The Effectiveness of the Video Conferencing Telerehabilitation Method, Delivered in One on One and Group Sessions, in Urinary Incontinence Cases
Phase: NA
Conditions: Urinary Incontinence,Stress, Telerehabilitation, Pelvic Floor Muscle Training, Videoconferencing
Sponsor: Marmara University

 
1 
 
The Effectiveness of the Video Conferencing Telerehabilitation Method, Delivered in One on 
One and Group Sessions, in Urinary Incontinence Cases. 
 
 
 
 
 
 
 
Study Protocol and Statistical Analysis Plan (SAP) (Pages 1 – 21) 
 
 
 
 
 
 
 
 
November 15,2021 
 
 
 

 
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The Effectiveness of the Video Conferencing  
Telerehabilitation Method, Delivered in One on One and Group Sessions, in Urinary 
Incontinence Cases. 
 
 
 
 
 
 
 
Study Protocol (Pages 2-6) 
 
 
 
 
 
 
 
 
 
 
November 15,2021 

 
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Study Protocol  
Study titled “The Effectiveness of the Video Conferencing Telerehabilitation Method, Delivered in 
One on One and Group Sessions, in Urinary Incontinence Cases.” was approved by Marmara 
University Faculty of Medicine Ethical Committee at the meeting on 30.11.2020 with approval 
number: 1195 (Annex-1).  
The legal representatives of the patients who participated in the study will be informed about the aim, 
duration and the programs to be applied throughout the study. Volunteer Information Form will be 
signed and approved in accordance with the standards deemed appropriate by the Ethical Committee 
of Marmara University Faculty of Medicine. The study will be conducted in accordance with the 
Declaration of Helsinki.  
Hypothesis of the Study  
H0: With one on one video conference method, exercise training is no superiority of exercise training 
with group video conferencing method in urinary incontinence. 
H1: Exercise training with one on one video conference method is more effective in increasing muscle 
strength in patients with urinary incontinence. 
H2: One on one videoconferencing and exercise training are more effective in reducing the degree of 
incontinence in patients with urinary incontinence. 
H3: Exercise training with one on one videoconferencing method is more effective in increasing the 
quality of life in patients with urinary incontinence. 
H4: Exercise training with one on one videoconferencing method is more effective in increasing 
patient satisfaction in patients with urinary incontinence. 
H5: Exercise training with one on one video conference method is more effective in increasing sexual 
function in patients with urinary incontinence. 
H6: Exercise training with one on one videoconferencing method is more effective in increasing 
exercise adherence in patients with urinary incontinence. 
 
 
 
Randomization of the Study Groups  
Individuals with Urinary İncontinence applying to Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi 
will be invited to participate in the study. Individuals who volunteered to participate and whom met 
the criteria for participation will be randomized with simple random sampling method and will be 

 
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divided into two groups. In both groups participants will receive same exercise program and 
physiotherapist will follow up the exercise program every week by video confernce method. While 
only the physiotherapist and the patient will take part in the one-on-one group, there will be a 
physiotherapist and 8 patients in the group sessions. 
 
Inclusion Criteria  
18-65 aged 
BMI 18-30 kg/m2 
Being diagnosed with stress incontinence or mixed incontinence (dominantly SUI) 
Mild or moderate incontinence (mild SUI; urinary incontinence with coughing, sneezing, laughing, or 
any strenuous activity. Moderate; urinary incontinence with carrying, pushing, lifting, walking, and 
any light physical activity) 
 
Exclusion Criteria 
Pregnancy 
Ongoing vulvovaginitis or urinary tract infection or malignancy 
Pelvic floor muscle strength is between 0-1 according to the Modified Oxford Scale, 
Previous surgery for SUI 
Problems with vision or inability to understand given commands 
Conservative therapy in the last 6 months 
Allergic reaction to the gel used with the perinometer/probe 
    Evaluations  
Evaluation parameters will be applied at the baseline, at the end of 4-weeks treatment program, at the 
end of 8 weeks treatment program. Outcome measures and applied evaluations are shown in Table 1.  
 
 
 
 
 

 
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Table 1. Outcome measures and evaluation methods  
Primary Outcome 
Measures  
Evaluation Methods  
Muscle Strength 
-PERFECT Scheme 
-Surface Electromyography  
 
Secondary Outcome 
Measures  
Evaluation Methods  
Symptom Evaluation 
-1 hour pad test 
-The International Consultation on Incontinence Questionnaire- 
Short Form 
- Urogenital Distress Inventory- 6 (UDI-6) 
- Incontinence Impact Questionnaire-7 (IIQ-7) 
- Overactive Bladder -Validated 8- Question Awereness Tool 
(OAB-V8) 
Patient Satisfaction 
Visual Analog Scale (VAS) 
Exercise Adherence  
VAS 
Broome Pelvic Floor Muscle Exercise Self- Efficiacy Scale 
Sexual Function 
Female Sexual Function Scale (FSFI) 
 
 
 
 
 
 
 
 
 

 
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Treatment Program 
The exercises which given the both groups compose same exercise protocols for 8 week. The exercise 
protocol includes pelvic floor muscle training, diaphragmatic breathing exercise and core exercise will 
be given the all participants.The participants in the study will be followed up with video conferecing 
method by weekly. 
Group I (one on one video conferencing group): In this group, exercise follow-up and transition to 
the next exercise phase will be realized with one-on-one video conference interviews. 
Group II (group sessions video conferencing group): In this group, exercise follow-up and 
transition to the next exercise stage will be realized with group video conference sessions consisting of 
8 participants. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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The Effectiveness of the Video Conferencing Telerehabilitation Method, Delivered in One on 
One and Group Sessions, in Urinary Incontinence Cases. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Statistical Analysis Plan (SAP) (Pages 7 –8) 
 
 
 
 
 
 
 
 
 
November 15,2021 

 
8 
 
 
Statatistical Analysis Plan (SAP) 
 
In the analysis of the data to be obtained in the study, the significance will be evaluated at the p<0.05 
level with the SPSS 22.0 statistical program at the 90% confidence interval. In the evaluation of 
variables; If the number of cases is sufficient, its conformity to the normal distribution will be 
questioned with the Kolmogorov Smirnov test and normal distribution graphs. In the examination of 
the variables, appropriate statistical tests will be applied depending on the provision of parametric or 
non-parametric test conditions. Normally distributed variables will be expressed as mean and standard 
deviation, and non-normally distributed variables will be expressed as numbers and percentages. If the 
groups fit the normal distribution, the evaluation results at the beginning, 4th week and 8th week will 
be compared with ANOVA, if the normal distribution is not met, comparisons will be made with 
Kruskal Wallis and appropriate post-hoc tests. In the correlation analysis, the appropriate Speerman or 
Pearson correlation analysis methods will be preferred. Chi-square test will be used in the evaluation 
of binary data. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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The Effectiveness of the Video Conferencing Telerehabilitation Method, Delivered in One on 
One and Group Sessions, in Urinary Incontinence Cases. 
 
 
 
 
 
 
 
                    
 
 
 
Annex (Pages 9 – 21)  
 
 
 
 
 
 
 
 
November 15,2021 
 
 
 

 
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Annex 1. Marmara University Faculty of Medicine Ethical Committee Approval (Approval made at 
the meeting on 30.11.2020 with number: 1195)  
 

 
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Annex 2. Patient Evaluation Form 
 
 
 
 
 
 
 
 
 
 
                DATE: 
 
 
PATİENT EVALUATİON FORM 
 
 
 
 
NAME-SURNAME: 
SEX: 
BİRTH DATE/AGE: 
HEIGHT: 
 
 
 
 
WEIGHT: 
 
 
 
BMI: 
EDUCATION LEVEL: 
MARITUAL STATUS: 
PHONE NUMBER: 
NUMBER OF BİRTH:  
 
 
 
 
TYPE OF BİRTH: 
MENOPEASE STATUS: 
WEEKLY ALCOHOL CONSUMPTION:     ………../ week 
WEEKLY TEA CONSUMPTION:    ………../ week 
WEEKLY CAFFEİNE CONSUMPTION:       ………../ week                  
MEDİCAL HİSTORY: 
 
 
 
 
 
DRUGS USED: 
 
 
 
 
 
 
 
 

 
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Annex 3. Assessment of Muscle Strength 
 
Surface EMG 
  
Resting 
tone 
Maximum 
Voluntary 
Contraction 
(MVC) 
Pelvic Floor 
Muscle Endurance 
1 
  
  
  
2 
  
  
  
3 
  
  
  
Mean 
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
PERFECT SCHEME 
Power 
(P) 
Endurance 
(E) 
Repetitions 
(R) 
Fast Contraction 
(F) 
Every Contraction Time 
(ECT) 
1 
  
  
  
  
  
2 
  
  
  
  
  
3 
  
  
  
  
  
MEAN 
  
  
  
  
  

 
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Annex 4. International Consultation on Incontinence Questionnaire-Urinary Incontinence Short 
Form 
 
ICIQ-UI Short Form 
Copyright © “ICIQ Group” 
 
Initial number  
 
 
       CONFIDENTIAL 
                 DAY          MONTH         YEAR   
                
 
 
 
 
 
 
 
 
 
Today’s date 
 
Many people leak urine some of the time. We are trying to find out how many people leak urine, 
and how much this bothers them. We would be grateful if you could answer the following 
questions, thinking about how you have been, on average, over the PAST FOUR WEEKS. 
 
1   Please write in your date of birth:  
 
 
 
 
DAY          MONTH         YEAR 
 
 
 
 
 
2   Are you (tick one): 
Female  
Male  
 
 
 
 
3   How often do you leak urine? (Tick one box) 
 
 
never  
0 
 
 
 
about once a week or less often  
1 
 
 
 
 
 two or three times a week  
2 
 
 
 
about once a day  
3 
 
 
 
several times a day  
4 
 
 
 
all the time  
5 
 
 
 
 
 
4   We would like to know how much urine you think leaks. 
 
     How much urine do you usually leak (whether you wear protection or not)? 
     (Tick one box)  
 
none  
0 
 
 
 
a small amount  
2 
 
 
 
a moderate amount  
4 
 
 
 
a large amount  
6 
 
 
 
 
 
5   Overall, how much does leaking urine interfere with your everyday life? 
 
     Please ring a number between 0 (not at all) and 10 (a great deal) 
 
0      1      2      3      4      5      6      7      8      9      10 
not at all 
 
a great deal 
 
 
 
ICIQ score: sum scores 3+4+5  
  
 
 
 
 
6   When does urine leak? (Please tick all that apply to you) 
 
   
 
 
 
never – urine does not leak  
 
 
  
 
 
leaks before you can get to the toilet  
 
 
  
 
 
leaks when you cough or sneeze  
 
 
  
 
 
leaks when you are asleep  
 
 
  
 
 
leaks when you are physically active/exercising  
 
 
  
 
 
leaks when you have finished urinating and are dressed   
 
 
  
 
 
leaks for no obvious reason   
 
 
  
 
 
leaks all the time  
 
 
 
 
 
 
Thank you very much for answering these questions. 
 

 
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Annex 5. Urogenıtal Dıstress Inventory (Udı 6) 
 
 
 
 
 
 

 
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Annex 6. Incontinence Impact Questionnaire, Short Form (Iıq-7)  
 
 
 
 
 
 
 
 
 
Urology 
Patient Name:                                                                  
Date of Birth:                                                                    
MRN:                                                                                  
Date of Service:                                                                
Physician:                                                                           
 
 
 
 
Incontinence Impact Questionnaire, Short Form (IIQ-7) 
 
Some people find that accidental urine loss may affect their activities, relationships, and feelings. 
For each question, circle the response that best describes how much your activities, relationships, 
and feelings are being affected by urine leakage over the past month. 
 
 
 
Has urine leakage (incontinence) affected your: 
 
Not at All 
Slightly 
Moderately 
Greatly 
Ability to do household chores 
(cooking, housecleaning, laundry)? 
 
 
0 
1 
2 
3 
Physical recreation such as walking, 
swimming, or other exercise? 
 
 
0 
1 
2 
3 
Entertaining activities (movies, 
concerts, etc.)? 
 
 
0 
1 
2 
3 
Ability to travel by car or bus more 
than 30 minutes from home? 
 
 
0 
1 
2 
3 
Participation in social activities 
outside your home? 
 
 
0 
1 
2 
3 
Emotional health (nervousness, 
depression, etc.)? 
 
 
0 
1 
2 
3 
Feeling frustrated? 
 
 
0 
1 
2 
3 
 
 
 
 
 
 
Adapted from Uebersax JS, Wyman FF, Shumaker SA, et al. Short forms to assess life quality and symptom distress for urinary incontinence in 
women: the incontinence impact questionnaire and urogenital distress inventory. Neurourol Urodyn 1995; 14: 131. 
 
 
 
 
 

 
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Annex 7. Assessment of Patient Satisfaction  
 
1) How satisfied were you with the treatment you received? 
0 .................................................5..................................................10 
(Not satisfied at all)                          
 
 
      (Very satisfied) 
 
2) How satisfied were you with the decrease in your complaints after your treatment? 
0 .................................................5..................................................10 
(Not satisfied at all)                          
 
 
      (Very satisfied) 
 
3) How satisfied were you that your exercise program is followed by online interviews? 
0 .................................................5..................................................10 
(Not satisfied at all)                          
 
 
      (Very satisfied) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Annex 8. Assesment of Exercise Adherence 
 
- 
Visual Analog Scale 
How long did you adhere to the exercise program during your treatment? 
0 .................................................5..................................................10 
(Not satisfied at all)                          
 
 
      (Very satisfied) 
 
- 
Broome Pelvic Muscle Exercise Self Efficiacy Scale 
 
 
 
 
 
 
 
 
 
 
 

 
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Annex 9. Female Sexual Function Index Score 
 

 
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20
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Annex 10.  Overactive Bladder 8- Question Awereness Tool