Clinical trial NCT01387893: A Self-Administered Maneuver to Relieve Symptoms Suggestive of Benign Prostatic Hyperplasia
Official title: Study of a Self-Administered Maneuver to Initiate and Maintain Urine Flow Impeded by Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign Prostatic Hyperplasia
BPH
Lower Urinary Tract Symptoms
LUTS
Self-Administered Maneuver
Symptomatic Relief
Digital Repetitive Infrapubic Pressure maneuver
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2011-07-06
Enrollment: 48
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Eligible patients were alternately assigned to either immediate instruction on the use of the Digital Repetitive Infrapubic Pressure maneuver (immediate intervention group) or to a return appointment to receive instructions in the maneuver four weeks after the initial assessment date (delayed intervention group). Patients were to utilize the procedure on every occasion they had difficulty initiating, maintaining, or completing urine flow between the time of their instruction and their subsequent visit. At the initial assessment visits and the final visit, the patients completed an International Prostate Score Sheet (IPSS). A telephone survey was conducted with all patients an average of nine months following their instruction in the maneuver, to determine the extent to which they were still using it.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in the International Prostate Symptom Score (IPSS)
timeFrame: The initial time frame was to average four weeks. There was a subsequent follow up time frame averaging nine months
Secondary outcomes:
measure: Continued use of technique following intervention
timeFrame: Nine months after intial 4 week intervention
Other outcomes:
Locations:
city: Santa Clara
country: United States
facility: Kaiser Permanente
state: California
Study officials:
affiliation: Kaiser Permanente Santa Clara
name: Perrin L French, MD
role: PRINCIPAL_INVESTIGATOR
References: