Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT06348342 |
| Other study ID # |
TÜTF-GOBAEK 2023/24 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 15, 2023 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
June 2024 |
| Source |
Trakya University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The prospective and four-arm randomized controlled study was conducted on n = 136 (34 =
control, 34 = kegel, 34 = core, 34 = kegel+ core group) menopausal women at Trakya University
Health Research and Application Center Urology Polyclinic between Oct 2023 and June 2024. In
the first interview, the researcher will apply an information form to all four groups, asking
about personal information, habits, bladder irritants and fluid intake-related features,
obstetric, gynecological and systemic disease-related features, and stress urinary
incontinence-related features. This form will only be filled at the beginning. In addition,
the "Pelvic Floor Distress Scale (PFDI)" and "Pelvic Floor Impact
Questionnaire (PFIQ)" will be applied and will be repeated by the executive
researcher at the 1st, 2nd and 3rd controls. It will be terminated at the 3rd follow-up.
Descriptive statistics, Pearson, Spearman's correlation, and regression analyzes will
be used in the analysis of research data.
Description:
In this prospective, randomized-controlled study, menopausal women over the age of 45 who
applied to Trakya University Health Research and Application Center Urology Polyclinic with
complaints of stress urinary incontinence (stage 1-2) and who do not require surgical or
medical treatment of stress urinary incontinence were included in the case and intervention
groups. will be divided into four groups:
In the first interview, the researcher will apply an information form to all four groups,
asking about personal information, habits, bladder irritants and fluid intake-related
features, obstetric, gynecological and systemic disease-related features, and stress urinary
incontinence-related features. This form will only be filled at the beginning. In addition,
the Pelvic Floor Distress Scale (PFDI); and Pelvic Floor Impact Questionnaire (PFIQ); will be
applied and will be repeated by the executive researcher at the 1st, 2nd and 3rd controls. It
will be terminated at the 3rd follow-up.
All four groups will be given a 3-day voiding diary, which will be requested at the check-up
and must be filled out at home for 3 consecutive days (a voiding diary will be given at each
follow-up and they will be asked to bring it at the 1st, 2nd and 3rd follow-up a month later)
and will be monitored by the leading researcher. It will be terminated at the 3rd follow-up.
At the 3rd follow-up, where the study was terminated; Trakya University Faculty of Medicine
Urology Department, which will perform routine control examinations of diagnosed patients and
is involved in the study. Faculty Member Assoc. Dr. Hakan AKDERE and Op. Dr. Hakan ÇAKICI at
Private Optimed Hospital Urology Department. Urogynecological evaluation tests (stress test,
uroflowmetry, pelvic floor muscle strength measurement, digital palpation) will be requested
and will be performed by the researchers in the examination room of the Urology Polyclinic of
the applied hospital, paying attention to the privacy of women. The requested
urogynecological evaluations will be requested in the 3rd follow-up and are the tests
included in the patient follow-up protocol of the specified diagnosis. No evaluation test
other than routine evaluation tests is specified.
Pelvic Floor Muscle Exercise (PFME/ Kegel Exercise): Training for PFME will be given orally
and will cover the importance of PFME and how to do the exercises, as well as the conditions
and frequency of doing the exercises. You will be told that the exercise should be done when
the bladder is empty, three times a day (morning, noon and evening) and repeated 10 times in
each set. In the first week of exercise, the PFM will be contracted for 3 seconds and relaxed
for 3 seconds, and will be increased by 1 second each week. It will be explained that from
the 8th week onwards, it will be done by contracting for 10 seconds and relaxing for 10
seconds and will continue. It will be stated that the learning process of pelvic floor muscle
exercise may take 6 weeks to 6 months. It will be stated that this exercise should be applied
throughout their lives for the sustainability of PFM strength. The training is planned to
last approximately 20 minutes. PFME will last for two months. Women in menopause will be
given an exercise chart (about how many times a day they should exercise) to guide them in
their exercise activities at home.
Core Exercise: Activating the contraction of the deep core muscles TrA and mutifidus without
disrupting breathing forms the basis of core stabilization exercises. To teach the abdominal
hallowing; maneuver, which enables the activation of these muscles, patients will be shown a
picture of the TrA muscle and asked to contract their lower abdominal muscles while lying on
their back in the hook position. During the maneuver, care will be taken to ensure that no
movement occurs in the trunk and pelvis and that diaphragmatic breathing continues. After the
abdominal hallowing maneuver is taught, the exercises will be progressed gradually. A home
exercise program will be given for this. The 7-level exercise program recommended by Hagins
et al. will be used as a home exercise program. The movements in this program load more
moments on the muscles that stabilize the lumbar spine as the levels progress. The stages of
the exercise program are shared in the brochure to be given to the patients. The aim of the
exercise program is to complete the movements without disrupting the abdominal hallowing.
Each patient, whose urogynecological values are completed and who meets the diagnosed
criteria, will visit the physiotherapist researcher at the Department of Physical Therapy and
Rehabilitation, Faculty of Health Sciences, after Trakya University Health Practice and
Research Hospital, to teach the abdominal hallowing maneuver and to determine at what level
they will start stabilization exercises. Patients will be given a program of 3 movements, one
level below and one above the level they can achieve. The program, which will last 15 minutes
in total, with each movement being five minutes, will be done 3 days a week, and the core
exercise will last for two months. Patients will be evaluated by a physiotherapist once a
month to evaluate the activation of the TrA muscle and their exercise programs will be
updated.
In the stress test, if the bladder is full and there is a feeling of urination, the patient
will first be evaluated in the lithotomy position on the examination table, and the same
procedure will be performed while standing, by asking for strong straining and coughing, by
increasing the intra-abdominal pressure, and visually visualizing whether there is urine
leakage.
After the stress test; With the uroflowmetry evaluation test, the woman will be seated on the
upper toilet, under which the uroflowmetric device is located, and the researcher will be
asked to urinate completely with the start. After urinating completely, the process will be
terminated with the finish from the researcher. With this method, urination volume, flow
duration, maximum flow rate, time to reach maximum speed, average flow rate and urination
time values will be measured and the values will be taken through the software to which the
device is connected.
Pelvic Floor Muscle Strength Measurement: With the device called perinometry, which measures
the pelvic floor muscle strength, the vaginal probe, which belongs only to the woman, will be
placed 3 cm inside the chamber, and the pelvic floor muscle strength will be evaluated by
giving the woman a muscle command to the pelvic floor muscles.
Digital Palpation is a subjective method applied by vaginal touch that evaluates the strength
and endurance (maximum duration of contractions) of the pelvic floor muscles. Evaluation by
digital palpation will be performed using the Modified Oxford Classification.
Evaluation of PTK strength by digital examination (Modified Oxford scoring) PTK strength
Muscle strength 0: No contraction Muscle strength 1: Contraction is minimal, able to hold
fingers for less than 1 second.
Muscle strength 2: Contraction is weak, there is no elevation of the fingers and can hold for
1-3 seconds.
Muscle strength 3: With contraction, the doctor's fingers are lifted up to the
posteriorvaginal wall, can hold for 4-6 seconds, can repeat 3 times.
Muscle strength 4: The doctor's fingers rise up to the posterior vaginal wall, there
is a feeling of more intense pressure on the fingers and can hold it for 7-9 seconds,
repeating it 3 times.
Muscle strength 5: Can make one strong contraction lasting 10 seconds and repeat 4 or more
times.
The type of stress incontinence will be determined after the evaluation tests applied during
the initial interview. Urogynecological evaluation tests and Pelvic Floor Distress Scale
(PFDI) and Pelvic Floor Impact Questionnaire (PFIQ) will be repeated at the 1st, 2nd and 3rd
controls. Initially, randomly assigned intervention groups will be given exercises that
strengthen the pelvic floor muscles (kegel exercise - applied) and core exercise training
(applied) after urogynecological evaluation tests, according to the exercise type of the
groups. Initially, all randomly assigned groups will be instructed to come for a check-up
once a month for 3 months after the urogynecological evaluation tests.
The control group will not do kegel or core exercises and routine treatment processes will
continue. Intervention 1 (kegel exercise group only) will only be given exercise training
that strengthens the pelvic floor muscles (kegel exercise - applied). Intervention 2 (group
doing only core exercise) will be given exercise training that strengthens only the abdominal
muscles (core exercise - applied). Intervention 3 (kegel exercise and core exercise group)
will be given exercise training (kegel exercise and core exercise - applied) that strengthens
the pelvic floor muscles and abdominal muscles.
An exercise tracking chart will be given to all four groups. The follow-up chart will be
filled out group-specific (intervention 1: kegel, intervention 2: abdomen and intervention 3:
kegel + abdomen) every day, 3 times a day for 3 months, and will be delivered to the
researchers at each follow-up, giving detailed information about the form. The 1st, 2nd and
3rd follow-ups after the beginning will be completed with one month intervals for a total of
2 months of follow-up, and the recovery status after exercise treatment will be evaluated
with urogynecological evaluation tests. Participants will be followed up by phone once a week
for control purposes.
Survey Form: Data collection form prepared by the researcher by scanning the literature; It
consists of a total of 55 questions to determine the patients' socio-demographic
characteristics, habits, characteristics regarding bladder irritants and fluid intake,
characteristics regarding obstetric-gynecological and systemic disease history, and
characteristics regarding stress urinary incontinence.
Pelvic Floor Distress Inventory (PFDI - Pelvic Floor Distress Inventionary): PFDI is a
symptom questionnaire consisting of 20 items used to measure the degree of discomfort caused
by pelvic symptoms in women. Each item consists of 4 options (Not at all, Rarely, Moderately,
Quite a lot) and is given a score between 1 and 4. PFDI consists of 3 subscales.
- POPDI-6 (Pelvic organ prolapse distress inventory): It consists of 6 questions and the
presence and degree of pelvic organ prolapse symptoms are questioned.
- UDI-6 (Urinary distress inventory): In this sub-dimension, urinary stress incontinence,
detrusor overactivity and extra-bladder obstructions are questioned. In addition,
according to patients UDI scores; Those with a UDI1 score>1 are classified as having
frequency urinary incontinence, those with a UDI2 score>1 as having urge urinary
incontinence, those with a UDI3 score>1 as having stress urinary incontinence, those
with a UDI2+UDI3 score>2 as having mixed urinary incontinence, and those with a UDI5
score>1 as having urinary retention. .
- CRADI-8 (Colo-rectal-anal distress inventory): It consists of 8 questions asking about
symptoms such as constipation, fecal incontinence and flatus incontinence. The average
scores of the items in each subscale are calculated, these scores are multiplied by 25,
and PFDI subscale scores ranging from 0 to 100 are calculated. Then, the 3 subscale
scores are summed to obtain the PFDI total score, which ranges from 0 to 300. A higher
score indicates poorer health status.
Pelvic Floor Impact Questionnaire (PFIQ Pelvic Floor Impact Questionnaire): PFIQ is a pelvic
floor quality of life questionnaire used to evaluate the effects of bowel, bladder and/or
pelvic symptoms on the individual's daily living activities, social relationships and
emotions. Each item consists of 4 options (Not at all, Rarely, Moderately, Quite a lot) and
is given a score between 0 and 3. The PFIQ scale also consists of 3 subscales.
- POPIQ-7 (Pelvic organ prolapse impact questionnaire): In this subscale consisting of 7
questions, it is questioned how pelvic organ prolapse affects the patient during travel,
social activity and physical activity and the impact of this situation on emotional
health.
- IIQ-7 (Incoinence impact questionnaire): In this subscale consisting of 7 questions, it
is questioned how urinary incontinence during travel, social activity and physical
activity affects the patient and the impact of this situation on his emotional health.
- CRAIQ-7 (Colo-rectal-anal impact questionnaire): In this sub-dimension, consisting of 7
questions, it is questioned how bowel complaints affect the patient during travel,
social activity and physical activity, and the impact of this situation on emotional
health.
The average scores of the items in each subscale are calculated and these scores are
multiplied by (100/3) and PFIQ subscale scores ranging from 0 to 100 are calculated. Then,
the 3 subscale scores are summed to obtain the PFIQ total score, which ranges from 0 to 300.
A higher score indicates poorer health status.
