Pregnancy Related Clinical Trial
Official title:
Pessary Use for Stress Urinary Incontinence in Pregnancy: a Pilot Randomized Controlled Trial
When women are pregnant they are more likely to leak urine which can severely affect their quality of life. This problem could be fixed by using a pessary. A pessary is a silicone ring that goes into the vagina which can stop or improve urinary leakage. These devices have been safely used for hundreds of years. However, pessaries has not been studied for urinary leakage in pregnancy. The investigators would like to compare severity of urinary leakage using a number of questionnaires during the last 3 months of pregnancy for women using a pessary versus women without a pessary.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | September 2022 |
Est. primary completion date | September 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 19 Years to 60 Years |
Eligibility | Inclusion Criteria: - English speaking women over 19 years old - Nulliparous and multiparous women over 26 weeks gestational age with a healthy singleton pregnancy - Bothersome symptoms of stress urinary incontinence or stress-predominant mixed urinary incontinence with a minimal PDFI score of 25 on the UDI-6 section. Exclusion Criteria: - Stage 3 or greater pelvic organ prolapse - Contraindication to pessary use (known pelvic infection, vaginal or cervical lesions) - Previous surgery for urinary incontinence - History of preterm delivery and current threatened preterm labour - Premature preterm rupture of membranes - Short cervix - Hospitalization in the current pregnancy - Antepartum hemorrhage - Fetal anomaly - Prior trial of pessary or current pessary use - Vulvodynia |
Country | Name | City | State |
---|---|---|---|
Canada | Providence Health Care - St Paul's Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Canada,
Al-Shaikh G, Syed S, Osman S, Bogis A, Al-Badr A. Pessary use in stress urinary incontinence: a review of advantages, complications, patient satisfaction, and quality of life. Int J Womens Health. 2018 Apr 17;10:195-201. doi: 10.2147/IJWH.S152616. eCollection 2018. Review. — View Citation
Balik G, Güven ES, Tekin YB, Sentürk S, Kagitci M, Üstüner I, Mete Ural Ü, Sahin FK. Lower Urinary Tract Symptoms and Urinary Incontinence During Pregnancy. Low Urin Tract Symptoms. 2016 May;8(2):120-4. doi: 10.1111/luts.12082. Epub 2014 Dec 11. — View Citation
Brown SJ, Donath S, MacArthur C, McDonald EA, Krastev AH. Urinary incontinence in nulliparous women before and during pregnancy: prevalence, incidence, and associated risk factors. Int Urogynecol J. 2010 Feb;21(2):193-202. doi: 10.1007/s00192-009-1011-x. Epub 2009 Oct 16. — View Citation
Daly D, Clarke M, Begley C. Urinary incontinence in nulliparous women before and during pregnancy: prevalence, incidence, type, and risk factors. Int Urogynecol J. 2018 Mar;29(3):353-362. doi: 10.1007/s00192-018-3554-1. Epub 2018 Jan 23. — View Citation
De Vita D, Giordano S. Two successful natural pregnancies in a patient with severe uterine prolapse: A case report. J Med Case Rep. 2011 Sep 14;5:459. doi: 10.1186/1752-1947-5-459. — View Citation
Farrell SA, Singh B, Aldakhil L. Continence pessaries in the management of urinary incontinence in women. J Obstet Gynaecol Can. 2004 Feb;26(2):113-7. — View Citation
Geoffrion R, Zhang T, Lee T, Cundiff GW. Clinical characteristics associated with unsuccessful pessary fitting outcomes. Female Pelvic Med Reconstr Surg. 2013 Nov-Dec;19(6):339-45. doi: 10.1097/SPV.0b013e3182a26174. — View Citation
Gyhagen M, Åkervall S, Molin M, Milsom I. The effect of childbirth on urinary incontinence: a matched cohort study in women aged 40-64 years. Am J Obstet Gynecol. 2019 Oct;221(4):322.e1-322.e17. doi: 10.1016/j.ajog.2019.05.022. Epub 2019 May 21. — View Citation
Jarde A, Lutsiv O, Beyene J, McDonald SD. Vaginal progesterone, oral progesterone, 17-OHPC, cerclage, and pessary for preventing preterm birth in at-risk singleton pregnancies: an updated systematic review and network meta-analysis. BJOG. 2019 Apr;126(5):556-567. doi: 10.1111/1471-0528.15566. Epub 2018 Dec 29. — View Citation
Richter HE, Burgio KL, Brubaker L, Nygaard IE, Ye W, Weidner A, Bradley CS, Handa VL, Borello-France D, Goode PS, Zyczynski H, Lukacz ES, Schaffer J, Barber M, Meikle S, Spino C; Pelvic Floor Disorders Network. Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial. Obstet Gynecol. 2010 Mar;115(3):609-617. doi: 10.1097/AOG.0b013e3181d055d4. — View Citation
Robert M, Schulz JA, Harvey MA; UROGYNAECOLOGY COMMITTEE. Technical update on pessary use. J Obstet Gynaecol Can. 2013 Jul;35(7):664-674. doi: 10.1016/S1701-2163(15)30888-4. Review. — View Citation
Rusavy Z, Bombieri L, Freeman RM. Procidentia in pregnancy: a systematic review and recommendations for practice. Int Urogynecol J. 2015 Aug;26(8):1103-9. doi: 10.1007/s00192-014-2595-3. Epub 2015 Jan 20. Review. — View Citation
Saccone G, Ciardulli A, Xodo S, Dugoff L, Ludmir J, Pagani G, Visentin S, Gizzo S, Volpe N, Maruotti GM, Rizzo G, Martinelli P, Berghella V. Cervical Pessary for Preventing Preterm Birth in Singleton Pregnancies With Short Cervical Length: A Systematic Review and Meta-analysis. J Ultrasound Med. 2017 Aug;36(8):1535-1543. doi: 10.7863/ultra.16.08054. Epub 2017 Apr 11. Review. — View Citation
Solans-Domènech M, Sánchez E, Espuña-Pons M; Pelvic Floor Research Group (Grup de Recerca del Sòl Pelvià; GRESP). Urinary and anal incontinence during pregnancy and postpartum: incidence, severity, and risk factors. Obstet Gynecol. 2010 Mar;115(3):618-628. doi: 10.1097/AOG.0b013e3181d04dff. — View Citation
Vasconcelos CTM, Silva Gomes ML, Ribeiro GL, Oriá MOB, Geoffrion R, Vasconcelos Neto JA. Women and healthcare providers' knowledge, attitudes and practice related to pessaries for pelvic organ prolapse: A Systematic review. Eur J Obstet Gynecol Reprod Biol. 2020 Apr;247:132-142. doi: 10.1016/j.ejogrb.2020.02.016. Epub 2020 Feb 14. Review. — View Citation
Viera AJ, Larkins-Pettigrew M. Practical use of the pessary. Am Fam Physician. 2000 May 1;61(9):2719-26, 2729. Erratum in: Am Fam Physician 2002 Jul 1;66(1):30. — View Citation
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Zeng C, Yang F, Wu C, Zhu J, Guan X, Liu J. Uterine Prolapse in Pregnancy: Two Cases Report and Literature Review. Case Rep Obstet Gynecol. 2018 Oct 22;2018:1805153. doi: 10.1155/2018/1805153. eCollection 2018. — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PFDI-20 score difference and variance | Pelvic Floor Disability Inventory (PFDI-20) score differences and variance between; intervention and control arms at 36 weeks gestational age; range 0-100; higher scores are a worse outcome. | At exit interview (36 weeks gestational age) | |
Secondary | Pelvic Floor Impact Questionnaire (PFIQ-7) score | Differences between intervention and control arms; Rang 0-300, high scores are worse | At exit interview (36 weeks gestational age) | |
Secondary | Bladder Diary | Differences between intervention and control arms | At exit interview (36 weeks gestational age) | |
Secondary | Female Sexual Function Index (FSFI) score | Differences between intervention and control arms; Range 2-36; low scores have a worse outcome. | At exit interview (36 weeks gestational age) | |
Secondary | Pessary Usability | Patient acceptability and global impression questionnaire. Intervention arm only; Scale of 0-5; higher score means pessary is more acceptable. | At exit interview (36 weeks gestational age) | |
Secondary | Vaginal discharge | Recorded as vaginal discharge present or absent | Biweekly from 28 weeks gestational age to 36 weeks gestational age | |
Secondary | Pessary fitting and success | Number women with a successful fitting/total number of attempted fittings | up to 24 months | |
Secondary | evaluate study retention rates | number of women who leave the study before the formal discharge criteria are met | up to 24 months | |
Secondary | Abdominal Pain | Recorded as abdominal pain present or absent | Biweekly from 28 weeks gestational age to 36 weeks gestational age | |
Secondary | Pelvic pain | Recorded as pelvic pain present or absent | Biweekly from 28 weeks gestational age to 36 weeks gestational age | |
Secondary | Pessary expulsion | Recorded as pessary has or has not fallen out of the vagina. | Biweekly from 28 weeks gestational age to 36 weeks gestational age | |
Secondary | Incomplete emptying | Recorded as incomplete emptying present or absent | Biweekly from 28 weeks gestational age to 36 weeks gestational age | |
Secondary | Difficult removing pessary | Recorded as the pessary is or is not difficult to remove. | Biweekly from 28 weeks gestational age to 36 weeks gestational age | |
Secondary | Difficult inserting the pessary | Recorded as the pessary is or is not difficult to insert. | Biweekly from 28 weeks gestational age to 36 weeks gestational age | |
Secondary | Number of daily hours of pessary use | Recorded as number of hours of pessary use on a daily bases. | Biweekly from 28 weeks gestational age to 36 weeks gestational age | |
Secondary | Difficulty with sexual activity | Recorded as yes or no difficulty with sexual activity | Biweekly from 28 weeks gestational age to 36 weeks gestational age | |
Secondary | Vaginal Bleeding | Recorded as absent or present. | Biweekly from 28 weeks gestational age to 36 weeks gestational age | |
Secondary | Delivery | Recorded as absent or present. | Biweekly from 28 weeks gestational age to 36 weeks gestational age | |
Secondary | Hospital Admission | Recorded as absent or present. | Biweekly from 28 weeks gestational age to 36 weeks gestational age | |
Secondary | Group B strep Positive | Recorded as absent or present. | Biweekly from 28 weeks gestational age to 36 weeks gestational age | |
Secondary | Rupture of membranes | Recorded as absent or present. | Biweekly from 28 weeks gestational age to 36 weeks gestational age |
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