Urinary Incontinence,StressNCT05154760
Effectiveness of Video Conferencing in Urinary Incontinence
A study testing Pelvic floor muscle training, diaphragmatic breathing exercise, core exercises in people with Urinary Incontinence,Stress and Telerehabilitation, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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 ). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Urinary Incontinence,Stress, Telerehabilitation, Pelvic Floor Muscle Training
- What is being tested?
- Pelvic floor muscle training, diaphragmatic breathing exercise, core exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2021to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of the Video Conferencing Telerehabilitation Method, Delivered in One on One and Group Sessions, in Urinary Incontinence Cases
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.
Read more
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.
Read the 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.
- Conditions
- Urinary Incontinence,Stress, Telerehabilitation, Pelvic Floor Muscle Training, Videoconferencing
- Being tested
- Pelvic floor muscle training, diaphragmatic breathing exercise, core exercises
- Keywords
- urinary incontinence, tele rehabilitation, video conferencing, pelvic floor muscle training
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor muscle training, diaphragmatic breathing exercise, core exercisesOther
An exercise program consisting of pelvic floor muscle training, diaphragmatic breathing exercise and core exercises will be applied to the patients.
| Study group | Role | What they receive |
|---|---|---|
| one on one video conference | Active comparator | 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. Receives: Other: Pelvic floor muscle training, diaphragmatic breathing exercise, core exercises |
| group videoconference | Active comparator | 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. Receives: Other: Pelvic floor muscle training, diaphragmatic breathing exercise, core exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Floor Muscle Strength
PERFECT scheme
Measured: Baseline
Pelvic Floor Muscle Strength Change
PERFECT scheme
Measured: end of the 4th week
Pelvic Floor Muscle Strength
PERFECT scheme
Measured: end of the 8th week
Pelvic Floor Muscle Strength change
Surface Electromyography
Measured: Baseline
Pelvic Floor Muscle Strength change
Surface Electromyography
Measured: end of the 4th week
Pelvic Floor Muscle Strength change
Surface Electromyography
Measured: end of the 8th week
Secondary outcomes (28)
Symptom Evaluation
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.
Measured: Baseline
Symptom Evaluation
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.
Measured: end of the 4th week
Symptom Evaluation
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.
Measured: end of the 8th week
Symptom Evaluation
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.
Measured: Baseline
Symptom Evaluation
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.
Measured: end of the 4th week
Symptom Evaluation
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.
Measured: end of the 8th week
Symptoms Evaluation
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
Measured: baseline
Symptoms Evaluation
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
Measured: end of the 4th week
Symptoms Evaluation
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
Measured: end of the 8th week
Symptoms Evaluation
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.
Measured: baseline
Symptoms Evaluation
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.
Measured: end of the 4th week
Symptoms Evaluation
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.
Measured: end of the 8th week
Symptoms Evaluation
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.
Measured: Baseline
Symptoms Evaluation
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.
Measured: end of the 4th week
Symptoms Evaluation
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.
Measured: end of the 8th week
Symptoms Evaluation
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.
Measured: baseline
Symptoms Evaluation
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.
Measured: end of the 4 week
Symptoms Evaluation
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.
Measured: end of the 8 week
Exercise Adherence
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.
Measured: end of the 4th week
Exercise Adherence
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.
Measured: end of the 8th week
Exercise Adherence
Broome Pelvic Muscle Self-Efficacy Scale will be used 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.
Measured: baseline
Exercise Adherence
Broome Pelvic Muscle Self-Efficacy Scale will be used 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.
Measured: end of the 4th week
Exercise Adherence
Broome Pelvic Muscle Self-Efficacy Scale will be used 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.
Measured: end of the 8 week
Patient Satisfaction
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.
Measured: end of the 4th week
Patient Satisfaction
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.
Measured: end of the 8th week
Sexual Function
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.
Measured: baseline
Sexual Function
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.
Measured: end of the 4th week
Sexual Function
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.
Measured: end of the 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start30 Nov 2021
- Primary completion1 Feb 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence,StressStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154760
- Sponsor's protocol ID
- urinary incontinence
- Status last verified
- Sep 2022
- First submitted
- 24 Sep 2021
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aoki Y, Brown HW, Brubaker L, Cornu JN, Daly JO, Cartwright R. Urinary incontinence in women. Nat Rev Dis Primers. 2017 Jul 6;3:17042. doi: 10.1038/nrdp.2017.42.
PubMed 28681849Basak T, Uzun S, Arslan F. Incontinence features, risk factors, and quality of life in Turkish women presenting at the hospital for urinary incontinence. J Wound Ostomy Continence Nurs. 2012 Jan-Feb;39(1):84-9. doi: 10.1097/WON.0b013e31823efd47.
PubMed 22193139Bezerra LO, de Oliveira MCE, da Silva Filho EM, Vicente da Silva HK, Menezes de Oliveira GF, da Silveira Goncalves AK, Pegado R, Micussi MTABC. Impact of Pelvic Floor Muscle Training Isolated and Associated with Game Therapy on Mixed Urinary Incontinence: A Randomized Controlled Trial. Games Health J. 2021 Feb;10(1):43-49. doi: 10.1089/g4h.2019.0207. Epub 2020 Jul 21.
PubMed 32716652Bo K. Pelvic floor muscle training is effective in treatment of female stress urinary incontinence, but how does it work? Int Urogynecol J Pelvic Floor Dysfunct. 2004 Mar-Apr;15(2):76-84. doi: 10.1007/s00192-004-1125-0. Epub 2004 Jan 24.
PubMed 15014933Brennan D, Tindall L, Theodoros D, Brown J, Campbell M, Christiana D, Smith D, Cason J, Lee A. A blueprint for telerehabilitation guidelines. Int J Telerehabil. 2010 Oct 27;2(2):31-4. doi: 10.5195/ijt.2010.6063. eCollection 2010 Fall.
PubMed 25945175Cacciari LP, Morin M, Mayrand MH, Tousignant M, Abrahamowicz M, Dumoulin C. Pelvic floor morphometrical and functional changes immediately after pelvic floor muscle training and at 1-year follow-up, in older incontinent women. Neurourol Urodyn. 2021 Jan;40(1):245-255. doi: 10.1002/nau.24542. Epub 2020 Oct 19.
PubMed 33075192Cam C, Sakalli M, Ay P, Cam M, Karateke A. Validation of the short forms of the incontinence impact questionnaire (IIQ-7) and the urogenital distress inventory (UDI-6) in a Turkish population. Neurourol Urodyn. 2007;26(1):129-33. doi: 10.1002/nau.20292.
PubMed 17083117Cayan S, Akbay E, Bozlu M, Canpolat B, Acar D, Ulusoy E. The prevalence of female sexual dysfunction and potential risk factors that may impair sexual function in Turkish women. Urol Int. 2004;72(1):52-7. doi: 10.1159/000075273.
PubMed 14730166Chen SY, Tzeng YL. Path analysis for adherence to pelvic floor muscle exercise among women with urinary incontinence. J Nurs Res. 2009 Jun;17(2):83-92. doi: 10.1097/JNR.0b013e3181a53e7e.
PubMed 19516102Cottrell MA, Russell TG. Telehealth for musculoskeletal physiotherapy. Musculoskelet Sci Pract. 2020 Aug;48:102193. doi: 10.1016/j.msksp.2020.102193. Epub 2020 May 30.
PubMed 32560876Çetinel B, Özkan B, Can G. ICIQ-SF Türkçe Versiyonu: Validasyon (Geçerlilik) Çalışması. Türk Üroloji Dergisi, 2004; 30: 332-8.
Dumoulin C, Hay-Smith EJ, Mac Habee-Seguin G. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2014 May 14;(5):CD005654. doi: 10.1002/14651858.CD005654.pub3.
PubMed 24823491Grimes CL, Balk EM, Crisp CC, Antosh DD, Murphy M, Halder GE, Jeppson PC, Weber LeBrun EE, Raman S, Kim-Fine S, Iglesia C, Dieter AA, Yurteri-Kaplan L, Adam G, Meriwether KV. A guide for urogynecologic patient care utilizing telemedicine during the COVID-19 pandemic: review of existing evidence. Int Urogynecol J. 2020 Jun;31(6):1063-1089. doi: 10.1007/s00192-020-04314-4. Epub 2020 Apr 27.
PubMed 32342112Hay-Smith J, Herderschee R, Dumoulin C, Herbison P. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women: an abridged Cochrane systematic review. Eur J Phys Rehabil Med. 2012 Dec;48(4):689-705.
PubMed 23183454Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798.
PubMed 19941278
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Video Conferencing Telerehabilitation Method, Delivered in One on One and Group Sessions, in Urinary Incontinence Cases
- ClinicalTrials.gov ID
- NCT05154760
- Acronym / sponsor ID
- urinary incontinence
- Conditions
- Urinary Incontinence,Stress, Telerehabilitation, Pelvic Floor Muscle Training, Videoconferencing
- Keywords
- urinary incontinence, tele rehabilitation, video conferencing, pelvic floor muscle training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 13 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| one on one video conference | Active comparator | Other: Pelvic floor muscle training, diaphragmatic breathing exercise, core exercisesPelvic 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. |
| group videoconference | Active comparator | Other: Pelvic floor muscle training, diaphragmatic breathing exercise, core exercisesPelvic 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor muscle training, diaphragmatic breathing exercise, core exercisesAn exercise program consisting of pelvic floor muscle training, diaphragmatic breathing exercise and core exercises will be applied to the patients. | Other | group videoconference, one on one video conference |
Primary outcome
Pelvic Floor Muscle Strength
Time frame: Baseline
PERFECT scheme
Pelvic Floor Muscle Strength Change
Time frame: end of the 4th week
PERFECT scheme
Pelvic Floor Muscle Strength
Time frame: end of the 8th week
PERFECT scheme
Pelvic Floor Muscle Strength change
Time frame: Baseline
Surface Electromyography
Pelvic Floor Muscle Strength change
Time frame: end of the 4th week
Surface Electromyography
Pelvic Floor Muscle Strength change
Time frame: end of the 8th week
Surface Electromyography
28 secondary outcomes
Symptom Evaluation
Time frame: Baseline
Symptom Evaluation
Time frame: end of the 4th week
Symptom Evaluation
Time frame: end of the 8th week
Symptom Evaluation
Time frame: Baseline
Symptom Evaluation
Time frame: end of the 4th week
Symptom Evaluation
Time frame: end of the 8th week
Symptoms Evaluation
Time frame: baseline
Symptoms Evaluation
Time frame: end of the 4th week
Symptoms Evaluation
Time frame: end of the 8th week
Symptoms Evaluation
Time frame: baseline
Symptoms Evaluation
Time frame: end of the 4th week
Symptoms Evaluation
Time frame: end of the 8th week
Symptoms Evaluation
Time frame: Baseline
Symptoms Evaluation
Time frame: end of the 4th week
Symptoms Evaluation
Time frame: end of the 8th week
Symptoms Evaluation
Time frame: baseline
Symptoms Evaluation
Time frame: end of the 4 week
Symptoms Evaluation
Time frame: end of the 8 week
Exercise Adherence
Time frame: end of the 4th week
Exercise Adherence
Time frame: end of the 8th week
Exercise Adherence
Time frame: baseline
Exercise Adherence
Time frame: end of the 4th week
Exercise Adherence
Time frame: end of the 8 week
Patient Satisfaction
Time frame: end of the 4th week
Patient Satisfaction
Time frame: end of the 8th week
Sexual Function
Time frame: baseline
Sexual Function
Time frame: end of the 4th week
Sexual Function
Time frame: end of the 8th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Background: PubMed 28681849Aoki Y, Brown HW, Brubaker L, Cornu JN, Daly JO, Cartwright R. Urinary incontinence in women. Nat Rev Dis Primers. 2017 Jul 6;3:17042. doi: 10.1038/nrdp.2017.42.
- Background: PubMed 22193139Basak T, Uzun S, Arslan F. Incontinence features, risk factors, and quality of life in Turkish women presenting at the hospital for urinary incontinence. J Wound Ostomy Continence Nurs. 2012 Jan-Feb;39(1):84-9. doi: 10.1097/WON.0b013e31823efd47.
- Background: PubMed 32716652Bezerra LO, de Oliveira MCE, da Silva Filho EM, Vicente da Silva HK, Menezes de Oliveira GF, da Silveira Goncalves AK, Pegado R, Micussi MTABC. Impact of Pelvic Floor Muscle Training Isolated and Associated with Game Therapy on Mixed Urinary Incontinence: A Randomized Controlled Trial. Games Health J. 2021 Feb;10(1):43-49. doi: 10.1089/g4h.2019.0207. Epub 2020 Jul 21.
- Background: PubMed 15014933Bo K. Pelvic floor muscle training is effective in treatment of female stress urinary incontinence, but how does it work? Int Urogynecol J Pelvic Floor Dysfunct. 2004 Mar-Apr;15(2):76-84. doi: 10.1007/s00192-004-1125-0. Epub 2004 Jan 24.
- Background: PubMed 25945175Brennan D, Tindall L, Theodoros D, Brown J, Campbell M, Christiana D, Smith D, Cason J, Lee A. A blueprint for telerehabilitation guidelines. Int J Telerehabil. 2010 Oct 27;2(2):31-4. doi: 10.5195/ijt.2010.6063. eCollection 2010 Fall.
- Background: PubMed 33075192Cacciari LP, Morin M, Mayrand MH, Tousignant M, Abrahamowicz M, Dumoulin C. Pelvic floor morphometrical and functional changes immediately after pelvic floor muscle training and at 1-year follow-up, in older incontinent women. Neurourol Urodyn. 2021 Jan;40(1):245-255. doi: 10.1002/nau.24542. Epub 2020 Oct 19.
- Background: PubMed 17083117Cam C, Sakalli M, Ay P, Cam M, Karateke A. Validation of the short forms of the incontinence impact questionnaire (IIQ-7) and the urogenital distress inventory (UDI-6) in a Turkish population. Neurourol Urodyn. 2007;26(1):129-33. doi: 10.1002/nau.20292.
- Background: PubMed 14730166Cayan S, Akbay E, Bozlu M, Canpolat B, Acar D, Ulusoy E. The prevalence of female sexual dysfunction and potential risk factors that may impair sexual function in Turkish women. Urol Int. 2004;72(1):52-7. doi: 10.1159/000075273.
- Background: PubMed 19516102Chen SY, Tzeng YL. Path analysis for adherence to pelvic floor muscle exercise among women with urinary incontinence. J Nurs Res. 2009 Jun;17(2):83-92. doi: 10.1097/JNR.0b013e3181a53e7e.
- Background: PubMed 32560876Cottrell MA, Russell TG. Telehealth for musculoskeletal physiotherapy. Musculoskelet Sci Pract. 2020 Aug;48:102193. doi: 10.1016/j.msksp.2020.102193. Epub 2020 May 30.
- BackgroundÇetinel B, Özkan B, Can G. ICIQ-SF Türkçe Versiyonu: Validasyon (Geçerlilik) Çalışması. Türk Üroloji Dergisi, 2004; 30: 332-8.
- Background: PubMed 24823491Dumoulin C, Hay-Smith EJ, Mac Habee-Seguin G. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2014 May 14;(5):CD005654. doi: 10.1002/14651858.CD005654.pub3.
- Individual participant dataSharing planned: No
Related trials for Urinary Incontinence,Stress
RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor muscle training, diaphragmatic breathing exercise, core exercises in people with Urinary Incontinence,Stress and Telerehabilitation, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Floor Muscle Strength (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05154760, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.