Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use

NCT02680145 | Completed Results DMC FDA Device

• 1 other identifier: 15-006186
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vaginal Vault Prolapse; Pelvic Organ Prolapse; Uterine Prolapse; Pelvic Floor Prolapse

Keywords

Pessary; Prolapse; Cystocele

Outcome Measures

Primary Outcomes (4)

• Patient Global Impression of Improvement (PGI-I) Score

  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.

  3 months postoperatively

• Prolapse Symptom Severity

  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.

  Baseline, 3 month post surgery

• Bother of Bladder/Vaginal/Bowel Symptoms

  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.

  Baseline, 3 month post surgery

• Overactive Bladder Symptom Score (OABSS)

  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.

  Baseline, 3 month post surgery

Study Arms (1)

Preoperative Pessary Use

EXPERIMENTAL

All patients will use a pessary for 1-4 weeks preoperatively to reparative surgery for pelvic organ prolapse

Device: Preoperative Pessary Use

Interventions

Preoperative Pessary Use DEVICE

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

Preoperative Pessary Use

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pelvic Organ Prolapse; Uterine Prolapse; Prolapse; Cystocele

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. John A. Occhino
• Organization: Mayo Clinic

Occhino.John@mayo.edu

(507) 538-5883

Study Officials

• John A Occhino, MD, MS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Brian Linder, MD

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics-Gynecology

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: February 11, 2016
• Study Start: March 11, 2016
• Primary Completion: October 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 20, 2020
• Results First Posted: August 20, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)