Pelvic Floor Prolapse, Pelvic Organ Prolapse, Uterine Prolapse, Vaginal Vault Prolapse
Conditions
Keywords
Pessary, Prolapse, Cystocele
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.
Detailed description
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.
Interventions
DEVICEPreoperative Pessary Use
Pessary use for 1-4 weeks prior to surgical prolapse repair
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Improvement (PGI-I) Score | 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. |
| Prolapse Symptom Severity | 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. |
| Bother of Bladder/Vaginal/Bowel Symptoms | 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. |
| Overactive Bladder Symptom Score (OABSS) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Preoperative Pessary Use All patients will use a pessary for 1-4 weeks preoperatively to reparative surgery for pelvic organ prolapse
Preoperative Pessary Use: Pessary use for 1-4 weeks prior to surgical prolapse repair | 58 |
| Total | 58 |
Baseline characteristics
| Characteristic | Preoperative Pessary Use |
|---|---|
| Age, Continuous | 60.7 years STANDARD_DEVIATION 10.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 56 Participants |
| Region of Enrollment United States | 58 participants |
| Sex: Female, Male Female | 58 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 58 |
| other Total, other adverse events | 13 / 58 |
| serious Total, serious adverse events | 0 / 58 |
Outcome results
Primary
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.
Time frame: Baseline, 3 month post surgery
Population: Data was available for analysis on 40 participants which completed questionnaire at both time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Preoperative Pessary Use | Bother of Bladder/Vaginal/Bowel Symptoms | Baseline score | 72.1 score on a scale | Standard Deviation 69.2 |
| Preoperative Pessary Use | Bother of Bladder/Vaginal/Bowel Symptoms | Follow-up score | 18.8 score on a scale | Standard Deviation 49.3 |
Comparison: Baseline score vs Follow-up scorep-value: 0.001Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Baseline, 3 month post surgery
Population: Data was available for analysis on 32 participants which completed questionnaire at both time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Preoperative Pessary Use | Overactive Bladder Symptom Score (OABSS) | Baseline score | 12.0 score on a scale | Standard Deviation 3.9 |
| Preoperative Pessary Use | Overactive Bladder Symptom Score (OABSS) | Follow-up score | 9.6 score on a scale | Standard Deviation 2.7 |
Comparison: Baseline score vs Follow-up scorep-value: 0.005Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: 3 months postoperatively
Population: 40 participants completed the PGI-I form 3 months after surgery for data analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Preoperative Pessary Use | Patient Global Impression of Improvement (PGI-I) Score | 39 Participants |
Primary
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.
Time frame: Baseline, 3 month post surgery
Population: Data was available for analysis on 36 participants which completed questionnaire at both time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Preoperative Pessary Use | Prolapse Symptom Severity | Baseline score | 48.6 score on a scale | Standard Deviation 24.7 |
| Preoperative Pessary Use | Prolapse Symptom Severity | Follow-up score | 7.3 score on a scale | Standard Deviation 14.2 |
Comparison: Baseline score vs Follow-up scorep-value: 0.001Wilcoxon (Mann-Whitney)