The Effectiveness of Transvaginal Radiofrequency in Women With Stress Urinary Incontinence

NCT05702567 | Completed DMC

• 1 other identifier: UV-INV_ETICA-1104660
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Changes in the ICIQ-SF scale before, after and six months after treatment in both groups.

  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.

  Before treatment, six weeks of treatment, and 6 months assessments were required.

• 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).

  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.

  Before treatment, six weeks of treatment, and 6 months assessments were required.

• 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)

  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.

  Before treatment, six weeks of treatment, and 6 months assessments were required.

Secondary Outcomes (6)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

RF + PFMT

EXPERIMENTAL

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.

Device: RF + PFMT

PFMT

PLACEBO COMPARATOR

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.

Other: PFMT + Placebo RF

Interventions

RF + PFMT DEVICE

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.

Also known as: INDIBA Activ CT9 SN: 19A150410

RF + PFMT

PFMT + Placebo RF OTHER

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.

Also known as: INDIBA Activ CT9 SN: 19A150410

PFMT

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• José Casaña Granell: lead
• University of Alcalá. Physiotherapy in Women's Health (FPSM) Research Group.: collaborator

Study Sites (1)

Yasmin Er Rabiai Boudallaa

San Agustín del Guadalix, Madrid, 28750, Spain

Location

Related Publications (26)

• Buchsbaum GM, McConville J, Korni R, Duecy EE. Outcome of transvaginal radiofrequency for treatment of women with stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Mar;18(3):263-5. doi: 10.1007/s00192-006-0136-4. Epub 2006 Jun 21.

  PMID: 16788852 BACKGROUND

• 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.

  PMID: 22007230 BACKGROUND

• 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.

  PMID: 15422687 BACKGROUND

• 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.

  PMID: 26524223 RESULT

• 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.

  PMID: 17942453 RESULT

• 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.

  PMID: 28257672 RESULT

• 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.

  PMID: 28556393 RESULT

• 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.

  PMID: 25524045 RESULT

• 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.

  PMID: 30989457 RESULT

• 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.

  PMID: 29791707 RESULT

• 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.

  PMID: 25785555 RESULT

• 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.

  PMID: 28727373 RESULT

• 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.

  PMID: 20738930 RESULT

• 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.

  PMID: 29844662 RESULT

• Soave I, Scarani S, Mallozzi M, Nobili F, Marci R, Caserta D. Pelvic floor muscle training for prevention and treatment of urinary incontinence during pregnancy and after childbirth and its effect on urinary system and supportive structures assessed by objective measurement techniques. Arch Gynecol Obstet. 2019 Mar;299(3):609-623. doi: 10.1007/s00404-018-5036-6. Epub 2019 Jan 16.

  PMID: 30649605 RESULT

• Dumoulin C, Cacciari LP, Hay-Smith EJC. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2018 Oct 4;10(10):CD005654. doi: 10.1002/14651858.CD005654.pub4.

  PMID: 30288727 RESULT

• 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.

  PMID: 25998603 RESULT

• 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.

  PMID: 31526791 RESULT

• 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.

  PMID: 31717291 RESULT

• 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.

  PMID: 23306768 RESULT

• Smith AL, Wein AJ. Urinary incontinence: pharmacotherapy options. Ann Med. 2011;43(6):461-76. doi: 10.3109/07853890.2011.564203. Epub 2011 Jun 3.

  PMID: 21639723 RESULT

• Tsakiris P, Oelke M, Michel MC. Drug-induced urinary incontinence. Drugs Aging. 2008;25(7):541-9. doi: 10.2165/00002512-200825070-00001.

  PMID: 18582143 RESULT

• Giarenis I, Cardozo L. Managing urinary incontinence: what works? Climacteric. 2014 Dec;17 Suppl 2:26-33. doi: 10.3109/13697137.2014.947256. Epub 2014 Sep 6.

  PMID: 25196507 RESULT

• Ben Ami N, Dar G. What is the most effective verbal instruction for correctly contracting the pelvic floor muscles? Neurourol Urodyn. 2018 Nov;37(8):2904-2910. doi: 10.1002/nau.23810. Epub 2018 Aug 28.

  PMID: 30152550 RESULT

• Messelink B, Benson T, Berghmans B, Bo K, Corcos J, Fowler C, Laycock J, Lim PH, van Lunsen R, a Nijeholt GL, Pemberton J, Wang A, Watier A, Van Kerrebroeck P. Standardization of terminology of pelvic floor muscle function and dysfunction: report from the pelvic floor clinical assessment group of the International Continence Society. Neurourol Urodyn. 2005;24(4):374-80. doi: 10.1002/nau.20144. No abstract available.

  PMID: 15977259 RESULT

• Leibaschoff G, Izasa PG, Cardona JL, Miklos JR, Moore RD. Transcutaneous Temperature Controlled Radiofrequency (TTCRF) for the Treatment of Menopausal Vaginal/Genitourinary Symptoms. Surg Technol Int. 2016 Oct 26;29:149-159.

  PMID: 27608749 RESULT

Related Links

• 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.

MeSH Terms

Conditions

Urinary Incontinence, Stress; Pelvic Floor Disorders; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications

Study Officials

• Yasmin Er Rabiai Boudallaa, Phd Student

  University of Valencia (Spain)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The INDIBA radiofrequency device is randomized in a total of 99 programs, and in order of arrival, a number is assigned to each patient in which the intervention of the number is unknown. Patients will always be treated with the same program number, throughout all sessions. 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Head of the Department of Physiotherapy (University of Valencia), Clinical Professor.

Model Details: 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.

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: January 27, 2023
• Study Start: January 9, 2023
• Primary Completion: July 27, 2023
• Study Completion: July 27, 2023
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)