None listed
Conditions
Brief summary
Executive Summary – The symptom of vaginal laxity or looseness is a common problem effecting anywhere from 24% to 50% of parous women(1,2). It is frequently underreported(1,2). Till recently, the only treatment options for this condition have included physiotherapy or surgery. Both are known to have inconclusive results. Additionally, surgical treatment remains largely diverse in technique with no strong literature suggesting it is effective. Also, risks associated with surgery often don’t make it an amiable choice for younger women who are more likely to be affected by this symptom and potentially considering future pregnancy. Recently, monopolar radiofrequency devices have shown some promising impact on the symptom of vaginal laxity(3, 4). More importantly, they are a low risk option in comparison to surgery. Therefore, we propose to perform a single blinded, randomized sham controlled trial at the Townsville Hospital. The trial will compare treatment with The Thermiva to sham treatment. The study will take place over a period of 24 months. Patients in the treatment and sham group will undergo the same study protocol. There will be an enrolment visit followed by three treatments at one month apart. Follow-up will be at the third treatment and at six and twelve months’ post treatment. According to our sample size calculation we need to recruit 168 patients (84 in the treatment and 84 in the sham group). We will be using the Thermiva monopolar radiofrequency device which is TGA approved and currently being used in Australia for the management of symptoms of vaginal laxity. We will be using the same Thermiva probe for the sham treatments however, will be operating it at sub therapeutic temperatures (at or below 30 degrees Celsius). The temperature suggested to optimal treatment is 47 degrees Celsius. For the Sham will be use 20 degrees Celsius. We will be obtaining HREC approval from The Townsville Hospital prior to commencement of the study. 1. Krychman M, Rowan CG, Allan BB, DeRogatis L, Durbin S, Yacoubian A, et al. Effect of Single-Treatment, Surface-Cooled Radiofrequency Therapy on Vaginal Laxity and Female Sexual Function: The VIVEVE I Randomized Controlled Trial. The Journal of Sexual Medicine. Elsevier; 2017 Feb;14(2):215–25. 2. Dietz HP, Stankiewicz M, Atan IK, Ferreira CW, Socha M. Vaginal laxity: what does this symptom mean? International Urogynecology Journal. Springer London; 2017 Jul 31;23(5):1435–6. 3. Magon N, Alinsod R. ThermiVa: The Revolutionary Technology for Vulvovaginal Rejuvenation and Noninvasive Management of Female SUI. J Obstet Gynaecol India. Springer India; 2016 Aug;66(4):300–2. 4. MD MK, PhD CGR, C BBAMPF, PhD LD, MPH SD, BSc AY, et al. Effect of Single-Treatment, Surface-Cooled Radiofrequency Therapy on Vaginal Laxity and Female Sexual Function: The VIVEVE I Randomized Controlled Trial. The Journal of Sexual Medicine. Elsevier Inc; 2017 Feb 1;14(2):215–25.
Interventions
Thermiva is a TGA approved device being utilised for the management of various vulvovaginal disorders including vaginal laxity. The Thermiva is a monopolar radiofrequency device which consists of a small generator, a probe and a grounding pad. The active aspect of the probe is only thumbprint sized and constant movement of the probe allows for tissue cooling to occur. Although, the optimal temperature is 47 degrees Celsius, feedback from the patient determines the maximum temperature achieved. A
Thermiva is a TGA approved device being utilised for the management of various vulvovaginal disorders including vaginal laxity. The Thermiva is a monopolar radiofrequency device which consists of a small generator, a probe and a grounding pad. The active aspect of the probe is only thumbprint sized and constant movement of the probe allows for tissue cooling to occur. Although, the optimal temperature is 47 degrees Celsius, feedback from the patient determines the maximum temperature achieved. Automated feedback from the machine prevents the clinician from reaching an unsafe temperature range. The device can be moved faster to reduce temperature and more slowly to increase it. Treatment for the trial will include internal (vaginal canal) and external (labial) treatment. Internal treatment will target each quadrant of the vagina for 2 minutes and bilateral labia for 2 minutes each. The ThermiVA group and placebo group will undergo the same treatment regimens. The only difference being in the placebo group sub therapeutic temperature of maximum 30 degrees Celsius will be maintained. Generally, patients receive a new probe at each visit. However, in our pilot study we have used one probe per patient. The probe is cleaned after each treatment (it does not need sterilisation) and given to the patient to bring back at subsequent treatments. Patients will undergo three treatments at one month intervals. The intervention will be delivered by an experienced Obstetrician and Gynecologist Fellow who has previous experience in delivering Thermiva treatment. The intervention will occur at a specialised Thermiva clinic at the Townsville Hospital.
Sponsors
Dr Sapna Dilgir
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
· Women who complain of vaginal laxity (or looseness) · Women greater than or equal to age of 18 · Patients able to and willing to give consent · History of at least one vaginal delivery
Exclusion criteria
· Any contraindication to radiofrequency including (women with cardiac devices, pregnancy, active sexually transmitted disease or urinary tract infections) · Women with a greater than or equal to Stage II prolapse · Women with body dysmorphic disorder · Women with a history of a recto-vaginal fistula · Non-English speaking background · Patients unable to follow-up for a period of 12 months’ post-treatment · Abnormal HPV DNA test and subsequent abnormal liquid based cytology · Abnormal uterine bleeding · Patients undergoing physiotherapy or surgical treatment for the management of their vaginal laxity
Outcome results
None listed