Effectiveness of Video Conferencing in Urinary Incontinence

Sponsor

Marmara University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05154760

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Telerehabilitation (TR) refers to the provision of rehabilitation services through information and communication technologies. The most widely used of these technologies are applications such as telephone and video conferencing.

Urinary incontinence is defined as involuntary urinary incontinence ). This condition, which affects both sexes, is more common in women. Urinary incontinence is caused by dysfunction in the bladder and pelvic floor muscles in women during menopause, childbirth, or pregnancy. Urinary incontinence is a health problem that significantly affects people's social interactions, interests, and psychosocial status. It has been shown that even mild incontinence complaints cause a decrease in the quality of life in women.

Pelvic floor muscle training is one of the conservative treatment methods used in the treatment of urinary incontinence.Adding breathing exercises and deep abdominal muscle strengthening exercises to pelvic floor muscle training may be beneficial in patients with urinary incontinence.

In patients with urinary incontinence, women who are in regular communication with the supervisor during pelvic floor muscle training are more likely to gain higher from the program. However, it has not been shown that group physiotherapy is less effective than physiotherapy administered individually in reducing incontinence episodes. In the light of this information in the literature, our research hypothesis is that in patients with urinary incontinence, follow-up the pelvic floor muscle training, breathing exercise, and core exercise training with individually video conference method can have positive effects on patients' muscle strength, incontinence degree, quality of life, patient satisfaction, exercise adherence, and sexual function.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence,Stress Telerehabilitation Pelvic Floor Muscle Training Videoconferencing	Other: Pelvic floor muscle training, diaphragmatic breathing exercise, core exercises	N/A

Detailed Description

During the COVID-19 pandemic in the world, telerehabilitation methods are widely used in order to ensure the continuity of patients' access to health services, as well as to reduce the likelihood of both health personnel and the patient catching the disease. Telerehabilitation (TR) refers to the provision of rehabilitation services through information and communication technologies. Information and communication technologies include secure messaging services and e-mail services, but new applications such as wearable, virtual reality and activity trackers are increasingly used in healthcare. On the other hand, real-time applications, where information is instantly exchanged between all users by telephone and video conferencing, are the most common of information and communication technologies.

Urinary incontinence is defined as the complaint of involuntary urinary incontinence. This condition, which affects both sexes, is more common in women. Urinary incontinence is caused by the disruption of the continence mechanism as a result of prostate enlargement or prostate cancer in men; In women, it is due to dysfunction in the bladder and pelvic floor muscles that occur during menopause, childbirth or pregnancy. urinary incontinence; It is classified as stress incontinence, urge incontinence, mixed type incontinence, overflow incontinence and functional incontinence. In a study conducted in our country, it was reported that stress type incontinence is the most common type of incontinence. Stress type incontinence is followed by mixed type incontinence and urge type incontinence, respectively. Urinary incontinence is a health problem that significantly affects people's social interactions, interests and psychosocial status. Studies have shown that even mild incontinence complaints cause a decrease in the quality of life in women.

Conservative treatment, pharmacological treatment and surgical interventions are used in the treatment of urinary incontinence. Pelvic floor muscle training is one of the conservative treatment methods used in the treatment of urinary incontinence. Studies in the literature have reported that pelvic floor muscle training should be included in the primary care program in women with stress or any type of incontinence, and this training causes less urinary incontinence, less urine in the pad test, and patients empty their bladders less frequently during the day. It has been shown that the pelvic floor muscles work synergistically with the diaphragm and abdominal muscles to control respiration and changes in intra-abdominal pressure. Therefore, it has been reported in the literature that adding breathing exercises and deep abdominal muscle strengthening exercises to pelvic floor muscle training in patients with urinary incontinence may be beneficial.

When the studies are examined, the programs that include pelvic floor muscle training are quite variable. Different methods were used in order to increase the effectiveness of the applied muscle training program and the adherence of the patients to the program. One of these applied methods is telerehabilitation applications. It has been shown that pelvic floor muscle training can be applied safely and effectively with telehealth applications, and significant improvements are achieved in stress incontinence and mixed type incontinence types with these applications. It has been reported that these technological methods are advantageous in order to ensure continuity of treatment without leaving the house during the pandemic process.

Women with regular contact with the supervisor during pelvic floor muscle training in patients with urinary incontinence are more likely to report their recovery. However, group physiotherapy has not been shown to be less effective than individual physiotherapy in reducing incontinence episodes. In the light of this information in the literature, pelvic floor muscle training, breathing exercise and core exercises performed individually with video conference monitoring, which is one of the telerehabilitation methods in patients with urinary incontinence, on muscle strength, incontinence degree, pelvic floor muscle thickness, symptoms on quality of life, patient satisfaction, exercise. We have established our hypothesis in terms of positive effects on commitment and sexual life. Therefore, the aim of this study is; The aim of this study is to compare the effectiveness of group video conferencing method and individual video conferencing method on urinary incontinence in patients with urinary incontinence.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Effectiveness of the Video Conferencing Telerehabilitation Method, Delivered in One on One and Group Sessions, in Urinary Incontinence Cases

Actual Study Start Date :

Nov 30, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: one on one video conference Pelvic floor muscle training, diaphragmatic breathing exercise, core strengthening exercise will continue for 8 weeks. Participants will be asked to practice the exercises at least 4 days in a week, and the program will be continued in the form of one on one interviews with video conference method once a week.	Other: Pelvic floor muscle training, diaphragmatic breathing exercise, core exercises An exercise program consisting of pelvic floor muscle training, diaphragmatic breathing exercise and core exercises will be applied to the patients.
Active Comparator: group videoconference Pelvic floor muscle training, diaphragmatic breathing exercise, core strengthening exercise will continue for 8 weeks. Participants will be asked to practice the exercises at least 4 days in a week, and the program will be continued in the form of group interviews with video conference method once a week.	Other: Pelvic floor muscle training, diaphragmatic breathing exercise, core exercises An exercise program consisting of pelvic floor muscle training, diaphragmatic breathing exercise and core exercises will be applied to the patients.

Arm

Intervention/Treatment

Active Comparator: one on one video conference

Pelvic floor muscle training, diaphragmatic breathing exercise, core strengthening exercise will continue for 8 weeks. Participants will be asked to practice the exercises at least 4 days in a week, and the program will be continued in the form of one on one interviews with video conference method once a week.

Other: Pelvic floor muscle training, diaphragmatic breathing exercise, core exercises

An exercise program consisting of pelvic floor muscle training, diaphragmatic breathing exercise and core exercises will be applied to the patients.

Active Comparator: group videoconference

Pelvic floor muscle training, diaphragmatic breathing exercise, core strengthening exercise will continue for 8 weeks. Participants will be asked to practice the exercises at least 4 days in a week, and the program will be continued in the form of group interviews with video conference method once a week.

Other: Pelvic floor muscle training, diaphragmatic breathing exercise, core exercises

An exercise program consisting of pelvic floor muscle training, diaphragmatic breathing exercise and core exercises will be applied to the patients.

Outcome Measures

Primary Outcome Measures

Pelvic Floor Muscle Strength [Baseline]
PERFECT scheme
Pelvic Floor Muscle Strength [Baseline]
Surface Electromyography

Secondary Outcome Measures

Symptom Evaluation [Baseline]
1-h pad test: It will be used for evaluating incontinence severity. It is a test that is standardized by the International Continence Association, reveals objective results after treatment and is routinely used in incontinence clinics. At the end of the test, the weight of the pad reweighed to calculate the urinary loss. Urinary continence was defined as when the 1 h pad test less than < 2g.
Symptom Evaluation [Baseline]
International Consultation on Incontinence Questionnaire - Short Form (ICIQ - SF): It is a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence in men and women in research and clinical practice across the world. The answers form a score ranging from 0 to 21. The higher the score, the worse the woman experiences her stress urinary incontinence to be.The overall scores can be divided into four severity categories: slight = 1-5 points, moderate = 6-12 points, severe = 13-18 points, and very severe = 19-21 points.
Symptoms Evaluation [Baseline]
Urogenital Distress Inventory (UDI-6) : It will be used to evaluate the presence of different urogenital symptoms and the effect of these symptoms on the patient's quality of life. Item responses range from 0 to 3. The total score on the questionnaire is obtained by averaging the results of all items multiplied by 33 and 1/3 put scores on a scale of 0 to 100. Higher scores indicates more symptoms distress
Symptoms Evaluation [Baseline]
Incontinence Impact Questionnaire - 7 (IIQ-7) : It will be used to evaluate the presence of different urogenital symptoms and the effect of these symptoms on the patient's quality of life, feelings and relationships. Item responses range from 0 to 3. A higher score indicates more severe symptoms and lower quality of life. The total score on the questionnaire is obtained by averaging the results of all items multiplied by 33 and 1/3 put scores on a scale of 0 to 100.
Symptoms Evaluation [Baseline]
Over Active Bladder -Validated 8- Question Awareness Tool (OAB-V8): It has been suggested that the questionnaire consisting of 8 questions be used as an overactive bladder screening and awareness test in patients. It is a self administered tool directed toward detecting patient suffering from over active bladder. It contains 8 items and items are measured on 6 point Likert scale. The total score range from 0 to 52 points, with a score above 8 points reflecting that the patient may have over active bladder.
Symptoms Evaluation [Baseline]
Bladder diary and urination chart : The patient will be asked to record the frequency of daytime urination, the frequency of nighttime urination, the frequency of urinary incontinence for 24 hours, the frequency of the need to urinate, and the amount of fluid taken daily for the first 3 days of starting the treatment and the last 3 days before the end of the treatment.
Exercise Adherence [Baseline]
Exercise adherence will be evaluated by Visual Analog Scale. The score ranges from 0 to 100. Participants will be asked to rate their degree of adherence to exercise by scoring between 0 and 100.
Exercise Adherence [Baseline]
Broome Pelvic Muscle Self-Efficacy Scale will be usef for assessment of exercise adherence. It is 23-item rating scale consisting of two domains: expectations and outcome expectations.The score ranges from 0 to 100. The higher score shows more exercise adherence.
Patient Satisfaction [Baseline]
Patient satisfaction will be evaluated by Visual analog Scale. Participants will be asked to rate their satisfaction level from the treatment by scoring between 0 and 100.
Sexual Function [Baseline]
Female Sexual Function Scale (FSFI): It will be used for measurement of female sexual functioning during previous 4 weeks.It is a 19-item questionnaire with six dimensions. The cut off value of FSFI is 26. Lower score indicates worse sexual function.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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