Vaginal Estrogen With Pessary Treatment

NCT01843166 | Completed

• 2 other identifiers: 10218618798
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Patients presenting with pelvic organ prolapse will be offered the use of a pessary. Vaginal estrogen cream treatment with the pessary will be randomized amongst the patients and patient satisfaction and complication rates will be assessed during follow-up.

Conditions

Vaginal Infection; Urinary Tract Infection; Quality of Life

Keywords

Pessary; Patient Satisfaction; Estrogen Cream

Outcome Measures

Primary Outcomes (1)

• Vaginal infections

  Vaginal swabs at each follow up visit will be used to detect presence or absence of vaginal infection. A total count of vaginal infections per patient will be compared between groups.

  60 weeks

Secondary Outcomes (2)

• Frequency of urinary tract infection

  60 weeks

• Quality of life

  60 weeks

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

These patients will utilize a pessary and be given instructions for use and prescription for Premarin vaginal cream 2g at bedtime twice weekly.

Drug: Premarin vaginal cream

Control group

PLACEBO COMPARATOR

These patients will utilize a pessary with an inactive placebo cream.

Drug: Placebo cream

Interventions

Premarin vaginal cream DRUG

2g at bedtime twice weekly

Treatment group

Placebo cream DRUG

2g at bedtime twice weekly

Control group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient presenting to the clinic with pelvic organ prolapse will be offered management with a pessary and will be offered participation in the study.

You may not qualify if:

• have a contraindication to the use of estrogen cream or products
• have any allergy to the use of estrogen cream or products
• have a past medical or family history of breast cancer
• have a past medical history of thromboembolism, myocardial infarction and stroke or are pregnant
• have previously used Premarin vaginal cream
• are currently using oral estrogen
• are not competent to consent

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Academic Medical Organization of Southwestern Ontario: collaborator
• University of Western Ontario, Canada: collaborator

Study Sites (1)

London Health Sciences Centre, University of Western Ontario

London, Ontario, N6A 5W9, Canada

Location

Related Publications (1)

• Bugge C, Adams EJ, Gopinath D, Stewart F, Dembinsky M, Sobiesuo P, Kearney R. Pessaries (mechanical devices) for managing pelvic organ prolapse in women. Cochrane Database Syst Rev. 2020 Nov 18;11(11):CD004010. doi: 10.1002/14651858.CD004010.pub4.

  PMID: 33207004 DERIVED

MeSH Terms

Conditions

Vaginitis; Urinary Tract Infections; Patient Satisfaction

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infections; Urologic Diseases; Male Urogenital Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Queena Chou, MD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2012
• First Posted: April 30, 2013
• Study Start: July 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 6, 2018

Record last verified: 2018-11

Locations

CA (1)