This chapter describes the women who, when assessed clinically before surgery, were not thought to need an anterior or posterior prolapse repair. If they had, they would have been eligible for randomisation in the mesh trials (see Chapters 4 and 5). These women had an upper compartment (uterine or vault) procedure and agreed to be followed up as part of the CC (CC3).
The flow of women through the study is shown in the CONSORT diagram (). The women received surgery in centres across the UK (see Table 4). Although 215 women had uterine or vault surgery in total, they have been reported separately because of the fundamental clinical differences between them. The most important difference is that women who have a vault prolapse must have had a hysterectomy in the past. Therefore, in this chapter, the data are presented according to clinical presentation, statistical comparisons are not made between the groups and the information is presented and discussed separately.
CONSORT diagram for uterine and vault groups.
It is important to realise that the total number of women in CC3 is not representative of the distribution of uterine and vault prolapse in the UK. There are an artificially high number of women who were having vault prolapse because several of the PROSPECT centres were tertiary referral centres for vault prolapse or specialised in its laparoscopic treatment. The true ratio of uterine–vault prolapse is around 4 : 1, suggesting that one in four women who have a hysterectomy go on to have a subsequent vault prolapse repair. These numbers are in line with Health Episode Statistics (HES) data, which suggest that 25% of women who were having a hysterectomy will go on to require a vault repair.6
Interestingly, although most (but not all) vaginal hysterectomies are carried out for prolapse and most (but not all) abdominal hysterectomies for other gynaecological conditions, the number of women with prolapse was marginally greater after an abdominal hysterectomy (543/961, 56.5%) than after a vaginal hysterectomy (418/961, 43.5%; see Table 5). This must be set against the much higher number of women who were having an abdominal hysterectomy in the past (e.g. > 31,000 women who were having an abdominal hysterectomy compared with around 6500 having a vaginal hysterectomy in 2004–5).6
Overall, around 25% of women who were having a uterine prolapse repair can expect to have a vault repair later.6 This information is derived from online HES data, and so may underestimate total procedures, as it was based only on numbers of main operations and therefore did not count concomitant procedures.
Baseline characteristics of women who were having a uterine or a vault prolapse repair
Women who were having surgery for a uterine prolapse were, on average, 5.6 years younger than those having a vault repair (). However, compared with women who were having a uterine prolapse repair, women who were having a vault repair had a higher prolapse symptom score (POP-SS of 15.3 vs. 12.8); higher score on QoL (7.3 vs. 6.5); worse generic QoL score (EQ-5D-3L score of 0.63 vs. 0.69); more severe incontinence (23.8% vs. 21%) and prior surgery for UI (16.8% vs. 7.4%) and were more likely to have had prolapse surgery before (57.5% vs. 14.5%). They were less likely to be currently using a pessary (11.8% vs. 15.9%) or to have received physiotherapy for their prolapse symptoms (27.5% vs. 34.3%).
Baseline characteristics: uterine/vault cohort (CC3)
Although not all of these differences were statistically significant, together they provide an impression of the qualitative differences between the populations of women with the two types of prolapse: this supports our decision not to combine or directly compare the data from the two groups. Thus, in summary, women who were having vault prolapse surgery were older, had more severe symptoms and had received more invasive treatment than those presenting with a uterine prolapse alone. For that reason, the two samples of women will be described separately in the rest of this chapter.
Uterine prolapse: women requiring a prolapse repair for descent of the uterus only
Women’s characteristics at baseline
The mean age of women presenting with a uterine prolapse alone was 56.9 years (see ). This is considerably younger than the other groups of women in PROSPECT, including those with a primary or secondary anterior or posterior prolapse (see Table 5) or a vault prolapse (see ). However, the groups were generally all comparable on other characteristics such as parity, BMI and delivery mode history.
About one-third of the women with a uterine prolapse had seen a physiotherapist for prolapse, and about one in eight had used a pessary for prolapse symptoms (see ). One in five women had seen a physiotherapist for urine symptoms and fewer than 1 in 10 had used drugs for urinary problems.
Preoperative prolapse measurements
The leading edge of the upper compartment (point C on the POP-Q) was, on average, at or beyond the hymen (1.7 cm for uterine prolapse; ). The majority of women had stage 3 or 4 prolapse, unlike those having only an anterior or posterior repair, for which the most common preoperative stage was stage 2 (see Table 7). Using a more strict definition of prolapse (leading edge > 0 cm beyond the hymen), 77.0% of women had a prolapse beyond the hymen.
Preoperative objective measures of prolapse: uterine/vault cohort (CC3)
Prolapse symptoms at baseline
All women had at least one prolapse symptom on the Pelvic Organ Prolapse Symptom scale, the most common of which was ‘a feeling of something coming down from or in (your) vagina’ (). Women who were having a uterine prolapse repair had a lower prolapse symptom score (POP-SS of 12.8) and less bother from their prolapse, based on their prolapse-related QoL score (6.5) than women who were having anterior or posterior repair (see Tables 15 and 50) or vault repair (see ). The principal individual prolapse symptom was a feeling of ‘something coming down’. They were also less likely to need to use preventative manoeuvres or extra hygiene measures to relieve their prolapse and other symptoms of pelvic floor dysfunction.
Prolapse symptoms at baseline: uterine/vault cohort (CC3)
Urinary symptoms at baseline
Based on a variety of validated measures of assessing bladder function, women with uterine prolapse were similar to the other groups of women who were having prolapse surgery on nearly every measure. In particular, UI was just as prevalent, four in five women had any incontinence, and one in five had severe symptoms ().
Urinary symptoms at baseline: uterine/vault cohort (CC3)
Bowel symptoms at baseline
Women with uterine prolapse were similar with respect to most aspects of bowel function to those with other types of prolapse. At least one-fifth had constipation and almost one-third had FI (). Passive FI was much more common than active (FI accompanied by bowel urgency).
Bowel symptoms at baseline: uterine/vault cohort (CC3)
Vaginal and sexual symptoms at baseline
About two in five women were sexually active (). For those who did have a partner, the most common reason for no sex life was their prolapse symptoms. Very few of the women (3.1%) had dyspareunia (pain with intercourse) but the numbers were small.
Vaginal and sexual symptoms at baseline: uterine/vault cohort (CC3)
Planned surgery and surgery actually carried out
Planned surgery
To be enrolled in CC3, women were clinically assessed as not needing an anterior or posterior repair. Only three women were thought to need continence surgery (despite > 20% having severe UI; ).
Planned surgery and surgery actually carried out: uterine/vault cohort (CC3)
Surgery actually received
Although the women in this cohort were thought to have a uterine prolapse, only around 30% had a vaginal hysterectomy. A total of 14.7% of uterine women had a hysterectomy with a concomitant vault repair (see ).
Description of surgical characteristics and protocols
The majority of women with a uterine prolapse received surgery from a consultant gynaecologist (70.6%); junior doctors were supervised in > 90% of cases (). Most women had a general anaesthetic, received prophylactic antibiotics and were in theatre for approximately 2 hours. The mean length of stay was > 2 days.
Description of surgical characteristics and protocols: uterine/vault cohort (CC3)
Outcomes for women who were having a uterine prolapse repair
Serious and related adverse effects in first and second years
The proportion of women who had at least one serious adverse effect in the first year (excluding mesh complications) was 4.3% in the uterine group (three women had seven events; ). One woman had urinary tract symptoms in the second year. Five women also had at least one non-serious adverse event in the first year (excluding mesh complications; ).
Serious and related adverse effects in years 1 and 2: uterine/vault cohort (CC3)
Other related adverse effects in years 1 and 2: uterine/vault cohort (CC3)
Prolapse symptoms and EuroQol-5 Dimensions (3-level version)
At 6 months, the women’s report of their prolapse symptoms, using the POP-SS (maximum score 28), fell from 12.8 (see ) for the uterine group to 4.3 (). Similarly, each individual prolapse symptom also improved (), as did the prolapse-related QoL scores ().
Prolapse symptoms at 6 months, 1 year and 2 years: uterine/vault cohort (CC3)
Individual prolapse symptoms at 6 months, 1 year and 2 years: uterine/vault cohort (CC3)
At 1 year, this improvement was maintained (POP-SS of 5.2 for the uterine group; see ). The improvement from baseline was supported by data from individual prolapse symptoms (measured as occurring ‘ever’ or ‘most or all of the time’); the proportion of women who had at least one prolapse symptom (‘symptomatic’); QoL data based on the interference of prolapse symptoms on everyday life; the generic QoL measure EQ-5D-3L; and the need to undertake extra hygiene measures or manoeuvres to assist pelvic floor functions (see and ). All of these measures demonstrated significant improvements from before surgery.
EuroQol-5 Dimensions (3-level version) at 1 year: uterine/vault cohort (CC3)
The improvement at 1 year was maintained at 2 years, with respect to all the prolapse outcomes and QoL outcomes measured.
Urinary symptoms
Detailed information on urinary symptoms was obtained at baseline, 1 year and 2 years (see and ). The number of women who had concomitant continence surgery was 3 of 69 in the uterine group (see ).
Urinary symptoms at 1 year and 2 years: uterine/vault cohort (CC3)
At 1 year in the uterine group, the proportion of women who had any UI decreased from 77.8% to 65.2% (see and ), and the proportion with severe UI more than halved (from 21% to 6.7%). There were similar moderate improvements in all the other measures of bladder function measured. The improvement at 1 year was maintained at 2 years, with respect to all the urinary outcomes and bladder-related QoL outcomes measured ().
Bowel symptoms
Detailed information on bowel symptoms was obtained at baseline, 1 year and 2 years (see and ). Frequency of bowel movements, constipation, bowel urgency and FI were common and largely unchanged from baseline to after prolapse surgery in the uterine group at both 1 year and 2 years ().
Bowel symptoms at 1 year and 2 years: uterine/vault cohort (CC3)
Vaginal and sexual symptoms
Detailed information on vaginal and sexual symptoms was obtained at baseline, 1 year and 2 years (see and ). Both the mean vaginal symptom score and the QoL score decreased (improved) after prolapse surgery, and this was maintained at 2 years (). More women were sexually active after surgery, and many fewer cited prolapse symptoms as a reason for not having a sex life (reduced from 36.1% to 12.0%). This was reflected in a more than halving of the ICI Sexual Matters score, and a reduction (improvement) to one-third of baseline levels in the sex life QoL score (see and ). These improvements were maintained at 2 years.
Vaginal and sexual symptoms at 1 year: uterine/vault cohort (CC3)
Further treatment required for failure or adverse effects at 6 months, 1 year and 2 years
When women reported, at 6 months or later, that they had been readmitted to hospital, we verified the information by enquiry from site staff when necessary and post-coded the corrected information. A hospital readmission was automatically counted as a SAE if it was related to the initial prolapse surgery. Repeat surgery for recurrence of prolapse (failure if same compartment, de novo if in the opposite compartment), or for continence surgery, was differentiated from readmission for related complications such as bleeding, infection and surgery for mesh removal.
The overall rate of readmission was low (two women in the uterine group in the first 6 months; ). Admissions in the first 6 months were related to adverse effects (pain). After that time, one woman had further surgery for prolapse in a different compartment, and one in the second year (see ). No women required surgery for mesh removal at any time point.
Further treatment required at 6 months, 1 year and 2 years: uterine/vault cohort (CC3)
Few women required other treatment – such as pessaries or physiotherapy – for symptoms.
Satisfaction with treatment at 1 year and 2 years
Although most women were better than before surgery by 1 year, around 10% (four women) were worse, with similar findings at 2 years (). This was reflected in the satisfaction rates and in the proportion of women who would recommend surgery to a friend.
Participant recovery and satisfaction: uterine/vault cohort (CC3)
Vault prolapse: women requiring a prolapse repair for vault descent alone
Women’s characteristics at baseline
The mean age of women presenting with a vault prolapse alone was 62.5 years (see ). This is older than the women who were having primary or uterine-only surgery in PROSPECT (see Table 5). However, the groups were generally all similar on other characteristics, such as parity, BMI and delivery mode history.
About one-third of the women with a vault prolapse had seen a physiotherapist, and about 1 in 10 were using a pessary for prolapse symptoms (see ). One in five women had seen a physiotherapist for urine symptoms and around 1 in 10 had used drugs for urinary problems.
Preoperative prolapse measurements
The leading edge of the upper compartment (point C on the POP-Q) was, on average, just inside the hymen (–0.4 cm for vault prolapse; see ). The majority of women had stage 3 or 4 prolapse, unlike those having only an anterior or posterior repair, for whom the most common preoperative stage was stage 2 (see Table 7). Using a more strict definition of prolapse (leading edge > 0 cm beyond the hymen), 84.3% of women had a prolapse beyond the hymen.
Prolapse symptoms at baseline
All women had at least one prolapse symptom on the Pelvic Organ Prolapse Symptom scale, the most common of which was ‘a feeling of something coming down from or in (your) vagina’ (see ). Women who were having a vault prolapse repair had a higher prolapse symptom score (POP-SS of 15.3) and more bother from their prolapse, based on their prolapse-related QoL score (7.3) than women who were having anterior or posterior repair (see Tables 15 and 50) or uterine-only repair (see ). The principal individual prolapse symptom was a feeling of ‘something coming down’. They were also more likely to need to use preventative manoeuvres or extra hygiene measures to relieve their prolapse and other symptoms of pelvic floor dysfunction (see ).
Urinary symptoms at baseline
Based on a variety of validated measures of assessing bladder function, women with vault prolapse were similar to the other groups of women who were having prolapse surgery on nearly every measure. In particular, UI was just as prevalent: three in four women with any incontinence, and one in four with severe symptoms (see ).
Bowel symptoms at baseline
Similarly, women with vault prolapse were similar to those with other types of prolapse with respect to most aspects of bowel function (see ). About one-quarter had constipation and almost one-third had FI. Passive FI was much more common than active (FI accompanied by bowel urgency).
Vaginal and sexual symptoms at baseline
About one-third of women were sexually active (see ). For those who did have a partner, the most common reason for no sex life was their prolapse symptoms. Around 15% of the women had dyspareunia (pain with intercourse) but the numbers were small.
Planned surgery and surgery actually carried out
To be enrolled in CC3, women were clinically assessed as not needing an anterior or posterior repair. Only six women were thought to need continence surgery (see ), despite > 20% having severe urine incontinence.
Surgery actually received
The women in this cohort were thought to have a vault prolapse, and nearly 90% did, in fact, have a vault repair (see ).
Description of surgical characteristics and protocols
The majority of women with a vault prolapse received surgery from a consultant gynaecologist (78.3%; see ); if carried out by a junior doctor, the surgeon was supervised in around 90% of cases. Most women had a general anaesthetic, received prophylactic antibiotics and, on average, were in theatre for approximately 2 hours. The mean length of stay was just under 2 days.
Outcomes for women who were having a vault prolapse repair
Serious and other related adverse effects in first and second years
The proportion of women who had at least one serious adverse effect in the first year (excluding mesh complications) was 2.7% in the vault group (four women; see ). One woman had serious infection and pain in the second year. No women had any incidence of mesh exposure.
Prolapse symptoms and EuroQol-5 Dimensions
At 6 months, the women’s report of their prolapse symptoms, using the POP-SS (maximum score 28), fell from 15.3 for the vault group to 5.8 (see ). Similarly, each individual prolapse symptom also improved (see ), as did the prolapse-related QoL scores (see ).
At 1 year, this improvement was maintained (POP-SS of 5.5 for the vault group; see ). The improvement from baseline was supported by data from individual prolapse symptoms (measured as occurring ‘ever’ or ‘most or all of the time’); the proportion of women who had at least one prolapse symptom (‘symptomatic’); QoL data, based on the interference of prolapse symptoms on everyday life (see ); the generic QoL measure EQ-5D-3L (see ); and the need to undertake extra hygiene measures or manoeuvres to assist pelvic floor functions. All of these measures demonstrated significant improvements from before surgery.
The improvement at 1 year was maintained at 2 years, with respect to all of the prolapse outcomes and QoL outcomes measured.
Urinary symptoms
Detailed information on urinary symptoms was obtained at baseline, 1 year and 2 years (see and ). The number of women who had concomitant continence surgery was 5/146 in the vault group (see ).
At 1 year in the vault group, the proportion of women who had any UI decreased from 73.7% to 68.5% and the proportion with severe UI more than halved (from 23.8% to 8.3%; see and ). There were similar moderate improvements in all of the other measures of bladder function measured. The improvement at 1 year was maintained at 2 years, with respect to all of the urinary outcomes and bladder-related QoL outcomes measured (see ).
Bowel symptoms
Detailed information on bowel symptoms was obtained at baseline, 1 year and 2 years (see and ). Frequency of bowel movements, constipation, bowel urgency and FI were common, and largely unchanged from baseline to after prolapse surgery in the vault group at both 1 year and 2 years (see ).
Vaginal and sexual symptoms
Detailed information on vaginal and sexual symptoms was obtained at baseline, 1 year and 2 years (see and ). Both the mean vaginal symptom score and the QoL score decreased (improved) after vault prolapse surgery, and this was maintained at 2 years. More women were sexually active after surgery, and many fewer cited prolapse symptoms as a reason for not having a sex life (reduced from 46.7% to 5.4% in the second year; see and ). This was reflected in a more than halving of the ICI Sexual Matters score and a reduction (improvement) to one-third of baseline levels in the sex life QoL score.
Further treatment required for failure or adverse effects at 6 months, 1 year and 2 years
When women reported, at 6 months or later, that they had been readmitted to hospital, we verified the information by enquiry from site staff when necessary and post-coded the corrected information. A hospital readmission was automatically counted as a SAE if it was related to the initial prolapse surgery. Repeat surgery for recurrence of prolapse (failure if same compartment, de novo if in the opposite compartment), or for continence surgery, was differentiated from readmission for related complications, such as bleeding, infection and surgery for mesh removal.
The overall rate of readmission was low (two women in the vault group in the first 6 months; ). Admissions in the first 6 months were related to adverse effects (constipation and pain). After that time, five women had further surgery for prolapse (two in the same and three in a different compartment, and five in the second year; see ). No women required surgery for mesh removal at any time point.
Few women required other treatment – such as pessaries or physiotherapy – for symptoms.
Satisfaction with treatment at 1 year and 2 years
Although most women were better than before surgery by 1 year, around 12% (12 women) were unchanged or worse, with similar findings at 2 years (see ). This was reflected in the satisfaction rates, and in the proportion of women who would recommend surgery to a friend (90.0%).
Discussion
Summary of findings
This chapter has reported the findings for the cohort of women (CC3) who were not eligible for the randomisation arms of PROSPECT because they were not thought to need either an anterior or posterior repair. The women who were having vault prolapse were clearly a different population from those with uterine prolapse, based on epidemiological and clinical characteristics. They have therefore been described separately.
