Pelvic Organ ProlapseNCT04369404

Impact of Decision Aids in Urogynecology

A study testing Pelvic organ prolapse decision aid, Stress urinary incontinence decision aid and Overactive bladder decision aid in people with Pelvic Organ Prolapse and Stress Urinary Incontinence, run by Massachusetts General Hospital 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

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Trial summary

To evaluate how patient knowledge and confidence in decision making can be impacted by shared decision making in common urogynecology conditions. Read more about this study

Who is it for?: Ages 18 to 95 years, women only
Conditions the study is for: Pelvic Organ Prolapse, Stress Urinary Incontinence, Overactive Bladder
What is being tested?: Pelvic organ prolapse decision aid, Stress urinary incontinence decision aid and Overactive bladder decision aid
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteUnited States
Study dates: 1 Feb 2019to 1 Jun 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 to 95 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults 18-95 years only
English speaking
Pelvic organ prolapse defined by noticeable (to the patient) vaginal bulging
Symptoms of stress urinary incontinence (cough, sneeze, laugh, exercise)
Presenting for initial consultation for either of the above symptoms

Who cannot join

Primary complaint is not vaginal bulging or stress urinary incontinence
Prior surgery for pelvic organ prolapse or any incontinence procedure

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

To evaluate how patient knowledge and confidence in decision making can be impacted by shared decision making in common urogynecology conditions.

Read the detailed description

The investigators will enroll patients seeing a specialist to discuss treatment of pelvic organ prolapse, overactive bladder and stress urinary incontinence in this pilot study. The study will evaluate the feasibility and acceptability of three decision aids designed to promote shared decision making conversations for these three condition. The investigators use a quasi-experimental design in which the investigators first enroll patients in the control arm and measure their outcomes. Then, the investigators enroll patients into the intervention arm and measure their outcomes. The investigators estimate that it will take about one month to recruit the control arm and one month to recruit the intervention arm. Patients will be surveyed after the clinic visit with a specialist and surveys will assess patients' knowledge, treatment preferences, shared decision making, decisional conflict and acceptability of the tool. A clinician survey will be administered and completed after each patient visit, that details how the physician felt about the length of the visit, how informed the patient was, and how far along they may be with their decision.

Conditions: Pelvic Organ Prolapse, Stress Urinary Incontinence, Overactive Bladder
Being tested: Pelvic organ prolapse decision aid, Stress urinary incontinence decision aid, Overactive bladder decision aid
Keywords: shared decision making
Medical subject headings: Pelvic Organ Prolapse, Urinary Incontinence, Stress, Urinary Bladder, Overactive

What participants receive

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

Pelvic organ prolapse decision aidBehavioural
Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse
Stress urinary incontinence decision aidBehavioural
Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence.
Overactive bladder decision aidBehavioural
Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.

Study groups in NCT04369404
Study group	Role	What they receive
Usual care	No intervention	In the usual care group, the providers do not have access to the decision aids.
Patient Decision Aid	Experimental	Providers have access to patient decision aids to review and discuss during the visit. Receives: Behavioral: Pelvic organ prolapse decision aid; Behavioral: Stress urinary incontinence decision aid; Behavioral: Overactive bladder decision aid

What is being measured

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

Patient Knowledge
Patients completed four multiple choice knowledge items for each condition and a total knowledge score (0-4) was calculated. The score was converted to a 0-100% scale, with higher scores indicating higher knowledge.
Measured: Within 1 day
Patient Treatment Preference
1 item assess patients' preferred treatment- Response options included no treatment at this time, conservative and non conservative options, or I am not sure. Responses were categorized into clear treatment preference (no treatment, conservative and non-conservative options) vs unsure (I am not sure) treatment preference.
Measured: Within 1 day
Physician Visit Satisfaction
Physicians answered 1 item on how satisfied they were with the visit: Extremely satisfied, Very satisfied, Somewhat satisfied, and Not at all satisfied
Measured: Within 1 day

Secondary outcomes (4)

SURE Scale
Measures decisional conflict, consists of 4 yes/no items. Total scores range 0-4 where 4 indicates no decisional conflict and scores less than or equal to 3 indicate decisional conflict. The number of participants who got a total score of 4, indicating no decisional conflict, is reported
Measured: Within 1 day
CollaboRATE
Three items ask patients to rate their provider on a scale of 1-10, with 10 being outstanding. The measure is a dichotomized score. Participants who reported a "10" on all 3 items were "topscored" into one group; everyone else were categorized into another group. The number of participants who gave a topscore (a "10" for all 3 items) was reported.
Measured: Within 1 day
SDM Process Scale
Four items that measures the amount of shared decision making that occurs in an interaction. Total scores ranged from 0-4, with higher scores indicating more shared decision making occurred.
Measured: Within 1 day
MD Perceptions of Length of Visit
One item assessed how physician felt about the length of the visit. Responses were: Shorter than normal, About normal, Longer than normal. Number of physicians who responded that the visit was "shorter than normal" or "about normal" is reported.
Measured: Within 1 day

Timeline

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

1 Feb 20191 Jun 2019

First posted30 Apr 2020
Study start1 Feb 2019
Primary completion1 Jun 2019
Study completion1 Jun 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe 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: Health services research
Allocation: Non-randomised
Intervention model: Sequential
Model description: A usual care arm was recruited first, then the intervention arm was recruited.
Masking: None (open label)
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04369404
Sponsor's protocol ID: 2017P001883 - 01
Status last verified: Apr 2024
First submitted: 24 Mar 2020
Last updated: 16 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Marques F, Josloff K, Hung K, Wakamatsu M, Sepucha KR. Decision aids and shared decision making in urogynecology. Menopause. 2021 Dec 13;29(2):178-183. doi: 10.1097/GME.0000000000001901.
PubMed 34905749

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

Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration

All Pelvic Organ Prolapse trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Decision Aids in Urogynecology
ClinicalTrials.gov ID: NCT04369404
Acronym / sponsor ID: 2017P001883 - 01
Conditions: Pelvic Organ Prolapse, Stress Urinary Incontinence, Overactive Bladder
Keywords: shared decision making
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: 1 Feb 2019 (actual)
Primary completion: 1 Jun 2019 (actual)
Study completion: 1 Jun 2019 (actual)
First posted: 30 Apr 2020 (actual)
Results: Posted 16 Apr 2024

Clinical summary

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

To evaluate how patient knowledge and confidence in decision making can be impacted by shared decision making in common urogynecology conditions.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: A usual care arm was recruited first, then the intervention arm was recruited.

Arm	Type	Receives
Usual care	No intervention	–In the usual care group, the providers do not have access to the decision aids.
Patient Decision Aid	Experimental	Behavioral: Pelvic organ prolapse decision aid, Behavioral: Stress urinary incontinence decision aid, Behavioral: Overactive bladder decision aidProviders have access to patient decision aids to review and discuss during the visit.

Who may qualify

Ages: 18 to 95 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Adults 18-95 years only
English speaking
Pelvic organ prolapse defined by noticeable (to the patient) vaginal bulging
Symptoms of stress urinary incontinence (cough, sneeze, laugh, exercise)
Presenting for initial consultation for either of the above symptoms

Key exclusion criteria (2 listed)

Primary complaint is not vaginal bulging or stress urinary incontinence
Prior surgery for pelvic organ prolapse or any incontinence procedure

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
Pelvic organ prolapse decision aidPaper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse	Behavioural	Patient Decision Aid
Stress urinary incontinence decision aidPaper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence.	Behavioural	Patient Decision Aid
Overactive bladder decision aidPaper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.	Behavioural	Patient Decision Aid

Primary outcome

Patient Knowledge
Time frame: Within 1 day
Patients completed four multiple choice knowledge items for each condition and a total knowledge score (0-4) was calculated. The score was converted to a 0-100% scale, with higher scores indicating higher knowledge.
Patient Treatment Preference
Time frame: Within 1 day
1 item assess patients' preferred treatment- Response options included no treatment at this time, conservative and non conservative options, or I am not sure. Responses were categorized into clear treatment preference (no treatment, conservative and non-conservative options) vs unsure (I am not sure) treatment preference.
Physician Visit Satisfaction
Time frame: Within 1 day
Physicians answered 1 item on how satisfied they were with the visit: Extremely satisfied, Very satisfied, Somewhat satisfied, and Not at all satisfied

4 secondary outcomes

SURE Scale
Time frame: Within 1 day
CollaboRATE
Time frame: Within 1 day
SDM Process Scale
Time frame: Within 1 day
MD Perceptions of Length of Visit
Time frame: Within 1 day

Results and safety

Results posted to the registry on 16 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	33	33
Patient Decision Aid	33	33

Primary outcome: Patient Knowledge

Time frame: Within 1 day. Mean (Standard Deviation). Unit: percentage of questions answered correct

Measure	Usual Care n = 33	Patient Decision Aid n = 33
Value	60 (30)	72 (21)

Usual Care vs Patient Decision Aid: Mean Difference (Final Values): 12 (95% CI 0.7 to 24.6), p = 0.06, t-test, 2 sided

Population analysed: Anyone who answered the knowledge items.

Primary outcome: Patient Treatment Preference

Time frame: Within 1 day. Count of participants. Unit: Participants

Measure	Usual Care n = 33	Patient Decision Aid n = 33
clear treatment preference	22	28
unsure treatment preference	11	5

Usual Care vs Patient Decision Aid: Pearson Chi-Square: 2.970, p = 0.085, Chi-squared

Primary outcome: Physician Visit Satisfaction

Time frame: Within 1 day. Count of participants. Unit: Participants

Measure	Usual Care n = 33	Patient Decision Aid n = 33
Not at all satisfied	0	0
Somewhat satisfied	5	9
Very satisfied	23	19
Extremely satisfied	5	5

Usual Care vs Patient Decision Aid: Pearson Chi-Square: 1.524, p = 0.47, Chi-squared

Population analysed: Physicians were not considered enrolled in the study, but did contribute to this assessment.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were assessed within one day of survey receipt. The surveys were completed within 2 weeks of the visit and were checked as they came in for evidence of adverse events.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	0 of 33 (0%)	0 of 33 (0%)	0 of 33
Patient Decision Aid	0 of 33 (0%)	0 of 33 (0%)	0 of 33

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34905749Marques F, Josloff K, Hung K, Wakamatsu M, Sepucha KR. Decision aids and shared decision making in urogynecology. Menopause. 2021 Dec 13;29(2):178-183. doi: 10.1097/GME.0000000000001901.
Individual participant dataSharing planned: No

Related trials for Pelvic Organ Prolapse

Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration

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.

Karen Sepucha, PhD principal investigator

Massachusetts General Hospital

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

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 2 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 16 Apr 2024. 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 16 Apr 2024). 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 Knowledge (time frame: Within 1 day). The study lists 3 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 NCT04369404, which also lists 1 linked publication.

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 16 Apr 2024.