Clinical trial NCT03323723: Disposable Stress Urinary Incontinence Pessary Device Study
Official title: Rinovum Subsidiary 2, LLC: Disposable Stress Urinary Incontinence Pessary Device Efficacy and Safety Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Rinovum Women's Health, Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-27
Enrollment: 73
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Efficacy and Safety Study, Single Group, Open Study, Open Label
Primary purpose: TREATMENT

Brief summary: This study is an interventional, single arm, multi-center study. It will be conducted at sites in the northeastern United States. The protocol will be approved by Chesapeake IRB or applicable local IRBs. The sample size will consist of approximately 50 participants. Participants will undergo an initial control period in which preweighed pads will be worn for 7 consecutive days for 12 hours. This will be followed by device usage for 14 consecutive days where participants will wear both device and preweighed pads simultaneously. for 12 hours.

Detailed description: The purpose of this study is to evaluate the efficacy and safety of an over-the-counter (OTC) disposable stress urinary incontinence (SUI) pessary device. Specifically, this study will evaluate the effectiveness of the pessary device by assessing reduction in urine leakage in approximately 50 women with Stress Urinary Incontinence (SUI). Efficacy will be assessed by mean pad weight gain per hour, reduction of stress urinary incontinence events per day, and a quality of life questionnaire. The safety of the OTC SUI pessary device will be evaluated by assessing all adverse events, including the results of urinalysis, vaginal swab, and vaginal examination.

Eligibility criteria: Inclusion Criteria:

* • Provision of signed and dated informed consent form

  * Literacy must be in English (able to read and understand Informed Consent)
  * Stated willingness to comply with all study procedures and availability for the duration of the study
  * Female, aged \>18
  * Be in generally good heath as determined by the Investigator
  * Have a physician diagnosis of SUI that occurred prior to or during the screening visit of this study
  * Have a \> 3-month history of experiencing \> 3 episodes of SUI per week
  * Be willing to use the investigational pessary device for the control of urinary incontinence
  * Have experience with wearing a tampon
  * The most recent Pap smear is normal within 36 months.

Exclusion Criteria:

* • Is pregnant, or planning to become pregnant during the study

  * Has been physician diagnosed with urge urinary incontinence or mixed urinary incontinence prior to or during the screening visit for this study
  * Is post-partum within 3 months
  * Has had an intrauterine device (IUD) placement of less than 6 months
  * Has self-reported difficulty emptying her bladder;
  * Has a history of Toxic Shock Syndrome (TSS) or symptoms consistent with TSS;
  * Has experienced difficulty inserting or wearing an intra-vaginal device, including a tampon;
  * Has had vaginal surgery, perineal surgery, uterine surgery, or abortion (spontaneous or induced) within the past 3 months;
  * Has any Screening laboratory value outside the laboratory reference range considered clinically significant by the Investigator which could impact the safety of the participant or the outcome of the study
  * Has an active urinary tract infection or vaginal infection requiring treatment
  * If for any reason, the Investigator decides that the participant should not participate in the study.
  * Class III Obesity (BMI\> 40.0 kg/m2)
  * Advanced prolapse
  * Fit assessment is not successful during screening visit

Primary outcomes:
measure: Percentage Reduction of Mean Pad Weight Gain (g/hr) During Treatment Phase as Compared to Baseline Phase.
timeFrame: 7 days of the baseline phase and 7 days of treatment phase
Secondary outcomes:
measure: Change in Mean SUI Episodes During Treatment Phase as Compared to Baseline Phase
timeFrame: 7 days of baseline period and last 7 days of treatment phase
measure: Change in Quality of Life From Before Treatment Phase to After Treatment Phase
timeFrame: Before Treatment Phase and After Treatment Phase is complete
measure: Adverse Events and Labs Evaluation to Determine Safety of the Device
timeFrame: 21 days
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Monroeville
country: United States
facility: Allegheny Health Network/East Suburban OB/GYN
state: Pennsylvania
city: Morgantown
country: United States
facility: West Virginia University Medicine
state: West Virginia
Study officials:
affiliation: West Virginia University Medicine
name: Omar Felipe Duenas Garcia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duenas-Garcia OF, Shapiro RE, Gaccione P. Safety and Efficacy of a Disposable Vaginal Device for Stress Urinary Incontinence. Female Pelvic Med Reconstr Surg. 2021 Jun 1;27(6):360-364. doi: 10.1097/SPV.0000000000000861.