Dataset Information

Pessary or surgery for a symptomatic pelvic organ prolapse: the PEOPLE study, a multicentre prospective cohort study.

ABSTRACT:

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.

SUBMITTER: van der Vaart LR

PROVIDER: S-EPMC9298049 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:To describe pelvic organ prolapse surgical success rates using a variety of definitions with differing requirements for anatomic, symptomatic, or re-treatment outcomes.Eighteen different surgical success definitions were evaluated in participants who underwent abdominal sacrocolpopexy within the Colpopexy and Urinary Reduction Efforts trial. The participants' assessments of overall improvement and rating of treatment success were compared between surgical success and failure for each of the definitions studied. The Wilcoxon rank sum test was used to identify significant differences in outcomes between success and failure.Treatment success varied widely depending on definition used (19.2-97.2%). Approximately 71% of the participants considered their surgery "very successful," and 85.2% considered themselves "much better" than before surgery. Definitions of success requiring all anatomic support to be proximal to the hymen had the lowest treatment success (19.2-57.6%). Approximately 94% achieved surgical success when it was defined as the absence of prolapse beyond the hymen. Subjective cure (absence of bulge symptoms) occurred in 92.1% while absence of re-treatment occurred in 97.2% of participants. Subjective cure was associated with significant improvements in the patient's assessment of both treatment success and overall improvement, more so than any other definition considered (P<.001 and <.001, respectively). Similarly, the greatest difference in symptom burden and health-related quality of life as measured by the Pelvic Organ Prolapse Distress Inventory and Pelvic Organ Prolapse Impact Questionnaire scores between treatment successes and failures was noted when success was defined as subjective cure (P<.001).The definition of success substantially affects treatment success rates after pelvic organ prolapse surgery. The absence of vaginal bulge symptoms postoperatively has a significant relationship with a patient's assessment of overall improvement, while anatomic success alone does not.II.

Project description:BackgroundWomen living in resource constrained settings often have limited knowledge of and access to surgical treatment for pelvic organ prolapse. Additionally, little is known about experiences during recovery periods or about the reintegration process for women who do gain access to medical services, including surgery. This study aimed to explore women's experiences related to recovery and reintegration after free surgical treatment for pelvic organ prolapse in a resource-constrained setting.MethodsThe study had a qualitative design and used in-depth interviews in the data collection with a purposive sample of 25 participants, including 12 women with pelvic organ prolapse. Recruitment took place at the University of Gondar Hospital, Ethiopia, where women with pelvic organ prolapse had been admitted for free surgical treatment. In-depth interviews were carried out with women at the hospital prior to surgery and in their homes 5-9 months following surgery. Interviews were also conducted with health-care providers (8), representatives from relevant organizations (3), and health authorities (2). The fieldwork was carried out in close collaboration with a local female interpreter.ResultsThe majority of the women experienced a transformation after prolapse surgery. They went from a life dominated by fear of disclosure, discrimination, and divorce due to what was perceived as a shameful and strongly prohibitive condition both physically and socially, to a life of gradually regained physical health and reintegration into a social life. The strong mobilization of family-networks for most of the women facilitated work-related help and social support during the immediate post-surgery period as well as on a long-term basis. The women with less extensive social networks expressed greater challenges, and some struggled to meet their basic needs. All the women openly disclosed their health condition after surgery, and several actively engaged in creating awareness about the condition.ConclusionsFree surgical treatment substantially improved the health and social life for most of the study participants. The impact of the surgery extended to the communities in which the women lived through increased openness and awareness and thus had the potential to ensure increased disclosure among other women who suffer from this treatable condition.

Project description:IntroductionPelvic organ prolapse (POP) is the descent of pelvic organs into the vagina resulting in bulge symptoms and occurs in approximately 50% of women. Almost 20% of women will elect surgical correction of this condition by age 85. Removal of the uterus (hysterectomy) with concomitant vaginal vault suspension is a long-standing practice in POP surgery to address apical (uterine) prolapse. Yet, contemporary evidence on the merits of this approach relative to preservation of the uterus through suspension is needed to better inform surgical decision making by patients and their healthcare providers. The objective of this study is to evaluate POP-specific health outcomes and service utilisation of women electing uterine suspension compared with those electing hysterectomy and vaginal vault suspension for POP surgery up to 1-year postsurgery.Methods and analysisThis is a prospective cohort study planning to enrol 321 adult women with stage ≥2 POP from multiple sites in Alberta, Canada. Following standardised counselling from study surgeons, participants self-select either a hysterectomy based or uterine preservation surgical group. Data are being collected through participant questionnaires, medical records and administrative data linkage at four time points spanning from the presurgical consultation to 1-year postsurgery. The primary outcome is anatomic failure to correct POP, and secondary outcomes include changes in positioning of pelvic structures, retreatment, subjective report of bulge symptoms, pelvic floor distress and impact, sexual function and health service use. Data will be analysed using inverse probability weighting of propensity scores and generalised linear models.Ethics and disseminationThis study is approved by the Conjoint Health Research Ethics Board at the University of Calgary (REB19-2134). Results will be disseminated via peer-reviewed publications, presentations at national and international conferences, and educational handouts for patients.Trial registration numberNCT04890951.