Cost-Effectiveness of perioperative Vaginally Administered estrogen in postmenopausal women undergoing prolapse surgery (EVA trial): study protocol for a multicenter double-blind randomized placebo-controlled trial.

BACKGROUND: Surgery for pelvic organ prolapse (POP) is associated with high recurrence rates. The costs associated with the treatment of recurrent POP are huge, and the burden from women who encounter recurrent POP, negatively impacts their quality of life. Estrogen therapy might improve surgical outcome for POP due to its potential beneficial effects. It is thought that vaginal estrogen therapy improves healing and long-term maintenance of connective tissue integrity. Hence, this study aims to evaluate the cost-effectiveness of perioperative vaginal estrogen therapy in postmenopausal women undergoing POP surgery. METHODS: The EVA trial is a multi-center double-blind randomized placebo-controlled trial conducted in the Netherlands comparing the effectiveness and costs-effectiveness of vaginal estrogen therapy. This will be studied in 300 postmenopausal women undergoing primary POP surgery, with a POP-Q stage of ≥ 2. After randomization, participants administer vaginal estrogen cream or placebo cream from 4 to 6 weeks preoperative until 12 months postoperative. The primary outcome is subjective improvement of POP symptoms at 1 year follow-up, measured with the Patient Global Impression of Improvement (PGI-I) scale. Secondary outcomes are POP-Q anatomy in all compartments, re-interventions, surgery related complications, general and disease specific quality of life, sexual function, signs and complaints of vaginal atrophy, vaginal pH, adverse events, costs, and adherence to treatment. Follow up is scheduled at 6 weeks, 6 months and 12 months postoperative. Data will be collected using validated questionnaires and out-patient visits including gynecological examination performed by an independent gynecologist. DISCUSSION: This study investigates whether perioperative vaginal estrogen will be cost-effective in the surgical treatment of POP in postmenopausal women. It is hypothesized that estrogen therapy will show a reduction in recurrent POP symptoms and a reduction in reoperations for POP, with subsequent improved quality of life among women and cost savings. Trial registrationNetherlands Trial Registry: NL6853; registered 19-02-2018, https://www.trialregister.nl/trial/6853 . EudraCT: 2017-003144-21; registered: 24-07-2017.

A nationwide survey concerning practices in pessary use for pelvic organ prolapse in The Netherlands: identifying needs for further research.

INTRODUCTION AND HYPOTHESIS: To identify practice variation in management of patients with a vaginal pessary for pelvic organ prolapse (POP). METHODS: A nationwide survey was sent to all Dutch gynecologists with a special interest in urogynecology. RESULTS: The response rate was 59 %. Of the respondents, 13 % had a written protocol for pessary treatment in their department. Pessary treatment was proposed by 69 % of respondents as a treatment option. Counseling about side effects varied. All respondents provided information concerning the possibility of serious vaginal discharge. Concerning this side effect, 15 % of the respondents stated that it occurs in 5 - 20 % of patients, 27 % that it occurs in 20 - 40 % of patients, and 57 % that it occurs in more than 40 % of patients. Another item concerned counseling for the likelihood of vaginal blood loss. All respondents provided information concerning the possibility of vaginal blood loss. Concerning this side effect, 53 % of the respondents stated that it occurs in 5 - 20 % of patients, 33 % that it occurs in 20 - 40 %, and 14 % that it occurs in more than 40 % of patients. Follow-up after initial placement was done by 69 % of the respondents at 2 - 6 weeks, by 2 % at 8 weeks, and by 29 % at 12 weeks or more. Most (98 %) of the respondents extended the interval between visits when the patient had no complaints, and 96 % of the respondents reported that they routinely instruct patients about self-management. CONCLUSIONS: Pessaries are suggested as a treatment option by a majority of gynecologists, but practice varies widely. We consider that the variation in practice is due to a lack of available protocols and lack of evidence.

Pessary treatment for pelvic organ prolapse and health-related quality of life: a review.

Pessaries have been used to treat women with pelvic organ prolapse (POP) since the beginning of recorded history. This review aims to assess the effect of pessary treatment on the disease-specific, health-related quality of life in women with pelvic organ prolapse. After a Medline search using the Mesh term 'pessary' and critical appraisal, 41 articles were selected and used in this review. Pessaries are widely used to treat pelvic organ prolapse. It is minimally invasive and appears to be safe. Although there is evidence that the use of pessaries in the treatment of pelvic organ prolapse is effective in alleviating symptoms and that patient satisfaction is high, the follow-up in many published papers is short, and the use of validated urogynaecological questionnaires is limited. Comparison with surgical treatment of pelvic organ prolapse is rare and not assessed in a randomised controlled trial.