Pelvic organ prolapse (POP) is a common condition and affects approximately 50% of women who deliver vaginally (Gyhagen et al, 2013). A feeling of a vaginal bulge is the most commonly reported symptom; however, difficulty in opening bowels, urinary incontinence, backache and sexual pain are also common presenting symptoms (Haylen et al, 2016).
Management options for POP consist of pelvic floor exercises, pessary insertion and surgery. It is customary to offer less invasive options first (Manonai et al, 2018).
A pessary is a device made of silicone or plastic that is placed in the vagina to achieve anatomical correction and reduction of prolapse for symptomatic relief. Once inserted, a pessary remains in situ for 4–6 months and is replaced at follow up provided the recipient has no complications (Lough et al, 2018). The use of a pessary for POP is extremely common, and according to a Cochrane database review, around 77% of physicians offer a pessary as first-line management (Bugge et al, 2013). A pessary is a safe and effective conservative treatment option, relieves almost half of all symptoms and has a beneficial effect on quality of life for affected women (Mao et al, 2018).
The offer of pessary to the patient, however, has been shown to vary with the case load of the surgeon. Surgeons with a higher case load are more likely to offer a pessary to women and perform a standardised preoperative evaluation that would include an assessment for urinary incontinence (Pulliam et al, 2016).
Since hysterectomy is a major surgery with a significant complication rate an offer of a conservative option seems worthwhile. We undertook this study to assess the documentation of pessary counselling in women who underwent surgery for POP.
Methods
This was a retrospective cohort study conducted from January 2017 to December 2018. Consent for use of hospital records was taken from the unit head. Case records of all women who underwent vaginal hysterectomy for POP were compiled and analysed. Women who had any other surgical procedure (ie anterior or posterior repair, Manchester repair, suspension procedures), but no hysterectomy for prolapse, were excluded. Also excluded were women who were advised to have a hysterectomy, but refused or did not have a hysterectomy at the facility. Women who had a third-degree prolapse or procidentia, and women who used a pessary as an interim measure while awaiting surgery, were also excluded. All women were offered the ring pessary, which is customary in local practice and provided free of cost at the facility. Documentation regarding the offer of a pessary was noted. ‘Pessary offer’ was defined as documentation that clearly stated that the care provider offered a pessary to the patient, that was declined, not tolerated or had failed prior to surgery. Patient information leaflets and a designated team involving a lead clinician, a nurse and three student nurses led the counselling session for the use of a pessary. A leaflet was provided at the end of the session. However, this session was only given when the patients were referred by the attending doctor's clinic.
A proforma was used to collect data. Sociodemographic data included age, height and weight of the woman, educational status, age of marriage, marital status, number of children. Past medical and surgical history was also included. Any concomitant procedure or secondary indication for surgery other than POP was also noted. The pessary offer for all cases was also assessed from each record.
Data were entered and analysed using SPSS version 15. Frequency and percentages were calculated for the qualitative variables: age range; body mass index (BMI); educational status; age of marriage; number of children; sexual activity; chronic cough; prior pelvic surgery; and concomitant procedures that formed secondary indications for surgery (anterior and posterior repair). The outcome variable was documentation of pessary offer. Effect modifiers were controlled through stratification of age range, BMI, educational status, age of marriage, marital status, number of children, chronic cough, prior pelvic surgery, concomitant procedure and secondary indication of surgery in order to see their effect on outcome variable. A bivariate analysis was conducted to test for a possible association between the dependent variable and the independent variables. The Pearson chi-squared test was used to assess associations between variables for an alpha error of 5%.
Ethical approval
The study used data records of patients who underwent surgery for pelvic prolapse. The hospital does not have a formal ethical review committee, but the principles of the Helsinki Declaration were followed. Data were coded and confidentiality was ensured. The Head of the hospital granted permission for the study.
Results
Over the study period, 230 hysterectomies were performed in the unit. Of these, 81 hysterectomies took place for POP and were included in the analysis. Hysterectomies for POP constituted 32.4% of all hysterectomies. Table 1 summarises the study population characteristics. The medical, surgical and sexual history is summarised in Table 2.
| Characteristic | Total number (%) |
|---|---|
| Age range | |
| 45-49 | 5 (6.2) |
| 50–54 | 8 (9.9) |
| 55–59 | 24 (29.6) |
| 60–64 | 19 (23.5) |
| >65 | 25 (30.9) |
| BMI | |
| <30 | 66 (81.5) |
| >30 | 15 (18.5) |
| Educational status | |
| illiterate | 47 (58.0) |
| literate | 34 (42.0) |
| Marital status | |
| Unmarried | 3 (3.7) |
| Married | 55 (67.9) |
| Divorced | 12 (14.8) |
| Widowed | 11 (13.6) |
| Length of time married | |
| <20 | 5 (6.2) |
| 20–30 | 45 (55.6) |
| >30 | 31 (38.3) |
| Number of children | |
| 1–2 | 13 (16.0) |
| 3–5 | 64 (79.0) |
| >5 | 4 (4.9) |
BMI=body mass index
| Characteristics | Total number (%) |
|---|---|
| Chronic cough | |
| No | 51 (63) |
| Previous pelvic surgery | |
| No | 63 (77.8) |
| Yes | 18 (22.2) |
| Secondary indication for surgery | |
| No | 53 (65.4) |
| Yes | 28 (34.6) |
| Other concomitant surgery performed | |
| No | 48 (59.3) |
| Yes | 33 (40.7) |
| Sexual activity | |
| Not active | 44 (54.3) |
| Active | 37 (45.7) |
| Documentation of a pessary offer | |
| No | 62 (76.5) |
| Yes | 19 (23.5) |
Characteristics significantly associated with pessary offer were history of chronic cough (P=0.031), previous pelvic surgery (P<0.001), no secondary indication for surgery (P=0.012), concomitant surgery performed other than hysterectomy (P=0.046), age range (P<0.001) and BMI range (P<0.001) (Table 3).
| Characteristics | Documentation of pessary Number (%) | P value | |
|---|---|---|---|
| No | Yes | ||
| Chronic cough | |||
| No | 43 (69.4) | 8 (42.1) | 0.031* |
| Yes | 19 (30.6) | 11 (57.9) | |
| Previous pelvic surgery | |||
| No | 57 (91.9) | 6 (31.6) | <0.001* |
| Yes | 5 (8.1) | 13 (68.4) | |
| Secondary indication for sugery | |||
| No | 36 (58.1) | 17 (89.5) | 0.012* |
| Yes | 26 (41.9) | 2 (10.5) | |
| Other concomitant surgery performed | |||
| No | 33 (53.2) | 15 (78.9) | 0.046* |
| Yes | 29 (46.8) | 4 (21.1) | |
| Age range | |||
| 45–49 | 2 (3.2) | 3 (15.8) | <0.001* |
| 50–54 | 7 (11.3) | 1 (5.3) | |
| 55–59 | 23 (37.1) | 1 (5.3) | |
| 60–64 | 18 (29.0) | 1 (5.3) | |
| >65 | 12 (19.4) | 13 (68.4) | |
| BMI | |||
| <30 | 57 (91.9) | 9 (47.4) | <0.001* |
| >30 | 5 (8.1) | 10 (52.6) | |
| Educational status | |||
| Illiterate | 39 (62.9) | 8 (42.1) | 0.108 |
| Literate | 23 (37.1) | 11 (57.9) | |
| Length of time married (years) | |||
| <20 | 4 (6.5) | 1 (5.3) | 0.336 |
| 20–30 | 37 (59.7) | 8 (42.1) | |
| >30 | 21 (33.9) | 10 (52.6) | |
| Number of children | |||
| 1–2 | 8 (12.9) | 5 (26.3) | 0.370 |
| 3–5 | 51 (82.3) | 13 (68.4) | |
| >5 | 3 (4.8) | 1 (5.3) | |
Discussion
Main findings
The present study assesses the documentation of pessary offer for women undergoing hysterectomy for POP at a tertiary care centre. Our study shows that a pessary offer was documented for approximately one-quarter of cases, which is very low.
Women who were offered a pessary had known risk factors for unfavourable outcomes, such as chronic cough and previous pelvic surgery. Additionally, women who had a secondary indication other than POP and where concomitant surgery other than hysterectomy had to be performed had no documented pessary offer.
Educational status and sexual activity were not significantly associated with a pessary offer. However, age range and BMI were significantly associated with pessary offer.
Strengths and limitations
To the authors' knowledge and literature search, this study is the first from the region to assess the documentation of a pessary offer prior to surgery.
The major limitation is the retrospective design so that pessary offer was heavily reliant on documentation and cases where documentation was not up to the mark may have been missed.
Interpretation
POP is a commonly seen in gynaecology clinics. As women report similar functional outcomes after pessary treatment or surgery, offering the conservative option to the patient is of paramount importance and shows patient autonomy (Miceli and Dueñas-Diez, 2019).
Documentation of a pessary offer denotes whether management options were discussed with the women. As this was a retrospective study, the documentation or lack of it, may suggest lack of proper documentation, counselling for pessary, or both. The pessary offer reported from the Michigan Surgical Quality Collaborative (MSQC) ranged from 3 to 76%, with an average of about 25.2% (Sammarco et al, 2018). This finding is in agreement with our study where the documentation was 23.5%. This is an area where improvement should be made and joint decision-making by the patient and the physician ensured.
Conservative options are offered more commonly in older women. In these women, surgery is presumed to be difficult or the patient is deemed unfit for surgery. In their retrospective study on older women, Ramsay et al (2016) showed that a pessary is a long-term effective management option in more than 60% of women aged 65 and older. In our study, most women were older than 65 years and the pessary offer was significantly associated with age range (P<0.001): older women were more likely to be offered a pessary compared with younger women. However, considering the fact that most women included in the study were aged 65 and above, a pessary offer rate of 23.5% is extremely low.
Pessary use avoids surgery and has a lower morbidity and cost. However, not all women are suitable candidates for a pessary and the decision needs to be taken in accordance with the history and clinical examination of the patient. Factors associated with persistent pessary use include primary diagnosis of prolapse and no significant complications (Chan et al, 2019). In our study women with secondary indications for surgery other than prolapse, and those who needed surgery other than a hysterectomy, had no documented pessary offer.
Women are as likely to choose a pessary as surgery for prolapse. However, counselling can shape a woman's decision-making in this regard. Several studies (Sung et al, 2016; Gerjivec et al, 2018) have assessed the effect of the content of the counselling on decision-making. Recipient factors more commonly associated with choosing a pessary include educational status, sexual activity and older age (Bodner-Adler et al, 2019). Provider factors for offering a management option vary with the expertise and case load of the surgeon. Surgeons with a higher case load advocate pessary use and offer this conservative option to women more commonly (Pulliam et al, 2016). In our study, pessary-associated counselling was initiated only after the consulting doctor prescribed a pessary, which goes against the essence of shared decision-making. Taking into account that offer of a pessary may not have been appropriate for some women, those with third-degree prolapse and procidentia were excluded from the analysis, allowing better analysis of the data.
However, the clinical acumen of the prescribing doctor continues to be a factor and there may not be a perfect answer for the many clinical situations that occur. In our study, counselling, although not a singular event, could only be initiated by the attending doctor. Where the doctor decided that a pessary was not a suitable option, the method was not offered or documented. This trend may skew data, but many confounding factors were considered as exclusion criteria in order to reach a reasonable diagnosis. The scope of the current paper is very wide and encourages examination of the grey areas witnessed every day in clinics, where there is often no perfect answer and certain ambiguities still remain even after thorough research. Can a pessary be offered to for procidentia? Yes, but only a clinician can assess all factors and decide whether this option is suitable for a particular patient. There are no hard and fast rules; certain scenarios rely on good clinical acumen rather than shared decision-making.
In this study, educational status and sexual activity were not significantly associated with a documented offer. These parameters are commonly associated with a patient's decision to use a pessary. However, women of older age, higher BMI, and having a significant medical or surgical history were offered a pessary. This may be due to provider factors being more pronounced in this offer. In our study, 58% of the women were illiterate. This high number was due to the catchment area of the hospital being wide. Additionally, it also reflects the lower literacy rate in the country at least two decades ago because the women with a prolapse mostly belonged to a higher age group.
The continuation rate for women who accepted a pessary were not assessed in this study and, thus, the study provides little information on outcomes for this treatment method. A prospective study using a similar set up may answer this question and provide numbers that would help in counselling women regarding this approach. A focus group whose members had used and found this option attractive and worthwhile could serve as the best guide for women searching for support and guidance in this regard. This study, however, generated data that would help improve practice and ensure shared decision-making in future consultations.
We would further propose an audit of clinical practice over the same time period to keep the services provided at the facility up to the mark. This would not only help assess practice, but also bring deficiencies to light.
This study shows that an offer of a pessary was documented in less than one-quarter of cases. This denotes a need to strengthen documentation of offer, counselling for pessary use, or both of these. Shared decision-making cannot be ensured without proper counselling. Uptake of pessaries may improve with good counselling with women reaping the benefits of trying a conservative option without going under the surgeon's knife.