A Self-Administered Maneuver to Relieve Symptoms Suggestive of Benign Prostatic Hyperplasia

NCT01387893 | Completed

• 2 other identifiers: CN-07PFren-01-H02-0115-9922
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to evaluate the effectiveness of the Digital Repetitive Infrapubic Pressure maneuver, a self-administered procedure used to provide symptomatic relief in initiating and maintaining urine flow impeded by benign prostatic hyperplasia.

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign Prostatic Hyperplasia; BPH; Lower Urinary Tract Symptoms; LUTS; Self-Administered Maneuver; Symptomatic Relief; Digital Repetitive Infrapubic Pressure maneuver

Outcome Measures

Primary Outcomes (1)

• Change in the International Prostate Symptom Score (IPSS)

  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.

  The initial time frame was to average four weeks. There was a subsequent follow up time frame averaging nine months

Secondary Outcomes (1)

• Continued use of technique following intervention

  Nine months after intial 4 week intervention

Study Arms (1)

Immediate & Delayed Instruction

EXPERIMENTAL

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

Interventions

the Digital Repetitive Infrapubic Pressure maneuver BEHAVIORAL

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.

Immediate & Delayed Instruction

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mild to moderate symptoms of difficulty initiating and maintaining the flow of urine
• not currently receiving treatment for the condition
• not taking an alpha-blocker at least one month before randomization
• not taking 5-alpha reductase inhibitor six months or more before randomization.

You may not qualify if:

• non-ambulatory
• taking medications known to affect urination,
• any of the following: a debilitating concomitant illness, a history of prostate or bladder cancer or prostate surgery or radiation treatment to the pelvis, urethral stricture, neurogenic bladder, current urinary tract infection or otherwise potentially compromised urinary tract systems, a creatinine level of over 3.0 mg per deciliter, or a residual urinary volume after voiding of over 350 cubic centimeters.

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente

Santa Clara, California, 95014, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Perrin L French, MD

  Kaiser Permanente Santa Clara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: July 6, 2011
• Study Start: May 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: November 1, 2009
• Last Updated: October 2, 2015

Record last verified: 2015-10

Locations

US (1)