NCT02680145

Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use

Completed NA Results posted Last updated 20 August 2020

What this trial tests

NA trial testing Preoperative Pessary Use in Vaginal Vault Prolapse in 58 participants. Completed in 31 December 2019.

Timeline

11 March 2016

Primary endpoint
31 October 2019

31 December 2019

Quick facts

Lead sponsor	Mayo Clinic
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	58
Start date	11 March 2016
Primary completion	31 October 2019
Estimated completion	31 December 2019
Sites	1 location across United States

Drugs / interventions tested

• Preoperative Pessary Use

Conditions studied

• Vaginal Vault Prolapse — all drugs for Vaginal Vault Prolapse →
• Pelvic Organ Prolapse — all drugs for Pelvic Organ Prolapse →
• Uterine Prolapse — all drugs for Uterine Prolapse →
• Pelvic Floor Prolapse — all drugs for Pelvic Floor Prolapse →

Sponsor

Mayo Clinic

Who can join

18 and older, female only, with Vaginal Vault Prolapse or Pelvic Organ Prolapse. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Preoperative Pessary Use	39

Prolapse Symptom Severity Primary · 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.

Baseline score

Group	Value	95% CI
Preoperative Pessary Use	48.6	± 24.7

Follow-up score

Group	Value	95% CI
Preoperative Pessary Use	7.3	± 14.2

Bother of Bladder/Vaginal/Bowel Symptoms Primary · 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.

Baseline score

Group	Value	95% CI
Preoperative Pessary Use	72.1	± 69.2

Follow-up score

Group	Value	95% CI
Preoperative Pessary Use	18.8	± 49.3

Overactive Bladder Symptom Score (OABSS) Primary · 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.

Baseline score

Group	Value	95% CI
Preoperative Pessary Use	12.0	± 3.9

Follow-up score

Group	Value	95% CI
Preoperative Pessary Use	9.6	± 2.7

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected for each subject through study participation, duration of approximately 3 months after pelvic surgery.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Preoperative Pessary Use

Serious: 0/58 (0%)

Deaths: 0/58

Other adverse events (17 terms — click to expand)

Reaction	System	Preoperative Pessary Use
Urinary Incontinence	Renal and urinary disorders	—
Pelvic Pain	Musculoskeletal and connective tissue disorders	—
Vaginal dryness with itching	Reproductive system and breast disorders	—
Allergic Reaction on abdomen at surgical site	General disorders	—
Dizziness	Nervous system disorders	—
Nausea	Gastrointestinal disorders	—
Vaginal Pain	Reproductive system and breast disorders	—
Vaginal Bleeding Post operative	Reproductive system and breast disorders	—
Hyperkalemia post operative	Metabolism and nutrition disorders	—
Hyponatremia post operative	Hepatobiliary disorders	—
Pelvic floor myalgia	Musculoskeletal and connective tissue disorders	—
Dyspepsia	Gastrointestinal disorders	—
Exacerbated chronic constipation	Gastrointestinal disorders	—
Incidental cystotomy repair (1 cm)	Renal and urinary disorders	—
Vaginal infection	Infections and infestations	—
Ureteral vaginal fistula	Reproductive system and breast disorders	—
Urinary Tract Infection	Renal and urinary disorders	—

Data from ClinicalTrials.gov NCT02680145 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.