Pelvic Organ ProlapseNCT02111642
Effect of a Risk Calculator on Patient Satisfaction With the Decision for Midurethral Sling During Prolapse Surgery
A study testing Online risk calculator in people with Pelvic Organ Prolapse and Stress Urinary Incontinence, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
Pelvic organ prolapse occurs with descent of one or more pelvic structures: the uterus and/or cervix, bowel, bladder, or rectum. Although options for treatment include expectant management, pelvic floor physical therapy, and pessary (intravaginal device) use, surgery is the only option which potentially offers a cure. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse, Stress Urinary Incontinence, Satisfaction
- What is being tested?
- Online risk calculator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ Stage 2 pelvic organ prolapse according to the Pelvic Organ Prolapse Quantification system (POP-Q)
- Desire for prolapse surgery
- No symptoms of stress urinary incontinence preoperatively
- Age ≥ 18
- English-speaking
Who cannot join
- Symptoms of stress urinary incontinence preoperatively
- History of previous prolapse or anti-incontinence surgery
- Pregnancy
- Dementia or other cognitive impairment
- Unable or unwilling to complete post-operative questionnaires
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Effect of a New Risk Calculator on Patient Satisfaction With the Decision for Concomitant Midurethral Sling During Prolapse Surgery
Pelvic organ prolapse occurs with descent of one or more pelvic structures: the uterus and/or cervix, bowel, bladder, or rectum. Although options for treatment include expectant management, pelvic floor physical therapy, and pessary (intravaginal device) use, surgery is the only option which potentially offers a cure.
It is well known that women with pelvic organ prolapse are at risk of developing new stress urinary incontinence symptoms after prolapse surgery. Stress urinary incontinence is defined as involuntary loss of urine with an increase in intra-abdominal pressure, such as sneezing, coughing, or laughing. Previous studies have demonstrated that the addition of a prophylactic anti-incontinence procedure at the time of prolapse surgery reduces this risk. One example of such a procedure is a mesh sling placed underneath the urethra (midurethral sling). Nevertheless, the decision to place a midurethral sling to prevent stress urinary incontinence after prolapse surgery remains controversial.
A new risk calculator tool has been developed to provide patients' with their individualized risk of developing de novo stress urinary incontinence after prolapse surgery. The primary objective of this study is to determine whether use of this new personalized online risk calculator tool increases patient satisfaction with the decision whether or not to have a midurethral sling placed at the time of prolapse surgery to prevent development of stress urinary incontinence. The investigators hypothesize that use of this tool will increase patient satisfaction with their decision regarding midurethral sling placement.
Read the detailed description
The investigators plan to conduct a randomized, controlled clinical trial involving women with pelvic organ prolapse planning to have prolapse surgery with 1 of 4 fellowship-trained Urogynecologists at the National Center for Advanced Pelvic Surgery at MedStar Washington Hospital Center in Washington, DC. Women will be recruited prior to their preoperative counseling sessions during routine office visits and/or by telephone. After obtaining informed consent, women who agree to participate will be randomized to preoperative counseling sessions where an online risk calculator tool for the development of postoperative de novo stress urinary incontinence is or is not used. This tool is accessible at no cost from the following website: http://www.r-calc.com/ExistingFormulas.aspx?filter=CCQHS. At the time of these sessions, participants will decide whether to have a midurethral sling placed at the time of their prolapse repair to prevent development of stress urinary incontinence after surgery. After making this decision, all participants will complete the validated Satisfaction with Decision Scale to assess their satisfaction with their decision regarding midurethral sling placement. This validated 6-item self-administered questionnaire with a 5 point response scale takes approximately 3 minutes to complete. Participants will complete the Satisfaction with Decision Scale a second time at the time of their 2 week postoperative visit. Three months after surgery, participants will complete the Satisfaction with Decision Scale a third time, along with other validated quality of life questionnaires.
- Being tested
- Online risk calculator
- Keywords
- Pelvic organ prolapse, Stress urinary incontinence, Midurethral sling, Patient satisfaction
- Medical subject headings
- Pelvic Organ Prolapse, Urinary Incontinence, Stress, Personal Satisfaction, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online risk calculatorOther
A new online risk calculator tool has been developed to predict a woman's individual risk of developing de novo stress urinary incontinence after prolapse surgery. This validated tool has been shown to outperform preoperative prolapse reduction stress testing results and expert predictions when providing risk assessment of de novo stress urinary incontinence after vaginal prolapse surgery. After inputting individual patient characteristics, including patient age, body mass index, number of vaginal deliveries, presence or absence of urgency urinary incontinence and diabetes, and prolapse reduction stress testing results if available, this tool calculates the theoretical risk of postoperative de novo stress urinary incontinence both with and without an anti-incontinence procedure.
| Study group | Role | What they receive |
|---|---|---|
| Online risk calculator used | Experimental | Online risk calculator tool for the development of postoperative de novo stress urinary incontinence used during preoperative counseling session. Receives: Other: Online risk calculator |
| Online risk calculator not used | Placebo comparator | Online risk calculator tool for the development of postoperative de novo stress urinary incontinence not used during preoperative counseling session. Receives: Other: Online risk calculator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with Decision Scale for Pelvic Floor Disorders
The primary outcome will be patient satisfaction with the decision for concomitant midurethral sling placement at 3 months postoperative in the intervention (risk calculator tool) group versus the control group, assessed using the Satisfaction with Decision Scale for Pelvic Floor Disorders.
Measured: 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeannine Miranne, Medstar Health Research Institute
- Investigators
- Jeannine M. Miranne, MD, MS, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111642
- Sponsor's protocol ID
- MHRI 2014-073
- Status last verified
- Jan 2022
- First submitted
- 9 Apr 2014
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Jelovsek JE, Chagin K, Brubaker L, Rogers RG, Richter HE, Arya L, Barber MD, Shepherd JP, Nolen TL, Norton P, Sung V, Menefee S, Siddiqui N, Meikle SF, Kattan MW; Pelvic Floor Disorders Network. A model for predicting the risk of de novo stress urinary incontinence in women undergoing pelvic organ prolapse surgery. Obstet Gynecol. 2014 Feb;123(2 Pt 1):279-287. doi: 10.1097/AOG.0000000000000094.
PubMed 24402598
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a New Risk Calculator on Patient Satisfaction With the Decision for Concomitant Midurethral Sling During Prolapse Surgery
- ClinicalTrials.gov ID
- NCT02111642
- Acronym / sponsor ID
- MHRI 2014-073
- Keywords
- Pelvic organ prolapse, Stress urinary incontinence, Midurethral sling, Patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 11 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pelvic organ prolapse occurs with descent of one or more pelvic structures: the uterus and/or cervix, bowel, bladder, or rectum. Although options for treatment include expectant management, pelvic floor physical therapy, and pessary (intravaginal device) use, surgery is the only option which potentially offers a cure.
It is well known that women with pelvic organ prolapse are at risk of developing new stress urinary incontinence symptoms after prolapse surgery. Stress urinary incontinence is defined as involuntary loss of urine with an increase in intra-abdominal pressure, such as sneezing, coughing, or laughing. Previous studies have demonstrated that the addition of a prophylactic anti-incontinence procedure at the time of prolapse surgery reduces this risk. One example of such a procedure is a mesh sling placed underneath the urethra (midurethral sling). Nevertheless, the decision to place a midurethral sling to prevent stress urinary incontinence after prolapse surgery remains controversial.
A new risk calculator tool has been developed to provide patients' with their individualized risk of developing de novo stress urinary incontinence after prolapse surgery. The primary objective of this study is to determine whether use of this new personalized online risk calculator tool increases patient satisfaction with the decision whether or not to have a midurethral sling placed at the time of prolapse surgery to prevent development of stress urinary incontinence. The investigators hypothesize that use of this tool will increase patient satisfaction with their decision regarding midurethral sling placement.
Detailed description
The investigators plan to conduct a randomized, controlled clinical trial involving women with pelvic organ prolapse planning to have prolapse surgery with 1 of 4 fellowship-trained Urogynecologists at the National Center for Advanced Pelvic Surgery at MedStar Washington Hospital Center in Washington, DC. Women will be recruited prior to their preoperative counseling sessions during routine office visits and/or by telephone. After obtaining informed consent, women who agree to participate will be randomized to preoperative counseling sessions where an online risk calculator tool for the development of postoperative de novo stress urinary incontinence is or is not used. This tool is accessible at no cost from the following website: http://www.r-calc.com/ExistingFormulas.aspx?filter=CCQHS. At the time of these sessions, participants will decide whether to have a midurethral sling placed at the time of their prolapse repair to prevent development of stress urinary incontinence after surgery. After making this decision, all participants will complete the validated Satisfaction with Decision Scale to assess their satisfaction with their decision regarding midurethral sling placement. This validated 6-item self-administered questionnaire with a 5 point response scale takes approximately 3 minutes to complete. Participants will complete the Satisfaction with Decision Scale a second time at the time of their 2 week postoperative visit. Three months after surgery, participants will complete the Satisfaction with Decision Scale a third time, along with other validated quality of life questionnaires.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online risk calculator used | Experimental | Other: Online risk calculatorOnline risk calculator tool for the development of postoperative de novo stress urinary incontinence used during preoperative counseling session. |
| Online risk calculator not used | Placebo comparator | Other: Online risk calculatorOnline risk calculator tool for the development of postoperative de novo stress urinary incontinence not used during preoperative counseling session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ Stage 2 pelvic organ prolapse according to the Pelvic Organ Prolapse Quantification system (POP-Q)
- Desire for prolapse surgery
- No symptoms of stress urinary incontinence preoperatively
- Age ≥ 18
- English-speaking
Key exclusion criteria (5 listed)
- Symptoms of stress urinary incontinence preoperatively
- History of previous prolapse or anti-incontinence surgery
- Pregnancy
- Dementia or other cognitive impairment
- Unable or unwilling to complete post-operative questionnaires
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 |
|---|---|---|
| Online risk calculatorA new online risk calculator tool has been developed to predict a woman's individual risk of developing de novo stress urinary incontinence after prolapse surgery. This validated tool has been shown to outperform preoperative prolapse reduction stress testing results and expert predictions when providing risk assessment of de novo stress urinary incontinence after vaginal prolapse surgery. After inputting individual patient characteristics, including patient age, body mass index, number of vaginal deliveries, presence or absence of urgency urinary incontinence and diabetes, and prolapse reduction stress testing results if available, this tool calculates the theoretical risk of postoperative de novo stress urinary incontinence both with and without an anti-incontinence procedure. | Other | Online risk calculator not used, Online risk calculator used |
Primary outcome
Satisfaction with Decision Scale for Pelvic Floor Disorders
Time frame: 3 months postoperative
The primary outcome will be patient satisfaction with the decision for concomitant midurethral sling placement at 3 months postoperative in the intervention (risk calculator tool) group versus the control group, assessed using the Satisfaction with Decision Scale for Pelvic Floor Disorders.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Background: PubMed 24402598Jelovsek JE, Chagin K, Brubaker L, Rogers RG, Richter HE, Arya L, Barber MD, Shepherd JP, Nolen TL, Norton P, Sung V, Menefee S, Siddiqui N, Meikle SF, Kattan MW; Pelvic Floor Disorders Network. A model for predicting the risk of de novo stress urinary incontinence in women undergoing pelvic organ prolapse surgery. Obstet Gynecol. 2014 Feb;123(2 Pt 1):279-287. doi: 10.1097/AOG.0000000000000094.
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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.
Jeannine M. Miranne, MD, MS principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online risk calculator in people with Pelvic Organ Prolapse and Stress Urinary Incontinence, run by Medstar Health Research Institute 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 5 inclusion and 5 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 Jan 2022. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Satisfaction with Decision Scale for Pelvic Floor Disorders (time frame: 3 months postoperative). 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 NCT02111642, 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 20 Jan 2022.