Treatment of incontinence after prostatectomy using a new minimally invasive device: adjustable continence therapy
OBJECTIVE To evaluate the safety and efficacy of a new minimally invasive urological implant for incontinence after prostatectomy. PATIENTS AND METHODS The adjustable continence therapy device (ProACTTM, Uromedica, Plymouth, MN, USA) consists of two balloons placed via a perineal approach bilaterall...
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| Veröffentlicht in: | BJU international 2005-09, Vol.96 (4), p.587-594 |
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| creator | Hübner, Wilhelm A. Schlarp, Oliver M. |
| description | OBJECTIVE
To evaluate the safety and efficacy of a new minimally invasive urological implant for incontinence after prostatectomy.
PATIENTS AND METHODS
The adjustable continence therapy device (ProACTTM, Uromedica, Plymouth, MN, USA) consists of two balloons placed via a perineal approach bilaterally at the bladder neck in patients after prostatectomy. Titanium ports, attached via discrete tubing to each balloon, are placed in the scrotum, allowing for separate volume adjustments of the balloons at any time during and after surgery. Changes in a quality‐of‐life questionnaire (I‐QoL), pad usage and a subjective continence grading score were assessed in 117 consecutive men after implanting the Pro‐ACT, at baseline and at 1, 3, 6, 12 and 24 months.
RESULTS
After a mean (range) follow‐up of 13 (3–54) months and with a mean of 3 (0–15) adjustments, 67% of men were dry, using at most one ‘security’ pad daily; 92% were significantly improved, and 8% showed no improvement. The I‐QoL score improved from a median of 34.7 to 66.3 after 2 years (42 men; P |
| doi_str_mv | 10.1111/j.1464-410X.2005.05689.x |
| format | Article |
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To evaluate the safety and efficacy of a new minimally invasive urological implant for incontinence after prostatectomy.
PATIENTS AND METHODS
The adjustable continence therapy device (ProACTTM, Uromedica, Plymouth, MN, USA) consists of two balloons placed via a perineal approach bilaterally at the bladder neck in patients after prostatectomy. Titanium ports, attached via discrete tubing to each balloon, are placed in the scrotum, allowing for separate volume adjustments of the balloons at any time during and after surgery. Changes in a quality‐of‐life questionnaire (I‐QoL), pad usage and a subjective continence grading score were assessed in 117 consecutive men after implanting the Pro‐ACT, at baseline and at 1, 3, 6, 12 and 24 months.
RESULTS
After a mean (range) follow‐up of 13 (3–54) months and with a mean of 3 (0–15) adjustments, 67% of men were dry, using at most one ‘security’ pad daily; 92% were significantly improved, and 8% showed no improvement. The I‐QoL score improved from a median of 34.7 to 66.3 after 2 years (42 men; P < 0.001), the daily pad count decreased from a mean of 6 (1–24)/day to 1 (0–6)/day at 2 years (P < 0.001). Continence achieved at ≤ 6 months after implantation through incremental adjustment remained durable at ≥ 2 years in most patients. There were complications during and after surgery in 54 patients, mostly minor and decreasing with increasing expertise, primarily reflecting the development and refinement of the new surgical technique and its instrumentation. Re‐implantation for complications was required in 32 patients, with a 75% success rate.
CONCLUSIONS
The ProACT peri‐urethral prosthesis produces durable outcomes equivalent or better than other minimally invasive treatments for incontinence after prostatectomy. Its unique design allows for easy adjustment after surgery to achieve the desired urethral resistance, with no further surgical intervention, thus allowing for an optimum balance between voiding pressures and continence. The promising results reported here suggest that this may be an appropriate, effective and durable first‐line treatment to offer men with stress urinary incontinence after prostatectomy.</description><identifier>ISSN: 1464-4096</identifier><identifier>EISSN: 1464-410X</identifier><identifier>DOI: 10.1111/j.1464-410X.2005.05689.x</identifier><identifier>PMID: 16104915</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Science Ltd</publisher><subject>Aged ; Aged, 80 and over ; Biological and medical sciences ; genitourinary sphincter artificial ; Humans ; Male ; Medical sciences ; Middle Aged ; Minimally Invasive Surgical Procedures ; Nephrology. Urinary tract diseases ; Patient Satisfaction ; Prospective Studies ; prostatectomy ; Prostatectomy - adverse effects ; quality of life ; Radiography ; stress urinary incontinence ; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases ; Surgery of the urinary system ; Treatment Outcome ; Urinary Bladder - diagnostic imaging ; Urinary Incontinence, Stress - diagnostic imaging ; Urinary Incontinence, Stress - etiology ; Urinary Incontinence, Stress - surgery ; Urinary Sphincter, Artificial ; Urinary system involvement in other diseases. Miscellaneous ; Urinary tract. Prostate gland</subject><ispartof>BJU international, 2005-09, Vol.96 (4), p.587-594</ispartof><rights>2005 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5139-dfa4521adec632a5d69a43d8934b9bc4643198e269d23197273152216dbf79cc3</citedby><cites>FETCH-LOGICAL-c5139-dfa4521adec632a5d69a43d8934b9bc4643198e269d23197273152216dbf79cc3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1464-410X.2005.05689.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1464-410X.2005.05689.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,778,782,1414,27907,27908,45557,45558</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=17101776$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16104915$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hübner, Wilhelm A.</creatorcontrib><creatorcontrib>Schlarp, Oliver M.</creatorcontrib><title>Treatment of incontinence after prostatectomy using a new minimally invasive device: adjustable continence therapy</title><title>BJU international</title><addtitle>BJU Int</addtitle><description>OBJECTIVE
To evaluate the safety and efficacy of a new minimally invasive urological implant for incontinence after prostatectomy.
PATIENTS AND METHODS
The adjustable continence therapy device (ProACTTM, Uromedica, Plymouth, MN, USA) consists of two balloons placed via a perineal approach bilaterally at the bladder neck in patients after prostatectomy. Titanium ports, attached via discrete tubing to each balloon, are placed in the scrotum, allowing for separate volume adjustments of the balloons at any time during and after surgery. Changes in a quality‐of‐life questionnaire (I‐QoL), pad usage and a subjective continence grading score were assessed in 117 consecutive men after implanting the Pro‐ACT, at baseline and at 1, 3, 6, 12 and 24 months.
RESULTS
After a mean (range) follow‐up of 13 (3–54) months and with a mean of 3 (0–15) adjustments, 67% of men were dry, using at most one ‘security’ pad daily; 92% were significantly improved, and 8% showed no improvement. The I‐QoL score improved from a median of 34.7 to 66.3 after 2 years (42 men; P < 0.001), the daily pad count decreased from a mean of 6 (1–24)/day to 1 (0–6)/day at 2 years (P < 0.001). Continence achieved at ≤ 6 months after implantation through incremental adjustment remained durable at ≥ 2 years in most patients. There were complications during and after surgery in 54 patients, mostly minor and decreasing with increasing expertise, primarily reflecting the development and refinement of the new surgical technique and its instrumentation. Re‐implantation for complications was required in 32 patients, with a 75% success rate.
CONCLUSIONS
The ProACT peri‐urethral prosthesis produces durable outcomes equivalent or better than other minimally invasive treatments for incontinence after prostatectomy. Its unique design allows for easy adjustment after surgery to achieve the desired urethral resistance, with no further surgical intervention, thus allowing for an optimum balance between voiding pressures and continence. The promising results reported here suggest that this may be an appropriate, effective and durable first‐line treatment to offer men with stress urinary incontinence after prostatectomy.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Biological and medical sciences</subject><subject>genitourinary sphincter artificial</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Minimally Invasive Surgical Procedures</subject><subject>Nephrology. Urinary tract diseases</subject><subject>Patient Satisfaction</subject><subject>Prospective Studies</subject><subject>prostatectomy</subject><subject>Prostatectomy - adverse effects</subject><subject>quality of life</subject><subject>Radiography</subject><subject>stress urinary incontinence</subject><subject>Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases</subject><subject>Surgery of the urinary system</subject><subject>Treatment Outcome</subject><subject>Urinary Bladder - diagnostic imaging</subject><subject>Urinary Incontinence, Stress - diagnostic imaging</subject><subject>Urinary Incontinence, Stress - etiology</subject><subject>Urinary Incontinence, Stress - surgery</subject><subject>Urinary Sphincter, Artificial</subject><subject>Urinary system involvement in other diseases. Miscellaneous</subject><subject>Urinary tract. Prostate gland</subject><issn>1464-4096</issn><issn>1464-410X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkEFv1DAUhC0EoqXwF5AvcNtgO4kTI3GAikJRJS6txM16sV_Aq8RZbGfb_Ps67EJ7xBeP7G-ePUMI5azgeb3bFryS1abi7EchGKsLVstWFXdPyOm_i6d_NVPyhLyIcctYPpD1c3LCJWeV4vUpCdcBIY3oE5166ryZfHIevUEKfcJAd2GKCRKaNI0LnaPzPylQj7d0dN6NMAxLtu0huj1Si3tn8D0Fu52zqxuQPhqYfmGA3fKSPOthiPjquJ-Rm4vP1-dfN1ffv1yef7zamJqXamN7qGrBwaKRpYDaSgVVaVtVVp3qTI5WctWikMqKrBrRlLwWgkvb9Y0ypjwjbw9zc4TfM8akRxcNDgN4nOaoZVu1SgmewfYAmpw1Buz1LuRkYdGc6bVvvdVrlXqtVa996z9967tsfX18Y-5GtA_GY8EZeHMEIBoY-gDeuPjANZzxppGZ-3Dgbt2Ay39_QH_6drOq8h4ivJ3z</recordid><startdate>200509</startdate><enddate>200509</enddate><creator>Hübner, Wilhelm A.</creator><creator>Schlarp, Oliver M.</creator><general>Blackwell Science Ltd</general><general>Blackwell</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>200509</creationdate><title>Treatment of incontinence after prostatectomy using a new minimally invasive device: adjustable continence therapy</title><author>Hübner, Wilhelm A. ; Schlarp, Oliver M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5139-dfa4521adec632a5d69a43d8934b9bc4643198e269d23197273152216dbf79cc3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Biological and medical sciences</topic><topic>genitourinary sphincter artificial</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Minimally Invasive Surgical Procedures</topic><topic>Nephrology. Urinary tract diseases</topic><topic>Patient Satisfaction</topic><topic>Prospective Studies</topic><topic>prostatectomy</topic><topic>Prostatectomy - adverse effects</topic><topic>quality of life</topic><topic>Radiography</topic><topic>stress urinary incontinence</topic><topic>Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases</topic><topic>Surgery of the urinary system</topic><topic>Treatment Outcome</topic><topic>Urinary Bladder - diagnostic imaging</topic><topic>Urinary Incontinence, Stress - diagnostic imaging</topic><topic>Urinary Incontinence, Stress - etiology</topic><topic>Urinary Incontinence, Stress - surgery</topic><topic>Urinary Sphincter, Artificial</topic><topic>Urinary system involvement in other diseases. Miscellaneous</topic><topic>Urinary tract. Prostate gland</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hübner, Wilhelm A.</creatorcontrib><creatorcontrib>Schlarp, Oliver M.</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>BJU international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hübner, Wilhelm A.</au><au>Schlarp, Oliver M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Treatment of incontinence after prostatectomy using a new minimally invasive device: adjustable continence therapy</atitle><jtitle>BJU international</jtitle><addtitle>BJU Int</addtitle><date>2005-09</date><risdate>2005</risdate><volume>96</volume><issue>4</issue><spage>587</spage><epage>594</epage><pages>587-594</pages><issn>1464-4096</issn><eissn>1464-410X</eissn><abstract>OBJECTIVE
To evaluate the safety and efficacy of a new minimally invasive urological implant for incontinence after prostatectomy.
PATIENTS AND METHODS
The adjustable continence therapy device (ProACTTM, Uromedica, Plymouth, MN, USA) consists of two balloons placed via a perineal approach bilaterally at the bladder neck in patients after prostatectomy. Titanium ports, attached via discrete tubing to each balloon, are placed in the scrotum, allowing for separate volume adjustments of the balloons at any time during and after surgery. Changes in a quality‐of‐life questionnaire (I‐QoL), pad usage and a subjective continence grading score were assessed in 117 consecutive men after implanting the Pro‐ACT, at baseline and at 1, 3, 6, 12 and 24 months.
RESULTS
After a mean (range) follow‐up of 13 (3–54) months and with a mean of 3 (0–15) adjustments, 67% of men were dry, using at most one ‘security’ pad daily; 92% were significantly improved, and 8% showed no improvement. The I‐QoL score improved from a median of 34.7 to 66.3 after 2 years (42 men; P < 0.001), the daily pad count decreased from a mean of 6 (1–24)/day to 1 (0–6)/day at 2 years (P < 0.001). Continence achieved at ≤ 6 months after implantation through incremental adjustment remained durable at ≥ 2 years in most patients. There were complications during and after surgery in 54 patients, mostly minor and decreasing with increasing expertise, primarily reflecting the development and refinement of the new surgical technique and its instrumentation. Re‐implantation for complications was required in 32 patients, with a 75% success rate.
CONCLUSIONS
The ProACT peri‐urethral prosthesis produces durable outcomes equivalent or better than other minimally invasive treatments for incontinence after prostatectomy. Its unique design allows for easy adjustment after surgery to achieve the desired urethral resistance, with no further surgical intervention, thus allowing for an optimum balance between voiding pressures and continence. The promising results reported here suggest that this may be an appropriate, effective and durable first‐line treatment to offer men with stress urinary incontinence after prostatectomy.</abstract><cop>Oxford, UK</cop><pub>Blackwell Science Ltd</pub><pmid>16104915</pmid><doi>10.1111/j.1464-410X.2005.05689.x</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Aged Aged, 80 and over Biological and medical sciences genitourinary sphincter artificial Humans Male Medical sciences Middle Aged Minimally Invasive Surgical Procedures Nephrology. Urinary tract diseases Patient Satisfaction Prospective Studies prostatectomy Prostatectomy - adverse effects quality of life Radiography stress urinary incontinence Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases Surgery of the urinary system Treatment Outcome Urinary Bladder - diagnostic imaging Urinary Incontinence, Stress - diagnostic imaging Urinary Incontinence, Stress - etiology Urinary Incontinence, Stress - surgery Urinary Sphincter, Artificial Urinary system involvement in other diseases. Miscellaneous Urinary tract. Prostate gland |
| title | Treatment of incontinence after prostatectomy using a new minimally invasive device: adjustable continence therapy |
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