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Completed

NCT Number: NCT00910338

Efficacy and Safety of Extracorporeal Biofeedback

Stress urinary incontinence is the most common type of female incontinence. The efficacy of pelvic floor muscle training with biofeedback has been already proved in many studies. But intravaginal probe is one of the limitation. So, the purpose of this study is to assess the efficacy and safety of extracorporeal biofeedback device with pelvic floor muscle training.

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Key information

Conditions

Female Stress Urinary Incontinence

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center, Irwon-dong, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women with stress urinary incontinence
  • Standard pad test > 2gram

Exclusion criteria

Women with:

  • Mixed urinary incontinence of which urgency incontinence is dominant
  • True incontinence
  • Overflow incontinence
  • Treatment within 14 days preceding screening, or expected to initiate treatment during the study with electrostimulation, bladder training
  • Treatment within 7 days preceding screening, or expected to initiate treatment during the study with OAB medication or other medication which affect bladder function
  • Pelvic organ prolapse which the stage is at least 2
  • Proven urinary tract infection during screening period
  • Pacemaker
  • Pregnant women
  • Neurogenic voiding dysfunction

Treatment and study plan

PFMT with Extracorporeal Biofeedback

Device

Pelvic Floor Muscle Training with Extracorporeal Biofeedback Device for 12 weeks

  • Twice a week for the first 4 weeks
  • Once a week for the next 8 weeks

Other names: HnJ-5300

Primary outcomes

  1. Cure rate according to standard pad test ; Cure is defined as less than 2g on the standard pad test.

    Time frame: After 12 weeks of treatment

Secondary outcomes

  1. Change in Incontinence severity VAS (I-VAS), Sandvik questionnaire, Incontinence Quality of Life (I-QoL), and Pelvic Floor Muscle Strength.

    Time frame: After 12 weeks of treatment

  2. Patient perception of Treatment Benefit, Satisfaction, Willingness to Retreatment/Recommendation (BSW).

    Time frame: After 12 weeks of treatment

Sponsors and collaborators

Lead sponsor

KYU-SUNG LEE

Other

Collaborators

  • Furun Medical

Registry information

Official study title

Efficacy and Safety of Extracorporeal Biofeedback Pelvic Floor Muscle Training to Treat Urodynamic Stress Incontinence

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 29, 2009
Registry last updated
Dec 2, 2019

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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