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RecruitingPhase 2

Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer

A Phase II Trial of Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 120 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 9 weeks, 6 weeks, 3 days, 3 weeks
  • Procedures mentioned: Urine samples, Physical exams, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Design: Participants will be in the study for about 9 weeks."
  • "They will have a physical exam with urine tests."
  • "They will use the device once a day for 20 minutes at a time; they will do this 5 days a week for 6 weeks."
  • "For 3 days before and 3 days after using the Elidah device, they will collect all of their used pads for each 24-hour period into a sealed plastic bag."
  • "Participants will have clinic visits after using the device for 3 weeks and after finishing the 6 weeks of treatment."
  • "Participants will complete 15-minute questionnaires."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the Elidah device can reduce urine leaks after prostate cancer treatment. The device sends electrical pulses through the skin to muscles and tissues under the pelvis. It is for men age 18 or older who have had moderate urine leaks for at least 6 months after treatment.

Background: Men who are treated for prostate cancer often develop urinary leakage (incontinence). An experimental device that uses electrical impulses to stimulate pelvic floor muscles and surrounding tissues may help. Objective: To see if the Elidah device can reduce urinary incontinence after prostate treatment. Eligibility: Men aged 18 years and older who have had moderate urinary incontinence for at least 6 months after treatment for prostate cancer. Design: Participants will be in the study for about 9 weeks. They will be screened. They will have a physical exam with urine tests. The Elidah device consists of a Controller and a GelPad. The Controller sets the strength of electrical impulses. The GelPad is placed against the skin under the pelvis. Participants will be given an Elidah device and taught how to use it at home. They will use the device once a day for 20 minutes at a time; they will do this 5 days a week for 6 weeks. Participants will complete a daily log. They will record the strength of electrical impulses (0-35); the number of incontinence episodes; the type of incontinence episode; and the number of used pads. Participants will do a pad weight test. For 3 days before and 3 days after using the Elidah device, they will collect all of their used pads for each 24-hour period into a sealed plastic bag. They will also collect a second set of bags that contain dry versions of each product used. Participants will have clinic visits after using the device for 3 weeks and after finishing the 6 weeks of treatment. Participants will complete 15-minute questionnaires.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be male and age 18 or older.
  • Have had urine leaks for at least 6 months after treatment in the prostate area for prostate cancer.
  • Leak urine during activity, coughing, or sneezing; or have a strong need to urinate because of pain or an unpleasant feeling that is hard to put off.
  • Use 1–4 pads a day for urine leaks.
  • Be able to read and write in English.
  • Be able to care for yourself and be out of bed or a chair for more than half of waking hours (ECOG score 0–2).
  • Be able to understand the study and willing to sign a consent form.

Who can't join

  • Plan to change prostate cancer treatment during the study treatment, or have changed medicines for urine leaks within 2 weeks before starting.
  • Have trouble emptying the bladder, leaks from outside the normal urine passage, or leaks from an overfull bladder. Trouble emptying the bladder only before prostate removal does not rule you out.
  • Have a urinary tract infection at screening, or have had 4 or more in the 12 months before study treatment.
  • Have complete loss of nerve supply to the muscles under the pelvis, a nerve or muscle disorder that could cause urine leaks, or epilepsy.
  • Have severe obesity (BMI over 35), pain in the pelvis, or painful bladder syndrome.
  • Have a metal implant in the belly or pelvis, or a long-term cough with ongoing symptoms.
  • Have an implanted heart device, a history of untreated abnormal heartbeat, or other heart problems.
  • Have an uncontrolled illness or life situation that would make it hard to follow study requirements.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* INCLUSION CRITERIA: * Participants must be male. * Participants must have a history of urinary incontinence for at least 6 months after local prostate cancer treatment. * Participants must have at least one of the following types of urinary incontinence: * stress urinary incontinence, defined as involuntary loss of urine on effort or physical exertion (e.g., sporting activities) or on sneezing or coughing * urge urinary incontinence, defined as a compelling need to urinate, due to pain or an unpleasant sensation, that is difficult to defer. * Participants must have moderate urinary incontinence defined as use of 1-4 pads per day by self-report at screening. * Participants must be able to read and write in English. * Age \>= 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status \<= 2. * Ability to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: * Change of therapy for prostate cancer planned during the study intervention. * History or symptoms of urinary retention (not an exclusion if this occurred before prostatectomy), extra-urethral incontinence, overflow incontinence. * Active urinary tract infection (UTI) at screening or history of recurrent urinary tract infections (\>= 4 UTIs within the 12 months prior to the study treatment initiation). * History of complete denervation of the pelvic floor. * Severe obesity (body mass index \[BMI\] \>35). * Pelvic pain/painful bladder syndrome. * Metal implant in the abdominal or pelvic area. * History of chronic cough with ongoing symptoms * An implanted cardiac device, history of untreated cardiac arrhythmia, or history of other heart problems. * History of epilepsy. * History of underlying neurologic/neuromuscular disorder that could contribute to urinary incontinence. * Change in medications prescribed for urinary incontinence within 2 weeks prior to the study treatment initiation. * Uncontrolled intercurrent illness evaluated by medical history and physical examination or social situations that would limit compliance with study requirements.

Study sites (1)

MD