Pelvic Organ ProlapsePAKSNCT04829721
Pelvic Floor Disorder Assessment of Knowledge and Symptoms: an Educational Model in Spanish-Speaking Women
A study testing Educational Intervention with video in people with Pelvic Organ Prolapse and Urinary Incontinence, run by Johns Hopkins University at 1 site in United States.
Trial summary
Pelvic floor health workshops have previously been shown to be effective in improving postpartum knowledge, performance of pelvic floor muscle exercises, and bowel-specific quality of life. 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, Urinary Incontinence, Patient Education
- What is being tested?
- Educational Intervention with video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 31 Dec 2021
- 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
- Women 18 years or older
- Interested in learning about pelvic floor disorders
- Spanish-speaking.
Who cannot join
- Women under 18 years of age
- Have previously completed the Prolapse and Incontinence Knowledge Questionnaire
- Unable to speak Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Pelvic floor health workshops have previously been shown to be effective in improving postpartum knowledge, performance of pelvic floor muscle exercises, and bowel-specific quality of life. Group learning through a class focused on behavioral modification and pelvic floor muscle exercises for women with urinary incontinence, has been shown to be an effective means to educate women about urinary incontinence management. The PAKS study hopes to demonstrate whether Spanish-speaking women that undergo an informative workshop on pelvic floor disorders via video in Spanish are more likely to raise their level of knowledge surrounding pelvic floor disorders and improve the pelvic floor symptoms.
Read the detailed description
Purpose: The purpose of this study is to determine if an informational workshop on pelvic floor disorders administered via a video intervention will increase Spanish-speaking women's knowledge of pelvic floor disorders and decrease pelvic floor symptoms post-intervention.
Hypothesis or Aim: A single 20 minute video workshop on pelvic floor disorders will improve Spanish-speaking women's knowledge of pelvic floor disorders immediately post-intervention and at 4 weeks post-intervention compared to a pre-intervention knowledge.
Justification of the Study (Background): It is estimated that by the year 2050 in the United States, 58.2 million women will have at least 1 pelvic floor disorder. However, understanding of these disorders among patients is low. Prior studies assessing patient knowledge have shown that participants often did not understand basic urogynecologic terms such as urinary incontinence, pelvic organ prolapse, and pelvic floor disorder and that the participants had poor knowledge of participants' conditions.
Latinos will comprise 30% of the population in the United States by year 2060. In Hispanic women, barriers such as lower income, lower education, limited English language proficiency and lack of health coverage influence access to health care. In those with pelvic floor disorders, additional barriers such as poor understanding of general medical conditions, medical terminology, and female anatomy may lead to low understanding of participants' condition, treatment options, and therapies. Given this high prevalence estimate, educating and optimizing care for Hispanic women with such disorders is imperative with implications of having a significant societal impact.
Pelvic floor health workshops have previously been shown to be effective in improving postpartum knowledge, performance of pelvic floor muscle exercises, and bowel-specific quality of life. Learning through a class focused on behavioral modification and pelvic floor muscle exercises for women with urinary incontinence, was shown to be an effective means to educate women about urinary incontinence management. Women's knowledge, symptoms, and quality-of-life scores significantly improved at 3 months after undergoing an educational pelvic health workshop on incontinence and pelvic organ prolapse.
Currently, no studies have investigated the effects of a formal educational pelvic floor disorder workshop in Spanish on this knowledge or its impact on patient symptoms in those who suffer from pelvic floor disorders at baseline. The investigators research project proposes to close the gap between patient knowledge and scientific knowledge and potentially improve pelvic floor symptoms. The investigators' video workshop will empower women with knowledge and allow the women to make informed decisions surrounding the women's pelvic floor health. It will provide the women with tools to improve the women's own pelvic floor health. A pelvic floor health workshop targeted to Spanish-speaking women is an innovative concept which could lead to better patient care in a growing population. It may be the first step in prevention of future pelvic floor conditions.
- Being tested
- Educational Intervention with video
- Medical subject headings
- Pelvic Organ Prolapse, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Intervention with videoOther
Women randomized to an educational video workshop group.
| Study group | Role | What they receive |
|---|---|---|
| Educational Video Workshop | Experimental | A single 20 minute video workshop on pelvic floor disorders. Receives: Other: Educational Intervention with video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Floor Knowledge Scores Immediately Postintervention
Difference in questionnaire scores based on the validated Spanish version of the Prolapse and Incontinence Knowledge Questionnaire from baseline compared to immediately post-intervention after an educational video workshop.
The Prolapse and Incontinence Knowledge Questionnaire is a 24-item condition-specific questionnaire that consists of 2 knowledge subscales: questions concerning pelvic organ prolapse (score range 0-12) and urinary incontinence (score range 0-12). Each item is given a score of 1 if answered correctly and 0 if answered incorrectly. Women are given a score of 0 if they answered "I don't know" or "No lo sé" presuming a lack of knowledge. Higher scores mean greater knowledge of these pelvic floor disorders.
Measured: Immediately after intervention administered
Secondary outcomes (2)
Pelvic Floor Knowledge Scores at 4 Weeks Postintervention
Difference in questionnaire scores based on the validated Spanish version of the Prolapse and Incontinence Knowledge Questionnaire from baseline compared to 4 weeks post-intervention after an educational video workshop
The Prolapse and Incontinence Knowledge Questionnaire is a 24-item condition-specific questionnaire that consists of 2 knowledge subscales: questions concerning pelvic organ prolapse (score range 0-12) and urinary incontinence (score range 0-12). Each item is given a score of 1 if answered correctly and 0 if answered incorrectly. Women are given a score of 0 if they answered "I don't know" or "No lo sé" presuming a lack of knowledge. Higher scores mean greater knowledge of these pelvic floor disorders.
Measured: At 4 weeks postintervention
Pelvic Floor Symptom Scores at 4 Weeks Postintervention
Difference in Pelvic Floor Distress Inventory-20 questionnaire scores at 4 weeks postintervention from baseline compared to 4 weeks post-intervention after an educational video workshop
The Pelvic Floor Distress Inventory-20 is a set of 20 symptom questions, answered on a 4-point Likert scale: 1 = not at all to 4 = quite a bit. The mean values of all answered items are multiplied by 25 to determine the scale score (range 0-100). A summary score is also reported (range 0-300). Higher scores denote a greater symptom burden.
Measured: At 4 weeks postintervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start1 May 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)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 Johns Hopkins UniversityThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keila S Muniz, MD, Study director, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829721
- Sponsor's protocol ID
- IRB00236091
- Acronym
- PAKS
- Status last verified
- Aug 2022
- First submitted
- 31 Mar 2021
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu JM, Hundley AF, Fulton RG, Myers ER. Forecasting the prevalence of pelvic floor disorders in U.S. Women: 2010 to 2050. Obstet Gynecol. 2009 Dec;114(6):1278-1283. doi: 10.1097/AOG.0b013e3181c2ce96.
PubMed 19935030Hawary A, Sinclair A, Pearce I. The origin of information: are IUGA-specific patient information leaflets the answer? Int Urogynecol J. 2010 Aug;21(8):1001-4. doi: 10.1007/s00192-010-1142-0. Epub 2010 Apr 17.
PubMed 20401466Senekjian L, Heintz K, Egger MJ, Nygaard I. Do Women Understand Urogynecologic Terminology? Female Pelvic Med Reconstr Surg. 2011 Sep;17(5):215-217. doi: 10.1097/SPV.0b013e31822dcffe.
PubMed 21984964Good MM, Korbly N, Kassis NC, Richardson ML, Book NM, Yip S, Saguan D, Gross C, Evans J, Harvie HS, Sung V; Society of Gynecologic Surgeons Fellows Pelvic Research Network. Prolapse-related knowledge and attitudes toward the uterus in women with pelvic organ prolapse symptoms. Am J Obstet Gynecol. 2013 Nov;209(5):481.e1-6. doi: 10.1016/j.ajog.2013.06.001. Epub 2013 Jun 5.
PubMed 23748108Colby SL, Ortman JM. Projections of the size and composition of the U.S. population: 2014 to 2060. Population Estimates 2015. https://www.census.gov/content/dam/Census/library/ publications/2015/demo/p25-1143.pdf. Accessed October 23, 2017.
Roberts RE, Lee ES. Medical care use by Mexican-Americans: evidence from the human population laboratory studies. Med Care. 1980 Mar;18(3):267-81.
PubMed 7366256Andersen R, Lewis SZ, Giachello AL, Aday LA, Chiu G. Access to medical care among the Hispanic population of the southwestern United States. J Health Soc Behav. 1981 Mar;22(1):78-89. No abstract available.
PubMed 7240708Freeman G, Lethbridge-Cejku M. Access to health care among Hispanic or Latino women: United States, 2000-2002. Adv Data. 2006 Apr 20;(368):1-25.
PubMed 16646390Insaf TZ, Jurkowski JM, Alomar L. Sociocultural factors influencing delay in seeking routine health care among Latinas: a community-based participatory research study. Ethn Dis. 2010 Spring;20(2):148-54.
PubMed 20503895Khan AA, Sevilla C, Wieslander CK, Moran MB, Rashid R, Mittal B, Maliski SL, Rogers RG, Anger JT. Communication barriers among Spanish-speaking women with pelvic floor disorders: lost in translation? Female Pelvic Med Reconstr Surg. 2013 May-Jun;19(3):157-64. doi: 10.1097/SPV.0b013e318288ac1c.
PubMed 23611934Hyakutake MT, Han V, Baerg L, Koenig NA, Cundiff GW, Lee T, Geoffrion R. Pregnancy-Associated Pelvic Floor Health Knowledge and Reduction of Symptoms: The PREPARED Randomized Controlled Trial. J Obstet Gynaecol Can. 2018 Apr;40(4):418-425. doi: 10.1016/j.jogc.2017.10.022.
PubMed 29680079Gerard L. Group learning behavior modification and exercise for women with urinary incontinence. Urol Nurs. 1997 Mar;17(1):17-22.
PubMed 9110901Geoffrion R, Robert M, Ross S, van Heerden D, Neustaedter G, Tang S, Milne J. Evaluating patient learning after an educational program for women with incontinence and pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Oct;20(10):1243-52. doi: 10.1007/s00192-009-0919-5. Epub 2009 Jun 11.
PubMed 19517050Shah AD, Massagli MP, Kohli N, Rajan SS, Braaten KP, Hoyte L. A reliable, valid instrument to assess patient knowledge about urinary incontinence and pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Sep;19(9):1283-9. doi: 10.1007/s00192-008-0631-x. Epub 2008 May 15.
PubMed 18480958
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Disorder Assessment of Knowledge and Symptoms: an Educational Model in Spanish-Speaking Women
- ClinicalTrials.gov ID
- NCT04829721
- Acronym / sponsor ID
- PAKS / IRB00236091
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 2 Apr 2021 (actual)
- 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 floor health workshops have previously been shown to be effective in improving postpartum knowledge, performance of pelvic floor muscle exercises, and bowel-specific quality of life. Group learning through a class focused on behavioral modification and pelvic floor muscle exercises for women with urinary incontinence, has been shown to be an effective means to educate women about urinary incontinence management. The PAKS study hopes to demonstrate whether Spanish-speaking women that undergo an informative workshop on pelvic floor disorders via video in Spanish are more likely to raise their level of knowledge surrounding pelvic floor disorders and improve the pelvic floor symptoms.
Detailed description
Purpose: The purpose of this study is to determine if an informational workshop on pelvic floor disorders administered via a video intervention will increase Spanish-speaking women's knowledge of pelvic floor disorders and decrease pelvic floor symptoms post-intervention.
Hypothesis or Aim: A single 20 minute video workshop on pelvic floor disorders will improve Spanish-speaking women's knowledge of pelvic floor disorders immediately post-intervention and at 4 weeks post-intervention compared to a pre-intervention knowledge.
Justification of the Study (Background): It is estimated that by the year 2050 in the United States, 58.2 million women will have at least 1 pelvic floor disorder. However, understanding of these disorders among patients is low. Prior studies assessing patient knowledge have shown that participants often did not understand basic urogynecologic terms such as urinary incontinence, pelvic organ prolapse, and pelvic floor disorder and that the participants had poor knowledge of participants' conditions.
Latinos will comprise 30% of the population in the United States by year 2060. In Hispanic women, barriers such as lower income, lower education, limited English language proficiency and lack of health coverage influence access to health care. In those with pelvic floor disorders, additional barriers such as poor understanding of general medical conditions, medical terminology, and female anatomy may lead to low understanding of participants' condition, treatment options, and therapies. Given this high prevalence estimate, educating and optimizing care for Hispanic women with such disorders is imperative with implications of having a significant societal impact.
Pelvic floor health workshops have previously been shown to be effective in improving postpartum knowledge, performance of pelvic floor muscle exercises, and bowel-specific quality of life. Learning through a class focused on behavioral modification and pelvic floor muscle exercises for women with urinary incontinence, was shown to be an effective means to educate women about urinary incontinence management. Women's knowledge, symptoms, and quality-of-life scores significantly improved at 3 months after undergoing an educational pelvic health workshop on incontinence and pelvic organ prolapse.
Currently, no studies have investigated the effects of a formal educational pelvic floor disorder workshop in Spanish on this knowledge or its impact on patient symptoms in those who suffer from pelvic floor disorders at baseline. The investigators research project proposes to close the gap between patient knowledge and scientific knowledge and potentially improve pelvic floor symptoms. The investigators' video workshop will empower women with knowledge and allow the women to make informed decisions surrounding the women's pelvic floor health. It will provide the women with tools to improve the women's own pelvic floor health. A pelvic floor health workshop targeted to Spanish-speaking women is an innovative concept which could lead to better patient care in a growing population. It may be the first step in prevention of future pelvic floor conditions.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Educational Video Workshop | Experimental | Other: Educational Intervention with videoA single 20 minute video workshop on pelvic floor disorders. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women 18 years or older
- Interested in learning about pelvic floor disorders
- Spanish-speaking.
Key exclusion criteria (3 listed)
- Women under 18 years of age
- Have previously completed the Prolapse and Incontinence Knowledge Questionnaire
- Unable to speak Spanish
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 |
|---|---|---|
| Educational Intervention with videoWomen randomized to an educational video workshop group. | Other | Educational Video Workshop |
Primary outcome
Pelvic Floor Knowledge Scores Immediately Postintervention
Time frame: Immediately after intervention administered
Difference in questionnaire scores based on the validated Spanish version of the Prolapse and Incontinence Knowledge Questionnaire from baseline compared to immediately post-intervention after an educational video workshop. The Prolapse and Incontinence Knowledge Questionnaire is a 24-item condition-specific questionnaire that consists of 2 knowledge subscales: questions concerning pelvic organ prolapse (score range 0-12) and urinary incontinence (score range 0-12). Each item is given a score of 1 if answered correctly and 0 if answered incorrectly. Women are given a score of 0 if they answered "I don't know" or "No lo sé" presuming a lack of knowledge. Higher scores mean greater knowledge of these pelvic floor disorders.
2 secondary outcomes
Pelvic Floor Knowledge Scores at 4 Weeks Postintervention
Time frame: At 4 weeks postintervention
Pelvic Floor Symptom Scores at 4 Weeks Postintervention
Time frame: At 4 weeks postintervention
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 12 Aug 2022.
- Background: PubMed 19935030Wu JM, Hundley AF, Fulton RG, Myers ER. Forecasting the prevalence of pelvic floor disorders in U.S. Women: 2010 to 2050. Obstet Gynecol. 2009 Dec;114(6):1278-1283. doi: 10.1097/AOG.0b013e3181c2ce96.
- Background: PubMed 20401466Hawary A, Sinclair A, Pearce I. The origin of information: are IUGA-specific patient information leaflets the answer? Int Urogynecol J. 2010 Aug;21(8):1001-4. doi: 10.1007/s00192-010-1142-0. Epub 2010 Apr 17.
- Background: PubMed 21984964Senekjian L, Heintz K, Egger MJ, Nygaard I. Do Women Understand Urogynecologic Terminology? Female Pelvic Med Reconstr Surg. 2011 Sep;17(5):215-217. doi: 10.1097/SPV.0b013e31822dcffe.
- Background: PubMed 23748108Good MM, Korbly N, Kassis NC, Richardson ML, Book NM, Yip S, Saguan D, Gross C, Evans J, Harvie HS, Sung V; Society of Gynecologic Surgeons Fellows Pelvic Research Network. Prolapse-related knowledge and attitudes toward the uterus in women with pelvic organ prolapse symptoms. Am J Obstet Gynecol. 2013 Nov;209(5):481.e1-6. doi: 10.1016/j.ajog.2013.06.001. Epub 2013 Jun 5.
- BackgroundColby SL, Ortman JM. Projections of the size and composition of the U.S. population: 2014 to 2060. Population Estimates 2015. https://www.census.gov/content/dam/Census/library/ publications/2015/demo/p25-1143.pdf. Accessed October 23, 2017.
- Background: PubMed 7366256Roberts RE, Lee ES. Medical care use by Mexican-Americans: evidence from the human population laboratory studies. Med Care. 1980 Mar;18(3):267-81.
- Background: PubMed 7240708Andersen R, Lewis SZ, Giachello AL, Aday LA, Chiu G. Access to medical care among the Hispanic population of the southwestern United States. J Health Soc Behav. 1981 Mar;22(1):78-89. No abstract available.
- Background: PubMed 16646390Freeman G, Lethbridge-Cejku M. Access to health care among Hispanic or Latino women: United States, 2000-2002. Adv Data. 2006 Apr 20;(368):1-25.
- Background: PubMed 20503895Insaf TZ, Jurkowski JM, Alomar L. Sociocultural factors influencing delay in seeking routine health care among Latinas: a community-based participatory research study. Ethn Dis. 2010 Spring;20(2):148-54.
- Background: PubMed 23611934Khan AA, Sevilla C, Wieslander CK, Moran MB, Rashid R, Mittal B, Maliski SL, Rogers RG, Anger JT. Communication barriers among Spanish-speaking women with pelvic floor disorders: lost in translation? Female Pelvic Med Reconstr Surg. 2013 May-Jun;19(3):157-64. doi: 10.1097/SPV.0b013e318288ac1c.
- Background: PubMed 29680079Hyakutake MT, Han V, Baerg L, Koenig NA, Cundiff GW, Lee T, Geoffrion R. Pregnancy-Associated Pelvic Floor Health Knowledge and Reduction of Symptoms: The PREPARED Randomized Controlled Trial. J Obstet Gynaecol Can. 2018 Apr;40(4):418-425. doi: 10.1016/j.jogc.2017.10.022.
- Background: PubMed 9110901Gerard L. Group learning behavior modification and exercise for women with urinary incontinence. Urol Nurs. 1997 Mar;17(1):17-22.
- Individual participant dataSharing planned: No
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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.
Keila S Muniz, MD study director
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention with video in people with Pelvic Organ Prolapse and Urinary Incontinence, run by Johns Hopkins University 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 3 inclusion and 3 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 12 Aug 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. 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?
Pelvic Floor Knowledge Scores Immediately Postintervention (time frame: Immediately after intervention administered). 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 NCT04829721, which also lists 14 linked publications.
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 12 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.