Quality of life after treatment by vaginal pessary versus surgery in symptomatic pelvic organ prolapsed patients

Panjapong S1, Temtanakitpaisan T1, Buppasiri P1, Chongsomchai C1

Research Type

Clinical

Abstract Category

Quality of Life / Patient and Caregiver Experiences

Abstract 603
Quality of Life and Health Delivery
Scientific Podium Short Oral Session 39
On-Demand
Quality of Life (QoL) Pelvic Organ Prolapse Questionnaire Prolapse Symptoms
1. Faculty of Medicine, Khon Kaen University
Presenter
S

Supakit Panjapong

Links

Abstract

Hypothesis / aims of study
Pelvic organ prolapse (POP) is the downward descent of one or more compartments of vagina and uterus into vagina or protrude through hymen. It is a benign condition causes vaginal bulge, pelvic pressure, voiding dysfunction, defecatory dysfunction and sexual dysfunction.[1] Symptomatic prolapse has a negative impact on quality of life. Age, parity, vaginal delivery, obesity, connective tissue diseases, chronic constipation and menopausal status are the risk factors developing POP.[1] 
Beside expectant management for treating the symptomatic prolapse, vaginal pessary is the non-surgical option to relieve the pelvic organ prolapse symptoms and considered to be offered before surgery.[2] 
Patients’ preference plays a potential role to select the choice of treatment after receiving the counselling from the physicians.[2] 
Prolapse surgery comprised of correcting all affected vaginal compartments to restore the vaginal anatomy as well as the surrounding visceral organ which technique was operated by physicians’ discretion and expertise.[3] 
The aim of the study was to evaluate and compare the effectiveness of vaginal pessaries and surgery among women with symptomatic pelvic organ prolapse after 3 and 6 months using validated prolapse quality of life (P-QOL) questionnaire and satisfaction score after treatment.
Study design, materials and methods
This is a prospective observational study comparing the quality of life score after treatment between pelvic organ prolapsed patients who opted pessary versus surgery. After the ethics committee was approved and informed consent was obtained, the data were collected from an urogynecology clinic at the tertiary hospital between January 2018 and August 2020. The inclusion criteria were women with age 18 years or more, prolapse stage II or more (POP-Q system) and had been treated with vaginal pessary or surgery. Patients who did not understand Thai language were excluded.
The Prolapse Quality of Life (P-QOL) questionnaire in Thai version was used at before treatment, 3 months and 6 months after treatment. Moreover, satisfaction score using visual analog scale was also used at 3 moths and 6 months after treatment.
Based on the pilot study, the mean difference + SD after treatment with pessary was 23.50 + 31.68 and 36.8 + 42.85 in surgery. We assumed 80% power, p-value <0.05 and mean difference more than 25 points for detect statistically significant and found sample size were 40 patients per arm.

Statistical analysis was performed using STATA/SE version 10.1. Normality testing was conducted using Kolmogorov-Smirnov testing. The descriptive data were presented as percentages, means, and medians. The t-test, chi-square, Fisher’s exact and Mann-Whitney U test were used as appropriate to compare between pessary and surgical groups. Generalized estimating equation (GEE) was used comparing the mean difference of QoL score between two groups. p-values of <0.05 were considered statistical significance.
Results
Eighty patients were prospectively recruited in the study. Forty patients in pessary group (50%) and another forty patients in surgery group (50%). We enrolled patients by determining the number of patients in the same stage. The data were collected during the follow-up period. Contacting by phone in case of loss to follow-up. Therefore, no missing data in our study. Thirty-nine patients (97.5%) in pessary group fitted with support pessaries, while only one (2.5%) fitted with space occupying pessary. There were two surgical routes to restore pelvic floor anatomy in our study that is vaginal approach in 31 patients (77.5%) and laparoscopic approach in 9 patients (22.5%).
The mean age + SD was 65.7 + 7.7 years. The mean BMI + SD and menopausal status were 24.9 + 3.7 kg/m2 and 96.3%, respectively. There was no statistical difference between pessary and surgery groups regarding age, BMI, parity, menopausal status, underlying diseases and POP-Q stage. 
The P-QOL score at baseline before treatment in each group as shown in Table1. Patients with treated symptomatic prolapse adversely affected the disease in general health perceptions, prolapse impact, role limitations, physical limitations, emotions and severity measures domains. After treatment either pessary or surgery, all P-QOL domains significantly improved at 3 months and 6 months except personal relationships and sleep/energy domains in the pessary group that had not different from baseline (Table2). When compared between two groups, general health perception and sleep/energy domains were significantly improved in the surgery group. The mean + SD of satisfaction score after treatment in pessary and surgery at 3 months and 6 months were 8.9 + 1.4 and 9.3 + 1.0 (p=0.509), 9.4 + 1.2 and 9.3 +1.1 (p=1.000), respectively.
Interpretation of results
The quality of life in symptomatic prolapsed patients after treatment significantly improved in quality of life from P-QOL questionnaire. However, personal relationships and sleep/energy domains in the pessary group had not significantly improved from baseline might be due to patients need to remove the pessary during night time to prevent complications regarding pessary use. Moreover, when compared between two groups, general health perception and sleep/energy domains were significantly improved in the surgery group. All symptomatic prolapsed patients extremely satisfied after treatment both pessary and surgery.
Concluding message
The quality of life in symptomatic prolapsed patients after treatment appeared apparently improved in quality of life from P-QOL questionnaire. General health perception and sleep/energy domains were significantly improved in the surgery group compared with the pessary group. All symptomatic prolapsed patients extremely satisfied after treatment both pessary and surgery.
Figure 1
Figure 2
References
  1. Pelvic Organ Prolapse. Female Pelvic Med Reconstr Surg. 2017;23:353–64.
  2. Bodner-Adler B, Bodner K, Stinglmeier A, Kimberger O, Halpern K, Koelbl H, et al. Prolapse surgery versus vaginal pessary in women with symptomatic pelvic organ prolapse: which factors influence the choice of treatment? Arch Gynecol Obstet. 2019;299:773–7.
  3. Pelvic Organ Prolapse. Female Pelvic Med Reconstr Surg. 2017;23:353–64.
Disclosures
Funding None Clinical Trial Yes Public Registry No RCT No Subjects Human Ethics Committee The institutional review board of The Khon Kaen University Ethics Committee on Human Research Helsinki Yes Informed Consent Yes
02/05/2024 07:17:08