Status:
UNKNOWN
Laser Therapy for Treatment of Genitourinary Syndrome of Menopause (GSM) in Postmenopausal Women
Lead Sponsor:
University of Malaga
Collaborating Sponsors:
Antonia Maria Ruiz Moreno
María Dolores Martínez Colmena
Conditions:
Genitourinary Syndrome of Menopause
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This is a prospective, multi-centre, double blinded, randomized controlled trial, which will be conducted under a common protocol. The aim of this study is to evaluate the efficacy of vaginal laser f...
Detailed Description
The clinical data will be analysed by comparing post-treatment data with the baseline data (clinical history, compliance with selection, inclusion and exclusion requirements, assessment of the muscle ...
Eligibility Criteria
Inclusion
- Women of any age with established menopause of 5 years or more who report genitourinary discomfort, dyspareunia, sequelae, genital atrophy, voiding discomfort, voiding urgency or urinary incontinence. Postmenopausal status is defined if patients have at least 12 continuous months of amenorrhea for no other apparent reason or permanently elevated follicle-stimulating hormone (FSH) blood levels (≥30 mIU/mL).
- Patients who have had cancer treatment already completed and in the process of remission.
- Sexually active
- Nulliparous or who have had vaginal deliveries or caesarean section
- That they do not receive hormone replacement therapy in any of its routes of administration. If you received HRT, 4 months must have elapsed since stopping treatment before starting the trial protocol.
- Motivated and committed to complete the trial
Exclusion
- According to the pelvic organ prolapse quantification system \[POP-Q\], POP\>Stage 2, , severe urinary or fecal incontinence (FI) or any disease that could influence the study protocol. In addition, patients will be advised to refrain from vaginal practices for three days prior to each biopsy (one at the beginning and one at the end of treatment).
- Women who are not sexually active, do not have coital relationships, either with a partner or alone
- Women with recurrent cystitis or candidiasis
- Women with little motivation to participate in the trial
- Minors
- Patients who do not have the ability to comprehend or understand what participation in a clinical trial entail
- Patients with severe psychiatric pathology (depression, anxiety)
- Patients with degenerative neurological pathology: either cognitive impairment or ALS, MS, diabetic neuropathy, etc.
- Patients with neuropathic genital pain (neuralgia or pudendal nerve entrapment)
- Vulvodynia, hyperalgesia, or genital allodynia
- Post-pelvic surgery of less than 3 months
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2022
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT05305209
Start Date
July 1 2022
End Date
December 15 2022
Last Update
May 18 2022
Active Locations (1)
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1
University of Málaga
Málaga, Spain