Urinary Incontinence Clinical Trial
— PAKSOfficial title:
Pelvic Floor Disorder Assessment of Knowledge and Symptoms: an Educational Model in Spanish-Speaking Women
Verified date | August 2022 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 114 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Women 18 years or older - Interested in learning about pelvic floor disorders - Spanish-speaking. Exclusion Criteria: - Women under 18 years of age - Have previously completed the Prolapse and Incontinence Knowledge Questionnaire - Unable to speak Spanish |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Bayview Medical Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
United States,
Andersen 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. — View Citation
Colby 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.
Freeman 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. — View Citation
Geoffrion 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. — View Citation
Gerard L. Group learning behavior modification and exercise for women with urinary incontinence. Urol Nurs. 1997 Mar;17(1):17-22. Review. — View Citation
Good 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. — View Citation
Hawary 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. — View Citation
Hyakutake 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. — View Citation
Insaf 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. — View Citation
Khan 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. — View Citation
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. — View Citation
Senekjian L, Heintz K, Egger MJ, Nygaard I. Do Women Understand Urogynecologic Terminology? Female Pelvic Med Reconstr Surg. 2011 Sep;17(5):215-217. — View Citation
Shah 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. — View Citation
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. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Immediately after intervention administered | |
Secondary | 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. |
At 4 weeks postintervention | |
Secondary | 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. |
At 4 weeks postintervention |
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