Table 3.
Published results of treatment of pelvic floor dyssenergia with BT.
| Author | Pts | Name of Drug/Dose (units) | Results | Complication |
|---|---|---|---|---|
| Hallan et al., 1988 [141] | 7 | Dysport—Nr | Maximum voluntary contraction from 70 to 28 cm H2O. Anorectal angle from 96° to 124°. Symptomatic improvement in four patients. | Incontinence in two patients |
| Joo et al., 1996 [142] | 4 | Botox—6–15 U | Symptomatic improvement in all treated patients. Two patients relapsed. | 0 |
| Shafik et al., 1998 [143] | 15 | Botox—25 U | Symptomatic improvement in 13 patients, on average 4, 8 months after the first treatment. | 0 |
| Maria et al., 2000 [144] | 4 | Botox—30 U | 75% were improved at 8 weeks. Anal tone during straining from 96.2 mm Hg to 42.5 mm Hg at 4 weeks, and to 63.2 mmHg at 8 weeks. Anorectal angle from 94° to 114°. | 0 |
| Maria et al., 2001 [145] | 14 AR | Botox—30 U | At 2-month evaluation, a symptomatic improvement was found in nine patients. At defecography, the rectocele depth was reduced from 4.3 ± 0.6 cm to 1.8 ± 0.5 (p < 0.001) and the rectocele area was reduced from 9.2 ± 1.2 cm2 to 2.8 ±1.6 cm2 (p < 0.001). The anorectal angle measured during straining increased from a mean of 98 ± 15° before treatment to a mean of 121° ± 19 ° (p = 0.001). At one-tear evaluation, there was no report of digitally rectal voiding and rectocele was no found at physical examination. | 0 |
| Ron et al., 2001 [146] | 25 | Botox—20 U | Symptomatic improvement in 75% of the patients. | Perianal pain in 3 patients |
| Madalinski et al., 2002 [147] | 39 | Botox—25 U | Nr | Perianal pain in 4 patients |
| Dysport—150 U | ||||
| Albanese et al., 2003 [148] | 10 PD | Botox—100 U | Following treatment, anal tone during straining was reduced from 97.4 ± 19.6 mm Hg at baseline to 40.7 ± 11.5 mm Hg one month after treatment (p = 0.00001); no further change was observed at two-month evaluation (38.2 ± 10.4 mm Hg; p = 0.00001 vs. baseline values). The anorectal angle during straining (as measured with defecography) increased from a mean of 90° ± 7.9° before treatment to 122.2° ± 15° (p = 0.0004); nine patients evacuated the barium past without the need for laxative or enemas. | 0 |
| Cadeddu et al., 2005 [149] | 18 PD | Botox—100 U | At 2 months evaluation inspection revealed a symptomatic improvement in 10 patients. Anorectal manometry demonstrated decreased tone during straining from 96.2 ± 17.1 mm Hg to 45.9 ± 16.2 mm Hg at 1 month evaluation (p < 0.00001) and to 56.1 ± 10.7 mm Hg at 2 month (p < 0.00001). Pressure during straining was lower than resting anal pressure at the same times in all patients. Defecography after the treatment showed improvement in anorectal angle during straining witch increased from 99.1° ± 8.4° to 121.7° ± 12.7° at 2 months (p < 0.00001). | 0 |
| Maria et al., 2006 [150] | 24 | Botox—60 U | At 2-month evaluation inspection revealed a symptomatic improvement in 19 patients. Anorectal manometry demonstrated decreased tone during straining from 98 ± 24 mm Hg to 56 ± 20 mmHg at 1 month evaluation (p < 0.01) and 56 ± 29 mm Hg at 2 months follow-up (p < 0.01). Defecography after the treatment showed improvement in anorectal angle during straining. | 0 |
| Keshtgar et al., 2007 [151] | 42 | Botox—60 U | BT injection (n = 21) is equally effective and less invasive than M of IAS (n = 21) for chronic idiopathic constipation. At 3 months the median preoperative SS score improved from 34 to 20 in BT group (p < 0.001) and from 31 to 18 in the M group (p < 0.002). At 12 months the score was 19 and 14, 5 in BT and M group respectively (p < 0.0001). | 0 |
| Irani et al., 2008 [152] | 24 | Botox—20 U | Of 24 patients, 22 experienced significant improvement in their constipation lasting greater than 22 weeks. There was a statistically significant improvement from 2.1 to 6.5 bowel movement per week (p < 0.001). The benefit of the BTX-A persisted a variable period of time among the responders, with 12 patient (55%) demonstrating a response lasting 6 months or more. | 5 fecal soiling |
| Farid et al., 2009 [153] | 48 | Dysport—100 U | In BFB group (n = 24) initial improvement was recorded in 12 patients (50%) while long-term success was recorded in 6 patients (25%). In the BT group (n = 24) clinical improvement was recorded in 17 patients (70.8%) but the improvement persisted only in 8 patients (33.3%). There is a significant difference between BT group and BFB group regard the initial success (p = 0.008) but this significant difference disappeared at the end of follow-up (p = 0.23). | Nr |
| Farid et al., 2009 [154] | 30 | Dysport—100 U | BT injection (n = 15) achieved initial success in 13 patients (86.7%). Long-term success persisted only in six patients (40%). PDPR (n = 15) achieved initial success in all patients (100%) with a long-term success in ten patients (66.6%). However this difference did not produce any significant value. Recurrence was observed in seven patients (53.8%) and five patients (33.4%) following BT injection and PDPR, respectively. | 0 |
| Keshtgar et al., 2009 [155] | 16 | Dysport—200 U | There were significant improvements in symptoms of constipation, soiling, painful defecation, general health and behavior, and fecal impaction of rectum (p < 0.05). Outcome was measured by a validated SS score questionnaire. At 3-months follow-up, the median SS score improved in all children after BT injection from 32.50 to 7.50 (p < 0.0001). At 12-months follow-up, the improvement of SS score in BT injection group was significantly more than the control group (n = 31) as follows: 4 vs. 15 respectively (p < 0.002). | 0 |
| Farid et al., 2009 [156] | 60 | Dysport—100 U | The groups differed significantly regarding clinical improvement at 1 month [50% for BFB (n = 20), 75% BT injection (n = 20), and 95% for PDPR (n = 20), p = 0.006] and differences persisted at 1 year (30% for BFB, 35% BT injection, and 70% for PDPR, p = 0.02). BT injection seems to be successful for temporary treatment but PDPR is found to be an effective with lower morbidity in contrast to its higher success rate. | Nr |
| Ahmadi et al., 2013 [157] | 88 | Dysport—160 U | Defecation of painful stool existed in 88% of patients before BT injection and it was reduced to 15% after BT injection (p = 0.0001). Stool was hard in 80% of patients before was reduced to 28% after BT injection (p = 0.0001). Soiling existed in 62% of patients before and was reduced to 8% after BT injection (p = 0.0001). Defecation intervals was 9.1 days, and after BTX-A injection was reduced to 2.6 days (p = 0.0001). | Nr |
| Zhang et al., 2014 [158] | 31 | Xeomin—100 U | After treatment, the pressure of the anal canal during rest and defecation was significantly reduced from (93 ± 16.5) mmHg and (105 ± 28.3) mm Hg to (63 ± 8.6.3) mm Hg and (42 ± 8.9) mm Hg, respectively. BT injection combined with pelvic floor biofeedback training achieved success in 24 patients with 23 maintaining persistent satisfaction during a mean period of 8.4 months. | 8 fecal incontinence |
AR: Anterior rectocele; BFB: Biofeedback training; BT: Botulinum toxin; M: myectomy; Nr: Non reported; PD: Parkinson’s disease; PDPR: Partial division of puborectalis; SS score: Symptom severity score.