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NCT Number: NCT02680145

Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use

This is a single center, prospective trial of pessary use prior to reconstructive pelvic floor surgery for pelvic organ prolapse. The goal of the study is to evaluate the change in pelvic floor symptoms with pessary use and subsequent reconstructive surgery. Additionally, we will assess the impact that preoperative pessary use has on patient self-reported preparedness for surgery.

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Key information

Conditions

Vaginal Vault Prolapse Cystocele Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Floor Prolapse Pelvic Organ Prolapse Prolapse Urinary Bladder Diseases Urogenital Diseases Urologic Diseases Uterine Diseases Uterine Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

It is anticipated that this trial will define the clinical utility of routine preoperative pessary placement, and by shaping patient expectations and increasing preparedness for surgery, we anticipate improving satisfaction and quality of life.

At the initial office visit baseline symptoms are evaluation with validated questionnaire.

The patients' will undergo pessary fitting at least 7 days (but no more than 28 days) prior to scheduled surgical prolapse repair.

Symptomatic change from baseline will be assessed with validated questionnaire preoperatively.

The pessary will be removed at the time of surgery, and the patient will undergo surgical correction of their pelvic organ prolapse (including all restorative surgical procedures, abdominal and transvaginal). A concomitant anti-incontinence procedure will be performed at the discretion of the treating physician in consultation with the patient.

The patients' symptomatic outcome from surgery will then be reassessed by validated questionnaire at 6 weeks and 3 months postoperatively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Older than 18 years of age
  • With symptomatic pelvic organ prolapse
  • Electing for surgical repair of pelvic organ prolapse (transvaginal or transabdominal) at least 7 days after office consultation
  • Understand and have signed written informed consent for preoperative pessary placement.

Exclusion criteria

  • Previous use of a pessary for pelvic organ prolapse
  • Patients undergoing obliterative prolapse surgery (i.e. Colpocleisis),
  • Are scheduled for surgery for pelvic organ prolapse less than 7 days after office consultation or greater than 4 weeks after office consultation
  • Have an isolated rectocele
  • Have allergies to both latex and silicone
  • Have an active pelvic infection

Treatment and study plan

Preoperative Pessary Use

Device

Pessary use for 1-4 weeks prior to surgical prolapse repair

Primary outcomes

  1. Patient Global Impression of Improvement (PGI-I) Score

    Time frame: 3 months postoperatively

    Number of participants considered treatment success assessed using the 7-point Likert scale of the Patient Global Impression of Improvement (PGI-I) of 1= very much better and 7=very much worse. Patient's will be considered treatment success if they answer "much better" or "very much better" on the PGI-I scale.

  2. Prolapse Symptom Severity

    Time frame: Baseline, 3 month post surgery

    Mean value of score on self-reported Pelvic Organ Prolapse Distress Inentory-6 (POPDI-6) questionnaire. Minimum scale score = 0; maximum scale score = 100 and a higher score indicates worse outcome.

  3. Bother of Bladder/Vaginal/Bowel Symptoms

    Time frame: Baseline, 3 month post surgery

    Mean value of score on self-reported Floor Impact Questionnaire-7 (PFIQ-7). Minimum scale score = 0; maximum scale score = 100 and a higher score indicates worse outcome.

  4. Overactive Bladder Symptom Score (OABSS)

    Time frame: Baseline, 3 month post surgery

    Mean value of score on self-reported Overactive Bladder Symptom Score (OABSS) questionnaire. Minimum scale score = 0; maximum scale score = 15 and a higher score indicates worse outcome.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 11, 2016
Registry last updated
Aug 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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