Surgical vs Progestin Treatment for Severe Deep Dyspareunia
A total of 192 women evaluated at our endometriosis outpatient clinic in the period 2007–2010 were eligible for this study, but 21 were lost to further contacts and 17 declined the proposed treatments. Fifty-one (33%) of the remaining patients chose surgical treatment, and 103 (67%) chose low-dose progestin treatment. The mean interval (±SD) between previous surgery and the start of the study was 15.2 ± 4.5 months in the former group and 16.5 ± 3.2 months in the latter.
The baseline clinical characteristics of the enrolled women are shown in Table 1. The differences between the study groups in the distribution of the variables considered were not statistically significant. The mean ± SD age and BMI in women operated and those receiving NETA were, respectively, 35.0 ± 4.7 and 34.3 ± 5.0 years and 21.0 ± 2.3 and 22.1 ± 3.0 Kg/m. Proportions of women with BMI under 21 or over 25 were, respectively, 33% (n = 17) and 10% (n = 5) and 30% (n = 31) and 15% (n = 15). Ovarian endometriomas and rectovaginal lesions were present in 20 (39%) and 24 (47%) women in the surgery group. Corresponding figures were 35 (34%) and 35 (34%) among participants who chose medical therapy.
In the surgery group, an attempt to remove all endometriotic lesions was systematically performed. Based on surgical records, this was always achieved. Two patients with rectovaginal endometriosis underwent colorectal resection with end-to-end anastomosis. No major intra-operative complications occurred. Post-operatively, a rectovaginal fistula developed in one woman who underwent excision of a rectovaginal plaque combined with rectal resection. She was treated with a temporary colostomy and subsequent surgical repair at laparotomy. Four women in the surgery group and 21 women in the progestin group withdrew from the study for various reasons (surgery group: medical treatment for pain, 2; oral contraceptive for recurrent endometrioma, 1; lost to follow-up, 1; progestin group: side effects, 8 (erratic bleeding, 3; weight gain, 2; decreased libido, 2; headache, 1); lost to follow-up, 5; preferred oral contraceptives, 4; surgery for persistent pain, 2; and desire for conception, 2).
The FSFI score variation is shown in Fig. 1. A within-group significant increase in total score was observed in both study groups (surgery group, P < 0.0001; progestin group, P = 0.002; adjusted random intercept model; Fig. 1A), with a tendency towards a slightly better total score after surgery at the end of the study period (P = 0.05). At 3 months, both the total score and the subscores for each of the six domains were significantly higher (better) in the surgery group than in the progestin group (Fig. 1B–G). This was confirmed also at 6 months, except for orgasm scores, which was similar in the two groups (Fig. 1E). At 12 months, desire, arousal and lubrication scores were still significantly higher in the surgery group, but the between-group difference in satisfaction and pain at intercourse observed at 3 and 6 months had vanished (Fig. 1F and 1G). In spite of the observed improvements, the mean total FSFI score remained below the threshold for sexual dysfunction in both study groups during the entire study period.
(Enlarge Image)
Figure 1.
Variation of FSFI overall scores and domain scores in the two treatment groups during the study period. Values are mean ± SD shown by vertical bars. Red line, surgery group; violet line, NETA group. (A) Total scores. (B) Desire domain scores. (C) Arousal domain scores. (D) Lubrication domain scores. (E) Orgasm domain scores. (F) Satisfaction domain scores. (G) Pain domain scores. FSFI, female sexual function index.
Interaction analyses between treatment and selected variables (age, parity, BMI, endometriosis stage, ovarian endometriomas and rectovaginal lesions) demonstrated some statistically significant results (Wald's test, P < 0.05). At stratified analyses, the difference in favour of surgery in lubrication was limited to nulliparous women, whereas a benefit of NETA over surgery on orgasm was observed in parous participants only. The effect of NETA on pain at intercourse was significantly higher than that of surgery in women without rectovaginal plaques, whereas no difference was observed in those with this lesion type. Finally, a slightly higher benefit of surgery on desire was observed in women without ovarian endometriomas.
Variations in anxiety and depression scores are shown in Fig. 2. Both total and subscale scores decreased substantially in both study groups (P ≤ 0.0001, adjusted random intercept model). Similarly, to findings relative to sexual functioning, women in the surgery group reported an immediate major benefit at the 3-month assessment that was confirmed at 6 months, but partly receded at the 12-month follow-up. In contrast, the improvement in psychological status in the medical treatment group was gradual but, at the end of the study period, lead to an essentially similar effect without a significant between-group difference (P = 0.22, adjusted random intercept model).
(Enlarge Image)
Figure 2.
Variation of HADS overall scores and anxiety and depression subdomain scores in the two treatment groups during the study period. Values are mean ± SD shown by vertical bars. Red line, surgery group; violet line, NETA group. (A) Total scores. (B) Anxiety subscale scores. (C) Depression subscale scores. HADS, hospital anxiety and depression scale.
The EHP-30 score variation during the study period is shown in Fig. 3. At baseline, the subjects in the progestin treatment group performed significantly worse than those in the surgery group in three dimensions (pain, control and powerlessness and medical profession) (Fig. 3A, B and I). At the 3-month evaluation, the women who underwent surgery scored significantly better in emotional well-being, social support, self-image, sexual intercourse, treatment and infertility (Fig. 3C–E, G, L and M). At 6 months, the comparison was more balanced, as a significant difference in favour of the surgery group was observed only in three modular dimensions, namely, control and powerlessness, self-image and sexual intercourse (Fig. 3B, E and G). Health-related quality of life further improved in the progestin group during the second half of the study period, and, at final assessment, significant differences were observed in control and powerlessness, work and relationship with children in favour of women who chose medical therapy (Fig. 3B, F and H). Only the score relative to the modular domain medical profession was better in the surgery group (Fig. 3I). In summary, a significant amelioration in average EHP scores from baseline to 12-month follow-up was observed for all domains in both the surgical and the progestin group. For women who underwent surgery, mean scores showed a dramatic reduction at 3 months, but crept back at 12 months, whereas for those women who underwent progestin treatment, the EHP-30 score reduced slowly over time.
(Enlarge Image)
Figure 3.
Variation of EHP-30 scores in the two treatment groups during the study period. Values are mean ± SD shown by vertical bars. EHP subdomains scores range from 0 to 100. Lower score indicates fewer negative symptoms. Red line, surgery group; violet line, NETA group. (A) Pain domain scores. (B) Control and powerlessness domain scores. (C) Emotional well-being domain scores. (D) Social support domain scores. (E) Self-image domain scores. (F) Work domain scores. (G) Sexual intercourse domain scores. (H) Relationship with children domain scores. (I) Medical profession domain scores. (L) Treatment domain scores. (M) Infertility domain scores. P-values are from random intercept model adjusted for age, parity, BMI, endometriosis stage, ovarian endometriomas and rectovaginal lesions. EHP-30, endometriosis health profile-30.
Results
A total of 192 women evaluated at our endometriosis outpatient clinic in the period 2007–2010 were eligible for this study, but 21 were lost to further contacts and 17 declined the proposed treatments. Fifty-one (33%) of the remaining patients chose surgical treatment, and 103 (67%) chose low-dose progestin treatment. The mean interval (±SD) between previous surgery and the start of the study was 15.2 ± 4.5 months in the former group and 16.5 ± 3.2 months in the latter.
The baseline clinical characteristics of the enrolled women are shown in Table 1. The differences between the study groups in the distribution of the variables considered were not statistically significant. The mean ± SD age and BMI in women operated and those receiving NETA were, respectively, 35.0 ± 4.7 and 34.3 ± 5.0 years and 21.0 ± 2.3 and 22.1 ± 3.0 Kg/m. Proportions of women with BMI under 21 or over 25 were, respectively, 33% (n = 17) and 10% (n = 5) and 30% (n = 31) and 15% (n = 15). Ovarian endometriomas and rectovaginal lesions were present in 20 (39%) and 24 (47%) women in the surgery group. Corresponding figures were 35 (34%) and 35 (34%) among participants who chose medical therapy.
In the surgery group, an attempt to remove all endometriotic lesions was systematically performed. Based on surgical records, this was always achieved. Two patients with rectovaginal endometriosis underwent colorectal resection with end-to-end anastomosis. No major intra-operative complications occurred. Post-operatively, a rectovaginal fistula developed in one woman who underwent excision of a rectovaginal plaque combined with rectal resection. She was treated with a temporary colostomy and subsequent surgical repair at laparotomy. Four women in the surgery group and 21 women in the progestin group withdrew from the study for various reasons (surgery group: medical treatment for pain, 2; oral contraceptive for recurrent endometrioma, 1; lost to follow-up, 1; progestin group: side effects, 8 (erratic bleeding, 3; weight gain, 2; decreased libido, 2; headache, 1); lost to follow-up, 5; preferred oral contraceptives, 4; surgery for persistent pain, 2; and desire for conception, 2).
The FSFI score variation is shown in Fig. 1. A within-group significant increase in total score was observed in both study groups (surgery group, P < 0.0001; progestin group, P = 0.002; adjusted random intercept model; Fig. 1A), with a tendency towards a slightly better total score after surgery at the end of the study period (P = 0.05). At 3 months, both the total score and the subscores for each of the six domains were significantly higher (better) in the surgery group than in the progestin group (Fig. 1B–G). This was confirmed also at 6 months, except for orgasm scores, which was similar in the two groups (Fig. 1E). At 12 months, desire, arousal and lubrication scores were still significantly higher in the surgery group, but the between-group difference in satisfaction and pain at intercourse observed at 3 and 6 months had vanished (Fig. 1F and 1G). In spite of the observed improvements, the mean total FSFI score remained below the threshold for sexual dysfunction in both study groups during the entire study period.
(Enlarge Image)
Figure 1.
Variation of FSFI overall scores and domain scores in the two treatment groups during the study period. Values are mean ± SD shown by vertical bars. Red line, surgery group; violet line, NETA group. (A) Total scores. (B) Desire domain scores. (C) Arousal domain scores. (D) Lubrication domain scores. (E) Orgasm domain scores. (F) Satisfaction domain scores. (G) Pain domain scores. FSFI, female sexual function index.
Interaction analyses between treatment and selected variables (age, parity, BMI, endometriosis stage, ovarian endometriomas and rectovaginal lesions) demonstrated some statistically significant results (Wald's test, P < 0.05). At stratified analyses, the difference in favour of surgery in lubrication was limited to nulliparous women, whereas a benefit of NETA over surgery on orgasm was observed in parous participants only. The effect of NETA on pain at intercourse was significantly higher than that of surgery in women without rectovaginal plaques, whereas no difference was observed in those with this lesion type. Finally, a slightly higher benefit of surgery on desire was observed in women without ovarian endometriomas.
Variations in anxiety and depression scores are shown in Fig. 2. Both total and subscale scores decreased substantially in both study groups (P ≤ 0.0001, adjusted random intercept model). Similarly, to findings relative to sexual functioning, women in the surgery group reported an immediate major benefit at the 3-month assessment that was confirmed at 6 months, but partly receded at the 12-month follow-up. In contrast, the improvement in psychological status in the medical treatment group was gradual but, at the end of the study period, lead to an essentially similar effect without a significant between-group difference (P = 0.22, adjusted random intercept model).
(Enlarge Image)
Figure 2.
Variation of HADS overall scores and anxiety and depression subdomain scores in the two treatment groups during the study period. Values are mean ± SD shown by vertical bars. Red line, surgery group; violet line, NETA group. (A) Total scores. (B) Anxiety subscale scores. (C) Depression subscale scores. HADS, hospital anxiety and depression scale.
The EHP-30 score variation during the study period is shown in Fig. 3. At baseline, the subjects in the progestin treatment group performed significantly worse than those in the surgery group in three dimensions (pain, control and powerlessness and medical profession) (Fig. 3A, B and I). At the 3-month evaluation, the women who underwent surgery scored significantly better in emotional well-being, social support, self-image, sexual intercourse, treatment and infertility (Fig. 3C–E, G, L and M). At 6 months, the comparison was more balanced, as a significant difference in favour of the surgery group was observed only in three modular dimensions, namely, control and powerlessness, self-image and sexual intercourse (Fig. 3B, E and G). Health-related quality of life further improved in the progestin group during the second half of the study period, and, at final assessment, significant differences were observed in control and powerlessness, work and relationship with children in favour of women who chose medical therapy (Fig. 3B, F and H). Only the score relative to the modular domain medical profession was better in the surgery group (Fig. 3I). In summary, a significant amelioration in average EHP scores from baseline to 12-month follow-up was observed for all domains in both the surgical and the progestin group. For women who underwent surgery, mean scores showed a dramatic reduction at 3 months, but crept back at 12 months, whereas for those women who underwent progestin treatment, the EHP-30 score reduced slowly over time.
(Enlarge Image)
Figure 3.
Variation of EHP-30 scores in the two treatment groups during the study period. Values are mean ± SD shown by vertical bars. EHP subdomains scores range from 0 to 100. Lower score indicates fewer negative symptoms. Red line, surgery group; violet line, NETA group. (A) Pain domain scores. (B) Control and powerlessness domain scores. (C) Emotional well-being domain scores. (D) Social support domain scores. (E) Self-image domain scores. (F) Work domain scores. (G) Sexual intercourse domain scores. (H) Relationship with children domain scores. (I) Medical profession domain scores. (L) Treatment domain scores. (M) Infertility domain scores. P-values are from random intercept model adjusted for age, parity, BMI, endometriosis stage, ovarian endometriomas and rectovaginal lesions. EHP-30, endometriosis health profile-30.
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