Abstract: The present invention provides methods of alleviating one or more signs or symptoms of smooth muscle diseases. Com-positions of the disclosure may include a plasmid vector containing a nucleic acid that encodes a Maxi-K channel peptide. Compositions of the disclosure may be administered intradetrusorally to at least two or more sites at a single unit dose.

Abstract: The present disclosure provides compositions and methods to treat diseases and conditions related to smooth muscle dysfunction, or to ameliorate symptoms thereof comprising gene therapy, wherein one or more polynucleotides encoding one or more subunits of the Maxi-K channel, or mutants, variants, functional fragments, or derivatives thereof (e.g., fusions and chimaeras) are administered to a subject in need thereof, and wherein the administration of the polypeptides result in the expression of functional Maxi-K channels in the targeted smooth muscle. In some aspects, the composition of the disclosure comprise plasmid vectors containing at least one nucleic acid encoding a Maxi-K channel peptide. Also disclosed are pharmaceutical compositions, articles or manufacture, and kits.

Abstract: The present invention provides methods of alleviating one or more signs or symptoms of smooth muscle diseases. Compositions of the disclosure may include a plasmid vector containing a nucleic acid that encodes a Maxi-K channel peptide. Compositions of the disclosure may be administered intradetrusorally to at least two or more sites at a single unit dose.

Abstract: The present disclosure provides compositions and methods to improve one or more signs or symptoms of smooth muscle diseases. Compositions of the disclosure may include a plasmid vector containing a variant nucleic that encodes for a variant amino acid sequence of the alpha subunit of the BK potassium channel. Compositions may further include a nanoparticle delivery system. Compositions and methods of use of the disclosure may be used to treat, for example, over active bladder (OAB) syndrome and erectile dysfunction (ED).

Abstract: The invention provides methods of regulating smooth muscle tone in a subject, comprising the introduction, into smooth muscle cells of the subject, of a DNA sequence encoding a potassium channel protein involved in the regulation of smooth muscle tone, and expression of the DNA sequence in a sufficient number of smooth muscle cells of the subject to regulate smooth muscle tone in the subject. The invention provides methods of gene transfer for treating erectile dysfunction, bladder dysfunction, and other smooth muscle disorders.

Abstract: The invention provides methods of regulating smooth muscle tone in a subject, comprising the introduction, into smooth muscle cells of the subject, of a DNA sequence encoding a potassium channel protein involved in the regulation of smooth muscle tone, and expression of the DNA sequence in a sufficient number of smooth muscle cells of the subject to regulate smooth muscle tone in the subject. The invention provides methods of gene transfer for treating erectile dysfunction, bladder dysfunction, and other smooth muscle disorders.

Abstract: The invention provides methods of regulating smooth muscle tone in a subject, comprising the introduction, into smooth muscle cells of the subject, of a DNA sequence encoding a potassium channel protein involved in the regulation of smooth muscle tone, and expression of the DNA sequence in a sufficient number of smooth muscle cells of the subject to regulate smooth muscle tone in the subject. The invention provides methods of gene transfer for treating erectile dysfunction, bladder dysfunction, and other smooth muscle disorders.

Abstract: Assays are provided for erectile and bladder dysfunction and vascular health (e.g., cardiovascular disease, hypertension), where the assays detect the expression of one or more of the human Vcsa1 gene family. The assays are also useful for monitoring the efficacy of treatment of these disorders.

Abstract: The present invention is directed towards a method of regulating smooth muscle tone, comprising the introduction, into smooth muscle cells of a subject, of a DNA sequence encoding a protein involved in the regulation of smooth muscle tone, and expression of the DNA sequence in a sufficient number of smooth muscle cells of the subject to regulate smooth muscle tone in the subject. Specifically, the invention provides methods of gene therapy for treating erectile dysfunction, bladder dysfunction, and other smooth muscle disorders. The present invention also provides recombinant viral and non-viral vectors comprising DNA encoding a protein involved in the regulation of smooth muscle tone. Further provided by the present invention is a smooth muscle cell which expresses a gene encoding a protein involved in the regulation of smooth muscle tone.

Abstract: A non-invasive quantitative somatosensory apparatus is provided for evaluating erectile dysfunctions and involves the applications to the glans penis of two different temperatures. If the patient is unable to differentiate the difference in temperature, a diagnosis of neurologic dysfunction can be made with greater than 90% reliability. The apparatus of this invention provides a relatively simple device to assess a patient's neurological response to therapies.

Abstract: The present invention is directed towards a method of regulating smooth muscle tone, comprising the introduction, into smooth muscle cells of a subject, of a DNA sequence encoding a protein involved in the regulation of smooth muscle tone, and expression of the DNA sequence in a sufficient number of smooth muscle cells of the subject to regulate smooth muscle tone in the subject. Specifically, the invention provides methods of gene therapy for treating erectile dysfunction, bladder dysfunction, and other smooth muscle disorders. The present invention also provides recombinant viral and non-viral vectors comprising DNA encoding a protein involved in the regulation of smooth muscle tone. Further provided by the present invention is a smooth muscle cell which expresses a gene encoding a protein involved in the regulation of smooth muscle tone.

Abstract: A non-invasive quantitative somatosensory apparatus is provided for evaluating erectile dysfunctions and involves the applications to the glans penis of two different temperatures. If the patient is unable to differentiate the difference in temperature, a diagnosis of neurologic dysfunction can be made with greater than 90% reliability. The apparatus of this invention provides a relatively simple device to assess a patient's neurological response to therapies.

Abstract: A non-invasive quantitative somatosensory method is provided for evaluating erectile dysfunctions and involves the applications to the glans penis of different temperatures in increments of about 1° C. until the patient can correctly identify which temperature starting at an ambient temperature was warmer for at least two consecutive times. The method of this invention provides a relatively simple procedure to assess a patient's neurological response to therapies. Incremental decreases in temperature can also be used to assess a patients's neurological response. The method of this invention can also be supplemented, if desired, by determination of the spatial perception threshold and/or the application of pressure, i.e., the sensitivity to touch determination to provide a two-point determination.

Abstract: The present invention is directed towards a method of regulating smooth muscle tone, comprising the introduction, into smooth muscle cells of a subject, of a DNA sequence encoding a protein involved in the regulation of smooth muscle tone, and expression of the DNA sequence in a sufficient number of smooth muscle cells of the subject to regulate smooth muscle tone in the subject. Specifically, the invention provides methods of gene therapy for treating erectile dysfunction, bladder dysfunction, and other smooth muscle disorders. The present invention also provides recombinant viral and non-viral vectors comprising DNA encoding a protein involved in the regulation of smooth muscle tone. Further provided by the present invention is a smooth muscle cell which expresses a gene encoding a protein involved in the regulation of smooth muscle tone.

Abstract: The present invention is directed towards a method of regulating smooth muscle tone, comprising the introduction, into smooth muscle cells of a subject, of a DNA sequence encoding a protein involved in the regulation of smooth muscle tone, and expression of the DNA sequence in a sufficient number of smooth muscle cells of the subject to regulate smooth muscle tone in the subject. Specifically, the invention provides methods of gene therapy for treating erectile dysfunction, bladder dysfunction, and other smooth muscle disorders. The present invention also provides recombinant viral and non-viral vectors comprising DNA encoding a protein involved in the regulation of smooth muscle tone. Further provided by the present invention is a smooth muscle cell which expresses a gene encoding a protein involved in the regulation of smooth muscle tone.

Abstract: The present invention is directed towards gene therapy for erectile dysfunction through delivery and expression of a recombinant vector containing a DNA sequence encoding a protein involved in the regulation of smooth muscle tone into a smooth muscle cell. Also provided by the present invention is a method of inducing penile erection in a subject comprising the introduction and expression of a DNA sequence encoding a protein involved in the regulation of smooth muscle tone into a sufficient number of cells of the subject to induce penile erection in the subject. The present invention also provides a recombinant vector comprising the DNA of or corresponding to at least a portion of the genome of a virus, which portion is capable of directing the expression of a DNA sequence, and DNA encoding a protein involved in the regulation of smooth muscle tone operably linked to the viral DNA and capable of being expressed as a functional gene product in the target cell.

Abstract: A drainage catheter system including a catheter, a collection bag, and a collection bag saddle, is provided. The catheter includes a catheter body having an interior lumen, an elongate tubular sheath operatively associated with the catheter body, and a layer of lubricant disposed between the catheter body and the tubular sheath. The sheath is inflatable after deployment to provide sealing engagement with an inner wall of the urethra. One end of the catheter body is adapted to be connected to the collection bag which includes a fluid entry portion having a one-way fluid valve, a gas separation chamber, and a one-way gas valve. The collection bag also includes a main liquid reservoir in fluid communication with the fluid entry portion and a sealed drainage member for permitting drainage of the main liquid reservoir.

Abstract: A urethral catheter assembly is disclosed which includes an elongate catheter body having an expandable retention balloon provided at a distal end thereof, and a progressively deployable lubricated sheath which encloses the exterior surface of the catheter body. Once deployed, the sheath permits relative movement of the catheter body relative to the urethra without causing discomfort or trauma to the patient.