A Self-Administered Maneuver to Relieve Symptoms Suggestive of Benign Prostatic Hyperplasia
|ClinicalTrials.gov Identifier: NCT01387893|
Recruitment Status : Completed
First Posted : July 6, 2011
Last Update Posted : October 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hyperplasia||Behavioral: the Digital Repetitive Infrapubic Pressure maneuver||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of a Self-Administered Maneuver to Initiate and Maintain Urine Flow Impeded by Benign Prostatic Hyperplasia|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||November 2009|
Experimental: Immediate & Delayed Instruction
Male patients with mild to moderate lower urinary tract symptoms will alternately be assigned to either immediate intervention or delayed intervention groups. Statistical assessments will be performed to establish comparability of baseline characteristics in the two groups.
Behavioral: the Digital Repetitive Infrapubic Pressure maneuver
The Digital Repetitive Infrapubic Pressure maneuver is performed by exerting moderate inwards pressure with the index and middle fingers, spread slightly apart, palm-side up, pushing into the fold of skin at the base of the penis, where it comes forward beneath the pubic bones, one fingertip on each side of the penis' suspensory ligament. By repeatedly pushing inwards and slightly upwards, at a rate of about once per second, to a distance of about two centimeters, at times of significant urinary hesitancy it is often possible either to initiate spontaneous flow, or to pass a small quantity of urine with each push, such that after a minute or two one can empty the bladder to a satisfactory degree. While a few men find it useful when voiding in a standing position, for the majority, the maneuver requires a forward-leaning seated posture for optimal results.
- Change in the International Prostate Symptom Score (IPSS) [ Time Frame: The initial time frame was to average four weeks. There was a subsequent follow up time frame averaging nine months ]The primary efficacy analyses compared the change over time in the IPSS scores between the immediate and the delayed intervention groups, and the changes over time between pre- and post-intervention scores for all patients completing the study.
- Continued use of technique following intervention [ Time Frame: Nine months after intial 4 week intervention ]Secondary efficacy analysis: The number of patients (percentage of patients completing the study) who were still employing the technique on follow-up nine months later.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387893
|United States, California|
|Santa Clara, California, United States, 95014|
|Principal Investigator:||Perrin L French, MD||Kaiser Permanente Santa Clara|