Study design, Setting and Population
We performed a prospective, non-pharmacologic, non-profit, monocentric interventional study. This pilot study was conducted on women who delivered and were admitted to the postpartum ward of Mangiagalli Center High risk Obstetric Unit - Ospedale Maggiore Policlinico Milano between 8th January to 8th August 2023.
Each consecutive Wednesday, we recruited patients who suffered either a spontaneous laceration and/or an episiotomy at delivery. Exclusion criteria were presence of clinical signs and /or symptoms of infection of the suture, pregestational or gestational diabetes under pharmacologic therapy, autoimmune diseases, other diseases that could interfere with the process of wound healing.
One hundred and seventy-two women were eligible for this study. Fifty-two women accepted to participate to this pilot study with TMR device (registered trademark Diapason by Thereson®). One hundred and twenty declined to participate to the treatment but accepted standard care, and follow-up according to the same schedule as those treated by TMR.
Treatment with TMR device required two sessions per day for 15 days. During the treatment, patients were lying down on the body emitter mat, while the local, smaller therapy emitter mat was positioned on the lower abdomen to cover the pubic bones and pelvis. Each treatment consisted of two phases, for a total of 32 minutes. During the first phase (“Local phase”), which lasted 16 minutes, the intensity ranged between 150–250 µT, and the electromagnetic fields were focused on the pelvic area. During the second phase (“Total phase”), which also lasted 16 minutes, three different intensities at different locations were provided, to allow systemic delivery of electromagnetic fields. Upon discharge form the Hospital, patients were provided with a TMR device to perform the treatment at home. Standard care was based on perineal hygiene with the addition of a topic spray until complete healing of the suture.
Patients were visited one day post-partum, before starting the treatment; then a follow-up visit was performed at three weeks (time 1), five weeks (time 2), and three months (time 3) after delivery.
To determine the status of the wound before the treatment, one day post-partum, and to assess the progression of healing at the three- and five-weeks follow-ups, we assigned to each patient a score, based on the REEDA scale (45) (Table 1), which can be used to assess all types of postpartum perineal trauma.
Table 1
The parameters of the REEDA scale
| Redness | Edema | Ecchymosis | Discharge | Approximation |
0 | None | None | None | None | None |
1 | Within 0.25 cm of the incision bilaterally | Perineal, less than 1 cm of the incision | Within 0.25 cm bilaterally or 0.5 cm unilaterally | Serous | Skin separation 3 mm or less |
2 | Within 0.5 cm of the incision bilaterally | Perineal and/or 1 to 2 cm from the incision | Between 0.25 to 1 cm bilaterally or between 0.5 to 2 cm unilaterally | Sero-sanguineous | Skin and subcutaneous fat separation |
3 | Beyond 0.5 cm of the incision bilaterally | Perineal and/or vulvar, greater than 2 cm from the incision | Greater than 1 cm bilaterally or 2 cm unilaterally | Bloody, purulent | Skin, subcutaneous fat and fascial layer separation |
At the three -and five-weeks follow-up visits, in addition to the healing progression, we also evaluated other possible complications and complaints, such as urinary discomfort and urinary leakage, infections, suture dehiscence, and fistulas.
At three months after delivery, patients were contacted via e-mail to answer the FSFI (Female Sexual Function Index) questionnaire (46, 47) (Table 2). This questionnaire collects self-reported answers on six sexual domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) and can provide a key to interpreting Female Sexual Dysfunctions. The total score is a sum of each domain score, ranging from 2 to 36 (Table 3), where a score below 26.5 is a good indicator of sexual dysfunction (48).
Table 2
The FSFI questionnaire adapted to the postpartum
Questions | Answers |
1- Over the months following childbirth, how often did you feel sexual desire or interest? | a. Almost always or always b. Most times (more than half the time) c. Sometimes (about half the time) d. A few times (less than half the time) e. Almost never or never |
2- Over the months following childbirth, how would you rate your level (degree) of sexual desire or interest? | a. Very high b. High c. Moderate d. Low e. Very low or none at all |
3- Over the months following childbirth, how often did you feel sexually aroused (“turned on”) during sexual activity or intercourse? | a. No sexual activity b. Almost always or always c. Most times (more than half the time) d. Sometimes (about half the time e. A few times (less than half the time) f. Almost never or never |
4- Over the months following childbirth, how would you rate your level of sexual arousal (“turn on”) during sexual activity or intercourse? | a. No sexual activity b. Very high c. High d. Moderate e. Low f. Very low or none at all |
5- Over the months following childbirth, how confident were you about becoming sexually aroused during sexual activity or intercourse? | a. No sexual activity b. Very high confidence c. High confidence d. Moderate confidence e. Low confidence f. Very low or no confidence |
6- Over the months following childbirth, how often have you been satisfied with your arousal (excitement) during sexual activity or intercourse? | a. No sexual activity b. Almost always or always c. Most times (more than half the time) d. Sometimes (about half the time e. A few times (less than half the time) f. Almost never or never |
7- Over the months following childbirth, how often did you become lubricated (“wet”) during sexual activity or intercourse? | a. No sexual activity b. Almost always or always c. Most times (more than half the time) d. Sometimes (about half the time e. A few times (less than half the time) f. Almost never or never |
8- Over the months following childbirth, how difficult was it to become lubricated (“wet”) during sexual activity or intercourse? | a. No sexual activity b. Extremely difficult or impossible c. Very difficult d. Difficult e. Slightly difficult f. Not difficult |
9- Over the months following childbirth, how often did you maintain your lubrication (“wetness”) until completion of sexual activity or intercourse? | a. No sexual activity b. Almost always or always c. Most times (more than half the time) d. Sometimes (about half the time e. A few times (less than half the time) f. Almost never or never |
10- Over the months following childbirth, how difficult was it to maintain your lubrication (“wetness”) until completion of sexual activity or intercourse? | a. No sexual activity b. Extremely difficult or impossible c. Very difficult d. Difficult e. Slightly difficult f. Not difficult |
11- Over the months following childbirth, when you had sexual stimulation or intercourse, how often did you reach orgasm (climax)? | a. No sexual activity b. Almost always or always c. Most times (more than half the time) d. Sometimes (about half the time e. A few times (less than half the time) f. Almost never or never |
12- Over the months following childbirth, when you had sexual stimulation or intercourse, how difficult was it for you to reach orgasm (climax)? | a. No sexual activity b. Extremely difficult or impossible c. Very difficult d. Difficult e. Slightly difficult f. Not difficult |
13- Over the months following childbirth, how satisfied were you with your ability to reach orgasm (climax) during sexual activity or intercourse? | a. No sexual activity b. Very satisfied c. Moderately satisfied d. About equally satisfied and dissatisfied e. Moderately dissatisfied f. Very dissatisfied |
14- Over the months following childbirth, how satisfied have you been with the amount of emotional closeness during sexual activity between you and your partner? | a. No sexual activity b. Very satisfied c. Moderately satisfied d. About equally satisfied and dissatisfied e. Moderately dissatisfied f. Very dissatisfied |
15- Over the months following childbirth, how satisfied have you been with your sexual relationship with your partner? | a. No sexual activity b. Very satisfied c. Moderately satisfied d. About equally satisfied and dissatisfied e. Moderately dissatisfied f. Very dissatisfied |
16- Over the months following childbirth, how satisfied have you been with your overall sexual life? | a. No sexual activity b. Very satisfied c. Moderately satisfied d. About equally satisfied and dissatisfied e. Moderately dissatisfied f. Very dissatisfied |
17- Over the months following childbirth, how often did you experience discomfort or pain during vaginal penetration? | a. Did not attempt intercourse b. Almost always or always c. Most times (more than half the time) d. Sometimes about half the time) e. A few times (less than half the time) f. Almost never or never |
18- Over the months following childbirth, how often did you experience discomfort or pain following vaginal penetration? | a. Did not attempt intercourse b. Almost always or always c. Most times (more than half the time) d. Sometimes about half the time) e. A few times (less than half the time) f. Almost never or never |
19- Over the months following childbirth, how would you rate your level (degree) of discomfort or pain during or following vaginal penetration? | a. Did not attempt intercourse b. Very high c. High d. Moderate e. Low f. Very low or none at all |
Table 3
Interpretation of the FSFI score
Domain | Items | Score range | Factor | Min score | Max score |
Desire | 1, 2 | 1–5 | 0.6 | 1.2 | 6 |
Arousal | 1, 3, 4, 5, 6, | 0–5 | 0.3 | 0 | 6 |
Lubrication | 7, 8, 9, 10 | 0–5 | 0.3 | 0 | 6 |
Orgasm | 11, 12, 13 | 0–5 | 0.4 | 0 | 6 |
Satisfaction | 14, 15, 16 | 1–5 | 0.4 | 0.8 | 6 |
Pain | 17, 18, 19 | 0–5 | 0.4 | 0 | 6 |
Scale range | 2 | 36 |
The main endpoint of the study was the time required for complete healing of the laceration and/or the episiotomy. Secondary endpoints were the prevalence of dehiscence, infections, urinary discomfort, urinary leakage, and the quality of restoration of sexual function.
Statistical analysis
Descriptive statistics were used to summarize selected baseline characteristics of intervention and control group. Categorical data were presented as absolute frequencies and percentages, while quantitative data were expressed as mean and standard deviation. Differences in categorical variables between the two groups were tested by using Fisher’s test. Continuous variables were compared by using the t-test for independent samples.
The REEDA scores obtained from women in the treatment and control groups one day, three weeks, and five weeks postpartum were expressed as medians and interquartile range, and differences were tested by Kruskal-Wallis. The frequencies of selected adverse outcomes were reported separately according to treatment, and Fisher's test was used to assess differences between the two groups. Finally, results from the FSFI questionnaire were reported as both categorical (i.e. ≤ 26.5 and > 26.5) and continuous scores (expressed as median and IQR). Differences were tested with Fisher’s test and Kruskal-Wallis test.