Fractional CO2 Laser Therapy Versus 4% Topical Lidocaine Gel for Dyspareunia in Breast Cancer Survivors

NCT03257670 | Unknown FDA Device

• 1 other identifier: UC Laser
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This trial seeks to determine if therapy with a CO2 laser to the vagina is more effective than lidocaine to the opening of the vagina before intercourse to reduce painful intercourse in women who are breast cancer survivors. This study will also be looking at whether or not the CO2 laser improves pelvic floor function, bowel and bladder function, and sexual function before and after treatment.

Conditions

Dyspareunia

Keywords

Dyspareunia; Laser; CO2; Breast Cancer; Vaginal Atrophy; Lidocaine

Outcome Measures

Primary Outcomes (1)

• Female Sexual Function Index (FSFI) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.

  The Female Sexual Function Index (FSFI) is a survey instrument used to determine the level of sexual function or dysfunction in females. It is comprised of a 19 item questionnaire focused on sexual functioning. There are six domains assessed: desire, arousal, lubrication, orgasm, satisfaction, and pain. The subject is to consider each of the questions in the context of the previous 4 weeks. The scores of each of the domains are then calculated into a final score. Initial and follow-up assessments will allow comparisons across this instrument as well as all the secondary and other pre-specified outcome measures.

  9 months

Secondary Outcomes (7)

• Numeric Pain Rating Scale (NPRS) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.

  9 months

• Incontinence Severity Index (ISI) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.

  9 months

• 3 Incontinence Questions (3-IQ) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.

  9 months

• Colon Rectal Anal Distress Inventory (CRADI) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.

  9 months

• Patient Global Impression of Severity (PGI-S) score before treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.

  9 months

Other Outcomes (1)

• Symptom inventory (number of voids/day, pads/day, etc.)

  9 months

Study Arms (2)

CO2RE Laser

ACTIVE COMPARATOR

This group will undergo vaginal CO2 laser therapy for a total of three (3) treatments with one month between treatments.

Device: CO2RE fractional laser therapy

4% Topical Lidocaine Gel

ACTIVE COMPARATOR

This group will be given 4% topical lidocaine gel to take home. The patient will apply the 4% lidocaine gel to the outside and opening of the vagina for 3 minutes before vaginal penetration. The patient will continue using the numbing gel prior to vaginal penetration for the extent of the study (3 months).

Drug: 4% Topical Lidocaine Gel

Interventions

4% Topical Lidocaine Gel DRUG

This group will be given 4% topical lidocaine gel to take home. The patient will apply the 4% lidocaine gel to the outside and opening of the vagina for 3 minutes before vaginal penetration. The patient will continue using the numbing gel prior to vaginal penetration for the extent of the study (3 months).

4% Topical Lidocaine Gel

CO2RE fractional laser therapy DEVICE

This group will undergo vaginal CO2 laser therapy for a total of three (3) treatments with one month between treatments.

CO2RE Laser

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Subjects must be female who have undergone treatment for breast cancer that have dyspareunia secondary to the treatment they received for breast cancer.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects included must be female breast cancer survivors over the age of 18, sexually active (at least 4 episodes of sexual intercourse per month), and find intercourse painful. Subjects must also be English speaking and able to give informed consent.

You may not qualify if:

• Subjects will be excluded if pregnant, has not had breast cancer, does not have painful intercourse secondary to treatment received for their breast cancer, is not English speaking, or lacks the ability to sign informed consent.

Sponsors & Collaborators

• University of Cincinnati: lead
• Syneron Candela: collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

Related Publications (18)

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MeSH Terms

Conditions

Dyspareunia; Breast Neoplasms

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• James L Whiteside, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James L Whiteside, MD

CONTACT

513-475-8713; whitesje@ucmail.uc.edu

Carson T Kaeser, MD

CONTACT

513-475-8713; carson.kaeser@thechristhospital.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Subjects will be randomized to two treatment cohorts (each with 35 patients): (1) treatment with the CO2RE laser or; (2) treatments of 4% aqueous lidocaine applied to the vulvar vestibule for 3 minutes before vaginal penetration. Both cohorts will have four follow-up assessments following initiation of treatment: (1) One-week post treatment initiation; (2) 1-month post treatment initiation; (3) 3-months post treatment initiation and; (4) 6-months post laser-only treatment initiation. At the 3-month assessment, subjects in the lidocaine arm will be allowed to try the CO2RE laser therapy. In doing this, an imbedded crossover trial is included that will allow assessment of subject decision-satisfaction between the two therapy approaches. The primary outcome will be the overall and lubrication, satisfaction, and pain domain scores on the Female Sexual Function Index instrument. Secondary outcomes will be other validated pain and pelvic floor symptom instruments.

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: August 22, 2017
• Study Start: March 20, 2018
• Primary Completion: January 1, 2022
• Study Completion: June 1, 2022
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)