None listed
Conditions
Brief summary
The aim of this study is to evaluate the use of Er:YAG laser treatment as a potential treatment for women with slight to severe stress urinary inconctinence. We hypothesize that Er:YAG Laser is superior to sham therapy in women who have slight to severe stress urinary incontinence, based on the Severity Index for Urinary Incontinence in women, with subjective improvement rates defined as a Minimal Important Difference (MID) of 4 points on the ICIQ-UI-SF questionnaire.
Interventions
If happy to participate, they will have their urine tested for infection (dipstick urinalysis) and pregnancy. If urinalysis is negative, they will be receiving laser or sham treatment as outlined. The whole appointment lasts approximately 30 minutes. The patient can return to most normal activities immediately but should refrain from intercourse for 2 weeks and vigorous exercise for 1 week. They will be given a leaflet outlining what to expect and a contact number if they have any concerns or
If happy to participate, they will have their urine tested for infection (dipstick urinalysis) and pregnancy. If urinalysis is negative, they will be receiving laser or sham treatment as outlined. The whole appointment lasts approximately 30 minutes. The patient can return to most normal activities immediately but should refrain from intercourse for 2 weeks and vigorous exercise for 1 week. They will be given a leaflet outlining what to expect and a contact number if they have any concerns or questions. They will be asked about any deleterious effects since their last appointment and asked to complete an ICIQ-UI-SF; UDI-6; PGI-I and PASS questionnaire (treatment 2 onwards). Patients will routinely receive 3 treatments. Each treatment can be 6 weeks apart (+/- 14 days) (ie. from 1 -2 months apart). The treatment protocol using the three phase IntimaLase protocol with glass speculum will be following the standard parameters by the manufacturer: Three non-ablative Er:YAG IncontiLase® treatments applied by a doctor of the research team at monthly intervals. The IncontiLase® protocol consists of three steps: 1. Intravaginal laser pulses with a directed angular, patterned laser beam (PS03-GAc, 7 mm, 6 J/cm2, 2.0 Hz, seven pulses, six positions, one pass per position) 2. Intravaginal laser pulses with a circular full laser beam (R11-GCc, 7 mm, 3 J/cm2, 2.0 Hz, seven pulses, two passes) 3. Laser pulses of vestibule and introitus with a straight, patterned laser (PS03, 7 mm, 10 J/cm2, 1.6 Hz, two to three pulses, two to three passes, 10% overlapping) The total duration of the treatment: 20 min/session. Treatment complication and discomfort evaluation will be performed after each treatment. Participants will be asked if they would recommend this treatment to a friend as a proxy for treatment acceptability. Patients will be invited to attend a follow up visit 3, 6 and 12 months after the 3rd treatment. They will be asked if they are happy to continue to participate in the trial and if happy, asked to complete Severity Index, ICIQ-SF, UDI-6, PGI-I and PASS symptom questionnaires and undergo a clinical examination to ensure the tissues are healthy. At 6 months after treatment, the patients will be asked if they reconsider retreatment and what treatment they got in their opinion. They will receive a transperineal ultrasound and will be asked to perform a 1 hour pad test at 3, 6 and 12 months. perform Patients randomised to the Sham arm will be un-blinded at 6 months and offered the three treatments if they wish.
Sponsors
Anna Rosamilia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Adult Female, 18 years of age or older • Slight to severe stress urinary incontinence, based on the Severity Index for Urinary Incontinence in women. • No significant improvement in urinary incontinence from at least one previous conservative treatment, such as pelvic floor muscle training • Capable of providing informed consent and able to return for follow-up. • Normal Cervical screening test within last five years
Exclusion criteria
• Very severe stress urinary incontinence, based on the Severity Index for Urinary Incontinence in women. • Diagnosis of OAB wet, based on UDI-6, question 2 “urine leakage related to the feeling of urgency” – answer “Moderately OR Greatly”. • Presence of vesicovaginal fistula • Fecal incontinence • Pregnant subjects or women less than 12-months post-partum • Actively breastfeeding or ceased breastfeeding less than three menstrual cycles • Any previous prolapse surgery • Any previous incontinence surgery • Any radical pelvic surgery • Transvaginal mesh or sling implant • Pre-existing bladder pathology including prior radiation treatment. • Previous surgery in the treatment area in the last year. • Active genital infection • Subject presenting with a cervical screening test demonstrating cervical dysplasia or another reason for colposcopic assessment • Systemic steroids use within the last 3 months • Pelvic organ prolapse (POP) > stage 2 according to pelvic organ prolapse quantification system • Diagnosis of collagen disorders eg. Benign joint hypermobility/Ehlers-Danlos/Marfan etc. • Serious systemic disease or any chronic condition that could interfere with study compliance. • Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety. • Other contraindications to laser treatment: UTI, injury or bleeding in areas of tissue to be treated (vestibule and anterior vaginal wall), Morbid obesity (BMI>40), Diabetes, A history of Photosensivity disorder or use of photosensitivity medications, abnormal scarring, excessive sun exposure, preoperative histology findings indicative of malignancy. • Unwillingness or inability to complete follow-up schedule • Unwillingness or inability to give Informed Consent
Outcome results
None listed