QoL as a major endpoint of efficacy of surgical treatment genital prolapse and LUTS in women

Tryfonyuk L1, Milinevsky V1, Trokhymovich R1, Pavlukovich N2, Nader M3, Protsepko O3

Research Type

Clinical

Abstract Category

Quality of Life / Patient and Caregiver Experiences

Abstract 191
Open Discussion ePosters
Scientific Open Discussion Session 11
Thursday 8th September 2022
16:25 - 16:30 (ePoster Station 6)
Exhibition Hall
Quality of Life (QoL) Pelvic Organ Prolapse Prolapse Symptoms Retrospective Study Female
1. Rivne Regional Hospital, Rivne, Ukraine, 2. Bukovinian State Medical University, Chernivtcy, Ukraine, 3. National Pirogov Memorial Medical University, Vinnytsya, Ukraine
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Abstract

Hypothesis / aims of study
Pelvic organ prolapse is one of the most pressing problems in modern medicine affecting women of all ages. The disease often begins in reproductive age and is progressive. As the process develops, functional disorders are aggravated, which often overlap each other, cause not only physical and moral suffering but also making patients partially or completely disabled. So far, according to the literature, there is a high-frequency development of relapses of genital prolapse (5–40%) and dissatisfaction with functional
results of operations. At the present stage of development of medicine, the quality of medical care and patient satisfaction have come to the fore. Correction of an anatomical defect during reconstructive plastic correction of genital prolapse (GP) may not be enough. For the patient, the most important outcome of treatment, in addition to anatomical recovery, is the elimination and/or alleviation of symptoms and an improvement in quality of life. Anatomical evaluation does not provide information on the degree of symptom relief after surgery.
Study design, materials and methods
The prospective study included women with GP at the age of 489 patients aged 32 to 86 years with symptomatic GP II and above stage (POP-Q), requiring surgical intervention from 2015 to 2019. In order to assess the impact of the reconstructive and plastic correction of GP on the quality of life, special questionnaires were used: The Perceived Quality of Life (P-QOL), Questionnaire Pelvic Floor Inventory-20 (PFDI-20),  Pelvic Floor Impact Inventory-7 (PFIQ-7) and Urogenital Distress Inventory (UDI-6) before surgery and 1, 3, 6 and 12 months after surgery. The responses range from ‘none/not at all’ through ‘slightly/a little’ and ‘moderately’ to ‘a lot’. A four-point scoring system for each item was used to measure the severity of the urogenital prolapse symptoms. Combined score is calculated for this questionnaire too. If a woman has only one affected life domain and another woman has another affected domain, they are both considered symptomatic, though in different aspects of QoL. In order to assess the course of the late postoperative period and determine the effectiveness of surgical treatment, the patients were invited to a dispensary examination (questionnaire and examination) after 1, 6 and 12 months. To assess the quality of life of patients, statistical significance was calculated using the Fisher-Student method, a p value < 0.05 was considered significant. In addition, depending on the method of surgical correction of ROP, group I was divided into: IA - 279 women who underwent ROP correction with synthetic materials, Group II - 211 women who underwent own tissues correction. According to the age of the patient, each of the groups was additionally divided into subgroups: persons of reproductive age 25-45 years - Ia, IIa; persons of perimenopausal age - 46-56 years - subgroup Ib, IIb and subgroup Ic, IIc were women of postmenopausal age (56-86 years).
Results
Group I of women is additionally for analysis divided by us into conditional subgroups according to the type of operations performed by them: women who underwent a “Manchester operation” using a simultaneous operation of hysterectomy with Birch colposuspension; who underwent plastic of the anterior and posterior walls of the vagina; and with the additional performance of levatoroplasty and perineoplasty. Research group II used synthetic materials for reconstructive of only anterior prolapse or total reconstructive at the same time or using TVT synthetic tape. The purpose of surgical treatment was to restore the normal architectonics of the pelvic floor, taking into account not only anatomical but also functional relationships. The choice of method and extent of surgical treatment of genital prolapse depended on the severity and form of genital prolapse, the presence of diseases of the uterus and ovaries, the desire to maintain reproductive function, the somatic status of patients, concomitant extragenital pathology requiring surgical correction, impaired urination and defecation, and also sexual activity. Intraoperative blood loss in 303 operated patients did not exceed 100 ml, and in 186 it was from 100 to 300 ml. The duration of the operation varied from 25 to 95 minutes. The length of stay of patients in the hospital was 2–5 days. Analyzed I group in terms of LUTS, 54% of women had urinary incontinence, 61% had urge incontinence, 49% had increased voiding frequency, 71% had obstructive urination, and 29% had a combination of symptoms. A statistically significant difference was noted for the analysis of functional results and evaluation of POP symptoms at 6 months when compared with the figures before surgical treatment: PFDI-20 159,1/15,7 (р<0,01), POPDI-6 73,8/12,5 (р<0,01), UDI-6 82/10,2 (р<0,01). Analyzed II group in terms of LUTS, 41% of women had urinary incontinence, 59% had urge incontinence, 27% had increased voiding frequency, 22% had obstructive urination, and 38% had a combination of symptoms. A statistically significant difference was noted for the analysis of functional results and evaluation of POP symptoms at 6 months when compared with the figures before surgical treatment: PFDI-20 162,1/15,9 (р<0,01), POPDI-6 74,9/12,4 (р<0,01), UDI-6 89/10,4 (р<0,01). In addition, patients were also separately asked after 12 months whether they would recommend surgery to other people with symptoms of prolapse, and received 86.5% of positive answers among all examined patients.
Interpretation of results
Indicators of physical and psychological health in women living with GP are quite reduced. Surgical correction of GH significantly improves these components of health in all categories of physical functioning, bodily pain, physical health, general health, vitality, social activity, emotional condition and mental health. Moreover, the psychological component of health improves already 3 months after the operation (p<0.05), and the physical one - 6 months after the operation (p<0.05) and both improves after 12 month (p<0.05).
POP in generally negative affects the quality of life of women leading to physical, social, psychological, family and sexual restrictions in each ages. Prior to selecting the therapeutic modality of POP, it is necessary to evaluate the subjective indicators of quality of life, since it is the resolution of the lower urinary tract symptoms and improvement of the quality of life after treatment that is the treatment efficacy criterion for patients. As a subjective indicator evaluation, validated clinical questionnaires and quality of life assessment questionnaires should be used.
Concluding message
A differentiated approach to surgical correction of pelvic organ prolapse, taking into account complaints and clinical picture in patients of different age groups allows to increase efficacy and safety of known treatments. Three groups were diagnosed
with improvement of functional results and anatomical outcomes, including long-term ones, which greatly improves the quality
women's lives and compliance. Mesh implants improve surgical outcomes treatment in patients with gross defects of the pubocervical fascia, in the presence of incontinence urine, operations using uroslings are effective. That native tissue repair of POP effectively improves in reproductive group patient’s symptoms, body image QoL, and patient satisfaction is high. More than 90% of patients reported better conditions compared to the preoperative situation, and approximately 85% out of all reconstructive patients achieved significantly better P-QoL over a 6-month follow-up. These results could be used in patient counseling to determine whether to undergo surgical treatment for POP and monitor the patient-centered effect of POP surgery.  Access to surgical services for disadvantaged patients and patients from low-cost countries may be important to choose the method of surgical treatment to improve QoL, and long-term studies evaluating anatomical and functional outcomes of reconstructive pelvic surgery are also recommended in different age groups.
References
  1. Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Brown J. Surgery for women with anterior compartment prolapse. Cochrane Database Syst Rev. 2016;11:4014
  2. Sayer T., Lim J., Gauld J. M. et al. Prosima Study Investigators. Medium-term clinical outcomes following surgical repair for vaginal prolapse with tension-free mesh and vaginal support device // Int. Urogynecol. J. — 2012. — Vol. 23 (4). —P. 487–93
  3. Maher CF, Baessler KK, Barber MD, Cheon C, Consten ECJ, Cooper KG, et al. Summary: 2017 international consultation on incontinence evidence-based surgical pathway for pelvic organ prolapse. Female Pelvic Med Reconstr Surg. 2018.
Disclosures
Funding no Clinical Trial No Subjects None
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