TY - JOUR
T1 - Pessary or surgery for a symptomatic pelvic organ prolapse
T2 - the PEOPLE study, a multicentre prospective cohort study
AU - van der Vaart, L. R.
AU - Vollebregt, A.
AU - Milani, A. L.
AU - Lagro-Janssen, A. L.
AU - Duijnhoven, R. G.
AU - Roovers, J. P. W. R.
AU - van der Vaart, C. H.
N1 - Funding Information: This study was funded by ZonMW, a Dutch governmental healthcare organisation. This organisation finances healthcare research and stimulates the use of the knowledge developed to improve care and health. This study was funded on 26 June 2014 (project no. 837002525). Funding Information: The PEOPLE project was initiated to compare the effectiveness of pessary and surgery in women with symptomatic POP, and includes a non‐inferiority randomised controlled trial (RCT) and this observational cohort study. While recruitment for the RCT was continuing, many women expressed strong preferences in treatment choice and, as a consequence, refused to participate in the RCT. Therefore, we set up this observational cohort alongside the RCT. This study was performed in 22 Dutch hospitals. The project was funded by ZonMw, a Dutch organisation for innovation and research in health care and was approved by the Medical Ethical Committee of the University Medical Centre Utrecht (UMCU). Publisher Copyright: © 2021 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.
PY - 2021
Y1 - 2021
N2 - Objective: To compare the 24-month efficacy of pessary or surgery as the primary treatment for symptomatic pelvic organ prolapse (POP). Design: Multicentre prospective comparative cohort study. Setting: Twenty-two Dutch hospitals. Population: Women referred with symptomatic POP of stage ≥2 and moderate-to-severe POP symptoms. Methods: The primary outcome was subjective improvement at the 24-month follow-up according to the Patient Global Impression of Improvement (PGI-I) scale. Secondary outcomes included improvement in prolapse-related symptoms measured with the Pelvic Floor Distress Inventory (PFDI-20), improvement in subjective severeness of symptoms according to the Patient Global Impression of Severity (PGI-S) scale and crossover between therapies. The primary safety outcome was the occurrence of adverse events. Main outcome measure: PGI-I at 24 months. Results: We included 539 women, with 335 women (62.2%) in the pessary arm and 204 women (37.8%) in the surgery arm. After 24 months, subjective improvement was reported by 134 women (83.8%) in the surgery group compared with 180 women (74.4%) in the pessary group (risk difference 9.4%, 95% CI 1.4–17.3%, P < 0.01). Seventy-nine women (23.6%) switched from pessary to surgery and 22 women (10.8%) in the surgery group underwent additional treatment. Both groups showed a significant reduction in bothersome POP symptoms (P ≤ 0.01) and a reduction in the perceived severity of symptoms (P ≤ 0.001) compared with the baseline. Conclusions: Significantly more women in the surgery group reported a subjective improvement after 24 months. Both therapies, however, showed a clinically significant improvement of prolapse symptoms. Tweetable abstract: Pessary treatment and vaginal surgery are both efficacious in reducing the presence and severity of prolapse symptoms, although the chance of significant improvement is higher following surgery.
AB - Objective: To compare the 24-month efficacy of pessary or surgery as the primary treatment for symptomatic pelvic organ prolapse (POP). Design: Multicentre prospective comparative cohort study. Setting: Twenty-two Dutch hospitals. Population: Women referred with symptomatic POP of stage ≥2 and moderate-to-severe POP symptoms. Methods: The primary outcome was subjective improvement at the 24-month follow-up according to the Patient Global Impression of Improvement (PGI-I) scale. Secondary outcomes included improvement in prolapse-related symptoms measured with the Pelvic Floor Distress Inventory (PFDI-20), improvement in subjective severeness of symptoms according to the Patient Global Impression of Severity (PGI-S) scale and crossover between therapies. The primary safety outcome was the occurrence of adverse events. Main outcome measure: PGI-I at 24 months. Results: We included 539 women, with 335 women (62.2%) in the pessary arm and 204 women (37.8%) in the surgery arm. After 24 months, subjective improvement was reported by 134 women (83.8%) in the surgery group compared with 180 women (74.4%) in the pessary group (risk difference 9.4%, 95% CI 1.4–17.3%, P < 0.01). Seventy-nine women (23.6%) switched from pessary to surgery and 22 women (10.8%) in the surgery group underwent additional treatment. Both groups showed a significant reduction in bothersome POP symptoms (P ≤ 0.01) and a reduction in the perceived severity of symptoms (P ≤ 0.001) compared with the baseline. Conclusions: Significantly more women in the surgery group reported a subjective improvement after 24 months. Both therapies, however, showed a clinically significant improvement of prolapse symptoms. Tweetable abstract: Pessary treatment and vaginal surgery are both efficacious in reducing the presence and severity of prolapse symptoms, although the chance of significant improvement is higher following surgery.
KW - Global improvement
KW - pelvic organ prolapse
KW - pessary
KW - surgery
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85117886035&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/34559932
U2 - https://doi.org/10.1111/1471-0528.16950
DO - https://doi.org/10.1111/1471-0528.16950
M3 - Article
C2 - 34559932
SN - 1470-0328
JO - BJOG
JF - BJOG
ER -