Vaginal Vault ProlapseNCT02680145

Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use

A study testing Preoperative Pessary Use in people with Vaginal Vault Prolapse and Pelvic Organ Prolapse, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Vaginal Vault Prolapse, Pelvic Organ Prolapse, Uterine Prolapse
What is being tested?: Preoperative Pessary Use
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 1 siteUnited States
Study dates: 11 Mar 2016to 31 Dec 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic
Rochester, Minnesota, 55905

Other trials in United States

About this study

Read the 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.

Conditions: Vaginal Vault Prolapse, Pelvic Organ Prolapse, Uterine Prolapse, Pelvic Floor Prolapse
Being tested: Preoperative Pessary Use
Keywords: Pessary, Prolapse, Cystocele
Medical subject headings: Pelvic Organ Prolapse, Uterine Prolapse, Prolapse, Cystocele

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02680145
Study group	Role	What they receive
Preoperative Pessary Use	Experimental	All patients will use a pessary for 1-4 weeks preoperatively to reparative surgery for pelvic organ prolapse Receives: Device: Preoperative Pessary Use

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 month post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Mar 201631 Dec 2019

First posted11 Feb 2016 (estimated)
Study start11 Mar 2016
Primary completion31 Oct 2019
Study completion31 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Vaginal Vault ProlapseStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02680145
Sponsor's protocol ID: 15-006186
Status last verified: Aug 2020
First submitted: 3 Feb 2016
Last updated: 20 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Transvaginal Mesh vs. Laparoscopic Colposacropexy- Study
Prolapse, Vaginal Vault
Recruiting
Post-Hysterectomy Vaginal Length: Horizontal vs. Vertical Closure
Prolapse, Vaginal, Vaginal Vault Prolapse
Enrolling by invitationObservational study
Laparoscopic Pectopexy and Laparoscopic Colporrhaphies in Pelvic Organ Prolapse Treatment
Vaginal Vault Prolapse, Uterine Prolapse
Enrolling by invitationObservational study
An Institutional Audit of the Short Term Complications and Long Term Outcomes of Patients Undergoing Laparoscopic Sacrocolpopexy for Vault/cervical Prolapse.
Vault Prolapse, Vaginal
Active, not recruiting
Pectopexy Autologous Vs Mesh
Uterine Prolapse, Vault Prolapse, Vaginal

All Vaginal Vault Prolapse trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use
ClinicalTrials.gov ID: NCT02680145
Acronym / sponsor ID: 15-006186
Conditions: Vaginal Vault Prolapse, Pelvic Organ Prolapse, Uterine Prolapse, Pelvic Floor Prolapse
Keywords: Pessary, Prolapse, Cystocele
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 11 Mar 2016 (actual)
Primary completion: 31 Oct 2019 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 11 Feb 2016 (estimated)
Results: Posted 20 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Preoperative Pessary Use	Experimental	Device: Preoperative Pessary UseAll patients will use a pessary for 1-4 weeks preoperatively to reparative surgery for pelvic organ prolapse

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Preoperative Pessary UsePessary use for 1-4 weeks prior to surgical prolapse repair	Device	Preoperative Pessary Use

Primary outcome

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.
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.
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.
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.

Results and safety

Results posted to the registry on 20 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Preoperative Pessary Use	58	47

Primary outcome: Patient Global Impression of Improvement (PGI-I) Score

Time frame: 3 months postoperatively. Count of participants. Unit: Participants

Measure	Preoperative Pessary Use n = 40
Value	39

Population analysed: 40 participants completed the PGI-I form 3 months after surgery for data analysis.

Primary outcome: Prolapse Symptom Severity

Time frame: Baseline, 3 month post surgery. Mean (Standard Deviation). Unit: score on a scale

Measure	Preoperative Pessary Use n = 36
Baseline score	48.6 (24.7)
Follow-up score	7.3 (14.2)

Preoperative Pessary Use: p = 0.001, Wilcoxon (Mann-Whitney)

Population analysed: Data was available for analysis on 36 participants which completed questionnaire at both time points.

Primary outcome: Bother of Bladder/Vaginal/Bowel Symptoms

Time frame: Baseline, 3 month post surgery. Mean (Standard Deviation). Unit: score on a scale

Measure	Preoperative Pessary Use n = 40
Baseline score	72.1 (69.2)
Follow-up score	18.8 (49.3)

Preoperative Pessary Use: p = 0.001, Wilcoxon (Mann-Whitney)

Population analysed: Data was available for analysis on 40 participants which completed questionnaire at both time points.

Primary outcome: Overactive Bladder Symptom Score (OABSS)

Time frame: Baseline, 3 month post surgery. Mean (Standard Deviation). Unit: score on a scale

Measure	Preoperative Pessary Use n = 32
Baseline score	12.0 (3.9)
Follow-up score	9.6 (2.7)

Preoperative Pessary Use: p = 0.005, Wilcoxon (Mann-Whitney)

Population analysed: Data was available for analysis on 32 participants which completed questionnaire at both time points.

Adverse events

Time frame: Adverse events were collected for each subject through study participation, duration of approximately 3 months after pelvic surgery.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Preoperative Pessary Use	0 of 58 (0%)	13 of 58 (22.4%)	0 of 58

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Vaginal Vault Prolapse

Recruiting
Transvaginal Mesh vs. Laparoscopic Colposacropexy- Study
Prolapse, Vaginal Vault
Recruiting
Post-Hysterectomy Vaginal Length: Horizontal vs. Vertical Closure
Prolapse, Vaginal, Vaginal Vault Prolapse
Enrolling by invitationObservational study
Laparoscopic Pectopexy and Laparoscopic Colporrhaphies in Pelvic Organ Prolapse Treatment
Vaginal Vault Prolapse, Uterine Prolapse
Enrolling by invitationObservational study
An Institutional Audit of the Short Term Complications and Long Term Outcomes of Patients Undergoing Laparoscopic Sacrocolpopexy for Vault/cervical Prolapse.
Vault Prolapse, Vaginal
Active, not recruiting
Pectopexy Autologous Vs Mesh
Uterine Prolapse, Vault Prolapse, Vaginal

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John A Occhino, MD, MS principal investigator

Mayo Clinic

Brian Linder, MD study chair

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Preoperative Pessary Use in people with Vaginal Vault Prolapse and Pelvic Organ Prolapse, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Global Impression of Improvement (PGI-I) Score (time frame: 3 months postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02680145.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2020; AzTrials last refreshed its copy on 7 Nov 2026.