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Completed

NCT Number: NCT01783392

Peripheral Electrical Stimulation for the Treatment of Overactive Bladder

This clinical trial testing three different sites of transcutaneous electrical nerve stimulation for the treatment of overactive bladder (OAB).

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Key information

Conditions

Idiopathic Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheffield Teaching Hospitals NHS foundation Trust, Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males and Females, at least 18 years of age
  • Documented symptoms of idiopathic overactive bladder for at least 3 months
  • Failure on primary OAB treatment, such as behavior modification or fluid/diet management
  • Patients can remain on stable medication
  • Willing and capable of understanding and complying with all requirements of the protocol
  • Signed Informed Consent to participate in the study after full discussion of the research nature of the treatment and its risks and benefits

Exclusion criteria

  • Urinary retention or post voiding residual greater than 100 ml
  • Clinically significant bladder outlet obstruction
  • Stress predominant mixed urinary incontinence
  • Neurological disease affecting urinary bladder function, including but not limited to Parkinson's disease, multiple sclerosis, stroke, spinal cord injury.
  • Pelvic surgery (such as sub-urethral sling, pelvic floor repair) within the past 6 months
  • Denovo OAB following pelvic surgery sub-urethral sling Intravesical or urethral sphincter Botulinum Toxin Type A injections within the past 6 months
  • Percutaneous Tibial Nerve Stimulation (PTNS) therapy for overactive bladder within the past 6 months
  • Any form of electric stimulation to the pelvis or lower limbs within 4 weeks
  • Vaginal prolapse greater than Stage II in the anterior compartment of the vagina using International Continence Society (ICS) Pelvic Organ ProlapseQuantification (POPQ) criteria.
  • Prior periurethral or transurethral bulking agent injections for bladder problems within the past 12 months.
  • History of pelvic radiation therapy
  • Any skin conditions affecting treatment sites
  • Lacking dexterity to properly utilize the components of the stimulator system.
  • Presence of an implanted electro-medical device (e.g. pacemaker, defibrillator, InterStim®, etc.),
  • Pregnant, nursing, suspected to be pregnant (by urine pregnancy method), or plans to become pregnant during the course of the study.
  • Recurrent Urinary Tract Infections UTI (>3 UTI's in the past year)
  • History of, or current, lower tract genitourinary malignancies
  • Any clinically significant systemic disease or condition that in the opinion of the Investigator would make the patient unsuitable for the study
  • Any other clinical trial within 6 months

Treatment and study plan

Transcutaneous Electrical Nerve Stimulation

Procedure

Primary outcomes

  1. Change in frequency of voiding

    Time frame: baseline, 4 weeks

    The change of urinary frequency from baseline to after 4 weeks of the treatment, measured by a 3 days bladder diary.

  2. Change in Patient Perception of Bladder Condition (PPBC)

    Time frame: baseline, 4 weeks

    Change in the patient's bladder condition based on the PPBC questionaire from baseline to after 4 weeks of the treatment.

Secondary outcomes

  1. Changes in symptom severity score and health-related quality of life score (HRQL) based on OAB-questionnaire

    Time frame: baseline, 4 weeks

    Change in symptom severity score and HRQL score from baseline to after 4weeks of the treatment.

  2. Changes in the mental/physical scores of RAND36

    Time frame: baseline, 4 weeks

  3. Change in urinary symptoms score and bother symptom score based on the ICIQ-OAB questionnaire

    Time frame: baseline, 4 weeks

    Change in urinary symptoms score and bother symptom score based on the ICIQ-OAB questionnaire from baseline to after 4 weeks of the treatment

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Registry information

Acronym: PESTOB

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Feb 4, 2013
Registry last updated
May 22, 2015

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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