 62, 65-75.
Rodríguez-Mansilla, J., González Sánchez, B., de Toro García, A. and González-López-Arza, M. (2013). Eficacia de la hipertermia como tratamiento en las tendinopatías. Rehabilitación, 47(3), pp.179-185.
Other Identifiers
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UV-INV_ETICA-1104660
Identifier Type: -
Identifier Source: org_study_id
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