Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04855071 |
| Other study ID # |
IB4459/21PS |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 23, 2021 |
| Est. completion date |
October 23, 2022 |
Study information
| Verified date |
April 2021 |
| Source |
Fundació d'investigació Sanitària de les Illes Balears |
| Contact |
Juan Carlos JC Fernández-Domínguez, PhD |
| Phone |
+34971259513 |
| Email |
jcarlos.fernandez[@]uib.es |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
Description:
Effectiveness and safety of non-ablative radiofrequency in the treatment of pelvic organ
prolapse and its associated symptoms OBJECTIVES Primary To compare the effectiveness of
application of non-ablative radiofrequency applied in combination with the usual treatment
versus usual treatment for the treatment of pelvic organ prolapse (POP) - specifically in the
reduction of vaginal prolapses.
Secondary To compare the effectiveness of both interventions in the symptoms most commonly
associated with vaginal prolapse (pelvic heaviness, bulging, and POP-related low back pain).
Specific
- To analyze the prevalence of symptoms associated with vaginal prolapse depending on the
stage of POP.
- Compare the effectiveness depending on the location of prolapse: anterior vaginal wall,
posterior vaginal wall or vaginal vault.
- Compare the effectiveness according to the degree of prolapse (stages extracted from the
simplified POP-Q: I, IIA, IIB and III).
- Compare the effectiveness based on age.
- Evaluate the relationship of vaginal prolapse symptoms with the location and severity of
vaginal prolapse, respectively in the anterior, posterior and apex wall (Ba, Bp and C).
- Evaluate the immediate effect of RF application on the stage of prolapse.
- Estimate the effect of both interventions (usual treatment vs usual treatment with
active RF), at the end of the 1st treatment session and after finishing the treatment:
short (1 week after the last session), medium (at 3 and 6 months post-intervention) and
long-term (at 12 months post-intervention) on the quantitative assessment of POP and the
most commonly associated symptoms.
- Evaluate the safety of the RF technique (presence of adverse events)
METHODOLOGY DESIGN Double-blind clinical trial with two interventions: usual treatment for
POP versus the usual treatment including application of RF. These interventions are randomly
assigned. The full follow-up period is 12 months. The study design conforms to the
recommendations of the Consolidated Standards of Reporting Trials (CONSORT) for Statement to
Randomized Trials of Nonpharmacological Treatment.
SAMPLE SELECTION CRITERIA
1. Subject inclusion criteria
- 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.
2. Criteria for exclusion of subjects
- 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,….
3. Study withdrawal criteria
- Revocation of informed consent
- Presence of severe adverse effects derived from RF treatment
RECRUITMENT The study will be carried out by the University of the Balearic Islands. The
women will be recruited from the patients who attend the Ketty Ruiz Pelviperineal
Physiotherapy Clinic, which it´s specialized in treating pelvic floor dysfunction.
The control group (CG) will receive the usual intervention (described later) plus the
"sham RF" application, that is, not active; while the intervention group (IG) will
receive the same usual intervention that is provided to the CG subjects plus the
application of active RF in the parameters that are considered most appropriate for the
approach of this kind of dysfunction (described later) The application of sham-RF will
allow, on the one hand, to blind women who have never received RF treatment and will
also allow the assessment of placebo effect of the RF application itself.
The interventions will be carried out by members of the work team, made up of 3
physiotherapists specialized in pelvic floor physiotherapy (KRL, ELlF, MAQ). The
homogeneity of the so-called "usual intervention" will be ensured because all the
physiotherapists who work in the clinic where the intervention is carried out (KRL,
ELlF, MAQ) use the same work protocol for the treatment of POPs. In addition, for the
application of RF (sham or active) a standardized protocol will be followed, to remove
differences in RF application that may influence the results obtained.
INTERVENTIONS USUAL INTERVENTION The usual intervention begins with a physical
examination that includes the assessment of the strength of pelvic floor muscles (PFM)
using the PERFECT method, assessment of tone of PFM to rule out hypertonia, ultrasound
evaluation of the abdominal-perineal synergies and electromyographic assessment (by
surface EMG) of pelvic floor and internal oblique muscles.
The intervention 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. If PFM strength is less than 3 on
modified Oxford scale, intravaginal electrotherapy (muscle electrostimulation) will be
applied. All treatment techniques will be adapted individually based on the results
obtained in the previous physical examination process.
In addition to the supervised sessions, the patient is given an exercise sheet that
includes reflex postural activation of transversus abdominis muscle and PFM by means of
slowed exhalation to be carried out daily (even after the supervised treatment sessions
have ended).
In addition, within the "usual intervention", standards of water, urination, food,
defecation, postural hygiene and physical activity for their generalization at home are
given to all women. They are provided with information on voiding and defecation
physiology and the importance of maintainance proper habits in each of these fields.
It is recommended the reduction or even avoidance of tobacco consumption, limit caffeine
intake, eat a balanced diet according to the Harvard dish to avoid constipation, avoid
weight gain or recommend to lose weight in case of overweight and avoid lifting weight,
as well as playing high-impact sports.
Patients who also present constipation (according to Rome IV criteria) are instructed in
proper habits to go to the bathroom, avoiding the push / tension of the pelvic floor.
Finally, patients with loss of abdominoperineal anticipation synergies (through
ultrasound evaluation) are taught the knack maneuver before and during any task that
involves an increase in intra-abdominal pressure.
RADIO FREQUENCY IG: active RF The active 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.
CG: sham RF The application of RF in the control group will follow the same application
procedure as in the intervention group i. e. it will be applied during the exercises of
reflex activation of transversus abdominis and pelvic floor muscles on a stretcher
(supine position) and with the same technical execution (including technical application
and duration of session, weekly frequency and total number of sessions). The only
difference will be that in the CG subjects, 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.
FOLLOW-UP The immediate and the short, medium and long term effects will be assessed
- Inmediate effect: the immediate effect of both treatments will be compared ("usual
intervention" plus " sham RF " vs "usual intervention" plus "active RF") in the
quantitative assessment of prolapse (through simplified POP-Q).
- Short term: the effect of both treatments at the end of the RF sessions (1 week
after the last session) will be compared both in the quantitative assessment of
prolapse (through simplified POP-Q) and in the symptoms most commonly associated
with vaginal prolapses: pelvic heaviness, bulging and low pelvic-lumbar pain
related to POP (through the measurement instruments described in the section
"Outcomes and measurement instruments"). The potential adverse events of RF in both
groups (CG and IG) will also be assessed.
- Medium term: three and six months after the end of the treatment, the effect of
both treatments will be compared on the previously mentioned variables.
- Long-term: twelve months after the end of the treatment, the effect of both
treatments will be compared on the variables mentioned above.
OUTCOMES AND MEASUREMENT INSTRUMENTS Main variable Degree of prolapse through the
simplified POP-Q (Parekh et al. 2011; Swift et al. 2006). This standardized prolapse
assessment method has excellent inter and intra observer reliability, as well as a
significant association between assessments using the POP-Q and the simplified POP-Q
itself (Manonai et al., 2011). This instrument is internationally recognized, being
considered the "gold standard" for prolapse classification (Hall et al., 1996).
For this, measurements that allow the quantitative description of the position of the
pelvic organs (i.e. the numerical values in cm of the various vaginal segments) will be
used (Bump 2014; Bump et al, 1996), specifically:
- Anterior vaginal segment: called point Ba (estimated around 3 cm proximal to the
hymenal caruncles)
- Posterior vaginal segment: called point Bp (estimated around 3 cm proximal to the
hymenal caruncles)
- Cervix: called point C
- Posterior apex / fornix: called point D
To measure these points, the subject is placed in a standardized dorsal lithotomy
position (90º hip and knee flexion and with leg support on the gynecological stretcher),
From there, the subject is asked to push hard, performing a standardized maximum
Valsalva maneuver with a minimum of 5 s in duration (Orejuela et al., 2012), closing the
mouth while pressing out as if the individual is straining to defecate (in order to
demonstrate the maximum descent of the pelvic organs). A mirror is used to confirm the
correlation of physical findings with the study participant's medical history (Manonai
et al. 2016).
Measurements will be made using a calliper, an hysterometer and a half leaflet of a
Collin-type speculum following the procedure described by Busquets et al. (Busquets et
al., 2009).
In addition, it will also be included the measurement of:
- Degree of prolapse (according to the simplified POP-Q classification): I, IIa, IIb,
III and IV.
- Prolapse location: anterior wall, posterior wall, cervix ("diagnosed" by ultrasound
and physical examination) (Dietz & Mann, 2014; Dietz, 2019).
Measurement standardization procedure To ensure that all measurements are carried out
equally by the members of the work team, made up of 3 physiotherapists specialized in
pelvic floor physiotherapy (KRL, ELlF, MAQ), a training activity will be carried out by
the principal investigator. Furthermore, a pilot test to verify the intra- and
inter-examiner reliability of the measurements with the POP-Q will be carried out.
Secondary variables A. Related to the effectiveness of the intervention Symptoms of POP
(vaginal prolapse)
Measurement of the most frequent symptoms derived from vaginal prolapse:
-Bulging It is defined as the sensation of bulging or that something is descending
through the vaginal introitus. The woman claims that she notices a lump by direct
palpation or that she sees it with the help of a mirror (Haylen et al., 2016).
This symptom is considered prolapse-specific and correlates with the severity of the
prolapse (Jelovsek et al., 2007, Ghetti et al., 2005).
-Pelvic heaviness It is defined as the feeling of heaviness, pressure or a dragging
sensation (pain or discomfort) in the suprapubic or pelvic area (Haylen et al., 2016).
To measure prolapse symptoms, the Pelvic Organ Prolapse Symptom Score (POP-SS)
questionnaire will be used in its Spanish version. It presents an adequate internal
consistency with a Cronbach's alpha coefficient> 0.7. It has adequate validity to
measure the symptoms of prolapse and correct sensitivity to change. It is especially
important in scales that measure the effectiveness of interventions for the treatment of
prolapse (Hagen et al., 2009).
-Low back pain - related to POP- It is defined as a complaint of low back or sacrum pain
(or quite similar to menstruation pain) temporarily associated with vaginal prolapse and
that is relieved when the prolapse is reduced.
It will be assessed using a visual analog scale (VAS). This scale allows one-dimensional
assessment of pain intensity to be measured in a horizontal line of 100 mm, in which
participants are asked to indicate the mean intensity of pain they feel, ranging from 0
mm (no pain) to 100 mm (the greatest pain imaginable). It is a simple, valid, reliable
and reproducible method (Thong et al., 2018; Eizaga & García, 2015).
Quality of life To measure quality of life related to prolapse symptoms, the Spanish
validated version (Flores-Espinoza et al., 2015) of the Prolapse Quality of Life (P-QOL)
questionnaire (Digesu et al., 2005) will be used. It shows an excellent content validity
(CVI = 0.9), adequate construct validity concerned to its association with the severity
of urogenital and intestinal symptoms (discriminative validity), and with respect to its
correlation with the POP stages assessed by the POP- Q in the domains of "impact of
prolapse", "personal relationships", "emotions" and "measures of severity". It also
presents adequate internal consistency, with Cronbach's alpha values higher than 0.70 in
all dimensions except for "severity measures".
Satisfaction with treatment (Sodré et al. 2019) For the subjective evaluation of
satisfaction with the treatment technique used, a 5-point Likert scale will be used: 1-
very dissatisfactory, 2- dissatisfactory, 3- neutral, 4- satisfied, 5-very satisfied
B. Basal
- Age
- Weight
- Height
- Waist circumference
- Menopause (yes / no / presence of perimenopausal symptoms)
- Use of hormone replacement therapy (in menopausal women)
- Hysterectomy: total or subtotal
- Women who have had previous surgeries for POP: type of intervention
- Women who have had previous surgeries for incontinence: type of intervention
- Consumption of hormonal contraceptive drugs (oral, contraceptive adhesive, vaginal
ring, injectable contraceptive, contraceptive implant, other: to be specified)
Obstetric history
- Date of last delivery
- Number of deliveries
- Type of delivery (of each delivery): vaginal, instrumental, caesarean section
- Episiotomy
If the woman is in immediate postpartum (<6 months):
- Current breastfeeding (yes / no / mixed)
- Presence of POP diagnosed prior to the current pregnancy (yes / no)
C. Related to the safety of the intervention Information about the safety of the
intervention will be collected through interviews with the study subjects.
All adverse events (AE) that occur from the beginning of the treatment procedure until
the end of the study will be recorded by each of the intervening physiotherapists.
For each AE, the description, start date, severity, duration and relationship with the
treatment will be recorded. All AEs will be followed until they decline or, in the case
of permanent damage, until the AEs stabilize and the overall clinical outcome is
determined.
It is also collected if the subjects had to discontinue the treatment, if they had to
discontinue any session or if they had to stop the application of RF at some point
during the course of treatment and their reason / s (Sodré et al. 2019).
The relationship of the EA with the treatment will be determined by the IP of the
project (JCFD) using the following classifications: related, possibly related, unknown
and unrelated.
Tamaño muestral:
Sample size:
The sample size for independent means with respect to both the CG and IG measurements
has been obtained. Considering a bilateral contrast accepting an alpha risk of 0.05 and
a beta risk of 0.20 and assuming a change in the main variable of the study, i.e. in the
position of the pelvic organs of at least 15 mm, regardless of the vaginal segment
(point Ba, Bp, C or D), a minimum total of 20 subjects in each group will be required
for a total of 40 subjects, estimating a loss to follow-up rate of 20%.
Randomization:
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.
Blinding It is not possible to blind the physiotherapist professionals who perform the
intervention (neither in the IG nor in the CG).
However, 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.
Statistical analysis A descriptive analysis of all variables, both categorical and
quantitative, will be carried out, with frequency and percentage for categorial, and
Exploratory Data Analysis (AED) for the latter; as well as the Shapiro-Wilk normality
tests to establish compliance or not with the statistical assumptions of the parametric
analysis. Shapiro-Wilk normality tests will be performed to establish compliance with
the statistical assumptions for the parametric analysis.
The differences in the baseline values between both study groups will be performed using
parametric (Student's t-test for independent samples) or non-parametric (U-Mann Whitney)
tests depending on the results of the goodness-of-fit tests. In case of statistically
significant differences between the groups in the baseline measurements, the
pre-intervention values will be included as a potential covariate (analysis of
covariance) to adjust the effect.
For the comparison between the pre and post intervention phases (at the end of the
intervention, 3 months, 6 months and 12 months) in each study group with respect to the
main and secondary variables related to both the effectiveness of the intervention and
the quality of life, Student's t test for independent samples or the U-Mann Whitney test
will be used. The effect size will be estimated using Cohen's d and the 95% confidence
interval of the difference of the pre-post means in the study variables mentioned above.
An analysis of the variance of repeated measures of two factors will be carried out
using time (pre and post-1 - at the end of the intervention and post 2- at 3 months,
post 3- at 6 months and post 4 - at 12 months) and the treatment group (control group
vs. intervention).
To check the immediate effect (after the 1st session) of the application of RF in the
IG, an analysis for within-subject measurements using the Student's t test for paired
means or the Wilcoxon test was performed. The effect size will also be estimated using
Cohen's d and the 95% confidence interval to check the magnitude of the differences, if
required.
Data will be analyzed and processed using the SPSS v.25 statistical package. Ethical
aspects The study will have the approval of the Committee of Ethics and Clinical
Research (CEI) of the Balearic Islands (in process).
All subjects in the study must be informed, and if they agree to participate, sign the
informed consent.
In the event that as a result of the treatment in the IG, significant results are
obtained in relation to the variables studied, the research team undertakes to offer the
same treatment and under the same conditions to the subjects randomly assigned to the
GC, once the study period is over.
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