NCT05154760

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

November 30, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 13, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 25, 2024

Status Verified

September 1, 2022

Enrollment Period

1.2 years

First QC Date

September 24, 2021

Last Update Submit

March 21, 2024

Conditions

Keywords

urinary incontinencetele rehabilitationvideo conferencingpelvic floor muscle training

Outcome Measures

Primary Outcomes (6)

  • Pelvic Floor Muscle Strength

    PERFECT scheme

    Baseline

  • Pelvic Floor Muscle Strength Change

    PERFECT scheme

    end of the 4th week

  • Pelvic Floor Muscle Strength

    PERFECT scheme

    end of the 8th week

  • Pelvic Floor Muscle Strength change

    Surface Electromyography

    Baseline

  • Pelvic Floor Muscle Strength change

    Surface Electromyography

    end of the 4th week

  • Pelvic Floor Muscle Strength change

    Surface Electromyography

    end of the 8th week

Secondary Outcomes (28)

  • Symptom Evaluation

    Baseline

  • Symptom Evaluation

    end of the 4th week

  • Symptom Evaluation

    end of the 8th week

  • Symptom Evaluation

    Baseline

  • Symptom Evaluation

    end of the 4th week

  • +23 more secondary outcomes

Study Arms (2)

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.

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.

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

Interventions

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

group videoconferenceone on one video conference

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Berivan Beril Kılıç

Istanbul, Turkey (Türkiye)

Location

Related Publications (27)

  • 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.

    PMID: 28681849BACKGROUND
  • Basak 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.

    PMID: 22193139BACKGROUND
  • Bezerra 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.

    PMID: 32716652BACKGROUND
  • Bo 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.

    PMID: 15014933BACKGROUND
  • Brennan 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.

    PMID: 25945175BACKGROUND
  • Cacciari 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.

    PMID: 33075192BACKGROUND
  • Cam 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.

    PMID: 17083117BACKGROUND
  • Cayan 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.

    PMID: 14730166BACKGROUND
  • Chen 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.

    PMID: 19516102BACKGROUND
  • Cottrell 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.

    PMID: 32560876BACKGROUND
  • Çetinel B, Özkan B, Can G. ICIQ-SF Türkçe Versiyonu: Validasyon (Geçerlilik) Çalışması. Türk Üroloji Dergisi, 2004; 30: 332-8.

    BACKGROUND
  • 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.

    PMID: 24823491BACKGROUND
  • Grimes 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.

    PMID: 32342112BACKGROUND
  • Hay-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.

    PMID: 23183454BACKGROUND
  • Haylen 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.

    PMID: 19941278BACKGROUND
  • Hu JS, Pierre EF. Urinary Incontinence in Women: Evaluation and Management. Am Fam Physician. 2019 Sep 15;100(6):339-348.

    PMID: 31524367BACKGROUND
  • Hui E, Lee PS, Woo J. Management of urinary incontinence in older women using videoconferencing versus conventional management: a randomized controlled trial. J Telemed Telecare. 2006;12(7):343-7. doi: 10.1258/135763306778682413.

    PMID: 17059650BACKGROUND
  • Hung HC, Hsiao SM, Chih SY, Lin HH, Tsauo JY. An alternative intervention for urinary incontinence: retraining diaphragmatic, deep abdominal and pelvic floor muscle coordinated function. Man Ther. 2010 Jun;15(3):273-9. doi: 10.1016/j.math.2010.01.008. Epub 2010 Feb 24.

    PMID: 20185357BACKGROUND
  • Krhut J, Gartner M, Mokris J, Horcicka L, Svabik K, Zachoval R, Martan A, Zvara P. Effect of severity of urinary incontinence on quality of life in women. Neurourol Urodyn. 2018 Aug;37(6):1925-1930. doi: 10.1002/nau.23568. Epub 2018 Mar 31.

    PMID: 29603780BACKGROUND
  • Laycock J, Jerwood D. Pelvic floor muscle assessment: The PERFECT Scheme. Physiotherapy, 2001; 87, 631-642.

    BACKGROUND
  • Novara G, Checcucci E, Crestani A, Abrate A, Esperto F, Pavan N, De Nunzio C, Galfano A, Giannarini G, Gregori A, Liguori G, Bartoletti R, Porpiglia F, Scarpa RM, Simonato A, Trombetta C, Tubaro A, Ficarra V; Research Urology Network (RUN). Telehealth in Urology: A Systematic Review of the Literature. How Much Can Telemedicine Be Useful During and After the COVID-19 Pandemic? Eur Urol. 2020 Dec;78(6):786-811. doi: 10.1016/j.eururo.2020.06.025. Epub 2020 Jun 18.

    PMID: 32616405BACKGROUND
  • Onur R, Bayrak Ö. Ürı̇ner İnkontı̇nans Tanı ve Tedavı̇. ISBN: 978-975-00112-5-2.TÜD/TÜRK Üroloji Akademisi Yayını No: 2, 2015

    BACKGROUND
  • Ozlu A, Yildiz N, Oztekin O. Comparison of the efficacy of perineal and intravaginal biofeedback assisted pelvic floor muscle exercises in women with urodynamic stress urinary incontinence. Neurourol Urodyn. 2017 Nov;36(8):2132-2141. doi: 10.1002/nau.23257. Epub 2017 Mar 27.

    PMID: 28345778BACKGROUND
  • Talasz H, Kremser C, Kofler M, Kalchschmid E, Lechleitner M, Rudisch A. Phase-locked parallel movement of diaphragm and pelvic floor during breathing and coughing-a dynamic MRI investigation in healthy females. Int Urogynecol J. 2011 Jan;22(1):61-8. doi: 10.1007/s00192-010-1240-z. Epub 2010 Aug 31.

    PMID: 20809211BACKGROUND
  • Tarcan T, Naşide M, Özgür MÖ, Akbal C. Oab V8 Aşırı Aktif Mesane Sorgulama Formu Validasyon Çalışması. Üroloji Bülteni, 2012;21, 113-116.

    BACKGROUND
  • Zachovajeviene B, Siupsinskas L, Zachovajevas P, Venclovas Z, Milonas D. Effect of diaphragm and abdominal muscle training on pelvic floor strength and endurance: results of a prospective randomized trial. Sci Rep. 2019 Dec 16;9(1):19192. doi: 10.1038/s41598-019-55724-4.

    PMID: 31844133BACKGROUND
  • Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.

MeSH Terms

Conditions

Urinary Incontinence, StressUrinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2021

First Posted

December 13, 2021

Study Start

November 30, 2021

Primary Completion

February 1, 2023

Study Completion

December 1, 2023

Last Updated

March 25, 2024

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations