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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative Pessary Use | Experimental | All patients will use a pessary for 1-4 weeks preoperatively to reparative surgery for pelvic organ prolapse |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative Pessary Use | Device | Pessary use for 1-4 weeks prior to surgical prolapse repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John A Occhino, MD, MS | Mayo Clinic | Principal Investigator |
| Brian Linder, MD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 40 participants completed the PGI-I form 3 months after surgery for data analysis. | Posted | Count of Participants | Participants | 3 months postoperatively |
|
Adverse events were collected for each subject through study participation, duration of approximately 3 months after pelvic surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Incontinence | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John A. Occhino | Mayo Clinic | (507) 538-5883 | Occhino.John@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 22, 2016 | Jul 31, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D014596 | Uterine Prolapse |
| D011391 | Prolapse |
| D052858 | Cystocele |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| 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. | Data was available for analysis on 36 participants which completed questionnaire at both time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 month post surgery |
|
|
|
|
| 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. | Data was available for analysis on 40 participants which completed questionnaire at both time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 month post surgery |
|
|
|
|
| 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. | Data was available for analysis on 32 participants which completed questionnaire at both time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 month post surgery |
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| 0 |
| 58 |
| 0 |
| 58 |
| 13 |
| 58 |
| Pelvic Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Vaginal dryness with itching | Reproductive system and breast disorders | Systematic Assessment |
|
| Allergic Reaction on abdomen at surgical site | General disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vaginal Pain | Reproductive system and breast disorders | Systematic Assessment |
|
| Vaginal Bleeding Post operative | Reproductive system and breast disorders | Systematic Assessment |
|
| Hyperkalemia post operative | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatremia post operative | Hepatobiliary disorders | Systematic Assessment |
|
| Pelvic floor myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Exacerbated chronic constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Incidental cystotomy repair (1 cm) | Renal and urinary disorders | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | Systematic Assessment |
|
| Ureteral vaginal fistula | Reproductive system and breast disorders | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
|
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| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |