A randomized clinical trial comparing internal and external pessaries in the treatment of pelvic organ prolapse in postmenopausal women: A pilot study

Hosoume, Renato Sugahara; Peterson, Thais Villela; Soares Júnior, José Maria; Baracat, Edmund Chada; Haddad, Jorge Milhem

doi:10.1016/j.clinsp.2024.100335

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Original articles • Clinics 79 • 2024 • https://doi.org/10.1016/j.clinsp.2024.100335 copy

A randomized clinical trial comparing internal and external pessaries in the treatment of pelvic organ prolapse in postmenopausal women: A pilot study

Authorship SCIMAGO INSTITUTIONS RANKINGS

Highlights

Internal and external pessaries improved the quality of life of women with pelvic organ prolapse.

The use of an internal pessary changed the POP-Q stage related to prolapse of the anterior and apical vaginal compartments in women with pelvic organ prolapse.

Studies investigating alternative treatments for Pelvic organ prolapse, such as the use of an external pessary, are extremely important.

Abstract

Introduction and hypothesis

Internal vaginal pessary is among the leading treatments for pelvic organ prolapse (POP); however, it has a high adverse event rate. An external pessary was recently developed as an alternative. The study's objective was to compare the efficacy of external and internal pessaries in treating POP in postmenopausal women.

Methods

This parallel randomized (1:1 ratio) open-blind study included 40 symptomatic women with stage 2 or 3 POP. They were randomized into two groups: group 1 (internal pessary) and group 2 (external pessary) (n = 20 in each); and evaluated at the start of and 3 months after the treatment. Statistical analysis was performed to compare the results within and between the groups before and after the 3-month treatment.

Results

The groups were homogeneous, except for the variables previous pregnancies (p = 0.030) and POP-Q score of apical prolapse (p = 0.023) whose values were higher in group 2. A significant improvement in quality of life was observed in both groups after 3 months of follow-up; however, internal pessaries were found to be more effective (p < 0.001). In group 1 there were differences between the initial and final POP-Q scores of anterior (0.004) and apical prolapse (p = 0.005). The complication rate associated with internal pessary use was high (p = 0.044).

Conclusions

The present data suggested that external pessaries have a similar effect to internal ones for the treatment of POP and improvement of the quality of life of postmenopausal women.

Keywords
Pelvic organ prolapse; Pessary; Quality of life; Randomized controlled trial

Group		External	Internal	p-value
		n = 20	n = 20
Age (years)	Mean (SD)	68.2 (9.3)	68.6 (12.4)	0.901^a a Student's t-test.
Age (years)	Median (min-max)	68.4 (47.8-82.3)	69.6 (35.5-83.3)
Number of pregnancies	Mean (SD)	6.3 (4.1)	3.5 (2.4)	0.030^b b Mann-Whitney test.
Number of pregnancies	Median (min-max)	4.5 (2-14)	3 (0-9)
Number of vaginal deliveries	Mean (SD)	5.2 (3.9)	3.1 (2.3)	0.121^b b Mann-Whitney test.
Number of vaginal deliveries	Median (min-max)	3.5 (1-12)	3 (0-9)
Number of caesarean sections	Mean (SD)	1 (0.6)	0.3 (0.6)	0.314^b b Mann-Whitney test.
Number of caesarean sections	Median (min-max)	0 (0-2)	0 (0-2)
Number of interrupted pregnancies	Mean (SD)	1 (0.9)	0.1 (0.5)	0.068^b b Mann-Whitney test.
Number of interrupted pregnancies	Median (min-max)	0 (0-3)	0 (0-2)
Type II diabetes mellitus	Yes	5 (25.0%)	6 (30.0%)	0.723^c c Pearson's Chi-Square test.
Type II diabetes mellitus	No	15 (75.0%)	14 (70.0%)
Systemic arterial hypertension	Yes	13 (65.0%)	12 (60.0%)	0.744^c c Pearson's Chi-Square test.
Systemic arterial hypertension	No	7 (35.0%)	8 (40.0%)
Menopause	Yes	20 (100%)	19 (95.0%)	₁ ^d d Fisher's exact test.
Menopause	No	0	1 (5.0%)
Previous surgeries	Yes	8 (40.0%)	8 (40.0%)	₁ ^c c Pearson's Chi-Square test.
Previous surgeries	No	12 (60.0%)	12 (60.0%)
Previous hysterectomy	Yes	5 (25.0%)	4 (20.0%)	₁ ^d d Fisher's exact test.
Previous hysterectomy	No	15 (75.0%)	16 (80.0%)

Measurement	Group			p-value
	External	Internal	Total
	n = 20	n = 20	n = 40
	n (%)	n (%)	n (%)
Cystocele POP-Q classification				0.131^a a Fisher's exact test.
No prolapse	0	3 (15.0)	3 (7.5)
Stage 1	1 (5.0)	1 (5.0)	2 (5.0)
Stage 2	3 (15.0)	6 (30.0)	9 (22.5)
Stage 3	16 (80.0)	10 (50.0)	26 (65.0)
Rectocele POP-Q classification				0.720^a a Fisher's exact test.
No prolapse	2 (10.0)	3 (15.0)	5 (12.5)
Stage 1	2 (10.0)	3 (15.0)	5 (12.5)
Stage 2	5 (25.0)	7 (35.0)	12 (30.0)
Stage 3	11 (55.0)	7 (35.0)	18 (45.0)
Apical prolapse POP-Q classification				0.023^a a Fisher's exact test.
No prolapse	1 (5.0)	0	1 (2.5)
Stage 1	8 (40.0)	10 (50.0)	18 (45.0)
Stage 2	0	5 (25.5)	5 (12.5)
Stage 3	11 (55.0)	5 (25.5)	16 (40.0)
POP-Q Ba (cystocele) (>0)	17 (85.0)	13 (65.0)	30 (75.0)	0.144^c c Pearson's Chi-Square test.
(≤0)	3 (15.0)	7 (35.0)	10 (25.0)
Mean (SD)	2.4 (1.7)	1.1 (2.5)	1.7 (2.2)	0.106^b b Mann-Whitney test.
Median (Q1-Q3)	2.5 (2.0; 3.0)	1.5 (−0.5; 3.0)	2.0 (0.25; 3.0)
POP-Q Bp (rectocele) (>0)	12 (60.0)	8 (40.0)	20 (50.0)	0.206^c c Pearson's Chi-Square test.
(≤0)	8 (40.0)	12 (60.0)	20 (50.0)
Mean (SD)	1.4 (2.2)	0.3 (2.6)	0.9 (2.5)	0.115^b b Mann-Whitney test.
Median (Q1-Q3)	2.0 (0; 3.0)	0 (−2.0; 2.0)	0.5 (−1.0; 3.0)
POP-Q C (apical prolapse) (>0)	11 (55.0)	6 (30.0)	17 (42.5)	0.110^c c Pearson's Chi-Square test.
(≤0)	9 (45.0)	14 (70.0)	23 (57.5)
Mean (SD)	0.1 (4.3)	−1.2 (3.8)	−0.6 (4.1)	0.392^b b Mann-Whitney test.
Median (Q1-Q3)	2.5 (−4.5; 4.0)	−1.5 (−4.0; 1.5)	−0.5 (−4.0; 3.0)

		Initial evaluation	Final evaluation	p-value^a a Wilcoxon test for dependent samples.
		n = 40	n = 28
Total PFBQ score
External	Mean (SD)	35.11 (28.68)	11.85 (19.26)	0.003
External	Median (Q1-Q3)	26.67 (10.00-54.44)	2.22 (0-14.44)
Internal	Mean (SD)	39.56 (20.64)	7.64 (10.13)	<0.001
Internal	Median (Q1-Q3)	38.89 (17.78-55.56)	2.22 (1.11-12.22)
p-value^b b Mann-Whitney test.		0.297	0.962
Total PFDI score
External	Mean (SD)	82.40 (63.18)	24.83 (42.61)	0.006
External	Median (Q1-Q3)	70.31 (35.42-129.17)	8.33 (0-19.79)
Internal	Mean (SD)	80.42 (44.70)	19.21 (26.07)	0.001
Internal	Median (Q1-Q3)	85.42 (37.50-101.04)	6.25 (0-36.46)
p-value^b b Mann-Whitney test.		0.685	0.924
Total PQOL score
External	Mean (SD)	35.77 (23.50)	12.19 (16.36)	0.005
External	Median (Q1-Q2)	31.99 (17.65-51.47)	7.72 (1.10-10.29)
Internal	Mean (SD)	32.83 (18.65)	4.64 (8.49)	0.001
Internal	Median (Q1-Q2)	32.72 (16.54-46.32)	1.84 (0.37-4.41)
p-value^b b Mann-Whitney test.		0.695	0.084

		Evaluation
		Initial (n = 40)	Final (n = 28)	p-value^a a Wilcoxon test for dependent samples.
External (POPQ)
BA Cystocele	Mean (SD)	2.4 (1.7)	1.8 (1.9)	1
BA Cystocele	Median (Q1-Q3)	2.5 (2.0; 3.0)	2.0 (0.5; 3.0)
BP rectocele	Mean (SD)	1.4 (2.2)	1.2 (2.2)	0.317
BP rectocele	Median (Q1-Q3)	2.0 (0; 3.0)	2.5 (0; 3.0)
C Apical Prolapse	Mean (SD)	0.1 (4.3)	−0.2 (3.9)	1
C Apical Prolapse	Median (Q1-Q3)	2.5 (−4.5; 4.0)	0 (−3.5; 3.0)
Internal (POPQ)
BA Cystocele	Mean (SD)	1.1 (2.5)	−0.7 (1.7)	0.004
BA Cystocele	Median (Q1-Q3)	1.5 (−0.5; 3.0)	−1.0 (−2.0; 0.5)
BP rectocele	Mean (SD)	0.3 (2.6)	−0.6 (1.6)	0.165
BP rectocele	Median (Q1-Q3)	0 (−2.0; 2.0)	0 (−1.5; 0)
C Apical Prolapse	Mean (SD)	−1.2 (3.8)	−3.1 (2.7)	0.005
C Apical Prolapse	Median (Q1-Q3)	−1.5 (−4.0; 1.5)	−3.5 (−4.0; −2.5)

	Type of pessary
	External	Internal	p-value
	n = 20	n = 20
	n (%)	n (%)
Did the patient have complications?			0.044^a a Fisher's exact test.
Yes	1 (5.0)	7 (35.0)
No	19 (95.0)	13 (65.0)
Which complication did the patient have?	n = 1	n = 7
Vaginal discharge	0	4 (57.1)	0.106^a a Fisher's exact test.
Pessary displacement	1 (100)	3 (42.9)

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[1] * Corresponding author. E-mail address:renato.hosoume@alumni.usp.br renatohosoume@gmail.com (R.S. Hosoume)