NCT05114395|CompletedDMC
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Sponsor study identifier
interventional
39
1 country
2
Study Start
March 8, 2021
Actual (reported)Primary Completion
July 12, 2021
Actual (reported)Study Completion
August 9, 2021
Actual (reported)Urinary incontinence (UI) is defined as any involuntary loss of urine. It affects a significant percentage of the population, mainly female, with a prevalence of 21.4% in Portuguese women, having a negative impact on quality of life and sexual function. About half presents with stress UI (SUI), followed by mixed UI (MUI), with isolated urgency UI being less common. Pelvic floor rehabilitiation is a first line treatment for SUI and MUI, however, it is not yet defined which is the best treatment program or the ideal strategies to improve adherence to it. Telerehabilitation assumed a leading role in the covid pandemic phase, although there are few studies on pelvic floor rehabilitation for UI, none in Portugal to date. The authors aim to evaluate the effectiveness of a hybrid program of pelvic floor rehabilitation in female patients with SUI and MUI with a predominance of SUI, including consultation and face-to-face sessions complemented with telerehabilitation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 9, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 8, 2021
Actual (reported)May 26, 2021
Actual (reported)July 12, 2021
Actual (reported)August 9, 2021
Actual (reported)November 10, 2021
Actual (reported)Assessment of urinary incontinence related quality of life using the Portuguese Version of the King's Health Questionnaire (KHQ).
The primary outcome is the assessment of urinary incontinence related quality of life using the Portuguese Version of KHQ.
From admission to discharge of the program, up to 13 weeks.
Assessment of UI severity.
From admission to discharge of the program, up to 13 weeks.
Evaluation of the global perception of improvement of the patient.
From admission to discharge of the program, up to 13 weeks.
The intervention group includes a hybrid program of face-to-face sessions and video sessions. In the first consultation, a face-to-face one, patients will be instructed with behavioral and lifestyle measures and it will be prescribed a 12-week exercise program, including exercises to be performed three times a day and two weekly exercise sessions - three face-to-face sessions (2 initial and one at 8 weeks) and video sessions of 30 minutes, divided into 3 phases with gradual addition of exercises of increasing difficulty in terms of duration, number of repetitions and positions. In the middle of the treatment (at 6 weeks) a medical teleconsultation is performed for reassessment. In the end of the 12-week program there will also be a face-to-face consultation.
The control group develops the entire program in face-to-face consultations and exercise sessions.
See experimental and active comparator arms.
See experimental and active comparator arms.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Physical and Rehabilitation Medicine Department - Centro Hospitalar Universitário de São João
Porto, 4200-319, Portugal
Susana Cristina Alves Moreira
Porto, 4200-319, Portugal
D'Ancona C, Haylen B, Oelke M, Abranches-Monteiro L, Arnold E, Goldman H, Hamid R, Homma Y, Marcelissen T, Rademakers K, Schizas A, Singla A, Soto I, Tse V, de Wachter S, Herschorn S; Standardisation Steering Committee ICS and the ICS Working Group on Terminology for Male Lower Urinary Tract & Pelvic Floor Symptoms and Dysfunction. The International Continence Society (ICS) report on the terminology for adult male lower urinary tract and pelvic floor symptoms and dysfunction. Neurourol Urodyn. 2019 Feb;38(2):433-477. doi: 10.1002/nau.23897. Epub 2019 Jan 25.
Correia S, Dinis P, Rolo F, Lunet N. Prevalence, treatment and known risk factors of urinary incontinence and overactive bladder in the non-institutionalized Portuguese population. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Dec;20(12):1481-9. doi: 10.1007/s00192-009-0975-x. Epub 2009 Aug 14.
Susana Moreira
Centro Hospitalar De São João, E.P.E.
39 participants (actual enrollment reported by the registry).
First Submitted
May 26, 2021
First Posted
November 10, 2021
Study Start
March 8, 2021
Actual (reported)The Role of Platelet Rich Plasma Injections in Cases of Stress Incontinence
Evaluation of sexual function.
From admission to discharge of the program, up to 13 weeks.
Assessment of the presence of symptoms of depression/anxiety.
From admission to discharge of the program, up to 13 weeks.
Assessment of satisfaction with the treatment.
From admission to discharge of the program, up to 13 weeks.
Contact the study team to confirm eligibility.
Hay-Smith EJ, Bo Berghmans LC, Hendriks HJ, de Bie RA, van Waalwijk van Doorn ES. Pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2001;(1):CD001407. doi: 10.1002/14651858.CD001407.
Carrion Perez F, Rodriguez Moreno MS, Carnerero Cordoba L, Romero Garrido MC, Quintana Tirado L, Garcia Montes I. [Telerehabilitation to treat stress urinary incontinence. Pilot study]. Med Clin (Barc). 2015 May 21;144(10):445-8. doi: 10.1016/j.medcli.2014.05.036. Epub 2014 Jul 30. Spanish.
Santiago M, Cardoso-Teixeira P, Pereira S, Firmino-Machado J, Moreira S. A Hybrid-Telerehabilitation Versus a Conventional Program for Urinary Incontinence: a Randomized Trial during COVID-19 Pandemic. Int Urogynecol J. 2023 Mar;34(3):717-727. doi: 10.1007/s00192-022-05108-6. Epub 2022 May 21.
Primary Completion
July 12, 2021
Actual (reported)Study Completion
August 9, 2021
Actual (reported)Last Updated
November 10, 2021
Record last verified: 2021-11
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Source: ClinicalTrials.gov.
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