Dyspareunia
Conditions
Keywords
dyspareunia, radiofrequency, postpartum pain, perineal massage, episiotomy
Brief summary
This study evaluates if the application of resistive capacitive monopolar radiofrequency therapy associated with Thiele massage is effective when treating de novo dyspareunia at 4 to 12 months postpartum.
Detailed description
Dyspareunia is a type of genito-pelvic pain (GPP) that takes place during vaginal penetration at some point in sexual intercourse. It greatly affects quality of life as well as psychological and sexual wellbeing. A delivery with episiotomy, perineal tearing or labor dystocia using forceps or vacuum, are risk factors that contribute to the appearance of de novo dyspareunia with a prevalence of 17-45% at 6 months postpartum. There is no evidence in the scientific literature of the effect of radiofrequency is this group of patients, however there is a clinical trial that describes the effect in scar tissue although not in the perineum. It is for all of the above that the following project is proposed, to evaluate the effect of RF in perineal healing and vaginal trigger points caused as a consequence of GPP. The main objective of this study is to evaluate the role that radiofrequency (RF) plays in reducing the level of pain in de novo dyspareunia in postpartum women that persists from 4 to 12 months.
Interventions
DEVICEResistive Capicitive Monopolar Radiofrequency
5 Radiofrequency sessions including the abdominal region, the vulva and pelvic floor tissue and Thiele massage done daily by the patient at home
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* 4-12 postpartum * de novo dyspareunia after delivery * obstetric injury * Grant informed consent
Exclusion criteria
* radiofrequency contraindications (pacemaker, active infection or pregnancy) * cesarean section * dyspareunia previous to labour * previous vulvo-vaginal pathology * patients with postpartum depression * patients with a pelvic region oncological history * patients with a history of pelvic trauma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of the baseline Level of pain during penetration and after 5 sessions | Baseline and after 7 weeks | Using the Visual Analogue Scale (VAS), where 10 is the highest level of pain possible and 0 is no pain at all. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of the baseline Sexual function and after 5 sessions | Baseline and after 7 weeks | Using the Female Sexual Function Index (FSFI), where higher scores indicate higher degrees of sexual functioning of a total of 36 points (and lower pain). |
| Change of the baseline muscle pain points and after 5 sessions | Baseline and after 7 weeks | A physical evaluation held by the physical therapist seeking for pain points and asking the patient to score the amount of pain using the visual analogue scale (VAS) where 10 is the highest level of pain possible and 0 is no pain at all. |
| Change in Pelvic floor dysfunctions in the baseline assesment and after 5 sessions | Baseline and after 7 weeks | Using the Pelvic Floor Distress Inventory-20 questionnaire (PFDI-20), in which the higher the score the greater the perceived impact that the pelvic floor dysfunction has on the patient's life (range 0 to 300 points). |
| Change of the baseline affection on the quality of life and after 5 sessions | Baseline and after 7 weeks | Using the EuroQuality of life-5D (EQ5D),where the maximum score of 1 indicates the best health state and therefore, higher scores indicate more severe or frequent problems (range from 0 to 10) |
Countries
Spain
Outcome results
None listed