Pessary Use for Stress Urinary Incontinence in Pregnancy

NCT04590092 | Unknown

• 1 other identifier: H20-02900
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress Urinary Incontinence; Pregnancy Related

Keywords

Stress urinary incontinence; Pregnancy; Pessary; Pelvic floor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Pelvic Floor Impact Questionnaire (PFIQ-7) score

  At exit interview (36 weeks gestational age)

• Bladder Diary

  At exit interview (36 weeks gestational age)

• Female Sexual Function Index (FSFI) score

  At exit interview (36 weeks gestational age)

• Pessary Usability

  At exit interview (36 weeks gestational age)

• Vaginal discharge

  Biweekly from 28 weeks gestational age to 36 weeks gestational age

Study Arms (2)

Control

NO INTERVENTION

Study Participants who do not receive a pessary. This group will be given an information pamphlet on pelvic floor (Kegel) exercises in pregnancy and will continue to have standard antenatal care with their maternity provider.

Pessary

EXPERIMENTAL

Study Participants who are fitted with a pessary for urinary incontinence. This group will be given an information pamphlet on pelvic floor (Kegel) exercises in pregnancy and pessary use in pregnancy. They will continue to have standard antenatal care with their maternity provider.

Device: Cooper Surgical Ring Pessary with Incontinence Knob

Interventions

Cooper Surgical Ring Pessary with Incontinence Knob DEVICE

A pessary is a silicone ring with a knob that in inserted into the vagina to treat urinary incontinence by providing urethral support.

Pessary

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Providence Health Care - St Paul's Hospital

Vancouver, British Columbia, V6H1J7, Canada

RECRUITING

Related Publications (18)

• 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.

  PMID: 29362836 BACKGROUND

• Balik G, Guven ES, Tekin YB, Senturk S, Kagitci M, Ustuner I, Mete Ural U, 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.

  PMID: 27111624 BACKGROUND

• Gyhagen M, Akervall 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.

  PMID: 31121136 BACKGROUND

• 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.

  PMID: 19834637 BACKGROUND

• Solans-Domenech M, Sanchez E, Espuna-Pons M; Pelvic Floor Research Group (Grup de Recerca del Sol Pelvia; 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.

  PMID: 20177295 BACKGROUND

• Robert M, Schulz JA, Harvey MA; UROGYNAECOLOGY COMMITTEE. RETIRED: Technical update on pessary use. J Obstet Gynaecol Can. 2013 Jul;35(7):664-674. doi: 10.1016/S1701-2163(15)30888-4.

  PMID: 23876646 BACKGROUND

• 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.

  PMID: 20177294 BACKGROUND

• 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. doi: 10.1016/s1701-2163(16)30486-8.

  PMID: 14965476 BACKGROUND

• 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.

  PMID: 24165447 BACKGROUND

• Vasconcelos CTM, Silva Gomes ML, Ribeiro GL, Oria 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.

  PMID: 32113060 BACKGROUND

• 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.

  PMID: 28398701 BACKGROUND

• 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.

  PMID: 30480871 BACKGROUND

• 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.

  PMID: 30425870 BACKGROUND

• 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.

  PMID: 21917162 BACKGROUND

• 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.

  PMID: 25600351 BACKGROUND

• Yohannes P, Schaefer J. Urinary retention during the second trimester of pregnancy: a rare cause. Urology. 2002 Jun;59(6):946. doi: 10.1016/s0090-4295(02)01551-0.

  PMID: 12031388 BACKGROUND

• Viera AJ, Larkins-Pettigrew M. Practical use of the pessary. Am Fam Physician. 2000 May 1;61(9):2719-26, 2729.

  PMID: 10821152 BACKGROUND

• 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.

  PMID: 29713205 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Catherine Smith, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Koenig

CONTACT

(604) 806-9829; NKoenig@providencehealth.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Administrator, Advanced Training in Female Pelvic Medicine & Reconstructive Surgery (FPMRS) program

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 19, 2020
• Study Start: February 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: June 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)