CompletedNot Applicable

RCT of Laser Therapy for GSM

United Kingdom88 participantsStarted 2018-07-01

Plain-language summary

The aim of the current study is to assess whether the CO2-laser results in superior alleviation of GSM symptoms compare to Er:YAG-laser. Specifically, we will compare objective and subjective measurements of symptoms and clinical signs of GSM, between groups of postmenopausal women with GSM receiving treatment with CO2-laser or Er:YAG-laser.

Who can participate

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Dryness and dyspareunia with moderate to severe intensity
✓. Vaginal Health Index \<15
✓. Absence of menstruation for at least 12 months
✓. Recent Negative Pap-smear test (For women over 65 years old a negative pap smear test up to the age of 65).

Exclusion criteria

✕. Not willing to abstain from vaginal intercourse for one week following the laser-therapy
✕. Use of hormonal therapy within 6 months prior to study inclusion (systemic or local)
✕. Acute urinary tract infections (UTIs)
✕. History of a genital fistula, a thin recto-vaginal septum as determined by the investigator or history of a fourth-degree laceration during screening physical exam (e.g., perineal body)
✕. Active sexually transmitted disease upon vaginal exam (as determined by the investigator) that precludes treatment or any other vaginal infection
✕. Active or history of genital herpes
✕. Prolapse stages \> II (according to the POP-Q system)
✕. History of radiotherapy for cervical or uterine cancer

What they're measuring

Dryness - 10cm visual analogue scale

Timeframe: 1 year

Dyspareunia- 10cm visual analogue scale

Timeframe: 1 year

Itching- 10cm visual analogue scale

Timeframe: 1 year

Burning- 10cm visual analogue scale

Timeframe: 1 year

Dysuria- 10cm visual analogue scale

Timeframe: 1 year

Frequency- 10cm visual analogue scale,

Timeframe: 1 year

Urgency-10cm visual analogue scale

Timeframe: 1 year

Urinary incontinence- 10cm visual analogue scale

Timeframe: 1 year

Overall sexual satisfaction- Female sexual function index

Trial details

NCT IDNCT03288883

SponsorKing's College Hospital NHS Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-02-11

View on ClinicalTrials.gov More Genitourinary Syndrome of Menopause trials

Plain-language summary

Who can participate

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Dryness and dyspareunia with moderate to severe intensity
✓. Vaginal Health Index \<15
✓. Absence of menstruation for at least 12 months
✓. Recent Negative Pap-smear test (For women over 65 years old a negative pap smear test up to the age of 65).

Exclusion criteria

✕. Not willing to abstain from vaginal intercourse for one week following the laser-therapy
✕. Use of hormonal therapy within 6 months prior to study inclusion (systemic or local)
✕. Acute urinary tract infections (UTIs)
✕. History of a genital fistula, a thin recto-vaginal septum as determined by the investigator or history of a fourth-degree laceration during screening physical exam (e.g., perineal body)
✕. Active sexually transmitted disease upon vaginal exam (as determined by the investigator) that precludes treatment or any other vaginal infection
✕. Active or history of genital herpes
✕. Prolapse stages \> II (according to the POP-Q system)
✕. History of radiotherapy for cervical or uterine cancer

What they're measuring

Dryness - 10cm visual analogue scale

Timeframe: 1 year

Dyspareunia- 10cm visual analogue scale

Timeframe: 1 year

Itching- 10cm visual analogue scale

Timeframe: 1 year

Burning- 10cm visual analogue scale

Timeframe: 1 year

Dysuria- 10cm visual analogue scale

Timeframe: 1 year

Frequency- 10cm visual analogue scale,

Timeframe: 1 year

Urgency-10cm visual analogue scale

Timeframe: 1 year

Urinary incontinence- 10cm visual analogue scale

Timeframe: 1 year

Overall sexual satisfaction- Female sexual function index