Clinical trial NCT03969368: rPMS Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence
Official title: Randomized Trial of rPMS Pelvic Floor Stimulation Device Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2019-05-31
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the clinical efficacy and safety between rPMS device and pelvic floor exercises for the treatment of urinary incontinence. The subjects will be enrolled and assigned into two study groups - active and control group. Subjects will be required to complete six (6) treatment visits and five follow-up visits - 1, 3, 6, 9 and 12 months after the final treatment.


Eligibility criteria: Inclusion Criteria:

* Female aged 25-70 years
* Suffers from specific types of UI - Stress Urinary Incontinence (SUI), Urge Urinary Incontinence (UUI) and/or Mixed Urinary Incontinence (MUI)
* Voluntarily signed informed consent form
* Subjects willing and able to abstain from partaking in any treatment of urinary incontinence other than the study procedure
* Subjects currently undergoing any treatment for stress, urge and/or mixed urinary incontinence, have to undergo a two-week wash-out period before start of the study

Exclusion Criteria:

* Use of Botox® in the bladder or pelvic muscles in the last year
* Use of Interstim® or similar device for the treatment of UI
* Suffers from other types of urinary incontinence other than SUI, UUI, MUI
* Pelvic organ prolapse grade 2 and higher
* Pronounced lesions of the pudendus nerve during clinical neurophysiological examination
* Currently lactating
* Cardiac pacemakers
* Implanted defibrillators and/or neurostimulators
* Electronic implants
* Metal implants, including copper IUD
* Drug pumps
* Hemorrhagic conditions
* Anticoagulation therapy
* Fever
* Pregnancy
* Following recent surgical procedures when muscle contraction may disrupt the healing process
* Application over areas of the skin which lack normal sensation
* Any disorders that the Investigator deems would interfere with study endpoints or subject safety

Primary outcomes:
measure: Evaluation of quality of life improvement using the UDI-6 questionnaire
timeFrame: 13 months
measure: Evaluation of incontinence episodes using Bladder diary
timeFrame: 13 months
measure: Evaluation of quality of life improvement using the ICIQ-LUTSqol questionnaire
timeFrame: 13 months
measure: Evaluation of quality of life improvement using the Pad Usage Questionnaire
timeFrame: 13 months
measure: Evaluation of pelvic floor muscle strength
timeFrame: 13 months
Secondary outcomes:
measure: Subject Satisfaction evaluation
timeFrame: 13 months
measure: Therapy comfort evaluation
timeFrame: 1 month
measure: Safety evaluation
timeFrame: 13 months
Other outcomes:
Locations:
city: Wellesley
country: United States
facility: Boston Urogyn
state: Massachusetts
city: Somerset
country: United States
facility: Center for Urogynecology and Reconstructive Surgery
state: New Jersey
city: Newtown
country: United States
facility: The Female Pelvic Health Center
state: Pennsylvania
city: Richmond
country: United States
facility: The Female Pelvic Medicine Institute
state: Virginia
Study officials:
References: