Personalizable pessary for pelvic organ prolapse

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study tests a novel personalizable pessary designed to match the natural shape of the vagina and be easier to remove and reinsert. It compares the personalizable pessary to standard pessaries in terms of efficacy and safety for treating pelvic organ prolapse. Eligible participants are adults with symptomatic prolapse who have been using a pessary for at least 3 months. The trial aims to determine non-inferiority in symptom relief while monitoring adverse events and device-related issues. Recruitment is centered at the University of Alberta and affiliated centers in Edmonton, Canada.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients assigned female at birth
* At least 18 years old at time of screening
* Patients with symptomatic POP using a pessary for ≥ 3 months
* Capable of giving informed consent
* Fluency in English

Exclusion Criteria:

* Pregnancy
* Short vaginal length (total vaginal length \<5 cm) or subjective vaginal narrowing
* Vaginal erosion due to current pessary
* Presence of vesicovaginal fistula
* Presence of rectovaginal fistula
* Current treatment for vaginal, rectal, or bladder tumor
* Presence of open wound or tear near vagina or anus by exam prior to removal of current pessary
* Presence of pelvic, vaginal, or urinary infection requiring treatment
* Ongoing treatment of recurrent urinary tract or vaginal infections
* Inflammatory bowel disease
* Chronic pain syndromes of pelvic or anorectal origin
* Previous pelvic floor surgery in last 12 months
* Congenital malformation of bladder, rectum, or vagina
* Significant medical condition interfering with study participation (psychologic, neurologic, active drug/alcohol abuse, ambulatory restrictions, etc.)
* Planning pregnancy in next 6 months

Where it's running

• Dale Sheard Centre for Solutions in Women's Health
  Edmonton, Alberta, Canada Recruiting

Study contacts

• Study coordinator: May Sanaee, BSc MD FRCSC MHScEd
• Email: sanaee@ualberta.ca
• Phone: 1-780-735-5290

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Risk predictor for new urinary incontinence after prolapse surgery

  This study tests a model to predict which women might develop new stress urinary incontinence after pelvic organ prolapse repair.

  Recruiting Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Shanghai, Shanghai Municipality · NCT07601282

• Comparing the Manchester procedure versus vaginal hysterectomy for uterine prolapse

  This study tests whether the Manchester procedure or vaginal hysterectomy works better for women with symptomatic uterine prolapse over a two-year follow-up.

  Recruiting at 6 sites Tampere University Hospital · Helsinki and 5 other locations · NCT07566949

• Poly-L-lactic acid injections for vulvovaginal tissue regeneration

  This trial will try injections of poly-L-lactic acid (PLLA) versus placebo to see if they strengthen vaginal tissue and reduce bulge symptoms and sexual problems in women with stage II anterior vaginal wall prolapse (cystocele).

  Recruiting Duke University · Durham, North Carolina · NCT07544667

• Pelvic floor mesh used in laparoscopic sacrocolpopexy to repair pelvic organ prolapse

  This study tests the ProGYNious mesh to see if it safely and effectively repairs pelvic organ prolapse in adults undergoing laparoscopic surgery.

  Recruiting A.M.I. Agency for Medical Innovations GmbH · Wiener Neustadt, Lower Austria and 3 other locations · NCT07497321

• Paracervical block for pain control after vNOTES uterosacral ligament suspension

  This will test whether a paracervical injection of bupivacaine reduces early postoperative pain in women having vNOTES uterosacral ligament suspension for pelvic organ prolapse.

  Recruiting Bakirkoy Dr. Sadi Konuk Research and Training Hospital · Istanbul, Istanbul · NCT07440576

• Postpartum pelvic floor recovery and early rehabilitation after vaginal birth

  This project tests whether early, individualized pelvic floor muscle training starting 2–3 weeks after a vaginal birth helps people with postpartum pelvic floor symptoms recover better than usual care.

  Recruiting at 2 sites Vastra Gotaland Region · Gothenburg and 1 other locations · NCT07430865

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.