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Completed

NCT Number: NCT02851719

Outpatient Biofeedback in Addition to Home Pelvic Floor Muscle Exercises

To test whether biofeedback (BF) added to pelvic floor muscle training (PFMT) promotes additional benefits over PFMT alone in the stress urinary incontinence (SUI) treatment.

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Key information

Conditions

Urinary Incontinence, Stress Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Health Behavior Lower Urinary Tract Symptoms Male Urogenital Diseases Motor Activity Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Signs and Symptoms Treatment Adherence and Compliance Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

Introduction: The aim of this study was to test the hypothesis that outpatient BF added to home PFMT results in increased frequency of home exercises sets per month performed by the patients and objective cure rate after 3 months of supervised training. Secondarily, to investigate other subjective and objective clinical parameters in the groups that received or not BF together with PFMT after 3 months of supervised training, and in a longer term of 9-month follow-up.

Method: 72 incontinent women were randomized to the: BF Group (outpatient BF + home PFMT) or PFMT Group (outpatient PFMT + home PFMT).

Assessments: baseline after 3 months of supervised treatment and at 9-month follow-up (after 6 additional months of home PFMT without supervision).

Primary outcomes: adherence - monthly exercises sets performed (exercise diary) and objective cure of SUI (pad test) after 3 months.

Secondary outcomes: urinary symptoms, muscle function, quality of life, adhesion and subject cure at the two time-points.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • SUI and mixed urinary incontinence with predominant symptoms of SUI with ≥ 2 g of leakage measured by pad test

Exclusion criteria

  • younger than 18 years old
  • chronic degenerative diseases
  • pelvic organ prolapse greater than stage I by POP-Q
  • neurologic or psychiatric diseases
  • previously undergone pelvic floor re-education programs and/or previous pelvic floor surgeries

Treatment and study plan

PFMT with biofeedback + Home PFMT

Other

24 outpatient sessions PFMT with biofeedback (twice a week). Simultaneously, it was prescribed a home exercise daily program during three months (supervised treatment).

Other names: Biofeedback

PFMT without biofeedback + Home PFMT

Other

24 outpatient sessions PFMT without biofeedback (twice a week). Simultaneously, it was prescribed a home exercise daily program during three months (supervised treatment).

Other names: PFMT alone

Primary outcomes

  1. Change in pad test

    Time frame: Baseline, after 3 months of supervised treatment and at 9-month follow-up

    To quantify the severity of SUI and as the tool to estimate objective cure rate

Secondary outcomes

  1. Change in 7-Day Voiding Diary

    Time frame: Baseline, after 3 months of supervised treatment and at 9-month follow-up

    To assess the loss efforts

  2. Change in pelvic floor muscle function (Oxford Grading Scale)

    Time frame: Baseline, after 3 months of supervised treatment and at 9-month follow-up

    To assess the function of the pelvic floor muscle

  3. Change in pelvic floor muscle function (Peritron manometer)

    Time frame: Baseline, after 3 months of supervised treatment and at 9-month follow-up

    To assess the function of the pelvic floor muscle

  4. Change in Incontinence Quality-of-Life Questionnaire (I-QoL)

    Time frame: Baseline, after 3 months of supervised treatment and at 9-month follow-up

    To quantify the impact of SUI on quality of life

  5. Subjective cure of SUI ("satisfied" or "dissatisfied")

    Time frame: After 3 months of supervised treatment and at 9-month follow-up

    To evaluate the patient satisfaction with treatment

  6. Frequency and adhesion to the home exercises

    Time frame: After 3 months of supervised treatment and at 9-month follow-up

    The weekly frequency (days/week that patients performed at least 1 set of exercises) and the number of sets per day

  7. Frequency of the outpatient sessions

    Time frame: After 3 months of supervised treatment

    The frequency of the outpatient sessions was monitored

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study title

Outpatient Biofeedback in Addition to Home Pelvic Floor Muscle Training for Stress Urinary Incontinence: a Randomized Controlled Trial

Important dates

Study start
2011
Primary completion
2011
Study completion
2014
First posted
Aug 2, 2016
Registry last updated
Aug 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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