Diagnostics and treatment of provoked vestibulodynia

A Systematic Review

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SBU Assessment

Presents a comprehensive, systematic assessment of available scientific evidence for effects on health, social welfare or disability. Full assessments include economic, social and ethical impact analyses. Assessment teams include professional practitioners and academics. Before publication the report is reviewed by external experts, and scientific conclusions approved by the SBU Board of Directors.

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Published: Report no: 326 Registration no: SBU 2020/58 ISBN: 978-91-88437-70-9 https://www.sbu.se/326e

Conclusions

  • It is not possible to estimate the effects of pharmacological treatment for provoked vestibulodynia from scientific studies, as the certainty of evidence is very low. For the same reason, it is not possible to estimate the effects of psychological treatments (various forms of cognitive behavioral therapy and mindfulness) or surgery.
  • Multi modal physiotherapy (manual treatment, patient education, pelvic floor treatment and home exercises) may significantly reduce dyspareunia and improve sexual function, compared with topical treatment with lidocaine gel (low certainty of evidence).
  • There are no well-conducted studies on diagnostic methods for provoked vestibulodynia.
  • There is a need for well-conducted studies on treatment of provoked vestibulodynia. In particular, there is a need for studies on the effect of combined and multi professional treatments. To facilitate evidence synthesis and effect estimates, it is desirable to establish a core outcome set (an agreed set of outcomes that should be measured and reported in all clinical trials).

Several different treatments with diverse mechanisms of action were identified in the review but in most cases only one small or medium-sized study was found. This limited the possibilities to synthesize results and reach reliable conclusions about effects. Lack of evidence does not imply, however, that an intervention lacks effect, but rather that its effect has not been sufficiently researched.

The lack of evidence regarding diagnostic methods is regarded as less problematic, while a patient’s anamnesis in addition to the clinical investigation often is sufficient for an experienced clinician to confirm diagnosis.

Background

Provoked vestibulodynia (localised provoked vulvodynia) is a condition characterised by pain in the vestibular region of the vulva, present in sexual and nonsexual situations. The prevalence is highest among young women. Provoked vestibulodynia has a negative impact on the women’s sexual relations, wellbeing and quality of life.

Aim

The aim was to assess the scientific evidence for methods of diagnosing and treating provoked vestibulodynia through a systematic review. In addition, social and ethical aspects were addressed.

Method

A systematic review was conducted in accordance with the PRISMA statement. The certainty of evidence was assessed with GRADE.

Inclusion criteria:

PICO for treatment studies

Population: Women with provoked vestibulodynia in premenopausal age (study populations with up to 25% postmenopausal women were accepted).

Interventions:

  • Pharmaceutical treatment
  • Surgery
  • Physiotherapy
  • Psychological and psychosocial treatment or counselling
  • Team based/multiprofessional treatment
  • Multimodal/combined treatment
  • Other treatments

Control: No treatment, wait-list, placebo or other defined treatment.

Outcome:

  • Dyspareunia
  • Pain upon pressure or touch
  • Sexual function or satisfaction
  • Quality of life
  • Anxiety and depression
  • Adverse effects and complications

Study design: Randomised controlled trials (RCT) and non-randomised studies of interventions (NRSI) with a comparison group.

PIRO for diagnostic studies

Population: Women with provoked vestibulodynia in premenopausal age.

Intervention: All diagnostic tests and methods.

Reference test: Clinical diagnosis.

Outcome: Sensitivity and specificity.

PICO for diagnostic studies

Population: Women with provoked vestibulodynia in premenopausal age.

Intervention: All diagnostic tests and methods.

Control: No diagnostic test or another diagnostic test.

Outcome: Positive and negative effects of the test.

Language:

English, Swedish, Norwegian or Danish.

Search period:

From 1990 to 2021. Final search January 2021.

Databases searched:

CINAHL (EBSCO), Cochrane Library (Wiley), Embase (Elsevier), Ovid (MEDLINE), PsycINFO (EBSCO) and Scopus (Elsevier). 

In addition, the following sources were searched for systematic reviews used for information:

International HTA database, CRD Database (including HTA Database, DARE, NHS EED), Epistemonikos, Evidence search (NICE), KSR Evidence and PROSPERO.

Client/patient involvement:

Yes.

Results

No eligible studies on diagnostic methods with low or moderate risk of bias were identified in the assessment.

Regarding treatment methods, 24 studies with low or moderate risk of bias were identified that investigated 26 unique comparisons of interventions (Table 1).

Table 1 Overview of treatment methods that are included in the assessment. 
CBT = Cognitive Behavioral Therapy; NRSI = Non-Randomised Studies of Interventions; RCT = Randomised Controlled Study; TENS = Transcutaneous Electric Nerve Stimulation
Treatment form Intervention Comparison Number of studies, study design Number of study participants
Pharmacological treatment, oral Gabapentin Placebo 1 RCT 89
Desipramine Placebo 1 RCT 65
Desipramine + lidocaine Placebo 1 RCT 67
Palmitoylethanolamide+ transpolydatine Placebo 1 RCT 20
Pharmacological treatment, topical Nifedinpine Placebo 1 NRSI 50
Fibroblast lysate Placebo 1 RCT 30
Lidocaine Placebo 1 RCT 66
Estrogen Placebo 1 RCT 20
Diazepam Placebo 1 RCT 42
Cromolyn Placebo 1 RCT 34
Pharmacological treatment, injection Botulinum toxin Placebo 3 RCT 174
Enoxaparin Placebo 1 RCT 38
Physiotherapy EMG biofeedback Lidocaine 1 RCT 46
Traditional acupuncture Non-traditional acupuncture 1 RCT 19
Multimodal physiotherapy Lidocaine 1 RCT 212
TENS Sham treatment 1 RCT 20
Psychological treatment Group CBT Hydrocortisone 1 RCT 87
Group CBT Biofeedback or vestibulectomy (3-arm) 1 RCT 97
Mindfulness-based cognitive therapy CBT 1 NRSI 47
CBT Physiotherapy 1 RCT 20
Mindfulness-based CBT Education support 1 RCT 31
Other treatments Low-level laser therapy Sham treatment 1 RCT 34
Transcranial direct-current stimulation Sham treatment 1 RCT 40
Shock wave therapy Sham treatment 1 RCT 34

Ethical and Social Aspects

The uncertainty regarding the effects of treatments for provoked vestibulodynia makes it difficult to help affected patients. This is unfortunate as the condition not only causes pain but also has psychosocial consequences. According to a previous Swedish report, patients have experienced difficulties in gaining access to investigation and treatment, and they do not always feel that they are taken seriously by the care staff. It is therefore important to improve the knowledge about provoked vulvodynia for healthcare professionals who meet women with the condition.

Conflicts of Interest

In accordance with SBU’s requirements, the experts and scientific reviewers participating in this project have submitted statements about conflicts of interest. These documents are available at SBU’s secretariat. SBU has determined that the conditions described in the submissions are compatible with the experts’ participation in the project.

The full report in Swedish

The full report in Swedish Diagnostik och behandling av provocerad vulvodyni

Scientific article

Bohm-Starke N, Ramsay KW, Lytsy P, Nordgren B, Sjöberg I, Moberg K, et al. Treatment of Provoked Vulvodynia: A Systematic Review. The Journal of Sexual Medicine. Available from: https://doi.org/10.1016/j.jsxm.2022.02.008.

Project group

Experts 

  • Nina Bohm Starke
  • Ida Flink
  • Birgitta Nordgren
  • Inga Sjöberg

SBU

  • Karin Wilbe Ramsay (Project Manager)
  • Per Lytsy 
  • Maria Ahlberg
  • Klas Moberg

Flow Chart

Figure 1 Flow Chart

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