Topical Anesthetic Use In Pessary Management

NCT02380742 | Completed Phase 2 Results

• 1 other identifier: 206945
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate if lidocaine-prilocaine (EMLA 5%) cream can reduce pain and discomfort at the time of vaginal pessary removal and insertion. Half of the participants will receive lidocaine-prilocaine (EMLA 5%) cream and the other half will receive a placebo cream.

Conditions

Pain

Keywords

Pessary; Pain; EMLA; lidocaine; prilocaine

Outcome Measures

Primary Outcomes (1)

• VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain

  Self-reported pain intensity at time of pessary removal controlling for baseline pain. Scale is from 0 to 10 (0=no pain and 10=worst pain)

  Removal of Pessary

Secondary Outcomes (3)

• VAS Score at the Time of Pessary Removal Adjusting for Pessary Type and Investigator Training

  Removal of Pessary

• VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain and Patient Age

  Removal of Pessary

• VAS Score at the Time of Pessary Insertion Adjusting for Baseline Pain

  Insertion of Pessary

Study Arms (2)

lidocaine-prilocaine

EXPERIMENTAL

4 mL of lidocaine-prilocaine cream

Drug: lidocaine-prilocaine cream

Placebo

PLACEBO COMPARATOR

4 mL of placebo cream

Drug: Placebo cream

Interventions

lidocaine-prilocaine cream DRUG

The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point

Also known as: 5% EMLA cream

lidocaine-prilocaine

Placebo cream DRUG

The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point

Placebo

Eligibility Criteria

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

You may qualify if:

• Women in the Loyola Urogynecology clinic who use a pessary for management of pelvic organ prolapse (POP) or urinary incontinence (UI)
• Read and speak the English language

You may not qualify if:

• Non-English speaking
• Allergy or contraindication to topical anesthetic
• Participation/randomization in the study at a previous visit
• Currently pregnant or lactating or planning a pregnancy within the next 6 months

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (10)

• Nygaard I, Bradley C, Brandt D; Women's Health Initiative. Pelvic organ prolapse in older women: prevalence and risk factors. Obstet Gynecol. 2004 Sep;104(3):489-97. doi: 10.1097/01.AOG.0000136100.10818.d8.

  PMID: 15339758 BACKGROUND

• Melville JL, Katon W, Delaney K, Newton K. Urinary incontinence in US women: a population-based study. Arch Intern Med. 2005 Mar 14;165(5):537-42. doi: 10.1001/archinte.165.5.537.

  PMID: 15767530 BACKGROUND

• Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.

  PMID: 9083302 BACKGROUND

• Donnelly MJ, Powell-Morgan S, Olsen AL, Nygaard IE. Vaginal pessaries for the management of stress and mixed urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2004 Sep-Oct;15(5):302-7. doi: 10.1007/s00192-004-1163-7. Epub 2004 Aug 5.

  PMID: 15300365 BACKGROUND

• Nguyen JN, Jones CR. Pessary treatment of pelvic relaxation: factors affecting successful fitting and continued use. J Wound Ostomy Continence Nurs. 2005 Jul-Aug;32(4):255-61; quiz 262-3. doi: 10.1097/00152192-200507000-00010.

  PMID: 16030465 BACKGROUND

• Lone F, Thakar R, Sultan AH, Karamalis G. A 5-year prospective study of vaginal pessary use for pelvic organ prolapse. Int J Gynaecol Obstet. 2011 Jul;114(1):56-9. doi: 10.1016/j.ijgo.2011.02.006. Epub 2011 May 14.

  PMID: 21575953 BACKGROUND

• Keskin AE, Onaran Y, Duvan IC, Simavli S, Kafali H. Topical anesthetic (lidocaine-prilocaine) cream application before speculum examination in postmenopausal women. J Minim Invasive Gynecol. 2012 May-Jun;19(3):350-5. doi: 10.1016/j.jmig.2012.01.005. Epub 2012 Mar 13.

  PMID: 22417905 BACKGROUND

• Zilbert A. Topical anesthesia for minor gynecological procedures: a review. Obstet Gynecol Surv. 2002 Mar;57(3):171-8. doi: 10.1097/00006254-200203000-00022.

  PMID: 11889416 BACKGROUND

• Wahlgren CF, Lillieborg S. Split-skin grafting with lidocaine-prilocaine cream: A meta-analysis of efficacy and safety in geriatric versus nongeriatric patients. Plast Reconstr Surg. 2001 Mar;107(3):750-6. doi: 10.1097/00006534-200103000-00015.

  PMID: 11304601 BACKGROUND

• Taege SK, Adams W, Mueller ER, Brubaker L, Fitzgerald CM, Brincat C. Anesthetic Cream Use During Office Pessary Removal and Replacement: A Randomized Controlled Trial. Obstet Gynecol. 2017 Jul;130(1):190-197. doi: 10.1097/AOG.0000000000002098.

  PMID: 28594757 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Lidocaine, Prilocaine Drug Combination

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Limitations and Caveats

There are no limitations or caveats to report.

Results Point of Contact

• Title: Brendan Martin, Biostatistician
• Organization: Loyola University

bmartin5@luc.edu

708-216-8051

Study Officials

• Cynthia Brincat, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 5, 2015
• Study Start: July 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 23, 2017
• Results First Posted: February 23, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)