R&D Supporting Pilot Study for the Assessment of the Safety and Effectiveness of the ProVATE (ProTIPI) Vaginal Pessary

• Register: ClinicalTrials.gov
• Last refreshed on: 18 January 2016
• Main ID: NCT02239133
• Date of registration: 08/09/2014
• Prospective Registration: No
• Primary sponsor: ConTIPI Medical
• Public title: R&D Supporting Pilot Study for the Assessment of the Safety and Effectiveness of the ProVATE (ProTIPI) Vaginal Pessary
• Scientific title: Pilot Study for the Evaluation of the ProVATE (ProTIPI) Pessary Designs in the Temporary Management of Pelvic Organ Prolapse (POP) in Women
• Date of first enrolment: August 2014
• Target sample size: 44
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02239133
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Israel

Key inclusion & exclusion criteria

Inclusion Criteria:

- Females aged 21-80 years

- Ability to use both hands and insert a device into the vagina

- Ability to attend the study site as explained by the investigator

- A symptomatic sensation of vaginal prolapse

- The subject has the ability to understand the nature of the study and sign the
informed consent

- On examination, the presence of a vaginal wall prolapse of one or more sites

- On examination, POP-Q grade 2 - 4 POP is demonstrated

- A 61-91 mm pessary is well fitted

- A 61-91 mm pessary is well retained

Exclusion Criteria:

- Previous inability to accommodate with tampons or vaginal pessaries

- Subject is currently participating in another clinical study which may directly or
indirectly affect the results of this study

- Co-morbid condition(s) or severe systemic disease that could limit the subject 's
ability to participate in the study, or impact the scientific integrity of the study

- Subject is pregnant, or suspected to be pregnant or is planning to be pregnant during
the course of the study

- Abnormal vaginal bleeding in the past 6 months

- Previous vaginal surgery during the last 3 months

- A severely atrophic vagina

- Existing vaginal or vulvar laceration

- Symptomatic vaginal infection as determined by physical examination and lab results

- Symptomatic urinary tract infection as determined by physical examination and lab
results

- Recurrent urinary tract infections

- Abnormal cervical cytology



Age minimum: 21 Years
Age maximum: 80 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Pelvic Organ Prolapse

Intervention(s)

Device: ProVATE vaginal pessary

Primary Outcome(s)

Degree of prolapse and POP symptoms following ProVATE device insertion, compared to the degree of prolapse prior to the insertion of the ProVATE device (by vaginal examination) [Time Frame: At day 1 - baseline, and following at least 28 and up to 45 days of using the ProVATE vaginal pessary]

Secondary ID(s)

ProVATE PT 103

Source(s) of Monetary Support

Please refer to primary and secondary sponsors