Ten nulliparous women with PVD, median age 21 (18 to 33), participated in this feasibility study. The sociodemographic and clinical characteristics of the participants are presented in Table 2. Seven of the women reported different comorbidities including jaw pain, muscle pain and twitching, anal pain, endometriosis, headache, migraine, fibromyalgia, irritable bowel syndrome and alopecia areata. Overall, the women were physically active, exercising from one to three times per week for 30–60 minutes at moderate to high intensity levels. Only one reported never exercising. At baseline, four subjects were on oral contraceptives; one on cerazette, one on marvelon and two on oralcon. In terms of concurrent drug use all participants reported to have tried topical lidocaine. At baseline, six patients used topical lidocaine on a weekly to daily basis. In addition, one participant was on systemic treatment with amitriptyline, another on levothyroxine and one on diclofenac.
Table 2
Sociodemographic and clinical characteristics of ten women with provoked vestibulodynia
Characteristics | Participants n = 10 |
Age (yrs.), median (Q1; Q3) | 21 (20; 26) |
Pain duration (yrs.), median (Q1; Q3) | 7 (3; 8) |
Primary PVD | 7 |
Relationship category | |
Married/common law | 2 |
In a relationship | 2 |
Single | 6 |
Childbirth | 0 |
Intercourse past 4 weeks | 2 |
Education category | |
High school student | 1 |
Undergraduate student | 7 |
Completed bachelor's degree | 2 |
Work category | |
Student | 9 |
Part time work | 5 |
Full time work | 1 |
Unemployed | 0 |
Participants with comorbidities | 7 |
BMI, median (Q1; Q3) | 23 (20; 23) |
Results of feasibility outcomes
Recruitment rate
Eighteen women were found eligible for participation, and ten women contacted the primary investigator and agreed to take part in the study. Ten participants were recruited over 11 weeks from the Vulva Clinic, achieving a recruitment rate of 0.9 participants per week. Recruitment was stopped when the targeted sample of ten participants was reached.
Follow-up rate
No participants were lost to follow-up. All the participants completed the SCT intervention and all partook at all measurement time points up until the eight months follow-up.
Adherence to assessment procedures
Overall adherence to the battery of self-report questionnaires was excellent, with all participants completing all the self-reported questionnaires at all three time points. In terms of adherence to the tampon tests across the three measurement time points, 81 out of 90 tampon tests were completed (90%). At baseline, there were nine full tampon test sets. Post treatment there were eight full tampon test sets and at the eight months follow-up there were six full tampon test sets. For the 14-day diary there were six full data sets at baseline, three post-treatment and two at the eight months follow-up. Regarding adherence to the bi-weekly forms about received treatments, two women did not record any of the SCT treatments, however all the other treatments received were recorded.
Evaluation of the tampon test as the primary outcome measure
Evaluation of the tampon test is reported in a separate paper (46). We concluded that the test may be suboptimal as a primary outcome measure in PVD research. The tampon test data demonstrated large intra- and inter-individual variability, furthermore the test seems to underestimate severity of pain in some women with PVD. Out of ten women with PVD, four of the women had an NRS score that was equal to, or below four, whilst concurrently reporting high levels of pain during sexual intercourse. Participants with low pain scores would be excluded from studies where the tampon test is part of the trial eligibility criteria, even though severe pain was experienced during sexual intercourse. Several women also reported in the interviews that they experienced the test as an inadequate measure of their problem (46).
Reporting of adverse events
There were no adverse events reported, i.e. no participants were pulled out of the study because SCT was considered as an inappropriate treatment. All participants turned up for their scheduled appointments and completed the intervention.
Results of secondary outcomes
Implementation and acceptability of somatocognitive therapy
In this study the participants received a median number of 12 sessions. The SCT was personalized, hence the number of treatments delivered varied from seven up to a maximum of 15 sessions. In the original protocol, we stipulated that treatment duration would last for up to ten weeks. In this study, the treatment course lasted a minimum of 13 weeks and a maximum of 22 weeks. The frequency of the treatment delivery varied as it was personalized to the individual’s needs. Patients communicated to the therapist that they needed time to practice home assignments and incorporate what they had learnt into their ADL. Frequency of treatment was also influenced by external factors such as study and work commitments, exams, and holidays.
Half of the participants were content with the number of treatment sessions received and felt ready to continue by themselves when the treatment period ended. The other half reported that they would have preferred a slightly longer treatment period. Several found it more difficult to keep motivated to prioritize their recovery process when their progress was no longer monitored by the therapist. P8: “Immediately after the treatment period ended it felt a bit tough. You receive such close guidance, and then you are suddenly alone with it again. I found it a bit difficult to keep my motivation up”. Most felt they would have benefited from one or two follow-up sessions a few months later, for repetition, motivation and guidance on how to move forward. P3: “Perhaps it could have been possible with a follow-up session six months later, in case things should get worse or you need some repetition, or when things have just been a little too much.”
Participants’ perceived effect of SCT
The GPE scale was used to provide quantitative estimation of participants’ perceived effect of the treatment measured directly after treatment and at eight months follow-up. Directly after treatment three women reported to be very much better, four reported to be much better and three reported a little better. At eight months follow-up one participant reported to be very much better, six participants reported much better, two reported a little better and one reported no change.
Participants’ experiences with the intervention
All participants expressed positive experiences with the SCT approach. They found it useful to learn techniques for deep breathing, relaxation, and self-management, as well as developing more constructive ways of thinking about and relating to their pain and sexuality. The participants largely expressed beliefs that PVD is complex and multidimensional in nature. They found it meaningful to combine physical and psychological aspects, and not exclusively focus on the painful vulvar area. P3: “I feel that somatocognitive therapy is more focused on the long-term recovery process. That it is easier to get lasting results when you not only treat the local muscles or problem area, but also include everything else around”. Furthermore, the importance of taking responsibility for their own recovery process was expressed by P6: “It makes so much sense that this is what I have to do. Not just talk about it and not just receive massage here or there. I have to make an active effort. Breathe. I have to relax”. Three participants however (P2, P7 and P9), felt the intervention would have benefitted from a specific focus on the vulvar area, including manual techniques to release tensions in the pelvic floor muscles. Most of the participants however, appreciated the gentle and desensitizing approach to the vulva. Several women also expressed that the encouragement to explore their own vulvas had helped them develop a more positive way of relating to this area. P4: I feel like I have made great improvements as before my vulva felt very unfamiliar, I just didn´t want to think about it. But now I actually feel that I have developed a completely different way of thinking about it and how it also is about being less afraid of the area”.
The secondary aim of this study was to evaluate if SCT intervention had the potential to improve sexual function and reduce pain, pain catastrophizing and psychological distress. The women improved on all the outcome measures from baseline to post treatment, with a slight deterioration of the effect at the eight months follow-up. Table 3 includes all the measurements and number of participants who had experienced intercourse in the past four weeks, at the three time points.
Table 3
Measurements at baseline, post-treatment and 8 months follow-up (n = 10), (none lost to follow-up)
| Pre-treatment | Post-treatment | 8 months follow-up |
Tampon test NRS (0–10), median (Q1; Q3) | 4.5 (2.5; 6) | 2 (1.5; 4.2) | 3.5 (1.8; 4.5) |
Intercourse past 4 weeks, n | 2 | 6 | 7 |
FSFI, median (Q1; Q3) | | | |
Total sum (0–36) | 14.8 (9.8; 19.8) | 22.8 (15.8; 25.4) | 20.9 (18; 27.1) |
Desire | 2.1 (1.6; 3.2) | 3.6 (2.3; 3.8) | 3.6 (2.7; 4.3) |
Arousal | 3.2 (1.6; 4.9) | 4.4 (2.7; 5.7) | 4.4 (3.0; 5.6) |
Lubrication | 4.2 (2.9; 5.2) | 4.8 (3.5; 5.8) | 4.7 (3.6; 6.0) |
Orgasm | 3.2 (0.9; 5.3) | 4.8 (2.6; 5.3) | 4.8 (1.2; 5.2) |
Satisfaction | 0.8 (0.4; 2.0) | 4.2 (1.1; 5.2) | 3.8 (1.2; 5.3) |
Pain | 0.0 (0.0; 0.3) | 1.8 (0.0; 3.6) | 2.0 (0.0; 3.6) |
PCS (0–52), median (Q1; Q3) | 20 (15.3; 29.3) | 9.5 (5.3; 20) | 12.5 (6.3; 22) |
HSCL-25, median (Q1; Q3) | 2.0 (1.7; 2.5) | 1.6 (1.3; 2.4) | 1.8 (1.6; 2.2) |
NRS: Numerical Rating Scale; (higher scores indicate more pain) FSFI: Female Sexual Function Index (higher scores indicate better sexual function); PCS: Pain Catastrophizing Scale (higher scores indicate higher levels of catastrophizing; HSCL-25: Hopkins Symptom Check List − 25 (higher scores indicate higher levels of psychological distress). |