Urinary Incontinence,StressNCT05702567
The Effectiveness of Transvaginal Radiofrequency in Women With Stress Urinary Incontinence
A study testing RF + PFMT in people with Urinary Incontinence,Stress and Pelvic Floor Disorders, run by José Casaña Granell at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Urinary Incontinence,Stress, Pelvic Floor Disorders, Urinary Incontinence
- What is being tested?
- RF + PFMT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 9 Jan 2023to 27 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 30Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Urinary Incontinence,Stress, Pelvic Floor Disorders, Urinary Incontinence, Pelvic Floor Muscle Weakness
- Being tested
- RF + PFMT, PFMT + Placebo RF
- Keywords
- Urinary loss, Pelvic floor dysfunctions, Women, Pelvic floor muscle training, Indiba Therapy, Physiotherapy
- Medical subject headings
- Urinary Incontinence, Stress, Pelvic Floor Disorders, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF + PFMTDevice
Also called INDIBA Activ CT9 SN: 19A150410
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 RFOther
Also called INDIBA Activ CT9 SN: 19A150410
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: PFMT + Placebo RF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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. .
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: Before treatment, six weeks of treatment, and 6 months assessments were required.
Changes in Pelvic Muscle Excersice Self-Efficacy (Broome scale) before, after and six months after treatment in both groups.
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.
Measured: Before treatment, six weeks of treatment, and 6 months assessments were required.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start9 Jan 2023
- Primary completion27 Jul 2023
- Study completion27 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence,StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- José Casaña Granell
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alcalá. Physiotherapy in Women's Health (FPSM) Research Group.
- Responsible party
- Sponsor-investigator, José Casaña Granell, University of Valencia
- Investigators
- Yasmin Er Rabiai Boudallaa, Phd Student, Principal investigator, University of Valencia (Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702567
- Sponsor's protocol ID
- UV-INV_ETICA-1104660
- Status last verified
- Aug 2023
- First submitted
- 12 Dec 2022
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16788852Lukban 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.
PubMed 22007230KEGEL 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.
PubMed 15422687Kumaran 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.
PubMed 26524223Giombini 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.
PubMed 17942453Smith 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.
PubMed 28257672Lalji 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.
PubMed 28556393Herman 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.
PubMed 25524045Sodre 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.
PubMed 30989457Caruth JC. Evaluation of the Safety and Efficacy of a Novel Radiofrequency Device for Vaginal Treatment. Surg Technol Int. 2018 Jun 1;32:145-149.
PubMed 29791707Kang 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.
PubMed 25785555Lordelo 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.
PubMed 28727373Imamura 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.
PubMed 20738930Radziminska 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.
PubMed 29844662Soave 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.
PubMed 30649605
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05702567
- Acronym / sponsor ID
- UV-INV_ETICA-1104660
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- José Casaña GranellUniversity, hospital or other
- Collaborators
- University of Alcalá. Physiotherapy in Women's Health (FPSM) Research Group.
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 27 Jul 2023 (actual)
- Study completion
- 27 Jul 2023 (actual)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| RF + PFMT | Experimental | Device: RF + PFMTThe 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 | Placebo comparator | Other: PFMT + Placebo RFThe 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (30 listed)
- Women > 75 years.
- Another type of urinary incontinence, urge or mixed.
- Difficulty urinating
- Hematuria
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RF + PFMTAlso: INDIBA Activ CT9 SN: 19A150410During 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. | Device | RF + PFMT |
| PFMT + Placebo RFAlso: INDIBA Activ CT9 SN: 19A150410The 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 | PFMT |
Primary outcome
Changes in the ICIQ-SF scale before, after and six months after treatment in both groups.
Time frame: 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.
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).
Time frame: 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)
Time frame: 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.
6 secondary outcomes
Changes in maximum and average strength of the pelvic floor before, after and six months after treatment in both groups. .
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Before treatment, six weeks of treatment, and 6 months assessments were required.
Changes in Pelvic Muscle Excersice Self-Efficacy (Broome scale) before, after and six months after treatment in both groups.
Time frame: Before treatment, six weeks of treatment, and 6 months assessments were required.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Background: PubMed 16788852Buchsbaum 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.
- Background: PubMed 22007230Lukban 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.
- Background: PubMed 15422687KEGEL 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.
- Results publication: PubMed 26524223Kumaran 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.
- Results publication: PubMed 17942453Giombini 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.
- Results publication: PubMed 28257672Smith 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.
- Results publication: PubMed 28556393Lalji 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.
- Results publication: PubMed 25524045Herman 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.
- Results publication: PubMed 30989457Sodre 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.
- Results publication: PubMed 29791707Caruth JC. Evaluation of the Safety and Efficacy of a Novel Radiofrequency Device for Vaginal Treatment. Surg Technol Int. 2018 Jun 1;32:145-149.
- Results publication: PubMed 25785555Kang 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.
- Results publication: PubMed 28727373Lordelo 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.
- Guy AW, Lehmann JF, Stonebridge JB (1974) Therapeutic application of electromagnetic power. Proc IEEE, 62, 65-75.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasmin Er Rabiai Boudallaa, Phd Student principal investigator
University of Valencia (Spain)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RF + PFMT in people with Urinary Incontinence,Stress and Pelvic Floor Disorders, run by José Casaña Granell at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the ICIQ-SF scale before, after and six months after treatment in both groups. (time frame: Before treatment, six weeks of treatment, and 6 months assessments were required.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05702567, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.