Injectable Silicone Biomaterial (PTQ™) to Treat Fecal Incontinence After Hemorrhoidectomy

Chan, Miranda K. Y.; Tjandra, Joe J.

doi:10.1007/s10350-005-0307-2

Cited by 52 publications

(39 citation statements)

References 28 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Moreover, its design was equivalent to a double-blind study because both patients and end point assessments were blinded to the treatment. This contrasts with previous nonblind 18,21,23 and non-placebo-controlled studies. 22 This point is of paramount importance as faecal incontinence is a functional complaint which cannot be objectively quantified.…”

Section: 1 12contrasting

confidence: 84%

“…This way is supposed to decrease the risks of infection, erosions of implants or anal pain when compared with intra-anal injections. When compared to Tjandra et al, 22,23 the present procedure differed by two points. First, PDMS was injected under digital but no ultrasound guidance.…”

Section: 1 12mentioning

confidence: 59%

“…Moreover, our patients were comparable, in terms of age and incontinence severity, to those of previous studies that reported a positive effect of PDMS. 18,[21][22][23] We cannot exclude that impaired EAS function may influence a low success rate for some patients but mean anal pressures during voluntary contraction remained at a normal level in the population study. With respect to the implant procedure, we used the same way of injection of PDMS implants than previous studies.…”

Section: 1 12mentioning

confidence: 89%

See 2 more Smart Citations

Elastomer implants in faecal incontinence: a blind, randomized placebo‐controlled study

Siproudhis¹,

Morçet

Lainé

2007

Aliment Pharmacol Ther

View full text Add to dashboard Cite

AimTo test efficacy and safety of polydimethylsiloxane elastomer implants, a silicone biomaterial, in patients with severe faecal incontinence related to an impaired internal anal sphincter. MethodsSubjects were randomized to receive three injections of 2.5 mL of either physiological saline or polydimethylsiloxane elastomer. After local anaesthesia, an 18 gauge, 2.5-in needle was inserted through the perianal skin and laid down into the intersphincteric space. Treatment (saline or polydimethylsiloxane elastomer) was administered by means of a ratchet gun. Three injections of 2.5 mL each were performed in the area of the internal anal sphincter at 3, 7 and 11 o'clock positions. Main end point was the percentage of subjects in each treatment arm experiencing a successful treatment, defined as a Cleveland Clinic FloridaFaecal Incontinence score <8, 3 months after treatment. Secondary end points were quality of life scores, weekly number of faecal incontinence episodes, subject acceptance and adverse events rate. Both patients and end point assessments were blinded to treatment.Results 44 women (64.3 AE 9 years) with a baseline Cleveland Clinic FloridaFaecal Incontinence score ‡8 were enrolled prospectively; 22 received polydimethylsiloxane elastomer and 22 saline treatment. Treatment was well tolerated. At 3 months, the percentage of subjects experiencing a successful treatment was not different between polydimethylsiloxane elastomer and saline groups (23% vs. 27%, respectively, P = 0.73). Moreover, Cleveland Clinic Florida-Faecal Incontinence score was not significantly different between polydimethylsiloxane elastomer and saline groups (11.7 AE 4.7 vs. 11.4 AE 4.5, respectively, P = 0.79). ConclusionsPolydimethylsiloxane elastomer implants cannot be recommended for treatment of severe faecal incontinence related to impaired internal anal sphincter.

show abstract

Section: 1 12contrasting

confidence: 84%

Section: 1 12mentioning

confidence: 59%

Section: 1 12mentioning

confidence: 89%

See 1 more Smart Citation

Elastomer implants in faecal incontinence: a blind, randomized placebo‐controlled study

Siproudhis¹,

Morçet

Lainé

2007

Aliment Pharmacol Ther

View full text Add to dashboard Cite

show abstract

“…The therapeutic approaches currently available range from non‐surgical options, including rehabilitation and biofeedback, to numerous surgical interventions with different levels of technical complexity1. Among the minimally invasive treatments, injectable bulking agents have been used extensively2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18. However, the results are still controversial, resulting in some scepticism and disillusion19, 20, 21, 22, 23.…”

Section: Introductionmentioning

confidence: 99%

Multicentre observational study of the Gatekeeper™ for faecal incontinence

Ratto

Buntzen

Aigner

et al. 2016

Journal of British Surgery

View full text Add to dashboard Cite

BackgroundA variety of therapeutic approaches are available for faecal incontinence. Implantation of Gatekeeper™ prostheses is a new promising option. The primary endpoint of this prospective observational multicentre study was to assess the clinical efficacy of Gatekeeper™ implantation in patients with faecal incontinence. Secondary endpoints included the assessment of patients' quality of life, and the feasibility and safety of implantation.MethodsPatients with faecal incontinence, with either intact sphincters or internal anal sphincter lesions extending for less than 60° of the anal circumference, were selected. Intersphincteric implantation of six prostheses was performed. At baseline, and 1, 3 and 12 months after implantation, the number of faecal incontinence episodes, Cleveland Clinic Faecal Incontinence, Vaizey and American Medical Systems, Faecal Incontinence Quality of Life Scale and Short Form 36 Health Survey scores were recorded. Endoanal ultrasonography was performed at baseline and follow‐up.ResultsFifty‐four patients were implanted. After Gatekeeper™ implantation, incontinence to gas, liquid and solid stool improved significantly, soiling was reduced, and ability to defer defaecation enhanced. All faecal incontinence severity scores were significantly reduced, and patients' quality of life improved. At 12 months, 30 patients (56 per cent) showed at least 75 per cent improvement in all faecal incontinence parameters, and seven (13 per cent) became fully continent. In three patients a single prosthesis was extruded during surgery, but was replaced immediately. After implantation, prosthesis dislodgement occurred in three patients; no replacement was required.ConclusionAnal implantation of the Gatekeeper™ in patients with faecal incontinence was effective and safe. Clinical benefits were sustained at 1‐year follow‐up.

show abstract

“…Fecal incontinence affects approximately 11% of the population, with equal incidence in elderly men and women [7,8]. Most therapies to treat fecal incontinence target the anal sphincter [9][10][11][12] or bulk the sphincter [13][14][15][16]. Others have a mode of action that is currently ill defined such as sacral nerve stimulation [17][18][19][20].…”

Section: Introductionmentioning

confidence: 99%

Functional Outcome After Anal Sphincter Injury and Treatment With Mesenchymal Stem Cells

Salcedo

Penn

Damaser

et al. 2014

Stem Cells Translational Medicine

View full text Add to dashboard Cite

This research demonstrates the regenerative effects of mesenchymal stem cells (MSCs) on the injured anal sphincter by comparing anal sphincter pressures following intramuscular and serial intravascular MSC infusion in a rat model of anal sphincter injury. Fifty rats were divided into injury (n = 35) and no injury (NI; n = 15) groups. Each group was further divided into i.m., serial i.v., or no-treatment (n = 5) groups and followed for 5 weeks. The injury consisted of an excision of 25% of the anal sphincter complex. Twenty-four hours after injury, 5 3 10 5 green fluorescent protein-labeled MSCs in 0.2 ml of phosphate-buffered saline (PBS) or PBS alone (sham) were injected into the anal sphincter for i.m. treatment; i.v. and sham i.v. treatments were delivered daily for 6 consecutive days via the tail vein. Anal pressures were recorded before injury and 10 days and 5 weeks after treatment. Ten days after i.m. MSC treatment, resting and peak pressures were significantly increased compared with those in sham i.m. treatment (p < .001). When compared with the NI group, the injury groups had anal pressures that were not significantly different 5 weeks after i.m./i.v. treatment. Both resting and peak pressures were also significantly increased after i.m./i.v. MSC treatment compared with treatment with PBS (p < .001), suggesting recovery. Statistical analysis was done using paired t test with Bonferroni correction. Marked decrease in fibrosis and scar tissue was seen in both MSC-treated groups. Both i.m. and i.v. MSC treatment after injury caused an increase in anal pressures sustained at 5 weeks, although fewer cells were injected i.m. The MSC-treated groups showed less scarring than the PBS-treated groups, with the i.v. infusion group showing the least scarring. STEM CELLS TRANSLATIONAL MEDICINE 2014;3:760-767

show abstract

Injectable Silicone Biomaterial (PTQ™) to Treat Fecal Incontinence After Hemorrhoidectomy

Abstract: The injectable silicone biomaterial is an effective treatment for passive fecal incontinence after hemorrhoidectomy providing good medium-term improvement in fecal incontinence and fecal incontinence-related quality of life.

Cited by 52 publications

References 28 publications

Elastomer implants in faecal incontinence: a blind, randomized placebo‐controlled study

Elastomer implants in faecal incontinence: a blind, randomized placebo‐controlled study

Multicentre observational study of the Gatekeeper™ for faecal incontinence

Functional Outcome After Anal Sphincter Injury and Treatment With Mesenchymal Stem Cells

Contact Info

Product

Resources

About