Radiofrequency and Pelvic Organ Prolapse

NCT04855071 | Unknown

• 1 other identifier: IB4459/21PS
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim To compare the effectiveness of the application of non-ablative radiofrequency (RF) applied in combination with the usual treatment for the treatment of pelvic organ prolapse (POP) versus the usual treatment in lowering its severity. The secondary objective is to compare the effectiveness of both interventions in the symptoms most commonly associated with POP (pelvic heaviness, bulging, and prolapse-related lumbar pain). Design Randomized, double-blind clinical trial. Women between 18 and 75 years old with symptoms of vaginal prolapse, defined as "sensation of mass or lump" and / or "sensation of dragging in the vagina", and who also have the presence of POP diagnosed under clinical criteria and quantified using simplified POP-Q assessment. All women with asymptomatic vaginal prolapse grade IV or less than GI of the cervix or less than or equal to GI of the anterior and / or posterior vaginal Wall (asymptomatic); presence of more than one vaginal prolapse, and also those women with chronic connective tissue diseases or who present some type of contraindication to the application of RF therapy, will be excluded from the study Methods The study will include 20 women in the intervention group and 20 women in the control group. The women will be recruited from the patients who attend the Ketty Ruiz Pelviperineal Physiotherapy Clinic, which it´s specialized in treating pelvic floor dysfunctions. Interventions The usual intervention will be applied to both groups of the study. It will consist of supervised individualized sessions (up to a maximum of 8 sessions) by physiotherapists who are part of the research team. They will include the application of exercises to balance the pelvis and the muscles related to it, treatment of the trigger points detected through the application of manual and / or instrumental techniques, teaching of the activation of the transverse abdominis with ultrasound biofeedback and teaching of reflex activation exercises of the transverse abdominis and pelvic floor muscles in different body positions. The RF will be administered during the exercises of reflex activation of transversus abdominis and pelvic floor muscles on a stretcher (supine position). It will be applied intracavitary, in monopolar application, reaching a temperature between 42-45ºC in the tissues (according to the patient's tolerance), and with a power of 50% until the desired temperature is reached. It will be applied with a frequency that will be individualized according to the maximum level of energy absorption by the patient's tissues (between 0.8-1.2MHz) and with a dose of approximately between 3-4 KJ depending on the application time (20 minutes / session). In addition, they will be applied 1 session per week. The treatment will last 8 weeks. The application of RF in the control group will follow the same application procedure as in the intervention group, but in this case, no type of parameter is applied to the RF device, ie, the device remains off for the entire duration of the session. Variables: For the measurement of the main variable of the study, the simplified POP-Q will be used, considered the "gold standard" for the classification of POP. To measure the secondary variables of the study, the Pelvic Organ Prolapse Symptom Score (POP-SS) questionnaire will be used to assess the symptoms of pelvic bulging and / or heaviness; a visual analog scale (VAS) for the intensity of lumbar pain related to prolapse, the Prolapse Quality of Life (P-QOL) questionnaire for measuring the quality of life related to vaginal prolapse and finally structured interviews will be conducted with all study subjects throughout the duration of the study to assess the safety of the intervention The immediate effect (ie, at the end of the 1st treatment session) in the quantitative assessment of prolapse and the short-term effects (i.e. 1 week after the last face-to-face treatment session) and medium (at 3 and 6 months after end of treatment) and long-term effects (at 12 months after finishing treatment) in all study variables will be evaluated. Statistical analysis and ethical aspects It will be carried out using the SPSS 25.0 statistical package. This project is in process of being approved by the Research Ethics Committee (CEI) of the Balearic Islands (IB 4459/21 PS).

Conditions

Pelvic Organ Prolapse

Keywords

Radiofrequency Therapy; Pelvic floor muscle training; Quality of Life; Low Back Pain; Women; Safety

Outcome Measures

Primary Outcomes (1)

• Change in degree of prolapse

  Quantitative description of the position of the pelvic organs through simplified POP-Q

  Change from baseline degree of prolapse at the end of the first treatment session, at 9th week and at 3rd, 6th and 12th months, post treatment

Secondary Outcomes (3)

• Changes in prolapse symptoms: bulging, pelvic heaviness and low back pain - related to POP-

  Change from baseline in prolapse symptoms at 9 weeks and 3, 6 and 12 months post treatment

• Changes in quality of life

  Change from baseline in prolapse symptoms at 9 weeks and 3, 6 and 12 months post treatment

• Satisfaction with treatment

  12 months post treatment

Other Outcomes (1)

• Safety of RF intervention

  Throughout the whole intervention

Study Arms (2)

Interventional group

ACTIVE COMPARATOR

The intervention will consist of supervised individualized sessions that will include application of exercises to balance the pelvis and their muscles, treatment of trigger points, teaching activation of the transverse abdominis with ultrasound biofeedback and teaching reflex activation exercises of the transverse abdominis and pelvic floor muscles in different body positions. In addition, standards of water, urination, food, defecation, postural hygiene and physical activity will be provided. It is also recommended different life habit advices related to tobacco use, constipation, etc. Furthemore, active RF will be applied intracavitary, in monopolar application, reaching a temperature between 42-45ºC in the tissues (according to the patient's tolerance), and with a power of 50% until the desired temperature is reached. It will be applied with a dose of approximately between 3-4 KJ depending on the application time (20 minutes / session).

Device: Non-ablative radiofrequency application; Other: Usual intervention

Comparator group

SHAM COMPARATOR

The intervention will be the same that in IG (exercises to balance the pelvis and their muscles, etc) an also standards of water, urination, food, defecation, postural hygiene and physical activity for their generalization at home and life habit advices. The application of RF in the control group will follow the same application procedure as in the intervention group with the only difference that no parameter is applied to the RF device (in terms of temperature, power, frequency and dose); that is, it remains off for the entire duration of the session.

Other: Usual intervention

Interventions

Non-ablative radiofrequency application DEVICE

Non-ablative radiofrequency application will be applied with MJS intracavitary probe, in monopolar application, reaching a temperature between 42-45ºC in the tissues (according to the patient's tolerance), and with a power of 50% until the desired temperature is reached. It will be applied with a frequency that will be individualized according to the maximum level of energy absorption by the patient's tissues (between 0.8-1.2MHz) and with a dose of approximately between 3-4 KJ depending on the application time (20 minutes / session). In addition, they will be applied 1 session per week. The treatment will last 8 weeks.

Also known as: Usual intervention

Interventional group

Usual intervention OTHER

The usual intervention will consist of supervised individualized sessions that will include application of exercises to balance the pelvis and their muscles, treatment of trigger points, teaching activation of the transverse abdominis with ultrasound biofeedback and teaching reflex activation exercises of the transverse abdominis and pelvic floor muscles in different body positions. In addition, standards of water, urination, food, defecation, postural hygiene and physical activity will be provided. It is also recommended different life habit advices related to tobacco use, constipation, etc.

Comparator group; Interventional group

Eligibility Criteria

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

You may qualify if:

• Women between 18 and 75 years old.
• Women who state symptoms of vaginal prolapse, defined as "sensation of mass or lump" and / or "sensation of dragging in the vagina" and who also have the presence of POP; i.e. descent of one of the anterior, posterior or uterus vaginal walls (cervix) diagnosed under clinical criteria and quantified using the simplified POP-Q assessment system.

You may not qualify if:

• Prolapse vaginal GIV (according to clinical stage evaluated by POP-Q -Pelvic Organ Prolapse Quantification-).
• Presence of more than one POP
• Asymptomatic vaginal prolapse grade IV or less than GI of the cervix or less than or equal to GI of the anterior and / or posterior vaginal Wall
• Women with chronic connective tissue diseases
• Women who present contraindication to the application of RF therapy such as: pregnancy, metallic prostheses within the electric field, decompensated arteriopathies, malignant neoplasms, active infectious processes, pacemakers, loss of thermal sensitivity,….
• Revocation of informed consent

Sponsors & Collaborators

• Fundació d'investigació Sanitària de les Illes Balears: lead
• University of the Balearic Islands: collaborator

Related Links

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• Bump RC. The POP-Q system: two decades of progress and debate. Int Urogynecol J. 2014;25(4):441-3.
• Bump RC, Mattiasson A, Bø K, Brubaker LP, DeLancey JO, Klarskov P, et al. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996;175(1):10-7.
• Busquets M., Castillo F., Bravo S., \& Contreras D. Uso del sistema POPQ para la clasificación de los prolapsos: hospital parroquial de San Bernardo. Rev. Chil. Obstet. Ginecol. 2009;74(1):4-10.
• Dietz HP. Ultrasound in the assessment of pelvic organ prolapse. Best Pract Res Clin Obstet Gynaecol. 2019 Jan;54:12-30.
• Dietz HP., \& Mann KP. What is clinically relevant prolapse? An attempt at defining cutoffs for the clinical assessment of pelvic organ descent. Int Urogynecol J. 2014;25:451-455. doi:10.1007/s00192-013-2307-4
• Digesu GA., Khullar V., Cardozo L., Robinson D., \& Salvatore S. P-QOL: a validated questionnaire to assess the symptoms and quality of life of women with urogenital prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2005;16(3):176-81; discussion 181. doi:
• Eizaga R., \& García M. Escalas de Valoración de Dolor. 2015.
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• Hagen S., Glazener C., Sinclair L., Stark D., \& Bugge C. (2009). Psychometric properties of the pelvic organ prolapse symptom score. BJOG. 2009;116(1):25-31. doi:10.1111/j.1471-0528.2008.01903.x
• Haylen BT, Maher CF, Barber MD, Camargo S, Dandolu V, Digesu A, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic organ prolapse (POP).
• Interobserver and intraobserver reliability of the proposed International Continence Society, Society of Gynecologic Surgeons, and American Urogynecologic Society
• Jelovsek JE., Maher C., \& Barber M. D. Pelvic organ prolapse. Lancet 2007;369(9566): 1027-38.
• Manonai J., Wattanayingcharoenchai R. Relationship between pelvic floor symptoms and POP-Q measurements. Neurourol Urodyn. 2016 Aug;35(6):724-7. doi: 10.1002/nau.22786. Epub 2015 Apr 28.
• The inter-system association between the simplified pelvic organ prolapse quantification system (S-POP) and the standard pelvic organ prolapse quantification system (POPQ) in describing pelvic organ prolapse
• Orejuela FJ., Shek KL., Dietz HP. The time factor in the assessment of prolapse and levator ballooning. Int Urogynecol J. 2012 Feb;23(2):175-8.
• Parekh M., Swift S., Lemos N., Iskander M., Freeman B., Arunkalaivanan AS., et al. Multicenter inter-examiner agreement trial for the validation of simplified POPQ system. Int Urogynecol J. 2011;22(6):645-50.
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MeSH Terms

Conditions

Pelvic Organ Prolapse; Low Back Pain

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ketty K Ruiz-López, BSc

  Centro de fisioterapia pelviperineal Ketty Ruiz

  STUDY DIRECTOR

Central Study Contacts

Juan Carlos JC Fernández-Domínguez, PhD

CONTACT

+34971259513; jcarlos.fernandez@uib.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The women will be assigned to each of the study groups in an individualized random way, based on the table of random numbers generated prior to the start of the study through the EPIDAT v.4 software (Galicia, Spain). The randomization sequence will be kept hidden, through the use of sealed and opaque envelopes previously prepared by the main investigator of the project (JCFD) and which will be placed in a box available to the physiotherapists who perform each of the interventions. The allocation of women to the treatment groups will be blinded and also the blinding will be maintained in the analysis (evaluation of results), in such a way that in the data analysis only the groups will be identified. It is not possible to blind the physiotherapist professionals who perform the intervention (neither in the IG nor in the CG).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: IG receives the usual intervention, which consists of performing exercises to balance the pelvis and their muscles and activation of the transverse abdominis and pelvic floor muscles and life habit advices plus the application of RF sessions. CG receives only the usual intervention. Sham RF sessions will be applied, using the same protocol as for the IG.

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: April 22, 2021
• Study Start: April 23, 2021
• Primary Completion: October 23, 2022
• Study Completion: October 23, 2022
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share